As of 2015, an estimated 30.2 million adults in the United States—12.2% of the population— had diabetes mellitus (DM). During that year, approximately 1.5 million new cases (6.7 cases for every 1000 people) were diagnosed in adults (≥ 18 years of age).¹

As the number of people with DM increases, so will the number of cases of diabetic retinopathy, the main cause of new cases of blindness in adults in the United States² and the leading cause of blindness among US working-age (20 to 74 years) adults.³ It is estimated that 4.1 million Americans have diabetic retinopathy³; it is projected that prevalence will reach 6 million this year.⁴

Blindness related to DM costs the United States approximately $500 million each year,⁵ including health care utilization: physician office visits, diagnostic testing, medication and other treatments, and hospitalization.⁶ Impairment of vision also results in social isolation, dependence on others to perform daily functions, and a decline in physical activity.

Several professional organizations, including the American Diabetes Association and the American Academy of Ophthalmology, have developed practice guidelines for diabetic retinopathy screening. Guidelines notwithstanding, only about 55% of people with DM in the United States receive the recommended dilated eye examination at established intervals.^2,3 In addition to screening by an ophthalmologist or optometrist, adherence to clinical guidelines for risk assessment, prevention, and early referral helps reduce the incidence and severity of retinopathy.⁵

The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that the prevalence of diabetic retinopathy varied from 28.8% in people who had diabetes mellitus (DM) for < 5 years to 77.8% in people who had DM for ≥ 15 years.

This article describes how to assess the risk of diabetic retinopathy in your patients, details the crucial role that you, the primary care physician, can play in prevention, and emphasizes the importance of referral to an eye specialist for screening, evaluation, treatment (when indicated), and follow-up.

Pathophysiology and classification

Diabetic retinopathy, the result of progressive blood vessel damage to the retina, has 2 major forms: nonproliferative and proliferative. Those forms are distinguished by the absence or presence of new growth of blood vessels (retinal neovascularization).^3,7 To improve communication and coordination among physicians who care for patients with DM worldwide, the International Clinical Diabetic Retinopathy Disease Severity Scale for diabetic retinopathy was developed,^8-10 comprising 5 levels of severity that are based on findings on dilated ophthalmoscopy (Table 1^8-10):

• Level 1. No apparent retinopathy. Funduscopic abnormalities are absent.
• Level 2. Mild nonproliferative diabetic retinopathy (NPDR). Only a few microaneurysms are seen.
• Level 3: Moderate NPDR. Characterized by microaneurysms and by intraretinal hemorrhage and venous beading, but less severe than what is seen in Level 4.
• Level 4. Severe NPDR. More than 20 intraretinal hemorrhages in each quadrant of the retina, definite venous beading in > 2 quadrants, intraretinal microvascular abnormalities in > 1 quadrant, or any combination of these findings.
• Level 5. Proliferative diabetic retinopathy. Characterized by neovascularization of the disc, retina, iris, or angle; vitreous hemorrhage; retinal detachment; or any combination of these findings. Further classified as “mild,” “moderate,” or “severe” if macular edema is present; severity is dependent on the distance of thickening and exudates from the center of the macula.⁹

Be attentive to risk factors

There are several risk factors for diabetic retinopathy, including duration of disease, type 1 DM, male gender, black race (non-Hispanic), elevated hemoglobin A1C(HbA1C) level, elevated systolic and diastolic blood pressure (BP), and insulin therapy. ^4,5,11,12

Continue to: Time since diagnosis

Time since diagnosis. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that the prevalence of diabetic retinopathy varied from 28.8% in people who had DM for < 5 years to 77.8% in people who had DM for ≥ 15 years. The rate of proliferative diabetic retinopathy was 2% in people who had DM for < 5 years and 15.5% in those who had DM for ≥ 15 years.¹¹

Diabetic retinopathy can deteriorate during pregnancy but generally reverts to the pre-pregnancy level; long-term progression of retinopathy is not affected.

Demographic variables. The prevalence of diabetic retinopathy is higher in men, non-Hispanic blacks (38.8%), and ­people with type 1 DM.^4,5,11-13 The Veterans ­Affairs Diabetes Trial found a higher prevalence of moderate-to-severe diabetic retinopathy in Hispanics (36%) and African Americans (29%) than in non-Hispanic whites (22%).¹⁴

Among people with DM who have ­diabetic retinopathy, systolic and diastolic BP and the HbA1C level tend to be higher. They are more likely to use insulin to control disease.^4,5,13 In a recent cross-sectional analysis, the prevalence of vision-threatening retinopathy was higher among people ≥ 65 years of age (1%; 95% confidence interval [CI], 0.7%-1.5%) than among people 40 to 64 years of age (0.4%; 95% CI, 0.3%-0.7%) (P = .009).⁵

Does pregnancy exacerbate retinopathy? Controversy surrounds the role of pregnancy in the development and progression of diabetic retinopathy. The Diabetes Control and Complications Trial found a short-term increase in the level of retinopathy during pregnancy that persisted into the first postpartum year. A 1.63-fold greater risk of any deterioration of retinopathy was observed in women who received intensive DM treatment from before to during pregnancy (P < .05); pregnant women who received conventional treatment had a 2.48-fold greater risk than nonpregnant women with DM who received conventional treatment (P < .001).

Deterioration of retinopathy during pregnancy had no long-term consequences, however, regardless of type of treatment.¹⁵ More importantly, in most cases, changes in the level of retinopathy revert to the pre-­pregnancy level after 1 year or longer, and pregnancy does not appear to affect long-term progression of retinopathy.¹⁵

Continue to: Proven primary prevention strategies

 

 

Proven primary prevention strategies

Glycemic control. Optimal glycemic control is an essential component of prevention of diabetic retinopathy. From 1983 to 1993, the Diabetes Control and Complications Trial randomized 1441 patients with type 1 DM to receive intensive therapy (median HbA1C level, 7.2%) or conventional therapy (median HbA1C level, 9.1%). During a mean of 6 years of follow-up, intensive therapy reduced the adjusted mean risk of retinopathy by 76% (95% CI, 62%-85%).^16,17 A 2007 systematic review of 44 studies of the treatment of diabetic retinopathy found that strict glycemic control was beneficial in reducing the incidence and progression of retinopathy.¹⁷

The American Diabetes Association’s Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers recommends that most nonpregnant adults maintain an HbA1Clevel < 7%. For patients with a history of hypoglycemia, limited life expectancy, advanced microvascular or macrovascular disease, other significant comorbid conditions, or longstanding DM in which it is difficult to achieve the optimal goal, a higher HbA1clevel (< 8%) might be appropriate.¹⁸

Control of BP. Strict control of BP is a major modifier of the incidence and progression of diabetic retinopathy.^17,19 In the United Kingdom Prospective Diabetes Study, 1148 patients with type 2 DM and a mean BP of 160/94 mm Hg at the onset of the study were randomly assigned to either (1) a “tight” blood pressure group (< 150/85 mm Hg) or (2) a “less-tight” group (< 180/105 mm Hg). The primary therapy for controlling BP was captopril or atenolol. After 9 years of follow-up, the tight-control group had a 34% mean reduction in risk in the percentage of patients with deterioration of retinopathy (99% CI, 11%-50%; P = .0004) and a 47% reduction in risk (99% CI, 7%-70%; P = .004) of deterioration in visual acuity.²⁰

Most patients with DM and hypertension should be treated to maintain a BP < 140/90 mm Hg. Although there is insufficient evidence to recommend a specific antihypertensive agent for preventing diabetic retinopathy, therapy should include agents from drug classes that have a demonstrated reduction in cardiovascular events in patients with DM. These include angiotensin-­converting enzyme inhibitors, angiotensin receptor blockers, thiazide diuretics, and dihydropyridine calcium channel blockers.¹⁸

Lipid management. The benefit of targeted therapy for lowering lipids for the prevention of diabetic retinopathy is not well established.¹⁷ In the Collaborative Atorvastatin Diabetes Study, 2838 patients with type 2 DM were randomized to atorvastatin (10 mg) or placebo; microvascular endpoint analysis demonstrated that patients taking atorvastatin needed less laser therapy (P = .14); however, progression of diabetic retinopathy was not reduced.²¹ Similarly, in the Action to Control Cardiovascular Risk in Diabetes Eye Study, slowing of progression to retinopathy was observed in patients with type 2 DM who were treated with fenofibrate (ie, progression in 6.5%, compared with progression in 10.2% of untreated subjects [odds ratio = 0.60 (95% CI, 0.42-0.87); P = .0056]).²²

Continue to: Despite limited data on...

Nonpregnant adults with diabetes should maintain an HbA1C level < 7%; a higher level (< 8%) might be appropriate in patients with various complicating factors.

Despite limited data on the impact of ­lipid-lowering agents on patients with diabetic retinopathy, those with type 2 DM (especially) and those who have, or are at risk of, atherosclerotic cardiovascular disease should receive statin therapy.¹⁸

Aspirin therapy. Aspirin has not been found to be beneficial for slowing progression of diabetic retinopathy. However, aspirin did not cause further deterioration of disease, specifically in patients with vitreous hemorrhages⁴; patients with diabetic retinopathy who require aspirin therapy for other medical reasons can therefore continue to take it without increasing the risk of damage to the retina.^4,18

When should you refer patients for screening?

Screening for diabetic retinopathy is important because affected patients can be asymptomatic but have significant disease. Early detection also helps determine which patients need treatment when it is most beneficial: early in its course.⁴

Type 1 DM. Retinopathy can become apparent as early as 6 or 7 years after the onset of disease, and is rare in children prior to puberty.^4,11 As a result, patients with type 1 DM should first be screened with a comprehensive eye examination by an ophthalmologist or optometrist within 5 years of DM onset.^4,18

Type 2 DM. Because of the insidious onset of type 2 DM, patients who are given a diagnosis of DM after 30 years of age might already have high-risk features of retinopathy.⁹ In patients with type 2 DM, therefore, initial screening for diabetic retinopathy should begin at the time of diagnosis and include a comprehensive eye examination by an ophthalmologist or optometrist.^4,18,23

Continue to: Components of the exam

Components of the exam. Initial evaluation by the ophthalmologist or optometrist should include a detailed history and comprehensive eye exam with pupil dilation. Table 2⁴ lists elements of the initial physical exam, which should assess for features that often lead to visual impairment. These features include macular edema, retinal hemorrhage, venous beading, neovascularization, and vitreous hemorrhage.⁴

Frequency of follow-up. The interval between subsequent examinations should be individualized, based on the findings of the initial assessment. Consider that:

• Screening should occur every 1 or 2 years in patients without evidence of retinopathy and with adequate glycemic control.^4,18,23
• Screening every 1 or 2 years appears to be cost-effective in patients who have had 1 or more normal eye exams.
• A 3-year screening interval does not appear to present a risk in well-controlled patients with type 2 DM.²⁴
• Women with type 1 or type 2 DM who are planning pregnancy or who are pregnant should have an eye exam prior to pregnancy or early in the first trimester.^4,18,23 They should then be monitored each trimester and at the end of the first postpartum year, depending on the severity of retinopathy.¹⁸

Alternative screening modalities

Seven-field stereoscopic fundus photography is an alternative screening tool that compares favorably to ophthalmoscopy when performed by an experienced ophthalmologist, optometrist, or ophthalmologic technician.²⁵ Nonmydriatic digital stereoscopic retinal imaging has been shown to be a cost-effective method of screening patients for diabetic retinopathy.²⁶ In a study that compared digital imaging with dilated funduscopic examination, investigators reported that, of 311 eyes evaluated, there was agreement between the methods in 86% of cases. Disagreement was mostly related to the greater frequency of finding mild-to-moderate NPDR when using digital imaging.²⁷

Screening in primary care

Programs that use telemedicine-based fundus photography to screen for diabetic retinopathy during primary care visits, followed by remote interpretation by an ophthalmologist, have been shown to increase the rate of retinal screening by offering an option other than direct referral to an ophthalmologist or optometrist.²⁸ However, telemedicine-based retinal photography can be successful as a screening tool for retinopathy only if timely referral to an eye specialist is arranged when indicated by findings.¹⁸

What therapy will your referred patients receive?

Patients found to have signs of diabetic retinopathy should be referred to an ophthalmologist who is knowledgeable and experienced in the management of diabetic retinopathy. Care will be managed according to the severity of the patient’s diabetic retinopathy.

Continue to: Patients with mild-to-moderate NPDR but without macular edema

Patients with mild-to-moderate NPDR but without macular edema. Treatment is generally not recommended. Patients should be reevaluated every 6 to 12 months because they have an increased risk of progression.⁵

Patients with mild-to-moderate NPDR and clinically significant macular edema (CSME). It is important for the eye specialist to assess for edema at the center of the macula because the risk of vision loss and need for treatment is greater when the center is involved. Vascular–endothelial growth factor (VEGF) is an important mediator of neovascularization and macular edema in diabetic retinopathy. For patients with center-­involving CSME, intravitreous injection of an anti-VEGF agent provides significant benefit and is first-line treatment in these cases.^4,29

Patients with DM (especially those with type 2 disease) who have, or are at risk of, atherosclerotic cardiovascular disease should receive statin therapy.

The Early Treatment for Diabetic Retinopathy Study evaluated the efficacy of focal photocoagulation, a painless laser therapy, for CSME and demonstrated that this modality reduces the risk of moderate visual loss; increases the likelihood of improvement in vision; and decreases the frequency of persistent macular edema.³⁰ Focal photocoagulation has been found effective in both non-center-involving CSME and center-involving CSME.⁵

Patients with severe NPDR. The recommendation is to initiate full panretinal photocoagulation prior to progression to proliferative diabetic retinopathy PDR. Researchers noted a 50% reduction in vision loss and vitrectomy when patients with type 2 DM were treated with panretinal photocoagulation early, compared with those in whom treatment was deferred until PDR developed.^4,31 The role of anti-VEGF treatment of severe NPDR is under investigation.⁴

Patients with high-risk and severe PDR. Panretinal photocoagulation is the recommended treatment for patients with high-risk and severe PDR, and usually induces regression of retinal neovascularization. In patients with CSME and high-risk PDR, the combination of anti-VEGF therapy and panretinal photocoagulation should be considered. Vitrectomy should be considered for patients who have failed panretinal photocoagulation or are not amenable to photocoagulation.⁴

CORRESPONDENCE
Bryan Farford, DO, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224; Farford.Bryan@mayo.edu.

As of 2015, an estimated 30.2 million adults in the United States—12.2% of the population— had diabetes mellitus (DM). During that year, approximately 1.5 million new cases (6.7 cases for every 1000 people) were diagnosed in adults (≥ 18 years of age).¹

As the number of people with DM increases, so will the number of cases of diabetic retinopathy, the main cause of new cases of blindness in adults in the United States² and the leading cause of blindness among US working-age (20 to 74 years) adults.³ It is estimated that 4.1 million Americans have diabetic retinopathy³; it is projected that prevalence will reach 6 million this year.⁴

Blindness related to DM costs the United States approximately $500 million each year,⁵ including health care utilization: physician office visits, diagnostic testing, medication and other treatments, and hospitalization.⁶ Impairment of vision also results in social isolation, dependence on others to perform daily functions, and a decline in physical activity.

Several professional organizations, including the American Diabetes Association and the American Academy of Ophthalmology, have developed practice guidelines for diabetic retinopathy screening. Guidelines notwithstanding, only about 55% of people with DM in the United States receive the recommended dilated eye examination at established intervals.^2,3 In addition to screening by an ophthalmologist or optometrist, adherence to clinical guidelines for risk assessment, prevention, and early referral helps reduce the incidence and severity of retinopathy.⁵

The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that the prevalence of diabetic retinopathy varied from 28.8% in people who had diabetes mellitus (DM) for < 5 years to 77.8% in people who had DM for ≥ 15 years.

This article describes how to assess the risk of diabetic retinopathy in your patients, details the crucial role that you, the primary care physician, can play in prevention, and emphasizes the importance of referral to an eye specialist for screening, evaluation, treatment (when indicated), and follow-up.

Pathophysiology and classification

Diabetic retinopathy, the result of progressive blood vessel damage to the retina, has 2 major forms: nonproliferative and proliferative. Those forms are distinguished by the absence or presence of new growth of blood vessels (retinal neovascularization).^3,7 To improve communication and coordination among physicians who care for patients with DM worldwide, the International Clinical Diabetic Retinopathy Disease Severity Scale for diabetic retinopathy was developed,^8-10 comprising 5 levels of severity that are based on findings on dilated ophthalmoscopy (Table 1^8-10):

• Level 1. No apparent retinopathy. Funduscopic abnormalities are absent.
• Level 2. Mild nonproliferative diabetic retinopathy (NPDR). Only a few microaneurysms are seen.
• Level 3: Moderate NPDR. Characterized by microaneurysms and by intraretinal hemorrhage and venous beading, but less severe than what is seen in Level 4.
• Level 4. Severe NPDR. More than 20 intraretinal hemorrhages in each quadrant of the retina, definite venous beading in > 2 quadrants, intraretinal microvascular abnormalities in > 1 quadrant, or any combination of these findings.
• Level 5. Proliferative diabetic retinopathy. Characterized by neovascularization of the disc, retina, iris, or angle; vitreous hemorrhage; retinal detachment; or any combination of these findings. Further classified as “mild,” “moderate,” or “severe” if macular edema is present; severity is dependent on the distance of thickening and exudates from the center of the macula.⁹

Be attentive to risk factors

There are several risk factors for diabetic retinopathy, including duration of disease, type 1 DM, male gender, black race (non-Hispanic), elevated hemoglobin A1C(HbA1C) level, elevated systolic and diastolic blood pressure (BP), and insulin therapy. ^4,5,11,12

Continue to: Time since diagnosis

Time since diagnosis. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that the prevalence of diabetic retinopathy varied from 28.8% in people who had DM for < 5 years to 77.8% in people who had DM for ≥ 15 years. The rate of proliferative diabetic retinopathy was 2% in people who had DM for < 5 years and 15.5% in those who had DM for ≥ 15 years.¹¹

Diabetic retinopathy can deteriorate during pregnancy but generally reverts to the pre-pregnancy level; long-term progression of retinopathy is not affected.

Demographic variables. The prevalence of diabetic retinopathy is higher in men, non-Hispanic blacks (38.8%), and ­people with type 1 DM.^4,5,11-13 The Veterans ­Affairs Diabetes Trial found a higher prevalence of moderate-to-severe diabetic retinopathy in Hispanics (36%) and African Americans (29%) than in non-Hispanic whites (22%).¹⁴

Among people with DM who have ­diabetic retinopathy, systolic and diastolic BP and the HbA1C level tend to be higher. They are more likely to use insulin to control disease.^4,5,13 In a recent cross-sectional analysis, the prevalence of vision-threatening retinopathy was higher among people ≥ 65 years of age (1%; 95% confidence interval [CI], 0.7%-1.5%) than among people 40 to 64 years of age (0.4%; 95% CI, 0.3%-0.7%) (P = .009).⁵

Does pregnancy exacerbate retinopathy? Controversy surrounds the role of pregnancy in the development and progression of diabetic retinopathy. The Diabetes Control and Complications Trial found a short-term increase in the level of retinopathy during pregnancy that persisted into the first postpartum year. A 1.63-fold greater risk of any deterioration of retinopathy was observed in women who received intensive DM treatment from before to during pregnancy (P < .05); pregnant women who received conventional treatment had a 2.48-fold greater risk than nonpregnant women with DM who received conventional treatment (P < .001).

Deterioration of retinopathy during pregnancy had no long-term consequences, however, regardless of type of treatment.¹⁵ More importantly, in most cases, changes in the level of retinopathy revert to the pre-­pregnancy level after 1 year or longer, and pregnancy does not appear to affect long-term progression of retinopathy.¹⁵

Continue to: Proven primary prevention strategies

 

 

Proven primary prevention strategies

Glycemic control. Optimal glycemic control is an essential component of prevention of diabetic retinopathy. From 1983 to 1993, the Diabetes Control and Complications Trial randomized 1441 patients with type 1 DM to receive intensive therapy (median HbA1C level, 7.2%) or conventional therapy (median HbA1C level, 9.1%). During a mean of 6 years of follow-up, intensive therapy reduced the adjusted mean risk of retinopathy by 76% (95% CI, 62%-85%).^16,17 A 2007 systematic review of 44 studies of the treatment of diabetic retinopathy found that strict glycemic control was beneficial in reducing the incidence and progression of retinopathy.¹⁷

The American Diabetes Association’s Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers recommends that most nonpregnant adults maintain an HbA1Clevel < 7%. For patients with a history of hypoglycemia, limited life expectancy, advanced microvascular or macrovascular disease, other significant comorbid conditions, or longstanding DM in which it is difficult to achieve the optimal goal, a higher HbA1clevel (< 8%) might be appropriate.¹⁸

Control of BP. Strict control of BP is a major modifier of the incidence and progression of diabetic retinopathy.^17,19 In the United Kingdom Prospective Diabetes Study, 1148 patients with type 2 DM and a mean BP of 160/94 mm Hg at the onset of the study were randomly assigned to either (1) a “tight” blood pressure group (< 150/85 mm Hg) or (2) a “less-tight” group (< 180/105 mm Hg). The primary therapy for controlling BP was captopril or atenolol. After 9 years of follow-up, the tight-control group had a 34% mean reduction in risk in the percentage of patients with deterioration of retinopathy (99% CI, 11%-50%; P = .0004) and a 47% reduction in risk (99% CI, 7%-70%; P = .004) of deterioration in visual acuity.²⁰

Most patients with DM and hypertension should be treated to maintain a BP < 140/90 mm Hg. Although there is insufficient evidence to recommend a specific antihypertensive agent for preventing diabetic retinopathy, therapy should include agents from drug classes that have a demonstrated reduction in cardiovascular events in patients with DM. These include angiotensin-­converting enzyme inhibitors, angiotensin receptor blockers, thiazide diuretics, and dihydropyridine calcium channel blockers.¹⁸

Lipid management. The benefit of targeted therapy for lowering lipids for the prevention of diabetic retinopathy is not well established.¹⁷ In the Collaborative Atorvastatin Diabetes Study, 2838 patients with type 2 DM were randomized to atorvastatin (10 mg) or placebo; microvascular endpoint analysis demonstrated that patients taking atorvastatin needed less laser therapy (P = .14); however, progression of diabetic retinopathy was not reduced.²¹ Similarly, in the Action to Control Cardiovascular Risk in Diabetes Eye Study, slowing of progression to retinopathy was observed in patients with type 2 DM who were treated with fenofibrate (ie, progression in 6.5%, compared with progression in 10.2% of untreated subjects [odds ratio = 0.60 (95% CI, 0.42-0.87); P = .0056]).²²

Continue to: Despite limited data on...

Nonpregnant adults with diabetes should maintain an HbA1C level < 7%; a higher level (< 8%) might be appropriate in patients with various complicating factors.

Despite limited data on the impact of ­lipid-lowering agents on patients with diabetic retinopathy, those with type 2 DM (especially) and those who have, or are at risk of, atherosclerotic cardiovascular disease should receive statin therapy.¹⁸

Aspirin therapy. Aspirin has not been found to be beneficial for slowing progression of diabetic retinopathy. However, aspirin did not cause further deterioration of disease, specifically in patients with vitreous hemorrhages⁴; patients with diabetic retinopathy who require aspirin therapy for other medical reasons can therefore continue to take it without increasing the risk of damage to the retina.^4,18

When should you refer patients for screening?

Screening for diabetic retinopathy is important because affected patients can be asymptomatic but have significant disease. Early detection also helps determine which patients need treatment when it is most beneficial: early in its course.⁴

Type 1 DM. Retinopathy can become apparent as early as 6 or 7 years after the onset of disease, and is rare in children prior to puberty.^4,11 As a result, patients with type 1 DM should first be screened with a comprehensive eye examination by an ophthalmologist or optometrist within 5 years of DM onset.^4,18

Type 2 DM. Because of the insidious onset of type 2 DM, patients who are given a diagnosis of DM after 30 years of age might already have high-risk features of retinopathy.⁹ In patients with type 2 DM, therefore, initial screening for diabetic retinopathy should begin at the time of diagnosis and include a comprehensive eye examination by an ophthalmologist or optometrist.^4,18,23

Continue to: Components of the exam

Components of the exam. Initial evaluation by the ophthalmologist or optometrist should include a detailed history and comprehensive eye exam with pupil dilation. Table 2⁴ lists elements of the initial physical exam, which should assess for features that often lead to visual impairment. These features include macular edema, retinal hemorrhage, venous beading, neovascularization, and vitreous hemorrhage.⁴

Frequency of follow-up. The interval between subsequent examinations should be individualized, based on the findings of the initial assessment. Consider that:

• Screening should occur every 1 or 2 years in patients without evidence of retinopathy and with adequate glycemic control.^4,18,23
• Screening every 1 or 2 years appears to be cost-effective in patients who have had 1 or more normal eye exams.
• A 3-year screening interval does not appear to present a risk in well-controlled patients with type 2 DM.²⁴
• Women with type 1 or type 2 DM who are planning pregnancy or who are pregnant should have an eye exam prior to pregnancy or early in the first trimester.^4,18,23 They should then be monitored each trimester and at the end of the first postpartum year, depending on the severity of retinopathy.¹⁸

Alternative screening modalities

Seven-field stereoscopic fundus photography is an alternative screening tool that compares favorably to ophthalmoscopy when performed by an experienced ophthalmologist, optometrist, or ophthalmologic technician.²⁵ Nonmydriatic digital stereoscopic retinal imaging has been shown to be a cost-effective method of screening patients for diabetic retinopathy.²⁶ In a study that compared digital imaging with dilated funduscopic examination, investigators reported that, of 311 eyes evaluated, there was agreement between the methods in 86% of cases. Disagreement was mostly related to the greater frequency of finding mild-to-moderate NPDR when using digital imaging.²⁷

Screening in primary care

Programs that use telemedicine-based fundus photography to screen for diabetic retinopathy during primary care visits, followed by remote interpretation by an ophthalmologist, have been shown to increase the rate of retinal screening by offering an option other than direct referral to an ophthalmologist or optometrist.²⁸ However, telemedicine-based retinal photography can be successful as a screening tool for retinopathy only if timely referral to an eye specialist is arranged when indicated by findings.¹⁸

What therapy will your referred patients receive?

Patients found to have signs of diabetic retinopathy should be referred to an ophthalmologist who is knowledgeable and experienced in the management of diabetic retinopathy. Care will be managed according to the severity of the patient’s diabetic retinopathy.

Continue to: Patients with mild-to-moderate NPDR but without macular edema

Patients with mild-to-moderate NPDR but without macular edema. Treatment is generally not recommended. Patients should be reevaluated every 6 to 12 months because they have an increased risk of progression.⁵

Patients with mild-to-moderate NPDR and clinically significant macular edema (CSME). It is important for the eye specialist to assess for edema at the center of the macula because the risk of vision loss and need for treatment is greater when the center is involved. Vascular–endothelial growth factor (VEGF) is an important mediator of neovascularization and macular edema in diabetic retinopathy. For patients with center-­involving CSME, intravitreous injection of an anti-VEGF agent provides significant benefit and is first-line treatment in these cases.^4,29

Patients with DM (especially those with type 2 disease) who have, or are at risk of, atherosclerotic cardiovascular disease should receive statin therapy.

The Early Treatment for Diabetic Retinopathy Study evaluated the efficacy of focal photocoagulation, a painless laser therapy, for CSME and demonstrated that this modality reduces the risk of moderate visual loss; increases the likelihood of improvement in vision; and decreases the frequency of persistent macular edema.³⁰ Focal photocoagulation has been found effective in both non-center-involving CSME and center-involving CSME.⁵

Patients with severe NPDR. The recommendation is to initiate full panretinal photocoagulation prior to progression to proliferative diabetic retinopathy PDR. Researchers noted a 50% reduction in vision loss and vitrectomy when patients with type 2 DM were treated with panretinal photocoagulation early, compared with those in whom treatment was deferred until PDR developed.^4,31 The role of anti-VEGF treatment of severe NPDR is under investigation.⁴

Patients with high-risk and severe PDR. Panretinal photocoagulation is the recommended treatment for patients with high-risk and severe PDR, and usually induces regression of retinal neovascularization. In patients with CSME and high-risk PDR, the combination of anti-VEGF therapy and panretinal photocoagulation should be considered. Vitrectomy should be considered for patients who have failed panretinal photocoagulation or are not amenable to photocoagulation.⁴

CORRESPONDENCE
Bryan Farford, DO, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224; Farford.Bryan@mayo.edu.

As of 2015, an estimated 30.2 million adults in the United States—12.2% of the population— had diabetes mellitus (DM). During that year, approximately 1.5 million new cases (6.7 cases for every 1000 people) were diagnosed in adults (≥ 18 years of age).¹

As the number of people with DM increases, so will the number of cases of diabetic retinopathy, the main cause of new cases of blindness in adults in the United States² and the leading cause of blindness among US working-age (20 to 74 years) adults.³ It is estimated that 4.1 million Americans have diabetic retinopathy³; it is projected that prevalence will reach 6 million this year.⁴

Blindness related to DM costs the United States approximately $500 million each year,⁵ including health care utilization: physician office visits, diagnostic testing, medication and other treatments, and hospitalization.⁶ Impairment of vision also results in social isolation, dependence on others to perform daily functions, and a decline in physical activity.

Several professional organizations, including the American Diabetes Association and the American Academy of Ophthalmology, have developed practice guidelines for diabetic retinopathy screening. Guidelines notwithstanding, only about 55% of people with DM in the United States receive the recommended dilated eye examination at established intervals.^2,3 In addition to screening by an ophthalmologist or optometrist, adherence to clinical guidelines for risk assessment, prevention, and early referral helps reduce the incidence and severity of retinopathy.⁵

The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that the prevalence of diabetic retinopathy varied from 28.8% in people who had diabetes mellitus (DM) for < 5 years to 77.8% in people who had DM for ≥ 15 years.

This article describes how to assess the risk of diabetic retinopathy in your patients, details the crucial role that you, the primary care physician, can play in prevention, and emphasizes the importance of referral to an eye specialist for screening, evaluation, treatment (when indicated), and follow-up.

Pathophysiology and classification

Diabetic retinopathy, the result of progressive blood vessel damage to the retina, has 2 major forms: nonproliferative and proliferative. Those forms are distinguished by the absence or presence of new growth of blood vessels (retinal neovascularization).^3,7 To improve communication and coordination among physicians who care for patients with DM worldwide, the International Clinical Diabetic Retinopathy Disease Severity Scale for diabetic retinopathy was developed,^8-10 comprising 5 levels of severity that are based on findings on dilated ophthalmoscopy (Table 1^8-10):

• Level 1. No apparent retinopathy. Funduscopic abnormalities are absent.
• Level 2. Mild nonproliferative diabetic retinopathy (NPDR). Only a few microaneurysms are seen.
• Level 3: Moderate NPDR. Characterized by microaneurysms and by intraretinal hemorrhage and venous beading, but less severe than what is seen in Level 4.
• Level 4. Severe NPDR. More than 20 intraretinal hemorrhages in each quadrant of the retina, definite venous beading in > 2 quadrants, intraretinal microvascular abnormalities in > 1 quadrant, or any combination of these findings.
• Level 5. Proliferative diabetic retinopathy. Characterized by neovascularization of the disc, retina, iris, or angle; vitreous hemorrhage; retinal detachment; or any combination of these findings. Further classified as “mild,” “moderate,” or “severe” if macular edema is present; severity is dependent on the distance of thickening and exudates from the center of the macula.⁹

Be attentive to risk factors

There are several risk factors for diabetic retinopathy, including duration of disease, type 1 DM, male gender, black race (non-Hispanic), elevated hemoglobin A1C(HbA1C) level, elevated systolic and diastolic blood pressure (BP), and insulin therapy. ^4,5,11,12

Continue to: Time since diagnosis

Time since diagnosis. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that the prevalence of diabetic retinopathy varied from 28.8% in people who had DM for < 5 years to 77.8% in people who had DM for ≥ 15 years. The rate of proliferative diabetic retinopathy was 2% in people who had DM for < 5 years and 15.5% in those who had DM for ≥ 15 years.¹¹

Diabetic retinopathy can deteriorate during pregnancy but generally reverts to the pre-pregnancy level; long-term progression of retinopathy is not affected.

Demographic variables. The prevalence of diabetic retinopathy is higher in men, non-Hispanic blacks (38.8%), and ­people with type 1 DM.^4,5,11-13 The Veterans ­Affairs Diabetes Trial found a higher prevalence of moderate-to-severe diabetic retinopathy in Hispanics (36%) and African Americans (29%) than in non-Hispanic whites (22%).¹⁴

Among people with DM who have ­diabetic retinopathy, systolic and diastolic BP and the HbA1C level tend to be higher. They are more likely to use insulin to control disease.^4,5,13 In a recent cross-sectional analysis, the prevalence of vision-threatening retinopathy was higher among people ≥ 65 years of age (1%; 95% confidence interval [CI], 0.7%-1.5%) than among people 40 to 64 years of age (0.4%; 95% CI, 0.3%-0.7%) (P = .009).⁵

Does pregnancy exacerbate retinopathy? Controversy surrounds the role of pregnancy in the development and progression of diabetic retinopathy. The Diabetes Control and Complications Trial found a short-term increase in the level of retinopathy during pregnancy that persisted into the first postpartum year. A 1.63-fold greater risk of any deterioration of retinopathy was observed in women who received intensive DM treatment from before to during pregnancy (P < .05); pregnant women who received conventional treatment had a 2.48-fold greater risk than nonpregnant women with DM who received conventional treatment (P < .001).

Deterioration of retinopathy during pregnancy had no long-term consequences, however, regardless of type of treatment.¹⁵ More importantly, in most cases, changes in the level of retinopathy revert to the pre-­pregnancy level after 1 year or longer, and pregnancy does not appear to affect long-term progression of retinopathy.¹⁵

Continue to: Proven primary prevention strategies

 

 

Proven primary prevention strategies

Glycemic control. Optimal glycemic control is an essential component of prevention of diabetic retinopathy. From 1983 to 1993, the Diabetes Control and Complications Trial randomized 1441 patients with type 1 DM to receive intensive therapy (median HbA1C level, 7.2%) or conventional therapy (median HbA1C level, 9.1%). During a mean of 6 years of follow-up, intensive therapy reduced the adjusted mean risk of retinopathy by 76% (95% CI, 62%-85%).^16,17 A 2007 systematic review of 44 studies of the treatment of diabetic retinopathy found that strict glycemic control was beneficial in reducing the incidence and progression of retinopathy.¹⁷

The American Diabetes Association’s Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers recommends that most nonpregnant adults maintain an HbA1Clevel < 7%. For patients with a history of hypoglycemia, limited life expectancy, advanced microvascular or macrovascular disease, other significant comorbid conditions, or longstanding DM in which it is difficult to achieve the optimal goal, a higher HbA1clevel (< 8%) might be appropriate.¹⁸

Control of BP. Strict control of BP is a major modifier of the incidence and progression of diabetic retinopathy.^17,19 In the United Kingdom Prospective Diabetes Study, 1148 patients with type 2 DM and a mean BP of 160/94 mm Hg at the onset of the study were randomly assigned to either (1) a “tight” blood pressure group (< 150/85 mm Hg) or (2) a “less-tight” group (< 180/105 mm Hg). The primary therapy for controlling BP was captopril or atenolol. After 9 years of follow-up, the tight-control group had a 34% mean reduction in risk in the percentage of patients with deterioration of retinopathy (99% CI, 11%-50%; P = .0004) and a 47% reduction in risk (99% CI, 7%-70%; P = .004) of deterioration in visual acuity.²⁰

Most patients with DM and hypertension should be treated to maintain a BP < 140/90 mm Hg. Although there is insufficient evidence to recommend a specific antihypertensive agent for preventing diabetic retinopathy, therapy should include agents from drug classes that have a demonstrated reduction in cardiovascular events in patients with DM. These include angiotensin-­converting enzyme inhibitors, angiotensin receptor blockers, thiazide diuretics, and dihydropyridine calcium channel blockers.¹⁸

Lipid management. The benefit of targeted therapy for lowering lipids for the prevention of diabetic retinopathy is not well established.¹⁷ In the Collaborative Atorvastatin Diabetes Study, 2838 patients with type 2 DM were randomized to atorvastatin (10 mg) or placebo; microvascular endpoint analysis demonstrated that patients taking atorvastatin needed less laser therapy (P = .14); however, progression of diabetic retinopathy was not reduced.²¹ Similarly, in the Action to Control Cardiovascular Risk in Diabetes Eye Study, slowing of progression to retinopathy was observed in patients with type 2 DM who were treated with fenofibrate (ie, progression in 6.5%, compared with progression in 10.2% of untreated subjects [odds ratio = 0.60 (95% CI, 0.42-0.87); P = .0056]).²²

Continue to: Despite limited data on...

Nonpregnant adults with diabetes should maintain an HbA1C level < 7%; a higher level (< 8%) might be appropriate in patients with various complicating factors.

Despite limited data on the impact of ­lipid-lowering agents on patients with diabetic retinopathy, those with type 2 DM (especially) and those who have, or are at risk of, atherosclerotic cardiovascular disease should receive statin therapy.¹⁸

Aspirin therapy. Aspirin has not been found to be beneficial for slowing progression of diabetic retinopathy. However, aspirin did not cause further deterioration of disease, specifically in patients with vitreous hemorrhages⁴; patients with diabetic retinopathy who require aspirin therapy for other medical reasons can therefore continue to take it without increasing the risk of damage to the retina.^4,18

When should you refer patients for screening?

Screening for diabetic retinopathy is important because affected patients can be asymptomatic but have significant disease. Early detection also helps determine which patients need treatment when it is most beneficial: early in its course.⁴

Type 1 DM. Retinopathy can become apparent as early as 6 or 7 years after the onset of disease, and is rare in children prior to puberty.^4,11 As a result, patients with type 1 DM should first be screened with a comprehensive eye examination by an ophthalmologist or optometrist within 5 years of DM onset.^4,18

Type 2 DM. Because of the insidious onset of type 2 DM, patients who are given a diagnosis of DM after 30 years of age might already have high-risk features of retinopathy.⁹ In patients with type 2 DM, therefore, initial screening for diabetic retinopathy should begin at the time of diagnosis and include a comprehensive eye examination by an ophthalmologist or optometrist.^4,18,23

Continue to: Components of the exam

Components of the exam. Initial evaluation by the ophthalmologist or optometrist should include a detailed history and comprehensive eye exam with pupil dilation. Table 2⁴ lists elements of the initial physical exam, which should assess for features that often lead to visual impairment. These features include macular edema, retinal hemorrhage, venous beading, neovascularization, and vitreous hemorrhage.⁴

Frequency of follow-up. The interval between subsequent examinations should be individualized, based on the findings of the initial assessment. Consider that:

• Screening should occur every 1 or 2 years in patients without evidence of retinopathy and with adequate glycemic control.^4,18,23
• Screening every 1 or 2 years appears to be cost-effective in patients who have had 1 or more normal eye exams.
• A 3-year screening interval does not appear to present a risk in well-controlled patients with type 2 DM.²⁴
• Women with type 1 or type 2 DM who are planning pregnancy or who are pregnant should have an eye exam prior to pregnancy or early in the first trimester.^4,18,23 They should then be monitored each trimester and at the end of the first postpartum year, depending on the severity of retinopathy.¹⁸

Alternative screening modalities

Seven-field stereoscopic fundus photography is an alternative screening tool that compares favorably to ophthalmoscopy when performed by an experienced ophthalmologist, optometrist, or ophthalmologic technician.²⁵ Nonmydriatic digital stereoscopic retinal imaging has been shown to be a cost-effective method of screening patients for diabetic retinopathy.²⁶ In a study that compared digital imaging with dilated funduscopic examination, investigators reported that, of 311 eyes evaluated, there was agreement between the methods in 86% of cases. Disagreement was mostly related to the greater frequency of finding mild-to-moderate NPDR when using digital imaging.²⁷

Screening in primary care

Programs that use telemedicine-based fundus photography to screen for diabetic retinopathy during primary care visits, followed by remote interpretation by an ophthalmologist, have been shown to increase the rate of retinal screening by offering an option other than direct referral to an ophthalmologist or optometrist.²⁸ However, telemedicine-based retinal photography can be successful as a screening tool for retinopathy only if timely referral to an eye specialist is arranged when indicated by findings.¹⁸

What therapy will your referred patients receive?

Patients found to have signs of diabetic retinopathy should be referred to an ophthalmologist who is knowledgeable and experienced in the management of diabetic retinopathy. Care will be managed according to the severity of the patient’s diabetic retinopathy.

Continue to: Patients with mild-to-moderate NPDR but without macular edema

Patients with mild-to-moderate NPDR but without macular edema. Treatment is generally not recommended. Patients should be reevaluated every 6 to 12 months because they have an increased risk of progression.⁵

Patients with mild-to-moderate NPDR and clinically significant macular edema (CSME). It is important for the eye specialist to assess for edema at the center of the macula because the risk of vision loss and need for treatment is greater when the center is involved. Vascular–endothelial growth factor (VEGF) is an important mediator of neovascularization and macular edema in diabetic retinopathy. For patients with center-­involving CSME, intravitreous injection of an anti-VEGF agent provides significant benefit and is first-line treatment in these cases.^4,29

Patients with DM (especially those with type 2 disease) who have, or are at risk of, atherosclerotic cardiovascular disease should receive statin therapy.

The Early Treatment for Diabetic Retinopathy Study evaluated the efficacy of focal photocoagulation, a painless laser therapy, for CSME and demonstrated that this modality reduces the risk of moderate visual loss; increases the likelihood of improvement in vision; and decreases the frequency of persistent macular edema.³⁰ Focal photocoagulation has been found effective in both non-center-involving CSME and center-involving CSME.⁵

Patients with severe NPDR. The recommendation is to initiate full panretinal photocoagulation prior to progression to proliferative diabetic retinopathy PDR. Researchers noted a 50% reduction in vision loss and vitrectomy when patients with type 2 DM were treated with panretinal photocoagulation early, compared with those in whom treatment was deferred until PDR developed.^4,31 The role of anti-VEGF treatment of severe NPDR is under investigation.⁴

Patients with high-risk and severe PDR. Panretinal photocoagulation is the recommended treatment for patients with high-risk and severe PDR, and usually induces regression of retinal neovascularization. In patients with CSME and high-risk PDR, the combination of anti-VEGF therapy and panretinal photocoagulation should be considered. Vitrectomy should be considered for patients who have failed panretinal photocoagulation or are not amenable to photocoagulation.⁴

CORRESPONDENCE
Bryan Farford, DO, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224; Farford.Bryan@mayo.edu.

Coronary bypass surgery patients who received a radial artery as their second bypass conduit had significantly better 10-year survival than did patients who received a saphenous vein graft in a combined analysis of more than 1,000 randomized patients who had originally been enrolled in any of five independent studies.

“This is the first report of a survival benefit for CABG [coronary artery bypass grafting] using multiple arterial conduits based on randomized data,” Mario F.L. Gaudino, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Dr. Gaudino acknowledged several limitations of the finding. First, the analysis included studies that enrolled patients during 1997-2009 in five diverse sites worldwide and, therefore, involved varying surgical methods. Second, the sample size was “relatively low and underpowered, even after 10-year follow-up.” And third, the survival analysis was post hoc, although the statistically significant 27% relative reduction in mortality during follow-up with radial artery bypass, compared with saphenous vein bypass, was fully consistent with both the primary endpoint of the five studies and also with the combined hard endpoint of death and myocardial infarction.

The primary outcome of all-cause death, MI, and repeat revascularization also fell by a relative 27% with radial artery bypass, compared with saphenous vein bypass, and the combined rate of death and MI fell by 23% with radial artery bypass, both statistically significant differences, reported Dr. Gaudino, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

“The overall message is that radial bypass is associated with better long-term outcomes and potentially better survival,” he concluded.

The left interior thoracic artery (also known as the left internal mammary artery) is well established as the primary CABG conduit, usually used for bypassing the left anterior descending coronary artery, but when a second conduit is needed, several options exist: a saphenous vein, the left radial artery, or possibly the right internal thoracic artery (RITA) as a different arterial option.

Dr. Gaudino claimed that his new results placed the left radial artery clearly superior to the RITA as the second arterial conduit of choice for CABG. Not only does the RITA lack a similar efficacy evidence base from randomized trials, but the method poses a higher risk for surgical wound infections, he noted. The most recent society recommendations on conduit choice for CABG, issued less than 2 years ago by the European Society of Cardiology and European Association for Cardio-Thoracic Surgery, tapped the left radial artery as a level I recommendation over a saphenous vein graft when patients have high-grade coronary stenosis, while the RITA trailed as a level IIa recommendation specified only for patients with a low risk for sternal-wound infection.

“This was a great study that brings home the point that, in general, the radial artery is better than a saphenous vein graft,” commented Marc R. Moon, MD, a designated discussant and a professor of surgery and chief of cardiac surgery at Washington University, St. Louis.

The long-term follow-up that Dr. Gaudino reported came from extended, patient-level data collection for all 1,036 patients included in the original RADIAL (Radial Artery Database International Alliance) analysis of 5-year outcomes and reported in 2018. Dr. Gaudino and his associates tracked down survival information for all those patients, with outcome records out to at least 10 years for 91% of the original participants and with a mean follow-up that was also 10 years. The prior 2018 report based on 5-year results had also shown a statistically significant reduction in the primary endpoint with radial artery grafting, but at that point, follow-up had not yet collected enough mortality endpoints to produce a statistically significant between-group difference in death from any cause, a shortcoming that may have limited the ability of the prior report to influence U.S. practice.

“In the United States, there has been very little uptake of multiarterial grafting,” commented Frederick G.P. Welt, MD, a designated discussant, interventional cardiologist, professor of medicine, and associate chief of cardiovascular medicine at the University of Utah, Salt Lake City. The results from several earlier studies did not show much benefit for graft patency using radial arteries, but more recently clinicians have made advances in radial artery harvesting methods, implantation techniques, and adjunctive medications including antispasmodic treatments, Dr. Welt noted. Improved methods for using radial artery grafts and the risk of wound infection with RITA grafts were summarized in an editorial that accompanied the report of the 5-year RADIAL findings.

Dr. Welt said that, among the new findings reported by Dr. Gaudino, “the mortality effect is the most impressive.” Despite the limitations of the post hoc survival analysis, the reduced mortality finding is “nevertheless really important. The patient-level data lend it more credence.”

The study received no commercial funding. Dr. Gaudino had no disclosures. Dr. Moon has been a consultant to Medtronic. Dr. Welt has been an adviser to Medtronic.

mzoler@mdedge.com

SOURCE: Gaudino MFL et al. ACC 20, Abstract 410-11.

Coronary bypass surgery patients who received a radial artery as their second bypass conduit had significantly better 10-year survival than did patients who received a saphenous vein graft in a combined analysis of more than 1,000 randomized patients who had originally been enrolled in any of five independent studies.

“This is the first report of a survival benefit for CABG [coronary artery bypass grafting] using multiple arterial conduits based on randomized data,” Mario F.L. Gaudino, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Dr. Gaudino acknowledged several limitations of the finding. First, the analysis included studies that enrolled patients during 1997-2009 in five diverse sites worldwide and, therefore, involved varying surgical methods. Second, the sample size was “relatively low and underpowered, even after 10-year follow-up.” And third, the survival analysis was post hoc, although the statistically significant 27% relative reduction in mortality during follow-up with radial artery bypass, compared with saphenous vein bypass, was fully consistent with both the primary endpoint of the five studies and also with the combined hard endpoint of death and myocardial infarction.

The primary outcome of all-cause death, MI, and repeat revascularization also fell by a relative 27% with radial artery bypass, compared with saphenous vein bypass, and the combined rate of death and MI fell by 23% with radial artery bypass, both statistically significant differences, reported Dr. Gaudino, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

“The overall message is that radial bypass is associated with better long-term outcomes and potentially better survival,” he concluded.

The left interior thoracic artery (also known as the left internal mammary artery) is well established as the primary CABG conduit, usually used for bypassing the left anterior descending coronary artery, but when a second conduit is needed, several options exist: a saphenous vein, the left radial artery, or possibly the right internal thoracic artery (RITA) as a different arterial option.

Dr. Gaudino claimed that his new results placed the left radial artery clearly superior to the RITA as the second arterial conduit of choice for CABG. Not only does the RITA lack a similar efficacy evidence base from randomized trials, but the method poses a higher risk for surgical wound infections, he noted. The most recent society recommendations on conduit choice for CABG, issued less than 2 years ago by the European Society of Cardiology and European Association for Cardio-Thoracic Surgery, tapped the left radial artery as a level I recommendation over a saphenous vein graft when patients have high-grade coronary stenosis, while the RITA trailed as a level IIa recommendation specified only for patients with a low risk for sternal-wound infection.

“This was a great study that brings home the point that, in general, the radial artery is better than a saphenous vein graft,” commented Marc R. Moon, MD, a designated discussant and a professor of surgery and chief of cardiac surgery at Washington University, St. Louis.

The long-term follow-up that Dr. Gaudino reported came from extended, patient-level data collection for all 1,036 patients included in the original RADIAL (Radial Artery Database International Alliance) analysis of 5-year outcomes and reported in 2018. Dr. Gaudino and his associates tracked down survival information for all those patients, with outcome records out to at least 10 years for 91% of the original participants and with a mean follow-up that was also 10 years. The prior 2018 report based on 5-year results had also shown a statistically significant reduction in the primary endpoint with radial artery grafting, but at that point, follow-up had not yet collected enough mortality endpoints to produce a statistically significant between-group difference in death from any cause, a shortcoming that may have limited the ability of the prior report to influence U.S. practice.

“In the United States, there has been very little uptake of multiarterial grafting,” commented Frederick G.P. Welt, MD, a designated discussant, interventional cardiologist, professor of medicine, and associate chief of cardiovascular medicine at the University of Utah, Salt Lake City. The results from several earlier studies did not show much benefit for graft patency using radial arteries, but more recently clinicians have made advances in radial artery harvesting methods, implantation techniques, and adjunctive medications including antispasmodic treatments, Dr. Welt noted. Improved methods for using radial artery grafts and the risk of wound infection with RITA grafts were summarized in an editorial that accompanied the report of the 5-year RADIAL findings.

Dr. Welt said that, among the new findings reported by Dr. Gaudino, “the mortality effect is the most impressive.” Despite the limitations of the post hoc survival analysis, the reduced mortality finding is “nevertheless really important. The patient-level data lend it more credence.”

The study received no commercial funding. Dr. Gaudino had no disclosures. Dr. Moon has been a consultant to Medtronic. Dr. Welt has been an adviser to Medtronic.

mzoler@mdedge.com

SOURCE: Gaudino MFL et al. ACC 20, Abstract 410-11.

Coronary bypass surgery patients who received a radial artery as their second bypass conduit had significantly better 10-year survival than did patients who received a saphenous vein graft in a combined analysis of more than 1,000 randomized patients who had originally been enrolled in any of five independent studies.

“This is the first report of a survival benefit for CABG [coronary artery bypass grafting] using multiple arterial conduits based on randomized data,” Mario F.L. Gaudino, MD, said at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.

Dr. Gaudino acknowledged several limitations of the finding. First, the analysis included studies that enrolled patients during 1997-2009 in five diverse sites worldwide and, therefore, involved varying surgical methods. Second, the sample size was “relatively low and underpowered, even after 10-year follow-up.” And third, the survival analysis was post hoc, although the statistically significant 27% relative reduction in mortality during follow-up with radial artery bypass, compared with saphenous vein bypass, was fully consistent with both the primary endpoint of the five studies and also with the combined hard endpoint of death and myocardial infarction.

The primary outcome of all-cause death, MI, and repeat revascularization also fell by a relative 27% with radial artery bypass, compared with saphenous vein bypass, and the combined rate of death and MI fell by 23% with radial artery bypass, both statistically significant differences, reported Dr. Gaudino, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

“The overall message is that radial bypass is associated with better long-term outcomes and potentially better survival,” he concluded.

The left interior thoracic artery (also known as the left internal mammary artery) is well established as the primary CABG conduit, usually used for bypassing the left anterior descending coronary artery, but when a second conduit is needed, several options exist: a saphenous vein, the left radial artery, or possibly the right internal thoracic artery (RITA) as a different arterial option.

Dr. Gaudino claimed that his new results placed the left radial artery clearly superior to the RITA as the second arterial conduit of choice for CABG. Not only does the RITA lack a similar efficacy evidence base from randomized trials, but the method poses a higher risk for surgical wound infections, he noted. The most recent society recommendations on conduit choice for CABG, issued less than 2 years ago by the European Society of Cardiology and European Association for Cardio-Thoracic Surgery, tapped the left radial artery as a level I recommendation over a saphenous vein graft when patients have high-grade coronary stenosis, while the RITA trailed as a level IIa recommendation specified only for patients with a low risk for sternal-wound infection.

“This was a great study that brings home the point that, in general, the radial artery is better than a saphenous vein graft,” commented Marc R. Moon, MD, a designated discussant and a professor of surgery and chief of cardiac surgery at Washington University, St. Louis.

The long-term follow-up that Dr. Gaudino reported came from extended, patient-level data collection for all 1,036 patients included in the original RADIAL (Radial Artery Database International Alliance) analysis of 5-year outcomes and reported in 2018. Dr. Gaudino and his associates tracked down survival information for all those patients, with outcome records out to at least 10 years for 91% of the original participants and with a mean follow-up that was also 10 years. The prior 2018 report based on 5-year results had also shown a statistically significant reduction in the primary endpoint with radial artery grafting, but at that point, follow-up had not yet collected enough mortality endpoints to produce a statistically significant between-group difference in death from any cause, a shortcoming that may have limited the ability of the prior report to influence U.S. practice.

“In the United States, there has been very little uptake of multiarterial grafting,” commented Frederick G.P. Welt, MD, a designated discussant, interventional cardiologist, professor of medicine, and associate chief of cardiovascular medicine at the University of Utah, Salt Lake City. The results from several earlier studies did not show much benefit for graft patency using radial arteries, but more recently clinicians have made advances in radial artery harvesting methods, implantation techniques, and adjunctive medications including antispasmodic treatments, Dr. Welt noted. Improved methods for using radial artery grafts and the risk of wound infection with RITA grafts were summarized in an editorial that accompanied the report of the 5-year RADIAL findings.

Dr. Welt said that, among the new findings reported by Dr. Gaudino, “the mortality effect is the most impressive.” Despite the limitations of the post hoc survival analysis, the reduced mortality finding is “nevertheless really important. The patient-level data lend it more credence.”

The study received no commercial funding. Dr. Gaudino had no disclosures. Dr. Moon has been a consultant to Medtronic. Dr. Welt has been an adviser to Medtronic.

mzoler@mdedge.com

SOURCE: Gaudino MFL et al. ACC 20, Abstract 410-11.

LAHAINA, HAWAII – Clascoterone cream, a first-in-class topical selective androgen receptor inhibitor for the treatment of acne now under review by the Food and Drug Administration, is already generating considerable buzz in the patient-advocacy community even though the agency won’t issue its decision until August.

Bruce Jancin/MDedge News

“I’ve actually had a lot of interest in this already from parents, especially regarding girls who have very hormonal acne but the parents are really not interested in starting them on a systemic hormonal therapy at their age,” Jessica Sprague, MD, said at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Clascoterone targets androgen receptors in the skin in order to reduce cutaneous 5-alpha dihydrotestosterone.

“It’s being developed for use in both males and females, which is great because at this point there’s no hormonal treatment for males,” noted Dr. Sprague, a pediatric dermatologist at Rady Children’s Hospital and the University of California, both in San Diego.

The manufacturer’s application for marketing approval of clascoterone cream 1% under FDA review includes evidence from two identical phase-3, double-blind, vehicle-controlled, 12-week, randomized trials. The two studies included a total of 1,440 patients aged 9 years through adulthood with moderate to severe facial acne vulgaris who were randomized to twice-daily application of clascoterone or its vehicle.

The primary outcome was the reduction in inflammatory lesions at week 12: a 46.2% decline from baseline with clascoterone 1% cream, which was a significantly greater improvement than the 32.7% reduction for vehicle. The secondary outcome – change in noninflammatory lesion counts at week 12 – was also positive for the topical androgen receptor inhibitor, which achieved a 29.8% reduction, compared with 18.9% for vehicle. Clascoterone exhibited a favorable safety and tolerability profile, with numerically fewer treatment-emergent adverse events than in the vehicle control group. A stronger formulation of the topical agent is in advanced clinical trials for the treatment of androgenetic alopecia in both males and females.

Dr. Sprague reported having no financial conflicts regarding her presentation.

The SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@mdedge.com

LAHAINA, HAWAII – Clascoterone cream, a first-in-class topical selective androgen receptor inhibitor for the treatment of acne now under review by the Food and Drug Administration, is already generating considerable buzz in the patient-advocacy community even though the agency won’t issue its decision until August.

Bruce Jancin/MDedge News

“I’ve actually had a lot of interest in this already from parents, especially regarding girls who have very hormonal acne but the parents are really not interested in starting them on a systemic hormonal therapy at their age,” Jessica Sprague, MD, said at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Clascoterone targets androgen receptors in the skin in order to reduce cutaneous 5-alpha dihydrotestosterone.

“It’s being developed for use in both males and females, which is great because at this point there’s no hormonal treatment for males,” noted Dr. Sprague, a pediatric dermatologist at Rady Children’s Hospital and the University of California, both in San Diego.

The manufacturer’s application for marketing approval of clascoterone cream 1% under FDA review includes evidence from two identical phase-3, double-blind, vehicle-controlled, 12-week, randomized trials. The two studies included a total of 1,440 patients aged 9 years through adulthood with moderate to severe facial acne vulgaris who were randomized to twice-daily application of clascoterone or its vehicle.

The primary outcome was the reduction in inflammatory lesions at week 12: a 46.2% decline from baseline with clascoterone 1% cream, which was a significantly greater improvement than the 32.7% reduction for vehicle. The secondary outcome – change in noninflammatory lesion counts at week 12 – was also positive for the topical androgen receptor inhibitor, which achieved a 29.8% reduction, compared with 18.9% for vehicle. Clascoterone exhibited a favorable safety and tolerability profile, with numerically fewer treatment-emergent adverse events than in the vehicle control group. A stronger formulation of the topical agent is in advanced clinical trials for the treatment of androgenetic alopecia in both males and females.

Dr. Sprague reported having no financial conflicts regarding her presentation.

The SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@mdedge.com

LAHAINA, HAWAII – Clascoterone cream, a first-in-class topical selective androgen receptor inhibitor for the treatment of acne now under review by the Food and Drug Administration, is already generating considerable buzz in the patient-advocacy community even though the agency won’t issue its decision until August.

Bruce Jancin/MDedge News

“I’ve actually had a lot of interest in this already from parents, especially regarding girls who have very hormonal acne but the parents are really not interested in starting them on a systemic hormonal therapy at their age,” Jessica Sprague, MD, said at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Clascoterone targets androgen receptors in the skin in order to reduce cutaneous 5-alpha dihydrotestosterone.

“It’s being developed for use in both males and females, which is great because at this point there’s no hormonal treatment for males,” noted Dr. Sprague, a pediatric dermatologist at Rady Children’s Hospital and the University of California, both in San Diego.

The manufacturer’s application for marketing approval of clascoterone cream 1% under FDA review includes evidence from two identical phase-3, double-blind, vehicle-controlled, 12-week, randomized trials. The two studies included a total of 1,440 patients aged 9 years through adulthood with moderate to severe facial acne vulgaris who were randomized to twice-daily application of clascoterone or its vehicle.

The primary outcome was the reduction in inflammatory lesions at week 12: a 46.2% decline from baseline with clascoterone 1% cream, which was a significantly greater improvement than the 32.7% reduction for vehicle. The secondary outcome – change in noninflammatory lesion counts at week 12 – was also positive for the topical androgen receptor inhibitor, which achieved a 29.8% reduction, compared with 18.9% for vehicle. Clascoterone exhibited a favorable safety and tolerability profile, with numerically fewer treatment-emergent adverse events than in the vehicle control group. A stronger formulation of the topical agent is in advanced clinical trials for the treatment of androgenetic alopecia in both males and females.

Dr. Sprague reported having no financial conflicts regarding her presentation.

The SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@mdedge.com

COVID-19 is less severe in children, compared with adults, early data suggest. “Yet many questions remain, especially regarding the effects on children with special health care needs,” according to a viewpoint recently published in JAMA Pediatrics.

Courtesy NIAID-RML

The COVID-19 pandemic also raises questions about clinic visits for healthy children in communities with widespread transmission and about the unintended effects of school closures and other measures aimed at slowing the spread of the disease, wrote Sonja A. Rasmussen, MD, and Lindsay A. Thompson, MD, both of the University of Florida, Gainesville.

In communities with widespread outbreaks, telephone triage and expanded use of telehealth may be needed to limit nonurgent clinic visits, they suggested.

“Community mitigation interventions, such as school closures, cancellation of mass gatherings, and closure of public places are appropriate” in places with widespread transmission, Dr. Rasmussen and Dr. Thompson wrote. “If these measures are required, pediatricians need to advocate to alleviate unintended consequences or inadvertent expansion of health disparities on children, such as by finding ways to maintain nutrition for those who depend on school lunches and provide online mental health services for stress management for families whose routines might be severely interrupted for an extended period of time.”

Continued preventive care for infants and vaccinations for younger children may be warranted, they wrote.
 

Clinical course

Overall, children have experienced lower-than-expected rates of COVID-19 disease, and deaths in this population appear to be rare, Dr. Rasmussen and Dr. Thompson wrote.

Common symptoms of COVID-19 in adults include fever, cough, myalgia, shortness of breath, headache, and diarrhea, and children have similar manifestations. In adults, older age and underlying illness increase the risk of severe disease. There has not been convincing evidence of intrauterine transmission of COVID-19, and whether breastfeeding can transmit the virus is unknown, they noted.

An analysis of more than 72,000 cases from China found that 1.2% were in patients aged 10-19 years, and 0.9% were in patients younger than 10 years. One death occurred in the adolescent age range. A separate analysis of 2,143 confirmed and suspected pediatric cases in China indicated that infants were at higher risk of severe disease (11%), compared with older children – 4% for those aged 11-15 years, and 3% in those 16 years and older.

There is less data available about the clinical course of COVID-19 in children in the United States, the authors noted. But among more than 4,000 patients with COVID-19 in the United States through March 16, no ICU admissions or deaths were reported for patients aged younger than 19 years (MMWR Morb Mortal Wkly Rep. 2020 Mar 26;69[12]:343-6).

Still, researchers have suggested that children with underlying illness may be at greater risk of COVID-19. In a study of 20 children with COVID-19 in China, 7 of the patients had a history of congenital or acquired disease, potentially indicating that they were more susceptible to the virus (Pediatr Pulmonol. 2020 Mar 5. doi: 10.1002/ppul.24718). Chest CT consolidations with surrounding halo sign was evident in half of the patients, and procalcitonin elevation was seen in 80% of the children; these were signs common in children, but not in adults with COVID-19.

“About 10% of children in the U.S. have asthma; many children live with other pulmonary, cardiac, neuromuscular, or genetic diseases that affect their ability to handle respiratory disease, and other children are immunosuppressed because of illness or its treatment,” Dr. Rasmussen and Dr. Thompson wrote. “It is possible that these children will experience COVID-19 differently than counterparts of the same ages who are healthy.”

The authors reported that they had no financial disclosures.

jremaly@mdedge.com

SOURCE: Rasmussen SA, Thompson LA. JAMA Pediatr. 2020 Apr 3. doi: 10.1001/jamapediatrics.2020.1224.

COVID-19 is less severe in children, compared with adults, early data suggest. “Yet many questions remain, especially regarding the effects on children with special health care needs,” according to a viewpoint recently published in JAMA Pediatrics.

Courtesy NIAID-RML

The COVID-19 pandemic also raises questions about clinic visits for healthy children in communities with widespread transmission and about the unintended effects of school closures and other measures aimed at slowing the spread of the disease, wrote Sonja A. Rasmussen, MD, and Lindsay A. Thompson, MD, both of the University of Florida, Gainesville.

In communities with widespread outbreaks, telephone triage and expanded use of telehealth may be needed to limit nonurgent clinic visits, they suggested.

“Community mitigation interventions, such as school closures, cancellation of mass gatherings, and closure of public places are appropriate” in places with widespread transmission, Dr. Rasmussen and Dr. Thompson wrote. “If these measures are required, pediatricians need to advocate to alleviate unintended consequences or inadvertent expansion of health disparities on children, such as by finding ways to maintain nutrition for those who depend on school lunches and provide online mental health services for stress management for families whose routines might be severely interrupted for an extended period of time.”

Continued preventive care for infants and vaccinations for younger children may be warranted, they wrote.
 

Clinical course

Overall, children have experienced lower-than-expected rates of COVID-19 disease, and deaths in this population appear to be rare, Dr. Rasmussen and Dr. Thompson wrote.

Common symptoms of COVID-19 in adults include fever, cough, myalgia, shortness of breath, headache, and diarrhea, and children have similar manifestations. In adults, older age and underlying illness increase the risk of severe disease. There has not been convincing evidence of intrauterine transmission of COVID-19, and whether breastfeeding can transmit the virus is unknown, they noted.

An analysis of more than 72,000 cases from China found that 1.2% were in patients aged 10-19 years, and 0.9% were in patients younger than 10 years. One death occurred in the adolescent age range. A separate analysis of 2,143 confirmed and suspected pediatric cases in China indicated that infants were at higher risk of severe disease (11%), compared with older children – 4% for those aged 11-15 years, and 3% in those 16 years and older.

There is less data available about the clinical course of COVID-19 in children in the United States, the authors noted. But among more than 4,000 patients with COVID-19 in the United States through March 16, no ICU admissions or deaths were reported for patients aged younger than 19 years (MMWR Morb Mortal Wkly Rep. 2020 Mar 26;69[12]:343-6).

Still, researchers have suggested that children with underlying illness may be at greater risk of COVID-19. In a study of 20 children with COVID-19 in China, 7 of the patients had a history of congenital or acquired disease, potentially indicating that they were more susceptible to the virus (Pediatr Pulmonol. 2020 Mar 5. doi: 10.1002/ppul.24718). Chest CT consolidations with surrounding halo sign was evident in half of the patients, and procalcitonin elevation was seen in 80% of the children; these were signs common in children, but not in adults with COVID-19.

“About 10% of children in the U.S. have asthma; many children live with other pulmonary, cardiac, neuromuscular, or genetic diseases that affect their ability to handle respiratory disease, and other children are immunosuppressed because of illness or its treatment,” Dr. Rasmussen and Dr. Thompson wrote. “It is possible that these children will experience COVID-19 differently than counterparts of the same ages who are healthy.”

The authors reported that they had no financial disclosures.

jremaly@mdedge.com

SOURCE: Rasmussen SA, Thompson LA. JAMA Pediatr. 2020 Apr 3. doi: 10.1001/jamapediatrics.2020.1224.

COVID-19 is less severe in children, compared with adults, early data suggest. “Yet many questions remain, especially regarding the effects on children with special health care needs,” according to a viewpoint recently published in JAMA Pediatrics.

Courtesy NIAID-RML

The COVID-19 pandemic also raises questions about clinic visits for healthy children in communities with widespread transmission and about the unintended effects of school closures and other measures aimed at slowing the spread of the disease, wrote Sonja A. Rasmussen, MD, and Lindsay A. Thompson, MD, both of the University of Florida, Gainesville.

In communities with widespread outbreaks, telephone triage and expanded use of telehealth may be needed to limit nonurgent clinic visits, they suggested.

“Community mitigation interventions, such as school closures, cancellation of mass gatherings, and closure of public places are appropriate” in places with widespread transmission, Dr. Rasmussen and Dr. Thompson wrote. “If these measures are required, pediatricians need to advocate to alleviate unintended consequences or inadvertent expansion of health disparities on children, such as by finding ways to maintain nutrition for those who depend on school lunches and provide online mental health services for stress management for families whose routines might be severely interrupted for an extended period of time.”

Continued preventive care for infants and vaccinations for younger children may be warranted, they wrote.
 

Clinical course

Overall, children have experienced lower-than-expected rates of COVID-19 disease, and deaths in this population appear to be rare, Dr. Rasmussen and Dr. Thompson wrote.

Common symptoms of COVID-19 in adults include fever, cough, myalgia, shortness of breath, headache, and diarrhea, and children have similar manifestations. In adults, older age and underlying illness increase the risk of severe disease. There has not been convincing evidence of intrauterine transmission of COVID-19, and whether breastfeeding can transmit the virus is unknown, they noted.

An analysis of more than 72,000 cases from China found that 1.2% were in patients aged 10-19 years, and 0.9% were in patients younger than 10 years. One death occurred in the adolescent age range. A separate analysis of 2,143 confirmed and suspected pediatric cases in China indicated that infants were at higher risk of severe disease (11%), compared with older children – 4% for those aged 11-15 years, and 3% in those 16 years and older.

There is less data available about the clinical course of COVID-19 in children in the United States, the authors noted. But among more than 4,000 patients with COVID-19 in the United States through March 16, no ICU admissions or deaths were reported for patients aged younger than 19 years (MMWR Morb Mortal Wkly Rep. 2020 Mar 26;69[12]:343-6).

Still, researchers have suggested that children with underlying illness may be at greater risk of COVID-19. In a study of 20 children with COVID-19 in China, 7 of the patients had a history of congenital or acquired disease, potentially indicating that they were more susceptible to the virus (Pediatr Pulmonol. 2020 Mar 5. doi: 10.1002/ppul.24718). Chest CT consolidations with surrounding halo sign was evident in half of the patients, and procalcitonin elevation was seen in 80% of the children; these were signs common in children, but not in adults with COVID-19.

“About 10% of children in the U.S. have asthma; many children live with other pulmonary, cardiac, neuromuscular, or genetic diseases that affect their ability to handle respiratory disease, and other children are immunosuppressed because of illness or its treatment,” Dr. Rasmussen and Dr. Thompson wrote. “It is possible that these children will experience COVID-19 differently than counterparts of the same ages who are healthy.”

The authors reported that they had no financial disclosures.

jremaly@mdedge.com

SOURCE: Rasmussen SA, Thompson LA. JAMA Pediatr. 2020 Apr 3. doi: 10.1001/jamapediatrics.2020.1224.

A major comprehensive cancer center at the epicenter of the New York City COVID-19 storm is preparing to scale back palliative radiation therapy (RT), anticipating a focus on only oncologic emergencies.

“We’re not there yet, but we’re anticipating when the time comes in the next few weeks that we will have a system in place so we are able to handle it,” Jonathan Yang, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, told Medscape Medical News.

Yang and an expert panel of colleagues reviewed high-impact evidence, prior systematic reviews, and national guidelines to compile a set of recommendations for triage and shortened palliative rRT at their center, should the need arise.

The recommendations on palliative radiotherapy for oncologic emergencies in the setting of COVID-19 appear in a preprint version in Advances in Radiation Oncology, released by the American Society of Radiation Oncology.

Yang says the recommendations are a careful balance between the risk of COVID-19 exposure of staff and patients with the potential morbidity of delaying treatment.

“Everyone is conscious of decisions about whether patients need treatment now or can wait,” he told Medscape Medical News. “It’s a juggling act every single day, but by having this guideline in place, when we face the situation where we do have to make decisions, is helpful.”

The document aims to enable swift decisions based on best practice, including a three-tiered system prioritizing only “clinically urgent cases, in which delaying treatment would result in compromised outcomes or serious morbidity.”

“It’s brutal, that’s the only word for it. Not that I disagree with it,” commented Padraig Warde, MB BCh, professor, Department of Radiation Oncology, University of Toronto, and radiation oncologist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

Like many places, Toronto is not yet experiencing the COVID-19 burden of New York City, but Warde says the MSKCC guideline is useful for everyone. “Other centers should review it and see how they could deal with resource limitations,” he said. “It’s sobering and sad, but if you don’t have the staff to treat all patients, which particular patients do you choose to treat?”

In a nutshell, the MSKCC recommendations defines Tier 1 patients as having oncologic emergencies that require palliative RT, including “cord compression, symptomatic brain metastases requiring whole-brain radiotherapy, life-threatening tumor bleeding, and malignant airway obstruction.”

According to the decision-making guideline, patients in Tiers 2 and 3 would have their palliative RT delayed. This would include Tier 2 patients whose needs are not classified as emergencies, but who have either symptomatic disease for which RT is usually the standard of care or asymptomatic disease for which RT is recommended “to prevent imminent functional deficits.” Tier 3 would be symptomatic or asymptomatic patients for whom RT is “one of the effective treatment options.”

“Rationing is always very difficult because as physicians you always want to do everything you can for your patients but we really have to strike the balance on when to do what, said Yang. The plan that he authored anticipates both reduced availability of radiation therapists as well as aggressive attempts to limit patients’ infection exposure.

“If a patient’s radiation is being considered for delay due to COVID-19, other means are utilized to achieve the goal of palliation in the interim, and in addition to the tier system, this decision is also made on a case-by-case basis with departmental discussion on the risks and benefits,” he explained.

“There are layers of checks and balances for these decisions...Obviously for oncologic emergencies, radiation will be implemented. However for less urgent situations, bringing them into the hospital when there are other ways to achieve the same goal, potential risk of exposure to COVID-19 is higher than the benefit we would be able to provide.”

The document also recommends shorter courses of RT when radiation is deemed appropriate.

“We have good evidence showing shorter courses of radiation can effectively treat the goal of palliation compared to longer courses of radiation,” he explained. “Going through this pandemic actually forces radiation oncologists in the United States to put that evidence into practice. It’s not suboptimal care in the sense that we are achieving the same goal — palliation. This paper is to remind people there are equally effective courses of palliation we can be using.”

“[There’s] nothing like a crisis to get people to do the right thing,” commented Louis Potters, MD, professor and chair of radiation medicine at the Feinstein Institutes, the research arm of Northwell Health, New York’s largest healthcare provider.

Northwell Health has been at the epicenter of the New York outbreak of COVID-19. Potters writes on an ASTRO blog that, as of March 26, Northwell Health “has diagnosed 4399 positive COVID-19 patients, which is about 20% of New York state and 1.2% of all cases in the world. All cancer surgery was discontinued as of March 20 and all of our 23 hospitals are seeing COVID-19 admissions, and ICU care became the primary focus of the entire system. As of today, we have reserved one floor in two hospitals for non-COVID care such as trauma. That’s it.”

Before the crisis, radiation medicine at Northwell consisted of eight separate locations treating on average 280 EBRT cases a day, not including SBRT/SRS and brachytherapy cases. “That of course was 3 weeks ago,” he notes.

Commenting on the recommendations from the MSKCC group, Potters told Medscape Medical News that the primary goal “was to document what are acceptable alternatives for accelerated care.”

“Ironically, these guidelines represent best practices with evidence that — in a non–COVID-19 world — make sense for the majority of patients requiring palliative radiotherapy,” he said.

Potters said there has been hesitance to transition to shorter radiation treatments for several reasons.

“Historically, palliative radiotherapy has been delivered over 2 to 4 weeks with good results. And, as is typical in medicine, the transition to shorter course care is slowed by financial incentives to protract care,” he explained.

“In a value-based future where payment is based on outcomes, this transition to shorter care will evolve very quickly. But given the current COVID-19 crisis, and the risk to patients and staff, the incentive for shorter treatment courses has been thrust upon us and the MSKCC outline helps to define how to do this safely and with evidence-based expected efficacy.”
 

This article first appeared on Medscape.com.

A major comprehensive cancer center at the epicenter of the New York City COVID-19 storm is preparing to scale back palliative radiation therapy (RT), anticipating a focus on only oncologic emergencies.

“We’re not there yet, but we’re anticipating when the time comes in the next few weeks that we will have a system in place so we are able to handle it,” Jonathan Yang, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, told Medscape Medical News.

Yang and an expert panel of colleagues reviewed high-impact evidence, prior systematic reviews, and national guidelines to compile a set of recommendations for triage and shortened palliative rRT at their center, should the need arise.

The recommendations on palliative radiotherapy for oncologic emergencies in the setting of COVID-19 appear in a preprint version in Advances in Radiation Oncology, released by the American Society of Radiation Oncology.

Yang says the recommendations are a careful balance between the risk of COVID-19 exposure of staff and patients with the potential morbidity of delaying treatment.

“Everyone is conscious of decisions about whether patients need treatment now or can wait,” he told Medscape Medical News. “It’s a juggling act every single day, but by having this guideline in place, when we face the situation where we do have to make decisions, is helpful.”

The document aims to enable swift decisions based on best practice, including a three-tiered system prioritizing only “clinically urgent cases, in which delaying treatment would result in compromised outcomes or serious morbidity.”

“It’s brutal, that’s the only word for it. Not that I disagree with it,” commented Padraig Warde, MB BCh, professor, Department of Radiation Oncology, University of Toronto, and radiation oncologist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

Like many places, Toronto is not yet experiencing the COVID-19 burden of New York City, but Warde says the MSKCC guideline is useful for everyone. “Other centers should review it and see how they could deal with resource limitations,” he said. “It’s sobering and sad, but if you don’t have the staff to treat all patients, which particular patients do you choose to treat?”

In a nutshell, the MSKCC recommendations defines Tier 1 patients as having oncologic emergencies that require palliative RT, including “cord compression, symptomatic brain metastases requiring whole-brain radiotherapy, life-threatening tumor bleeding, and malignant airway obstruction.”

According to the decision-making guideline, patients in Tiers 2 and 3 would have their palliative RT delayed. This would include Tier 2 patients whose needs are not classified as emergencies, but who have either symptomatic disease for which RT is usually the standard of care or asymptomatic disease for which RT is recommended “to prevent imminent functional deficits.” Tier 3 would be symptomatic or asymptomatic patients for whom RT is “one of the effective treatment options.”

“Rationing is always very difficult because as physicians you always want to do everything you can for your patients but we really have to strike the balance on when to do what, said Yang. The plan that he authored anticipates both reduced availability of radiation therapists as well as aggressive attempts to limit patients’ infection exposure.

“If a patient’s radiation is being considered for delay due to COVID-19, other means are utilized to achieve the goal of palliation in the interim, and in addition to the tier system, this decision is also made on a case-by-case basis with departmental discussion on the risks and benefits,” he explained.

“There are layers of checks and balances for these decisions...Obviously for oncologic emergencies, radiation will be implemented. However for less urgent situations, bringing them into the hospital when there are other ways to achieve the same goal, potential risk of exposure to COVID-19 is higher than the benefit we would be able to provide.”

The document also recommends shorter courses of RT when radiation is deemed appropriate.

“We have good evidence showing shorter courses of radiation can effectively treat the goal of palliation compared to longer courses of radiation,” he explained. “Going through this pandemic actually forces radiation oncologists in the United States to put that evidence into practice. It’s not suboptimal care in the sense that we are achieving the same goal — palliation. This paper is to remind people there are equally effective courses of palliation we can be using.”

“[There’s] nothing like a crisis to get people to do the right thing,” commented Louis Potters, MD, professor and chair of radiation medicine at the Feinstein Institutes, the research arm of Northwell Health, New York’s largest healthcare provider.

Northwell Health has been at the epicenter of the New York outbreak of COVID-19. Potters writes on an ASTRO blog that, as of March 26, Northwell Health “has diagnosed 4399 positive COVID-19 patients, which is about 20% of New York state and 1.2% of all cases in the world. All cancer surgery was discontinued as of March 20 and all of our 23 hospitals are seeing COVID-19 admissions, and ICU care became the primary focus of the entire system. As of today, we have reserved one floor in two hospitals for non-COVID care such as trauma. That’s it.”

Before the crisis, radiation medicine at Northwell consisted of eight separate locations treating on average 280 EBRT cases a day, not including SBRT/SRS and brachytherapy cases. “That of course was 3 weeks ago,” he notes.

Commenting on the recommendations from the MSKCC group, Potters told Medscape Medical News that the primary goal “was to document what are acceptable alternatives for accelerated care.”

“Ironically, these guidelines represent best practices with evidence that — in a non–COVID-19 world — make sense for the majority of patients requiring palliative radiotherapy,” he said.

Potters said there has been hesitance to transition to shorter radiation treatments for several reasons.

“Historically, palliative radiotherapy has been delivered over 2 to 4 weeks with good results. And, as is typical in medicine, the transition to shorter course care is slowed by financial incentives to protract care,” he explained.

“In a value-based future where payment is based on outcomes, this transition to shorter care will evolve very quickly. But given the current COVID-19 crisis, and the risk to patients and staff, the incentive for shorter treatment courses has been thrust upon us and the MSKCC outline helps to define how to do this safely and with evidence-based expected efficacy.”
 

This article first appeared on Medscape.com.

A major comprehensive cancer center at the epicenter of the New York City COVID-19 storm is preparing to scale back palliative radiation therapy (RT), anticipating a focus on only oncologic emergencies.

“We’re not there yet, but we’re anticipating when the time comes in the next few weeks that we will have a system in place so we are able to handle it,” Jonathan Yang, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, told Medscape Medical News.

Yang and an expert panel of colleagues reviewed high-impact evidence, prior systematic reviews, and national guidelines to compile a set of recommendations for triage and shortened palliative rRT at their center, should the need arise.

The recommendations on palliative radiotherapy for oncologic emergencies in the setting of COVID-19 appear in a preprint version in Advances in Radiation Oncology, released by the American Society of Radiation Oncology.

Yang says the recommendations are a careful balance between the risk of COVID-19 exposure of staff and patients with the potential morbidity of delaying treatment.

“Everyone is conscious of decisions about whether patients need treatment now or can wait,” he told Medscape Medical News. “It’s a juggling act every single day, but by having this guideline in place, when we face the situation where we do have to make decisions, is helpful.”

The document aims to enable swift decisions based on best practice, including a three-tiered system prioritizing only “clinically urgent cases, in which delaying treatment would result in compromised outcomes or serious morbidity.”

“It’s brutal, that’s the only word for it. Not that I disagree with it,” commented Padraig Warde, MB BCh, professor, Department of Radiation Oncology, University of Toronto, and radiation oncologist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

Like many places, Toronto is not yet experiencing the COVID-19 burden of New York City, but Warde says the MSKCC guideline is useful for everyone. “Other centers should review it and see how they could deal with resource limitations,” he said. “It’s sobering and sad, but if you don’t have the staff to treat all patients, which particular patients do you choose to treat?”

In a nutshell, the MSKCC recommendations defines Tier 1 patients as having oncologic emergencies that require palliative RT, including “cord compression, symptomatic brain metastases requiring whole-brain radiotherapy, life-threatening tumor bleeding, and malignant airway obstruction.”

According to the decision-making guideline, patients in Tiers 2 and 3 would have their palliative RT delayed. This would include Tier 2 patients whose needs are not classified as emergencies, but who have either symptomatic disease for which RT is usually the standard of care or asymptomatic disease for which RT is recommended “to prevent imminent functional deficits.” Tier 3 would be symptomatic or asymptomatic patients for whom RT is “one of the effective treatment options.”

“Rationing is always very difficult because as physicians you always want to do everything you can for your patients but we really have to strike the balance on when to do what, said Yang. The plan that he authored anticipates both reduced availability of radiation therapists as well as aggressive attempts to limit patients’ infection exposure.

“If a patient’s radiation is being considered for delay due to COVID-19, other means are utilized to achieve the goal of palliation in the interim, and in addition to the tier system, this decision is also made on a case-by-case basis with departmental discussion on the risks and benefits,” he explained.

“There are layers of checks and balances for these decisions...Obviously for oncologic emergencies, radiation will be implemented. However for less urgent situations, bringing them into the hospital when there are other ways to achieve the same goal, potential risk of exposure to COVID-19 is higher than the benefit we would be able to provide.”

The document also recommends shorter courses of RT when radiation is deemed appropriate.

“We have good evidence showing shorter courses of radiation can effectively treat the goal of palliation compared to longer courses of radiation,” he explained. “Going through this pandemic actually forces radiation oncologists in the United States to put that evidence into practice. It’s not suboptimal care in the sense that we are achieving the same goal — palliation. This paper is to remind people there are equally effective courses of palliation we can be using.”

“[There’s] nothing like a crisis to get people to do the right thing,” commented Louis Potters, MD, professor and chair of radiation medicine at the Feinstein Institutes, the research arm of Northwell Health, New York’s largest healthcare provider.

Northwell Health has been at the epicenter of the New York outbreak of COVID-19. Potters writes on an ASTRO blog that, as of March 26, Northwell Health “has diagnosed 4399 positive COVID-19 patients, which is about 20% of New York state and 1.2% of all cases in the world. All cancer surgery was discontinued as of March 20 and all of our 23 hospitals are seeing COVID-19 admissions, and ICU care became the primary focus of the entire system. As of today, we have reserved one floor in two hospitals for non-COVID care such as trauma. That’s it.”

Before the crisis, radiation medicine at Northwell consisted of eight separate locations treating on average 280 EBRT cases a day, not including SBRT/SRS and brachytherapy cases. “That of course was 3 weeks ago,” he notes.

Commenting on the recommendations from the MSKCC group, Potters told Medscape Medical News that the primary goal “was to document what are acceptable alternatives for accelerated care.”

“Ironically, these guidelines represent best practices with evidence that — in a non–COVID-19 world — make sense for the majority of patients requiring palliative radiotherapy,” he said.

Potters said there has been hesitance to transition to shorter radiation treatments for several reasons.

“Historically, palliative radiotherapy has been delivered over 2 to 4 weeks with good results. And, as is typical in medicine, the transition to shorter course care is slowed by financial incentives to protract care,” he explained.

“In a value-based future where payment is based on outcomes, this transition to shorter care will evolve very quickly. But given the current COVID-19 crisis, and the risk to patients and staff, the incentive for shorter treatment courses has been thrust upon us and the MSKCC outline helps to define how to do this safely and with evidence-based expected efficacy.”
 

This article first appeared on Medscape.com.

Influenza activity measures dropped during the week ending March 28, but the percentage of deaths attributed to pneumonia and influenza (P&I) has risen into epidemic territory, according to the Centers for Disease Control and Prevention.

This influenza news, however, needs to be viewed through a COVID-19 lens.

The P&I mortality data are reported together and are always a week behind the other measures, in this case covering the week ending March 21, but they show influenza deaths dropping to 0.8% as the overall P&I rate rose from 7.4% to 8.2%, a pneumonia-fueled increase that was “likely associated with COVID-19 rather than influenza,” the CDC’s influenza division noted.

The two main activity measures, at least, are on the same page for the first time since the end of February.

The rate of outpatient visits for influenza-like illness (ILI) had been dropping up to that point but then rose for an unprecedented third time this season, a change probably brought about by COVID-related health care–seeking behavior, the influenza division reported in its weekly FluView report.

This corresponding third drop in ILI activity brought the rate down to 5.4% this week from 6.2% the previous week, the CDC reported. The two previous high points occurred during the weeks ending Dec. 28 (7.0%) and Feb. 8 (6.7%)

The COVID-related changes, such as increased use of telemedicine and social distancing, “impact data from [the Outpatient Influenza-Like Illness Surveillance Network] in ways that are difficult to differentiate from changes in illness levels and should be interpreted with caution,” the CDC investigators noted.

The other activity measure, positive tests of respiratory specimens for influenza at clinical laboratories, continued the decline that started in mid-February by falling from 7.3% to 2.1%, its lowest rate since October, CDC data show.

Overall flu-related deaths may be down, but mortality in children continued at a near-record level. Seven such deaths were reported this past week, which brings the total for the 2019-2020 season to 162. “This number is higher than recorded at the same time in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

rfranki@mdedge.com

Influenza activity measures dropped during the week ending March 28, but the percentage of deaths attributed to pneumonia and influenza (P&I) has risen into epidemic territory, according to the Centers for Disease Control and Prevention.

This influenza news, however, needs to be viewed through a COVID-19 lens.

The P&I mortality data are reported together and are always a week behind the other measures, in this case covering the week ending March 21, but they show influenza deaths dropping to 0.8% as the overall P&I rate rose from 7.4% to 8.2%, a pneumonia-fueled increase that was “likely associated with COVID-19 rather than influenza,” the CDC’s influenza division noted.

The two main activity measures, at least, are on the same page for the first time since the end of February.

The rate of outpatient visits for influenza-like illness (ILI) had been dropping up to that point but then rose for an unprecedented third time this season, a change probably brought about by COVID-related health care–seeking behavior, the influenza division reported in its weekly FluView report.

This corresponding third drop in ILI activity brought the rate down to 5.4% this week from 6.2% the previous week, the CDC reported. The two previous high points occurred during the weeks ending Dec. 28 (7.0%) and Feb. 8 (6.7%)

The COVID-related changes, such as increased use of telemedicine and social distancing, “impact data from [the Outpatient Influenza-Like Illness Surveillance Network] in ways that are difficult to differentiate from changes in illness levels and should be interpreted with caution,” the CDC investigators noted.

The other activity measure, positive tests of respiratory specimens for influenza at clinical laboratories, continued the decline that started in mid-February by falling from 7.3% to 2.1%, its lowest rate since October, CDC data show.

Overall flu-related deaths may be down, but mortality in children continued at a near-record level. Seven such deaths were reported this past week, which brings the total for the 2019-2020 season to 162. “This number is higher than recorded at the same time in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

rfranki@mdedge.com

Influenza activity measures dropped during the week ending March 28, but the percentage of deaths attributed to pneumonia and influenza (P&I) has risen into epidemic territory, according to the Centers for Disease Control and Prevention.

This influenza news, however, needs to be viewed through a COVID-19 lens.

The P&I mortality data are reported together and are always a week behind the other measures, in this case covering the week ending March 21, but they show influenza deaths dropping to 0.8% as the overall P&I rate rose from 7.4% to 8.2%, a pneumonia-fueled increase that was “likely associated with COVID-19 rather than influenza,” the CDC’s influenza division noted.

The two main activity measures, at least, are on the same page for the first time since the end of February.

The rate of outpatient visits for influenza-like illness (ILI) had been dropping up to that point but then rose for an unprecedented third time this season, a change probably brought about by COVID-related health care–seeking behavior, the influenza division reported in its weekly FluView report.

This corresponding third drop in ILI activity brought the rate down to 5.4% this week from 6.2% the previous week, the CDC reported. The two previous high points occurred during the weeks ending Dec. 28 (7.0%) and Feb. 8 (6.7%)

The COVID-related changes, such as increased use of telemedicine and social distancing, “impact data from [the Outpatient Influenza-Like Illness Surveillance Network] in ways that are difficult to differentiate from changes in illness levels and should be interpreted with caution,” the CDC investigators noted.

The other activity measure, positive tests of respiratory specimens for influenza at clinical laboratories, continued the decline that started in mid-February by falling from 7.3% to 2.1%, its lowest rate since October, CDC data show.

Overall flu-related deaths may be down, but mortality in children continued at a near-record level. Seven such deaths were reported this past week, which brings the total for the 2019-2020 season to 162. “This number is higher than recorded at the same time in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

rfranki@mdedge.com

Recent research has shown that severe cases of COVID-19 show an excessive immune response and a strong cytokine storm, which may include high levels of granulocyte-macrophage colony-stimulating factor (GSF) and interleukin-6 (IL-6). Following up on that research, investigators from China reported the first case of COVID-19 in a patient with multiple myeloma (MM) who was successfully treated with the humanized anti–IL-6 receptor antibody tocilizumab (an off-label use in the United States). The exceptional case report was published online in Blood Advances, an American Society of Hematology journal.

A 60-year-old man working in Wuhan, China, developed chest tightness without fever and cough on Feb. 1, 2020, and was admitted immediately after computed tomography (CT) imaging of his chest showed multiple ground-glass opacities and pneumatocele located in both subpleural spaces. He received 400 mg of moxifloxacin IV daily for 3 days while swab specimens were collected and tested by real-time reverse transcriptase–polymerase chain reaction. A positive result for SARS-CoV-2 infection was received 3 days later. The patient was subsequently given 200-mg umifenovir (Arbidol) tablets orally, three times daily, for antiviral treatment.

The patient had a history of symptomatic MM, which was diagnosed in 2015. The patient received two cycles of induction chemotherapy consisting of bortezomib, thalidomide, and dexamethasone, and his symptoms completely disappeared. After that, he received thalidomide for maintenance.

Chest CT imaging on hospital day 8 showed that the bilateral, multiple ground-glass opacities from the first scan remained, and laboratory investigations revealed a high level of serum IL-6. On hospital day 9, the patient was given a single, one-time dose of 8 mg/kg tocilizumab, administered by IV. On hospital day 12, his chest tightness disappeared. “After tocilizumab administration, the IL-6 level decreased gradually over the following 10 days (from 121.59 to 20.81 pg/mL), then increased rapidly to the peak (317.38 pg/mL), and then decreased to a low level (117.10 pg/mL). The transient rebounding of the IL-6 level to the peak does not mean COVID-19 relapse: Instead, this might be attributed to the recovery of the normal T cells,” the authors wrote.

On hospital day 19, the patient’s chest CT scan showed that the range of ground-glass opacities had obviously decreased, and he was declared cured and discharged from the hospital. The patient had no symptoms of MM, and related laboratory findings were all in normal ranges, according to the researchers.

“This case is the first to prove that tocilizumab is effective in the treatment of COVID-19 in MM with obvious clinical recovery; however, randomized controlled trials are needed to determine the safety and efficacy of tocilizumab,” the researchers concluded.

The authors declared that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhang X et al. Blood Adv. 2020;4(7):1307-10.

Recent research has shown that severe cases of COVID-19 show an excessive immune response and a strong cytokine storm, which may include high levels of granulocyte-macrophage colony-stimulating factor (GSF) and interleukin-6 (IL-6). Following up on that research, investigators from China reported the first case of COVID-19 in a patient with multiple myeloma (MM) who was successfully treated with the humanized anti–IL-6 receptor antibody tocilizumab (an off-label use in the United States). The exceptional case report was published online in Blood Advances, an American Society of Hematology journal.

A 60-year-old man working in Wuhan, China, developed chest tightness without fever and cough on Feb. 1, 2020, and was admitted immediately after computed tomography (CT) imaging of his chest showed multiple ground-glass opacities and pneumatocele located in both subpleural spaces. He received 400 mg of moxifloxacin IV daily for 3 days while swab specimens were collected and tested by real-time reverse transcriptase–polymerase chain reaction. A positive result for SARS-CoV-2 infection was received 3 days later. The patient was subsequently given 200-mg umifenovir (Arbidol) tablets orally, three times daily, for antiviral treatment.

The patient had a history of symptomatic MM, which was diagnosed in 2015. The patient received two cycles of induction chemotherapy consisting of bortezomib, thalidomide, and dexamethasone, and his symptoms completely disappeared. After that, he received thalidomide for maintenance.

Chest CT imaging on hospital day 8 showed that the bilateral, multiple ground-glass opacities from the first scan remained, and laboratory investigations revealed a high level of serum IL-6. On hospital day 9, the patient was given a single, one-time dose of 8 mg/kg tocilizumab, administered by IV. On hospital day 12, his chest tightness disappeared. “After tocilizumab administration, the IL-6 level decreased gradually over the following 10 days (from 121.59 to 20.81 pg/mL), then increased rapidly to the peak (317.38 pg/mL), and then decreased to a low level (117.10 pg/mL). The transient rebounding of the IL-6 level to the peak does not mean COVID-19 relapse: Instead, this might be attributed to the recovery of the normal T cells,” the authors wrote.

On hospital day 19, the patient’s chest CT scan showed that the range of ground-glass opacities had obviously decreased, and he was declared cured and discharged from the hospital. The patient had no symptoms of MM, and related laboratory findings were all in normal ranges, according to the researchers.

“This case is the first to prove that tocilizumab is effective in the treatment of COVID-19 in MM with obvious clinical recovery; however, randomized controlled trials are needed to determine the safety and efficacy of tocilizumab,” the researchers concluded.

The authors declared that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhang X et al. Blood Adv. 2020;4(7):1307-10.

Recent research has shown that severe cases of COVID-19 show an excessive immune response and a strong cytokine storm, which may include high levels of granulocyte-macrophage colony-stimulating factor (GSF) and interleukin-6 (IL-6). Following up on that research, investigators from China reported the first case of COVID-19 in a patient with multiple myeloma (MM) who was successfully treated with the humanized anti–IL-6 receptor antibody tocilizumab (an off-label use in the United States). The exceptional case report was published online in Blood Advances, an American Society of Hematology journal.

A 60-year-old man working in Wuhan, China, developed chest tightness without fever and cough on Feb. 1, 2020, and was admitted immediately after computed tomography (CT) imaging of his chest showed multiple ground-glass opacities and pneumatocele located in both subpleural spaces. He received 400 mg of moxifloxacin IV daily for 3 days while swab specimens were collected and tested by real-time reverse transcriptase–polymerase chain reaction. A positive result for SARS-CoV-2 infection was received 3 days later. The patient was subsequently given 200-mg umifenovir (Arbidol) tablets orally, three times daily, for antiviral treatment.

The patient had a history of symptomatic MM, which was diagnosed in 2015. The patient received two cycles of induction chemotherapy consisting of bortezomib, thalidomide, and dexamethasone, and his symptoms completely disappeared. After that, he received thalidomide for maintenance.

Chest CT imaging on hospital day 8 showed that the bilateral, multiple ground-glass opacities from the first scan remained, and laboratory investigations revealed a high level of serum IL-6. On hospital day 9, the patient was given a single, one-time dose of 8 mg/kg tocilizumab, administered by IV. On hospital day 12, his chest tightness disappeared. “After tocilizumab administration, the IL-6 level decreased gradually over the following 10 days (from 121.59 to 20.81 pg/mL), then increased rapidly to the peak (317.38 pg/mL), and then decreased to a low level (117.10 pg/mL). The transient rebounding of the IL-6 level to the peak does not mean COVID-19 relapse: Instead, this might be attributed to the recovery of the normal T cells,” the authors wrote.

On hospital day 19, the patient’s chest CT scan showed that the range of ground-glass opacities had obviously decreased, and he was declared cured and discharged from the hospital. The patient had no symptoms of MM, and related laboratory findings were all in normal ranges, according to the researchers.

“This case is the first to prove that tocilizumab is effective in the treatment of COVID-19 in MM with obvious clinical recovery; however, randomized controlled trials are needed to determine the safety and efficacy of tocilizumab,” the researchers concluded.

The authors declared that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhang X et al. Blood Adv. 2020;4(7):1307-10.

Danielle Scheurer, MD, MSRC, SFHM, is the chief quality officer and professor of medicine at the Medical University of South Carolina, Charleston. She is the outgoing medical editor of The Hospitalist, and the new president of the Society of Hospital Medicine. She assumes the role from immediate past-president Christopher Frost, MD, SFHM.

Brennan Wesley, Medical University of South Carolina

As a hospitalist for 17 years, Dr. Scheurer has practiced in both academic tertiary care, as well as community hospital settings. As a chief quality officer, she has worked to improve quality and safety in all health care settings, including ambulatory care, nursing homes, home health, and surgical centers. She brings a broad experience in the medical industry to the SHM presidency.
 

At what point in your education/training did you decide to practice hospital medicine?

I always loved inpatient medicine throughout my entire meds-peds residency training at Duke University in Durham, N.C. I honestly never had a doubt that hospital medicine was going to be my career. What appeals to me is that each hour and each day is different, which is invigorating.

What are your favorite aspects of clinical practice and of your administrative duties?

I like doing both administrative work and clinical work because I believe having a view of both worlds helps me to be a better physician and a better administrator. It greatly helps me bring realistic solutions to the front lines since I have a good understanding of what needs to be done, but also what is likely to actually work.

As president of SHM over the next year, what are your primary goals?

My primary goal is to deeply connect with the SHM membership and understand what their needs are. There is enormous change happening in the medical industry, and SHM should be a conduit for information sharing, resources, and most importantly, answers to all our difficult problems. Hospitalists are critical to success for our hospitals and our communities during the COVID-19 pandemic. We must be able to give and receive information quickly and seamlessly to effectively help each other across the country and the world. SHM must be seen as a critical convener, especially in times of crisis.

Additionally, SHM has always fostered a “big tent” philosophy, so we will continue to explore ways to expand membership beyond “the core” of internal medicine, family medicine, and pediatrics and reach a better understanding of what our constituents need and how we can add value to their work lives and careers. In addition to expanding membership within our borders, other expansions already include working with international chapters and members with an “all teach, all learn” attitude to better understand mutually beneficial partnerships with international members. Through all these expansions, we will come closer to truly realizing our mission at SHM, which is to “promote exceptional care for hospitalized patients.”
 

You mention COVID-19. What resources is SHM offering to members?

We have opened up the SHM Learning Portal to help members and non-members address upcoming challenges, such as expanding ICU coverage or cross-training providers for hospital medicine. Several modules in SHM’s “Critical Care for the Hospitalist” series may be especially relevant during the COVID-19 crisis:

• Fluid Resuscitation in the Critically Ill
• Mechanical Ventilation Part I – The Basics
• Mechanical Ventilation Part II – Beyond the Basics
• Mechanical Ventilation Part III – ARDS

Finally, in this time when so many hospitalists are busy dealing with COVID-19, SHM is committed to offering valuable resources and is in the process of offering new material, including Twitter chats, webinars, blogs, and podcasts to help hospitalists share best practices. Please bookmark SHM’s compilation of COVID-19 resources at hospitalmedicine.org/coronavirus.

We also continue to forge ahead with our publications, The Hospitalist and the Journal of Hospital Medicine, by adding online content as it becomes available. Visit the COVID-19 news feed on The Hospitalist website at www.the-hospitalist.org/hospitalist/coronavirus-updates.

In this trying time, we can still connect as a community and continue to learn from each other. We encourage you to use SHM’s online community, HMX, to share resources and crowd-source solutions. Ideas for SHM resources can be submitted via email at ideas@hospitalmedicine.org.
 

What are some of the current challenges for hospital medicine?

The demands placed on hospitalists are greater than ever. With shortening length of stay, rising acuity and complexity, increasing administrative burdens, and high emphasis on care transitions, our skills (and our patience) need to rise to these increasing demands. As a member-based society, SHM (and the board of directors) seeks to ensure we are helping hospitalists be the very best they can be, regardless of hospitalist type or practice setting.

The good news is that we are still in high demand. Within the medical industry, there has been an explosive growth in the need for hospitalists, and we can now be found in almost every hospital setting in the United States. But as a current commodity, it is imperative that we continue to prove the value we are adding to our patients and their families, the systems in which we work, and the industry as a whole.
 

How will hospital medicine change in the next decade?

I believe one of the biggest changes we will see is the shift to ambulatory settings and the use of telehealth, and we all need to gain significant comfort with both to be effective.
 

Do you have any advice for students and residents interested in hospital medicine?

It is an incredibly dynamic and invigorating career; I can’t imagine doing anything else.

Danielle Scheurer, MD, MSRC, SFHM, is the chief quality officer and professor of medicine at the Medical University of South Carolina, Charleston. She is the outgoing medical editor of The Hospitalist, and the new president of the Society of Hospital Medicine. She assumes the role from immediate past-president Christopher Frost, MD, SFHM.

Brennan Wesley, Medical University of South Carolina

As a hospitalist for 17 years, Dr. Scheurer has practiced in both academic tertiary care, as well as community hospital settings. As a chief quality officer, she has worked to improve quality and safety in all health care settings, including ambulatory care, nursing homes, home health, and surgical centers. She brings a broad experience in the medical industry to the SHM presidency.
 

At what point in your education/training did you decide to practice hospital medicine?

I always loved inpatient medicine throughout my entire meds-peds residency training at Duke University in Durham, N.C. I honestly never had a doubt that hospital medicine was going to be my career. What appeals to me is that each hour and each day is different, which is invigorating.

What are your favorite aspects of clinical practice and of your administrative duties?

I like doing both administrative work and clinical work because I believe having a view of both worlds helps me to be a better physician and a better administrator. It greatly helps me bring realistic solutions to the front lines since I have a good understanding of what needs to be done, but also what is likely to actually work.

As president of SHM over the next year, what are your primary goals?

My primary goal is to deeply connect with the SHM membership and understand what their needs are. There is enormous change happening in the medical industry, and SHM should be a conduit for information sharing, resources, and most importantly, answers to all our difficult problems. Hospitalists are critical to success for our hospitals and our communities during the COVID-19 pandemic. We must be able to give and receive information quickly and seamlessly to effectively help each other across the country and the world. SHM must be seen as a critical convener, especially in times of crisis.

Additionally, SHM has always fostered a “big tent” philosophy, so we will continue to explore ways to expand membership beyond “the core” of internal medicine, family medicine, and pediatrics and reach a better understanding of what our constituents need and how we can add value to their work lives and careers. In addition to expanding membership within our borders, other expansions already include working with international chapters and members with an “all teach, all learn” attitude to better understand mutually beneficial partnerships with international members. Through all these expansions, we will come closer to truly realizing our mission at SHM, which is to “promote exceptional care for hospitalized patients.”
 

You mention COVID-19. What resources is SHM offering to members?

We have opened up the SHM Learning Portal to help members and non-members address upcoming challenges, such as expanding ICU coverage or cross-training providers for hospital medicine. Several modules in SHM’s “Critical Care for the Hospitalist” series may be especially relevant during the COVID-19 crisis:

• Fluid Resuscitation in the Critically Ill
• Mechanical Ventilation Part I – The Basics
• Mechanical Ventilation Part II – Beyond the Basics
• Mechanical Ventilation Part III – ARDS

Finally, in this time when so many hospitalists are busy dealing with COVID-19, SHM is committed to offering valuable resources and is in the process of offering new material, including Twitter chats, webinars, blogs, and podcasts to help hospitalists share best practices. Please bookmark SHM’s compilation of COVID-19 resources at hospitalmedicine.org/coronavirus.

We also continue to forge ahead with our publications, The Hospitalist and the Journal of Hospital Medicine, by adding online content as it becomes available. Visit the COVID-19 news feed on The Hospitalist website at www.the-hospitalist.org/hospitalist/coronavirus-updates.

In this trying time, we can still connect as a community and continue to learn from each other. We encourage you to use SHM’s online community, HMX, to share resources and crowd-source solutions. Ideas for SHM resources can be submitted via email at ideas@hospitalmedicine.org.
 

What are some of the current challenges for hospital medicine?

The demands placed on hospitalists are greater than ever. With shortening length of stay, rising acuity and complexity, increasing administrative burdens, and high emphasis on care transitions, our skills (and our patience) need to rise to these increasing demands. As a member-based society, SHM (and the board of directors) seeks to ensure we are helping hospitalists be the very best they can be, regardless of hospitalist type or practice setting.

The good news is that we are still in high demand. Within the medical industry, there has been an explosive growth in the need for hospitalists, and we can now be found in almost every hospital setting in the United States. But as a current commodity, it is imperative that we continue to prove the value we are adding to our patients and their families, the systems in which we work, and the industry as a whole.
 

How will hospital medicine change in the next decade?

I believe one of the biggest changes we will see is the shift to ambulatory settings and the use of telehealth, and we all need to gain significant comfort with both to be effective.
 

Do you have any advice for students and residents interested in hospital medicine?

It is an incredibly dynamic and invigorating career; I can’t imagine doing anything else.

Danielle Scheurer, MD, MSRC, SFHM, is the chief quality officer and professor of medicine at the Medical University of South Carolina, Charleston. She is the outgoing medical editor of The Hospitalist, and the new president of the Society of Hospital Medicine. She assumes the role from immediate past-president Christopher Frost, MD, SFHM.

Brennan Wesley, Medical University of South Carolina

As a hospitalist for 17 years, Dr. Scheurer has practiced in both academic tertiary care, as well as community hospital settings. As a chief quality officer, she has worked to improve quality and safety in all health care settings, including ambulatory care, nursing homes, home health, and surgical centers. She brings a broad experience in the medical industry to the SHM presidency.
 

At what point in your education/training did you decide to practice hospital medicine?

I always loved inpatient medicine throughout my entire meds-peds residency training at Duke University in Durham, N.C. I honestly never had a doubt that hospital medicine was going to be my career. What appeals to me is that each hour and each day is different, which is invigorating.

What are your favorite aspects of clinical practice and of your administrative duties?

I like doing both administrative work and clinical work because I believe having a view of both worlds helps me to be a better physician and a better administrator. It greatly helps me bring realistic solutions to the front lines since I have a good understanding of what needs to be done, but also what is likely to actually work.

As president of SHM over the next year, what are your primary goals?

My primary goal is to deeply connect with the SHM membership and understand what their needs are. There is enormous change happening in the medical industry, and SHM should be a conduit for information sharing, resources, and most importantly, answers to all our difficult problems. Hospitalists are critical to success for our hospitals and our communities during the COVID-19 pandemic. We must be able to give and receive information quickly and seamlessly to effectively help each other across the country and the world. SHM must be seen as a critical convener, especially in times of crisis.

Additionally, SHM has always fostered a “big tent” philosophy, so we will continue to explore ways to expand membership beyond “the core” of internal medicine, family medicine, and pediatrics and reach a better understanding of what our constituents need and how we can add value to their work lives and careers. In addition to expanding membership within our borders, other expansions already include working with international chapters and members with an “all teach, all learn” attitude to better understand mutually beneficial partnerships with international members. Through all these expansions, we will come closer to truly realizing our mission at SHM, which is to “promote exceptional care for hospitalized patients.”
 

You mention COVID-19. What resources is SHM offering to members?

We have opened up the SHM Learning Portal to help members and non-members address upcoming challenges, such as expanding ICU coverage or cross-training providers for hospital medicine. Several modules in SHM’s “Critical Care for the Hospitalist” series may be especially relevant during the COVID-19 crisis:

• Fluid Resuscitation in the Critically Ill
• Mechanical Ventilation Part I – The Basics
• Mechanical Ventilation Part II – Beyond the Basics
• Mechanical Ventilation Part III – ARDS

Finally, in this time when so many hospitalists are busy dealing with COVID-19, SHM is committed to offering valuable resources and is in the process of offering new material, including Twitter chats, webinars, blogs, and podcasts to help hospitalists share best practices. Please bookmark SHM’s compilation of COVID-19 resources at hospitalmedicine.org/coronavirus.

We also continue to forge ahead with our publications, The Hospitalist and the Journal of Hospital Medicine, by adding online content as it becomes available. Visit the COVID-19 news feed on The Hospitalist website at www.the-hospitalist.org/hospitalist/coronavirus-updates.

In this trying time, we can still connect as a community and continue to learn from each other. We encourage you to use SHM’s online community, HMX, to share resources and crowd-source solutions. Ideas for SHM resources can be submitted via email at ideas@hospitalmedicine.org.
 

What are some of the current challenges for hospital medicine?

The demands placed on hospitalists are greater than ever. With shortening length of stay, rising acuity and complexity, increasing administrative burdens, and high emphasis on care transitions, our skills (and our patience) need to rise to these increasing demands. As a member-based society, SHM (and the board of directors) seeks to ensure we are helping hospitalists be the very best they can be, regardless of hospitalist type or practice setting.

The good news is that we are still in high demand. Within the medical industry, there has been an explosive growth in the need for hospitalists, and we can now be found in almost every hospital setting in the United States. But as a current commodity, it is imperative that we continue to prove the value we are adding to our patients and their families, the systems in which we work, and the industry as a whole.
 

How will hospital medicine change in the next decade?

I believe one of the biggest changes we will see is the shift to ambulatory settings and the use of telehealth, and we all need to gain significant comfort with both to be effective.
 

Do you have any advice for students and residents interested in hospital medicine?

It is an incredibly dynamic and invigorating career; I can’t imagine doing anything else.

Curative treatments for metastatic prostate, renal, and urothelial cancer – and germ cell tumors – should continue as usual amid the COVID-19 pandemic, but “the risk/benefit ratio of a number of palliative and (neo)adjuvant treatments has to be reconsidered,” according to an editorial set to be published in European Urology.

“Regimens with a clear survival advantage should be prioritized, with curative treatments remaining mandatory,” wrote Silke Gillessen Sommer, MD, of Istituto Oncologico della Svizzera Italiana in Bellizona, Switzerland, and Thomas Powles, MD, of Barts Cancer Institute in London.

However, it may be appropriate to stop or delay therapies with modest or unproven survival benefits. “Delaying the start of therapy ... is an appropriate measure for many of the therapies in urology cancer,” they wrote.
 

Timely recommendations for oncologists

The COVID-19 pandemic is limiting resources for cancer, noted Zachery Reichert, MD, PhD, a urological oncologist and assistant professor at the University of Michigan, Ann Arbor, who was asked for his thoughts about the editorial.

Oncologists and oncology nurses are being shifted to care for COVID-19 patients, space once devoted to cancer care is being repurposed for the pandemic, and personal protective equipment needed to prepare chemotherapies is in short supply.

Meanwhile, cancer patients are at increased risk of dying from the virus (Lancet Oncol. 2020;21:335-7), so there’s a need to minimize their contact with the health care system to protect them from nosocomial infection, and a need to keep their immune system as strong as possible to fight it off.

To help cancer patients fight off infection and keep them out of the hospital, the editorialists recommended growth factors and prophylactic antibiotics after chemotherapy, palliative therapies at doses that avoid febrile neutropenia, discontinuing steroids or at least reducing their doses, and avoiding bisphosphonates if they involve potential COVID-19 exposure in medical facilities.

The advice in the editorial mirrors many of the discussions going on right now at the University of Michigan, Dr. Reichert said, and perhaps other oncology services across the United States.

It will come down to how severe the pandemic becomes locally, but he said it seems likely “a lot of us are going to be wearing a different hat for a while.”

Patients who have symptoms from a growing tumor will likely take precedence at the university, but treatment might be postponed until after COVID-19 peaks if tumors don’t affect quality of life. Also, bladder cancer surgery will probably remain urgent “because the longer you wait, the worse the outcomes,” but perhaps not prostate and kidney cancer surgery, where delay is safer, Dr. Reichert said.
 

Prostate/renal cancers and germ cell tumors

The editorialists noted that oral androgen receptor therapy should be preferred over chemotherapy for prostate cancer. Dr. Reichert explained that’s because androgen blockade is effective, requires less contact with health care providers, and doesn’t suppress the immune system or tie up hospital resources as much as chemotherapy. “In the world we are in right now, oral pills are a better choice,” he said.

The editorialists recommended against both nephrectomy for metastatic renal cancer and adjuvant therapy after orchidectomy for stage 1 germ cell tumors for similar reasons, and also because there’s minimal evidence of benefit.

Dr. Powles and Dr. Gillessen Sommer suggested considering a break from immune checkpoint inhibitors (ICIs) and oral vascular endothelial growth factors (VEGFs) for renal cancer patients who have been on them a year or two. It’s something that would be considered even under normal circumstances, Dr. Reichert explained, but it’s more urgent now to keep people out of the hospital. VEGFs should also be prioritized over ICIs; they have similar efficacy in renal cancer, but VEGFs are a pill.

They also called for oncologists to favor conventional-dose treatments for germ cell tumors over high-dose treatments, meaning bone marrow transplants or high-intensity chemotherapy. Amid a pandemic, the preference is for options “that don’t require a hospital bed,” Dr. Reichert said.
 

Urothelial cancer

Dr. Powles and Dr. Gillessen Sommer suggested not starting or continuing second-line chemotherapies in urothelial cancer patients refractory to first-line platinum-based therapies. The chance they will respond to second-line options is low, perhaps around 10%. That might have been enough before the pandemic, but it’s less justified amid resource shortages and the risk of COVID-19 in the infusion suite, Dr. Reichert explained.

Along the same lines, they also suggested reconsidering perioperative chemotherapy for urothelial cancer, and, if it’s still a go, recommended against going past three cycles, as the benefits in both scenarios are likely marginal. However, if COVID-19 cancels surgeries, neoadjuvant therapy might be the right – and only – call, according to the editorialists.

They recommended prioritizing ICIs over chemotherapy in patients with metastatic urothelial cancer who are positive for programmed death-ligand 1 (PD-L1). PD-L1–positive patients have a good chance of responding, and ICIs don’t suppress the immune system.

“Chemotherapy still has a slightly higher percent response, but right now, this is a better choice for” PD-L1-positive patients, Dr. Reichert said.

Dr. Gillessen Sommer and Dr. Powles disclosed ties to Bristol-Myers Squibb, Roche, and numerous other companies. Dr. Reichert has no relevant disclosures.

aotto@mdedge.com

SOURCE: Gillessen Sommer S, Powles T. “Advice regarding systemic therapy in patients with urological cancers during the COVID-19 pandemic.” Eur Urol. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/eururo/EURUROL-D-20-00382-1585928967060.pdf.

Curative treatments for metastatic prostate, renal, and urothelial cancer – and germ cell tumors – should continue as usual amid the COVID-19 pandemic, but “the risk/benefit ratio of a number of palliative and (neo)adjuvant treatments has to be reconsidered,” according to an editorial set to be published in European Urology.

“Regimens with a clear survival advantage should be prioritized, with curative treatments remaining mandatory,” wrote Silke Gillessen Sommer, MD, of Istituto Oncologico della Svizzera Italiana in Bellizona, Switzerland, and Thomas Powles, MD, of Barts Cancer Institute in London.

However, it may be appropriate to stop or delay therapies with modest or unproven survival benefits. “Delaying the start of therapy ... is an appropriate measure for many of the therapies in urology cancer,” they wrote.
 

Timely recommendations for oncologists

The COVID-19 pandemic is limiting resources for cancer, noted Zachery Reichert, MD, PhD, a urological oncologist and assistant professor at the University of Michigan, Ann Arbor, who was asked for his thoughts about the editorial.

Oncologists and oncology nurses are being shifted to care for COVID-19 patients, space once devoted to cancer care is being repurposed for the pandemic, and personal protective equipment needed to prepare chemotherapies is in short supply.

Meanwhile, cancer patients are at increased risk of dying from the virus (Lancet Oncol. 2020;21:335-7), so there’s a need to minimize their contact with the health care system to protect them from nosocomial infection, and a need to keep their immune system as strong as possible to fight it off.

To help cancer patients fight off infection and keep them out of the hospital, the editorialists recommended growth factors and prophylactic antibiotics after chemotherapy, palliative therapies at doses that avoid febrile neutropenia, discontinuing steroids or at least reducing their doses, and avoiding bisphosphonates if they involve potential COVID-19 exposure in medical facilities.

The advice in the editorial mirrors many of the discussions going on right now at the University of Michigan, Dr. Reichert said, and perhaps other oncology services across the United States.

It will come down to how severe the pandemic becomes locally, but he said it seems likely “a lot of us are going to be wearing a different hat for a while.”

Patients who have symptoms from a growing tumor will likely take precedence at the university, but treatment might be postponed until after COVID-19 peaks if tumors don’t affect quality of life. Also, bladder cancer surgery will probably remain urgent “because the longer you wait, the worse the outcomes,” but perhaps not prostate and kidney cancer surgery, where delay is safer, Dr. Reichert said.
 

Prostate/renal cancers and germ cell tumors

The editorialists noted that oral androgen receptor therapy should be preferred over chemotherapy for prostate cancer. Dr. Reichert explained that’s because androgen blockade is effective, requires less contact with health care providers, and doesn’t suppress the immune system or tie up hospital resources as much as chemotherapy. “In the world we are in right now, oral pills are a better choice,” he said.

The editorialists recommended against both nephrectomy for metastatic renal cancer and adjuvant therapy after orchidectomy for stage 1 germ cell tumors for similar reasons, and also because there’s minimal evidence of benefit.

Dr. Powles and Dr. Gillessen Sommer suggested considering a break from immune checkpoint inhibitors (ICIs) and oral vascular endothelial growth factors (VEGFs) for renal cancer patients who have been on them a year or two. It’s something that would be considered even under normal circumstances, Dr. Reichert explained, but it’s more urgent now to keep people out of the hospital. VEGFs should also be prioritized over ICIs; they have similar efficacy in renal cancer, but VEGFs are a pill.

They also called for oncologists to favor conventional-dose treatments for germ cell tumors over high-dose treatments, meaning bone marrow transplants or high-intensity chemotherapy. Amid a pandemic, the preference is for options “that don’t require a hospital bed,” Dr. Reichert said.
 

Urothelial cancer

Dr. Powles and Dr. Gillessen Sommer suggested not starting or continuing second-line chemotherapies in urothelial cancer patients refractory to first-line platinum-based therapies. The chance they will respond to second-line options is low, perhaps around 10%. That might have been enough before the pandemic, but it’s less justified amid resource shortages and the risk of COVID-19 in the infusion suite, Dr. Reichert explained.

Along the same lines, they also suggested reconsidering perioperative chemotherapy for urothelial cancer, and, if it’s still a go, recommended against going past three cycles, as the benefits in both scenarios are likely marginal. However, if COVID-19 cancels surgeries, neoadjuvant therapy might be the right – and only – call, according to the editorialists.

They recommended prioritizing ICIs over chemotherapy in patients with metastatic urothelial cancer who are positive for programmed death-ligand 1 (PD-L1). PD-L1–positive patients have a good chance of responding, and ICIs don’t suppress the immune system.

“Chemotherapy still has a slightly higher percent response, but right now, this is a better choice for” PD-L1-positive patients, Dr. Reichert said.

Dr. Gillessen Sommer and Dr. Powles disclosed ties to Bristol-Myers Squibb, Roche, and numerous other companies. Dr. Reichert has no relevant disclosures.

aotto@mdedge.com

SOURCE: Gillessen Sommer S, Powles T. “Advice regarding systemic therapy in patients with urological cancers during the COVID-19 pandemic.” Eur Urol. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/eururo/EURUROL-D-20-00382-1585928967060.pdf.

Curative treatments for metastatic prostate, renal, and urothelial cancer – and germ cell tumors – should continue as usual amid the COVID-19 pandemic, but “the risk/benefit ratio of a number of palliative and (neo)adjuvant treatments has to be reconsidered,” according to an editorial set to be published in European Urology.

“Regimens with a clear survival advantage should be prioritized, with curative treatments remaining mandatory,” wrote Silke Gillessen Sommer, MD, of Istituto Oncologico della Svizzera Italiana in Bellizona, Switzerland, and Thomas Powles, MD, of Barts Cancer Institute in London.

However, it may be appropriate to stop or delay therapies with modest or unproven survival benefits. “Delaying the start of therapy ... is an appropriate measure for many of the therapies in urology cancer,” they wrote.
 

Timely recommendations for oncologists

The COVID-19 pandemic is limiting resources for cancer, noted Zachery Reichert, MD, PhD, a urological oncologist and assistant professor at the University of Michigan, Ann Arbor, who was asked for his thoughts about the editorial.

Oncologists and oncology nurses are being shifted to care for COVID-19 patients, space once devoted to cancer care is being repurposed for the pandemic, and personal protective equipment needed to prepare chemotherapies is in short supply.

Meanwhile, cancer patients are at increased risk of dying from the virus (Lancet Oncol. 2020;21:335-7), so there’s a need to minimize their contact with the health care system to protect them from nosocomial infection, and a need to keep their immune system as strong as possible to fight it off.

To help cancer patients fight off infection and keep them out of the hospital, the editorialists recommended growth factors and prophylactic antibiotics after chemotherapy, palliative therapies at doses that avoid febrile neutropenia, discontinuing steroids or at least reducing their doses, and avoiding bisphosphonates if they involve potential COVID-19 exposure in medical facilities.

The advice in the editorial mirrors many of the discussions going on right now at the University of Michigan, Dr. Reichert said, and perhaps other oncology services across the United States.

It will come down to how severe the pandemic becomes locally, but he said it seems likely “a lot of us are going to be wearing a different hat for a while.”

Patients who have symptoms from a growing tumor will likely take precedence at the university, but treatment might be postponed until after COVID-19 peaks if tumors don’t affect quality of life. Also, bladder cancer surgery will probably remain urgent “because the longer you wait, the worse the outcomes,” but perhaps not prostate and kidney cancer surgery, where delay is safer, Dr. Reichert said.
 

Prostate/renal cancers and germ cell tumors

The editorialists noted that oral androgen receptor therapy should be preferred over chemotherapy for prostate cancer. Dr. Reichert explained that’s because androgen blockade is effective, requires less contact with health care providers, and doesn’t suppress the immune system or tie up hospital resources as much as chemotherapy. “In the world we are in right now, oral pills are a better choice,” he said.

The editorialists recommended against both nephrectomy for metastatic renal cancer and adjuvant therapy after orchidectomy for stage 1 germ cell tumors for similar reasons, and also because there’s minimal evidence of benefit.

Dr. Powles and Dr. Gillessen Sommer suggested considering a break from immune checkpoint inhibitors (ICIs) and oral vascular endothelial growth factors (VEGFs) for renal cancer patients who have been on them a year or two. It’s something that would be considered even under normal circumstances, Dr. Reichert explained, but it’s more urgent now to keep people out of the hospital. VEGFs should also be prioritized over ICIs; they have similar efficacy in renal cancer, but VEGFs are a pill.

They also called for oncologists to favor conventional-dose treatments for germ cell tumors over high-dose treatments, meaning bone marrow transplants or high-intensity chemotherapy. Amid a pandemic, the preference is for options “that don’t require a hospital bed,” Dr. Reichert said.
 

Urothelial cancer

Dr. Powles and Dr. Gillessen Sommer suggested not starting or continuing second-line chemotherapies in urothelial cancer patients refractory to first-line platinum-based therapies. The chance they will respond to second-line options is low, perhaps around 10%. That might have been enough before the pandemic, but it’s less justified amid resource shortages and the risk of COVID-19 in the infusion suite, Dr. Reichert explained.

Along the same lines, they also suggested reconsidering perioperative chemotherapy for urothelial cancer, and, if it’s still a go, recommended against going past three cycles, as the benefits in both scenarios are likely marginal. However, if COVID-19 cancels surgeries, neoadjuvant therapy might be the right – and only – call, according to the editorialists.

They recommended prioritizing ICIs over chemotherapy in patients with metastatic urothelial cancer who are positive for programmed death-ligand 1 (PD-L1). PD-L1–positive patients have a good chance of responding, and ICIs don’t suppress the immune system.

“Chemotherapy still has a slightly higher percent response, but right now, this is a better choice for” PD-L1-positive patients, Dr. Reichert said.

Dr. Gillessen Sommer and Dr. Powles disclosed ties to Bristol-Myers Squibb, Roche, and numerous other companies. Dr. Reichert has no relevant disclosures.

aotto@mdedge.com

SOURCE: Gillessen Sommer S, Powles T. “Advice regarding systemic therapy in patients with urological cancers during the COVID-19 pandemic.” Eur Urol. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/eururo/EURUROL-D-20-00382-1585928967060.pdf.

In mid-March, the Society of Hospital Medicine board of directors concluded that it was impossible for SHM to move forward with Hospital Medicine 2020 because of the continued spread of virus that causes Coronavirus Disease 2019 (COVID-19).

Given the most recent information available from the Centers for Disease Control & Prevention and the World Health Organization about the evolving global pandemic and the number of institutions that had travel bans in place, SHM leadership concluded that canceling the Annual Conference was the only path forward.

“Canceling the conference during this unprecedented time is the right thing to do,” said Benji K. Mathews, MD, SFHM, CLHM, course director for HM20. “With the evolving circumstances out of our control, there were risks to our community as it would have gathered, communities we connect with on our travels, and our home communities and hospitals – canceling was the best way to mitigate these risks. Through it all, I couldn’t have asked for a better leadership team and the larger SHM community for their support.”

Because hospitalists are on the front lines of patient care at their institutions, they will be needed more than ever as the pandemic continues to grow in order to manage care of hospitalized patients with COVID-19 and other illnesses. As the only medical society dedicated to hospital medicine, SHM will continue to support hospitalists with resources and research specific to COVID-19 and its impact on the practice of hospital medicine.

SHM is aware that this necessary cancellation impacts many from both a financial and logistical perspective. As such, SHM will refund all conference registration fees for HM20 in full. SHM is also providing the opportunity to defer your HM20 registration to HM21, taking place May 4-7, 2021 in Las Vegas, or Pediatric Hospital Medicine 2020, taking place July 23-26, 2020 in Lake Buena Vista, Fla.

For accommodation or travel cancellations, SHM requests that individuals please refer to their respective hotel or carrier’s customer service team and related cancellation policies.

To provide the world-class education that conference attendees have come to expect from SHM over the years, the SHM team is exploring virtual options to offer select content originally anticipated at HM20. SHM also offers online education via the SHM Learning Portal and the new SHM Education app.

Visit shmannualconference.org/faqs for a full list of FAQs. For additional questions, please contact meetings@hospitalmedicine.org.

SHM will continue to monitor the COVID-19 pandemic and provide hospitalists with useful resources in this time of need at hospitalmedicine.org/coronavirus. For news coverage of COVID-19, visit https://www.the-hospitalist.org/hospitalist/coronavirus-updates.

In mid-March, the Society of Hospital Medicine board of directors concluded that it was impossible for SHM to move forward with Hospital Medicine 2020 because of the continued spread of virus that causes Coronavirus Disease 2019 (COVID-19).

Given the most recent information available from the Centers for Disease Control & Prevention and the World Health Organization about the evolving global pandemic and the number of institutions that had travel bans in place, SHM leadership concluded that canceling the Annual Conference was the only path forward.

“Canceling the conference during this unprecedented time is the right thing to do,” said Benji K. Mathews, MD, SFHM, CLHM, course director for HM20. “With the evolving circumstances out of our control, there were risks to our community as it would have gathered, communities we connect with on our travels, and our home communities and hospitals – canceling was the best way to mitigate these risks. Through it all, I couldn’t have asked for a better leadership team and the larger SHM community for their support.”

Because hospitalists are on the front lines of patient care at their institutions, they will be needed more than ever as the pandemic continues to grow in order to manage care of hospitalized patients with COVID-19 and other illnesses. As the only medical society dedicated to hospital medicine, SHM will continue to support hospitalists with resources and research specific to COVID-19 and its impact on the practice of hospital medicine.

SHM is aware that this necessary cancellation impacts many from both a financial and logistical perspective. As such, SHM will refund all conference registration fees for HM20 in full. SHM is also providing the opportunity to defer your HM20 registration to HM21, taking place May 4-7, 2021 in Las Vegas, or Pediatric Hospital Medicine 2020, taking place July 23-26, 2020 in Lake Buena Vista, Fla.

For accommodation or travel cancellations, SHM requests that individuals please refer to their respective hotel or carrier’s customer service team and related cancellation policies.

To provide the world-class education that conference attendees have come to expect from SHM over the years, the SHM team is exploring virtual options to offer select content originally anticipated at HM20. SHM also offers online education via the SHM Learning Portal and the new SHM Education app.

Visit shmannualconference.org/faqs for a full list of FAQs. For additional questions, please contact meetings@hospitalmedicine.org.

SHM will continue to monitor the COVID-19 pandemic and provide hospitalists with useful resources in this time of need at hospitalmedicine.org/coronavirus. For news coverage of COVID-19, visit https://www.the-hospitalist.org/hospitalist/coronavirus-updates.

In mid-March, the Society of Hospital Medicine board of directors concluded that it was impossible for SHM to move forward with Hospital Medicine 2020 because of the continued spread of virus that causes Coronavirus Disease 2019 (COVID-19).

Given the most recent information available from the Centers for Disease Control & Prevention and the World Health Organization about the evolving global pandemic and the number of institutions that had travel bans in place, SHM leadership concluded that canceling the Annual Conference was the only path forward.

“Canceling the conference during this unprecedented time is the right thing to do,” said Benji K. Mathews, MD, SFHM, CLHM, course director for HM20. “With the evolving circumstances out of our control, there were risks to our community as it would have gathered, communities we connect with on our travels, and our home communities and hospitals – canceling was the best way to mitigate these risks. Through it all, I couldn’t have asked for a better leadership team and the larger SHM community for their support.”

Because hospitalists are on the front lines of patient care at their institutions, they will be needed more than ever as the pandemic continues to grow in order to manage care of hospitalized patients with COVID-19 and other illnesses. As the only medical society dedicated to hospital medicine, SHM will continue to support hospitalists with resources and research specific to COVID-19 and its impact on the practice of hospital medicine.

SHM is aware that this necessary cancellation impacts many from both a financial and logistical perspective. As such, SHM will refund all conference registration fees for HM20 in full. SHM is also providing the opportunity to defer your HM20 registration to HM21, taking place May 4-7, 2021 in Las Vegas, or Pediatric Hospital Medicine 2020, taking place July 23-26, 2020 in Lake Buena Vista, Fla.

For accommodation or travel cancellations, SHM requests that individuals please refer to their respective hotel or carrier’s customer service team and related cancellation policies.

To provide the world-class education that conference attendees have come to expect from SHM over the years, the SHM team is exploring virtual options to offer select content originally anticipated at HM20. SHM also offers online education via the SHM Learning Portal and the new SHM Education app.

Visit shmannualconference.org/faqs for a full list of FAQs. For additional questions, please contact meetings@hospitalmedicine.org.

SHM will continue to monitor the COVID-19 pandemic and provide hospitalists with useful resources in this time of need at hospitalmedicine.org/coronavirus. For news coverage of COVID-19, visit https://www.the-hospitalist.org/hospitalist/coronavirus-updates.