FDA approves first maintenance therapy for AML

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The Food and Drug Administration has approved an oral form of azacitidine (Onureg) for use as maintenance therapy for patients with acute myeloid leukemia (AML) who have achieved a first complete remission.

The approval extends to patients who have achieved complete remission with incomplete blood count recovery following intensive induction chemotherapy and who are unable to complete intensive curative therapy.

The approval was based on data from the QUAZAR AML-001 trial, which showed that oral azacitidine significantly improved overall survival when compared with placebo.

“It’s not too hard to get these patients into remission,” Harry P. Erba, MD, PhD, director of the Leukemia Program at the Duke Cancer Institute, Durham, N.C., said in an interview last year when these results were first presented at the 2019 annual meeting of the American Society of Hematology. “The problem comes in keeping them in remission.”

Despite various attempts, there has been no success over the past 30 years in defining maintenance treatment for these patients, Andrew H. Wei, MBBS, PhD, from the Alfred Hospital in Melbourne, Australia, said.

“Oral azacitidine represents a new therapeutic standard for patients with AML in remission,” he said.

Azacitidine is a hypomethylating agent that incorporates into DNA and RNA. It has long been used as an injectable therapy for the treatment of myelodysplastic syndromes.

The approval of the new oral formulation for the new indication of AML “is the culmination of over a decade of research and 13 preclinical and clinical trials,” said Giovanni Caforio, M.D., chairman and chief executive officer of Bristol-Myers Squibb, in a statement.

QUAZAR results

The QUAZAR AML-001 trial was a phase 3, international study involving 472 patients with AML who were within achieving a first complete remission or remission with incomplete blood recovery. All patients had received intensive induction chemotherapy with or without consolidation treatment per investigator preference prior to study entry and were not candidates for hematopoietic stem cell transplant at the time of screening.

Patients were randomly assigned to receive either oral azacitidine 200 mg daily on days 1-14 of a repeat 28-day cycle (n = 278) or matching placebo (n = 274). Treatment was continued indefinitely until blast count was more than 15% or patients experienced unacceptable toxicity or underwent transplant.

At a median follow-up of more than 41.2 months, the median overall survival was significantly longer for patients who received oral azacitidine at 24.7 months versus 14.8 months for those who received placebo (hazard ratio, 0.69; P < .0009).

Relapse-free survival was also significantly prolonged to 10.2 months for patients who received oral azacitidine vs. 4.8 months for those who received placebo (HR, 0.65; P < .0001).

Serious adverse reactions occurred in 15% of patients who received azacitidine. Events that occurred in 2% of patients or more include pneumonia (8%) and febrile neutropenia (7%). There was one fatal event.

The most common adverse reactions were nausea (65% vs. 24%), vomiting (60% vs. 10%), diarrhea (50% vs. 21%), fatigue/asthenia (44% vs. 25%), constipation (39% vs. 24%), pneumonia (27% vs. 17%), abdominal pain (22% vs. 13%) arthralgia (14% vs. 10%), decreased appetite (13% vs. 6%), febrile neutropenia (12% vs. 8%), dizziness (11% vs. 9%), and pain in extremity (11% vs. 5%). Permanent discontinuation because of an adverse reaction occurred in 8% of patients.
 

A version of this article originally appeared on Medscape.com.

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The Food and Drug Administration has approved an oral form of azacitidine (Onureg) for use as maintenance therapy for patients with acute myeloid leukemia (AML) who have achieved a first complete remission.

The approval extends to patients who have achieved complete remission with incomplete blood count recovery following intensive induction chemotherapy and who are unable to complete intensive curative therapy.

The approval was based on data from the QUAZAR AML-001 trial, which showed that oral azacitidine significantly improved overall survival when compared with placebo.

“It’s not too hard to get these patients into remission,” Harry P. Erba, MD, PhD, director of the Leukemia Program at the Duke Cancer Institute, Durham, N.C., said in an interview last year when these results were first presented at the 2019 annual meeting of the American Society of Hematology. “The problem comes in keeping them in remission.”

Despite various attempts, there has been no success over the past 30 years in defining maintenance treatment for these patients, Andrew H. Wei, MBBS, PhD, from the Alfred Hospital in Melbourne, Australia, said.

“Oral azacitidine represents a new therapeutic standard for patients with AML in remission,” he said.

Azacitidine is a hypomethylating agent that incorporates into DNA and RNA. It has long been used as an injectable therapy for the treatment of myelodysplastic syndromes.

The approval of the new oral formulation for the new indication of AML “is the culmination of over a decade of research and 13 preclinical and clinical trials,” said Giovanni Caforio, M.D., chairman and chief executive officer of Bristol-Myers Squibb, in a statement.

QUAZAR results

The QUAZAR AML-001 trial was a phase 3, international study involving 472 patients with AML who were within achieving a first complete remission or remission with incomplete blood recovery. All patients had received intensive induction chemotherapy with or without consolidation treatment per investigator preference prior to study entry and were not candidates for hematopoietic stem cell transplant at the time of screening.

Patients were randomly assigned to receive either oral azacitidine 200 mg daily on days 1-14 of a repeat 28-day cycle (n = 278) or matching placebo (n = 274). Treatment was continued indefinitely until blast count was more than 15% or patients experienced unacceptable toxicity or underwent transplant.

At a median follow-up of more than 41.2 months, the median overall survival was significantly longer for patients who received oral azacitidine at 24.7 months versus 14.8 months for those who received placebo (hazard ratio, 0.69; P < .0009).

Relapse-free survival was also significantly prolonged to 10.2 months for patients who received oral azacitidine vs. 4.8 months for those who received placebo (HR, 0.65; P < .0001).

Serious adverse reactions occurred in 15% of patients who received azacitidine. Events that occurred in 2% of patients or more include pneumonia (8%) and febrile neutropenia (7%). There was one fatal event.

The most common adverse reactions were nausea (65% vs. 24%), vomiting (60% vs. 10%), diarrhea (50% vs. 21%), fatigue/asthenia (44% vs. 25%), constipation (39% vs. 24%), pneumonia (27% vs. 17%), abdominal pain (22% vs. 13%) arthralgia (14% vs. 10%), decreased appetite (13% vs. 6%), febrile neutropenia (12% vs. 8%), dizziness (11% vs. 9%), and pain in extremity (11% vs. 5%). Permanent discontinuation because of an adverse reaction occurred in 8% of patients.
 

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration has approved an oral form of azacitidine (Onureg) for use as maintenance therapy for patients with acute myeloid leukemia (AML) who have achieved a first complete remission.

The approval extends to patients who have achieved complete remission with incomplete blood count recovery following intensive induction chemotherapy and who are unable to complete intensive curative therapy.

The approval was based on data from the QUAZAR AML-001 trial, which showed that oral azacitidine significantly improved overall survival when compared with placebo.

“It’s not too hard to get these patients into remission,” Harry P. Erba, MD, PhD, director of the Leukemia Program at the Duke Cancer Institute, Durham, N.C., said in an interview last year when these results were first presented at the 2019 annual meeting of the American Society of Hematology. “The problem comes in keeping them in remission.”

Despite various attempts, there has been no success over the past 30 years in defining maintenance treatment for these patients, Andrew H. Wei, MBBS, PhD, from the Alfred Hospital in Melbourne, Australia, said.

“Oral azacitidine represents a new therapeutic standard for patients with AML in remission,” he said.

Azacitidine is a hypomethylating agent that incorporates into DNA and RNA. It has long been used as an injectable therapy for the treatment of myelodysplastic syndromes.

The approval of the new oral formulation for the new indication of AML “is the culmination of over a decade of research and 13 preclinical and clinical trials,” said Giovanni Caforio, M.D., chairman and chief executive officer of Bristol-Myers Squibb, in a statement.

QUAZAR results

The QUAZAR AML-001 trial was a phase 3, international study involving 472 patients with AML who were within achieving a first complete remission or remission with incomplete blood recovery. All patients had received intensive induction chemotherapy with or without consolidation treatment per investigator preference prior to study entry and were not candidates for hematopoietic stem cell transplant at the time of screening.

Patients were randomly assigned to receive either oral azacitidine 200 mg daily on days 1-14 of a repeat 28-day cycle (n = 278) or matching placebo (n = 274). Treatment was continued indefinitely until blast count was more than 15% or patients experienced unacceptable toxicity or underwent transplant.

At a median follow-up of more than 41.2 months, the median overall survival was significantly longer for patients who received oral azacitidine at 24.7 months versus 14.8 months for those who received placebo (hazard ratio, 0.69; P < .0009).

Relapse-free survival was also significantly prolonged to 10.2 months for patients who received oral azacitidine vs. 4.8 months for those who received placebo (HR, 0.65; P < .0001).

Serious adverse reactions occurred in 15% of patients who received azacitidine. Events that occurred in 2% of patients or more include pneumonia (8%) and febrile neutropenia (7%). There was one fatal event.

The most common adverse reactions were nausea (65% vs. 24%), vomiting (60% vs. 10%), diarrhea (50% vs. 21%), fatigue/asthenia (44% vs. 25%), constipation (39% vs. 24%), pneumonia (27% vs. 17%), abdominal pain (22% vs. 13%) arthralgia (14% vs. 10%), decreased appetite (13% vs. 6%), febrile neutropenia (12% vs. 8%), dizziness (11% vs. 9%), and pain in extremity (11% vs. 5%). Permanent discontinuation because of an adverse reaction occurred in 8% of patients.
 

A version of this article originally appeared on Medscape.com.

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The Vaping Epidemic: Implications for Cancer Care

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BACKGROUND: There has been an unprecedented increase in vaping by young people. In 2019, an outbreak of acute lung injuries linked to vaping was later recognized as a disease entity known as e-cigarette or vaping product-use associated lung injury (EVALI). A number of cancer therapeutics have been associated with pulmonary toxicity, and the incidence and severity of immune- and chemotherapy-related pneumonitis may be additionally compounded by EVALI. Here we present the case of a 42-year-old male with good-risk advanced seminoma treated with three cycles of bleomycin, etoposide, and cisplatin for curative intent.

CASE REPORT: The patient developed febrile neutropenia after the third cycle of treatment, and upon count recovery, he rapidly deteriorated into acute hypoxic respiratory failure that was ultimately fatal and most consistent with bleomycin-induced lung toxicity. It was later revealed that the patient had been an avid user of tetrahydrocannabinol-containing vaping products, and whether this contributed to a more progressive injurious picture is unknown.

DISCUSION: We have also encountered several cases of non-infectious hypoxic respiratory failure in patients who reported a history of vaping while receiving checkpoint inhibitor immunotherapy for advanced lung cancer. While the incidence of EVALI has declined following its highly publicized notoriety, vaping remains quite popular despite known hazards and represents a significant public health challenge. The risks posed by the use of vaping products may be higher for individuals with cancer who are often older and more frequently suffer from comorbidities that may increase susceptibility to drug-induced lung injury. Consequently, additional efforts should be made to increase awareness of the harmful effects of vaping, especially in the era of COVID-19. To minimize oncology-related pulmonary complications for which vaping may be a risk factor, we updated our infusion nursing evaluation to include questions on vaping activities and implemented provider notification before administering cancer-directed therapy. We have also educated our oncology team about the importance of obtaining a vaping history.

CONCLUSION: As oncology providers for the Veteran population, we should be mindful to counsel our cancer patients about the health risks of vaping and encourage alternative nicotine replacement therapy for those who use nicotine-based vaping products for smoking cessation.

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BACKGROUND: There has been an unprecedented increase in vaping by young people. In 2019, an outbreak of acute lung injuries linked to vaping was later recognized as a disease entity known as e-cigarette or vaping product-use associated lung injury (EVALI). A number of cancer therapeutics have been associated with pulmonary toxicity, and the incidence and severity of immune- and chemotherapy-related pneumonitis may be additionally compounded by EVALI. Here we present the case of a 42-year-old male with good-risk advanced seminoma treated with three cycles of bleomycin, etoposide, and cisplatin for curative intent.

CASE REPORT: The patient developed febrile neutropenia after the third cycle of treatment, and upon count recovery, he rapidly deteriorated into acute hypoxic respiratory failure that was ultimately fatal and most consistent with bleomycin-induced lung toxicity. It was later revealed that the patient had been an avid user of tetrahydrocannabinol-containing vaping products, and whether this contributed to a more progressive injurious picture is unknown.

DISCUSION: We have also encountered several cases of non-infectious hypoxic respiratory failure in patients who reported a history of vaping while receiving checkpoint inhibitor immunotherapy for advanced lung cancer. While the incidence of EVALI has declined following its highly publicized notoriety, vaping remains quite popular despite known hazards and represents a significant public health challenge. The risks posed by the use of vaping products may be higher for individuals with cancer who are often older and more frequently suffer from comorbidities that may increase susceptibility to drug-induced lung injury. Consequently, additional efforts should be made to increase awareness of the harmful effects of vaping, especially in the era of COVID-19. To minimize oncology-related pulmonary complications for which vaping may be a risk factor, we updated our infusion nursing evaluation to include questions on vaping activities and implemented provider notification before administering cancer-directed therapy. We have also educated our oncology team about the importance of obtaining a vaping history.

CONCLUSION: As oncology providers for the Veteran population, we should be mindful to counsel our cancer patients about the health risks of vaping and encourage alternative nicotine replacement therapy for those who use nicotine-based vaping products for smoking cessation.

BACKGROUND: There has been an unprecedented increase in vaping by young people. In 2019, an outbreak of acute lung injuries linked to vaping was later recognized as a disease entity known as e-cigarette or vaping product-use associated lung injury (EVALI). A number of cancer therapeutics have been associated with pulmonary toxicity, and the incidence and severity of immune- and chemotherapy-related pneumonitis may be additionally compounded by EVALI. Here we present the case of a 42-year-old male with good-risk advanced seminoma treated with three cycles of bleomycin, etoposide, and cisplatin for curative intent.

CASE REPORT: The patient developed febrile neutropenia after the third cycle of treatment, and upon count recovery, he rapidly deteriorated into acute hypoxic respiratory failure that was ultimately fatal and most consistent with bleomycin-induced lung toxicity. It was later revealed that the patient had been an avid user of tetrahydrocannabinol-containing vaping products, and whether this contributed to a more progressive injurious picture is unknown.

DISCUSION: We have also encountered several cases of non-infectious hypoxic respiratory failure in patients who reported a history of vaping while receiving checkpoint inhibitor immunotherapy for advanced lung cancer. While the incidence of EVALI has declined following its highly publicized notoriety, vaping remains quite popular despite known hazards and represents a significant public health challenge. The risks posed by the use of vaping products may be higher for individuals with cancer who are often older and more frequently suffer from comorbidities that may increase susceptibility to drug-induced lung injury. Consequently, additional efforts should be made to increase awareness of the harmful effects of vaping, especially in the era of COVID-19. To minimize oncology-related pulmonary complications for which vaping may be a risk factor, we updated our infusion nursing evaluation to include questions on vaping activities and implemented provider notification before administering cancer-directed therapy. We have also educated our oncology team about the importance of obtaining a vaping history.

CONCLUSION: As oncology providers for the Veteran population, we should be mindful to counsel our cancer patients about the health risks of vaping and encourage alternative nicotine replacement therapy for those who use nicotine-based vaping products for smoking cessation.

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The Effect of Treatment Facility and Race on Survival for Signet Ring Cell Carcinoma of the Esophagus: An Analysis of the National Cancer Database

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BACKGROUND: Signet ring cell carcinoma of the esophagus (SRCCE) is an aggressive tumor that represents approximately 3.5-5.0% of all esophageal cancers. Prior studies have shown a strong correlation between treating facility and survival for different cancers, but this has not been studied in SRCCE. The goal of this study is to assess differences in survival based on the type of treatment facility.

METHODS: There were 1,442 patients with SRCCE identified using the histology 8490 and topography codes C15.0-C15.9 in the National Cancer Database (NCDB). Descriptive analysis, Kaplan-Meier curves, and a multivariable Cox hazard regression analysis were all utilized to determine the significance and impact of treatment facility type, race, age, sex, tumor stage, use of adjuvant or neoadjuvant radiation, and surgical margins on survival.

RESULTS: The cohort was mostly male (86.6%) and Non-Hispanic Caucasian (96.3%) with 52.7% receiving treatment at academic centers followed by 35.9% at community programs and 11.4% at integrated cancer programs. As age increased, mortality also increased (HR = 1.02; 95% CI: 1.01-1.02, p < 0.001). Both Hispanic Caucasians (HR = 2.09; 95% CI: 1.21-3.62, = 0.009) and Africans Americans (HR = 1.69; 95% CI: 1.04-2.75, = 0.036) had an increased risk of mortality when compared to Non-Hispanic Caucasians. Patients at academic facilities demonstrated a decreased risk of mortality when compared to community programs (HR = 0.73; 95% CI: 0.63-0.86, p < 0.001) and integrated cancer programs (HR = 0.74; 95% CI: 0.60- 0.93, = 0.008).

CONCLUSION: For patients diagnosed with SRCCE, receiving treatment at academic centers resulted in better survival probabilities compared to nonacademic facilities. Older patients, African Americans and Hispanic Caucasians, increasing tumor stage, positive surgical margins, and comorbidities with Charlson- Deyo scores of 1 and 2+ were all associated with an increased risk of mortality from SRCCE.

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BACKGROUND: Signet ring cell carcinoma of the esophagus (SRCCE) is an aggressive tumor that represents approximately 3.5-5.0% of all esophageal cancers. Prior studies have shown a strong correlation between treating facility and survival for different cancers, but this has not been studied in SRCCE. The goal of this study is to assess differences in survival based on the type of treatment facility.

METHODS: There were 1,442 patients with SRCCE identified using the histology 8490 and topography codes C15.0-C15.9 in the National Cancer Database (NCDB). Descriptive analysis, Kaplan-Meier curves, and a multivariable Cox hazard regression analysis were all utilized to determine the significance and impact of treatment facility type, race, age, sex, tumor stage, use of adjuvant or neoadjuvant radiation, and surgical margins on survival.

RESULTS: The cohort was mostly male (86.6%) and Non-Hispanic Caucasian (96.3%) with 52.7% receiving treatment at academic centers followed by 35.9% at community programs and 11.4% at integrated cancer programs. As age increased, mortality also increased (HR = 1.02; 95% CI: 1.01-1.02, p < 0.001). Both Hispanic Caucasians (HR = 2.09; 95% CI: 1.21-3.62, = 0.009) and Africans Americans (HR = 1.69; 95% CI: 1.04-2.75, = 0.036) had an increased risk of mortality when compared to Non-Hispanic Caucasians. Patients at academic facilities demonstrated a decreased risk of mortality when compared to community programs (HR = 0.73; 95% CI: 0.63-0.86, p < 0.001) and integrated cancer programs (HR = 0.74; 95% CI: 0.60- 0.93, = 0.008).

CONCLUSION: For patients diagnosed with SRCCE, receiving treatment at academic centers resulted in better survival probabilities compared to nonacademic facilities. Older patients, African Americans and Hispanic Caucasians, increasing tumor stage, positive surgical margins, and comorbidities with Charlson- Deyo scores of 1 and 2+ were all associated with an increased risk of mortality from SRCCE.

BACKGROUND: Signet ring cell carcinoma of the esophagus (SRCCE) is an aggressive tumor that represents approximately 3.5-5.0% of all esophageal cancers. Prior studies have shown a strong correlation between treating facility and survival for different cancers, but this has not been studied in SRCCE. The goal of this study is to assess differences in survival based on the type of treatment facility.

METHODS: There were 1,442 patients with SRCCE identified using the histology 8490 and topography codes C15.0-C15.9 in the National Cancer Database (NCDB). Descriptive analysis, Kaplan-Meier curves, and a multivariable Cox hazard regression analysis were all utilized to determine the significance and impact of treatment facility type, race, age, sex, tumor stage, use of adjuvant or neoadjuvant radiation, and surgical margins on survival.

RESULTS: The cohort was mostly male (86.6%) and Non-Hispanic Caucasian (96.3%) with 52.7% receiving treatment at academic centers followed by 35.9% at community programs and 11.4% at integrated cancer programs. As age increased, mortality also increased (HR = 1.02; 95% CI: 1.01-1.02, p < 0.001). Both Hispanic Caucasians (HR = 2.09; 95% CI: 1.21-3.62, = 0.009) and Africans Americans (HR = 1.69; 95% CI: 1.04-2.75, = 0.036) had an increased risk of mortality when compared to Non-Hispanic Caucasians. Patients at academic facilities demonstrated a decreased risk of mortality when compared to community programs (HR = 0.73; 95% CI: 0.63-0.86, p < 0.001) and integrated cancer programs (HR = 0.74; 95% CI: 0.60- 0.93, = 0.008).

CONCLUSION: For patients diagnosed with SRCCE, receiving treatment at academic centers resulted in better survival probabilities compared to nonacademic facilities. Older patients, African Americans and Hispanic Caucasians, increasing tumor stage, positive surgical margins, and comorbidities with Charlson- Deyo scores of 1 and 2+ were all associated with an increased risk of mortality from SRCCE.

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Short Story Clubs to Decrease Burnout

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Burnout is common in hematology/oncology practice where work pressure is high, patients are complex, and outcomes are variable. We hypothesized that a short story club could be helpful to improve community, humanism, and transcendence; and thereby to decrease burnout. Most of the potential participants indicated little time for preparation and we, therefore, chose short stories rather than books as reading material. The meetings began in April 2019 and continued until April 2020 when they were suspended for the COVID-19 epidemic. Participants included oncologists (6), oncology fellows (2), psychologist (1), social workers (2), research writer (1) and, student (1). Of these, 7 were females and 6 were males; 4 in senior and 9 in junior positions. Country of origin of participants was USA (6), India (3), Syria (2), Pakistan (1) and, Poland (1). Meetings were held every two months, each time with different stories, focus, themes, and points of view. Readings included classical stories, modern stories, and personal essays, from the eyes of other oncologists, country doctor, patients, nurses, or students. Stories included “The Doctor” by Chekhov, “The Country Doctor” by Kafka, “Three Questions” by Tolstoy, “Elephant Hills” and “Indian Camp” each by Hemingway, “Interpreter of Maladies” by Lahiri, “Get your Own Fatal Disease” by Yalom, “Caves of Lascaux” by Karmel, “The Plagiarist” by Seamon and three essays on “undying,” end-of-life and love. Themes included falling in love with a patient, empathy, loneliness, burnout, communication, helplessness, and end-of-life issues. Discussions lasted two hours and promoted a sense of belonging and community; sharing of feelings and concerns; and transcendence of everyday burdens. Attendance was more than 80% at each meeting and all participants indicated an interest in continuing the club for the foreseeable future. Short story clubs may be one way to overcome or prevent burnout in oncology. Further quantitative and qualitative studies are needed.

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Burnout is common in hematology/oncology practice where work pressure is high, patients are complex, and outcomes are variable. We hypothesized that a short story club could be helpful to improve community, humanism, and transcendence; and thereby to decrease burnout. Most of the potential participants indicated little time for preparation and we, therefore, chose short stories rather than books as reading material. The meetings began in April 2019 and continued until April 2020 when they were suspended for the COVID-19 epidemic. Participants included oncologists (6), oncology fellows (2), psychologist (1), social workers (2), research writer (1) and, student (1). Of these, 7 were females and 6 were males; 4 in senior and 9 in junior positions. Country of origin of participants was USA (6), India (3), Syria (2), Pakistan (1) and, Poland (1). Meetings were held every two months, each time with different stories, focus, themes, and points of view. Readings included classical stories, modern stories, and personal essays, from the eyes of other oncologists, country doctor, patients, nurses, or students. Stories included “The Doctor” by Chekhov, “The Country Doctor” by Kafka, “Three Questions” by Tolstoy, “Elephant Hills” and “Indian Camp” each by Hemingway, “Interpreter of Maladies” by Lahiri, “Get your Own Fatal Disease” by Yalom, “Caves of Lascaux” by Karmel, “The Plagiarist” by Seamon and three essays on “undying,” end-of-life and love. Themes included falling in love with a patient, empathy, loneliness, burnout, communication, helplessness, and end-of-life issues. Discussions lasted two hours and promoted a sense of belonging and community; sharing of feelings and concerns; and transcendence of everyday burdens. Attendance was more than 80% at each meeting and all participants indicated an interest in continuing the club for the foreseeable future. Short story clubs may be one way to overcome or prevent burnout in oncology. Further quantitative and qualitative studies are needed.

Burnout is common in hematology/oncology practice where work pressure is high, patients are complex, and outcomes are variable. We hypothesized that a short story club could be helpful to improve community, humanism, and transcendence; and thereby to decrease burnout. Most of the potential participants indicated little time for preparation and we, therefore, chose short stories rather than books as reading material. The meetings began in April 2019 and continued until April 2020 when they were suspended for the COVID-19 epidemic. Participants included oncologists (6), oncology fellows (2), psychologist (1), social workers (2), research writer (1) and, student (1). Of these, 7 were females and 6 were males; 4 in senior and 9 in junior positions. Country of origin of participants was USA (6), India (3), Syria (2), Pakistan (1) and, Poland (1). Meetings were held every two months, each time with different stories, focus, themes, and points of view. Readings included classical stories, modern stories, and personal essays, from the eyes of other oncologists, country doctor, patients, nurses, or students. Stories included “The Doctor” by Chekhov, “The Country Doctor” by Kafka, “Three Questions” by Tolstoy, “Elephant Hills” and “Indian Camp” each by Hemingway, “Interpreter of Maladies” by Lahiri, “Get your Own Fatal Disease” by Yalom, “Caves of Lascaux” by Karmel, “The Plagiarist” by Seamon and three essays on “undying,” end-of-life and love. Themes included falling in love with a patient, empathy, loneliness, burnout, communication, helplessness, and end-of-life issues. Discussions lasted two hours and promoted a sense of belonging and community; sharing of feelings and concerns; and transcendence of everyday burdens. Attendance was more than 80% at each meeting and all participants indicated an interest in continuing the club for the foreseeable future. Short story clubs may be one way to overcome or prevent burnout in oncology. Further quantitative and qualitative studies are needed.

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In-Depth Look at a Community- Based Population of Multiple Myeloma (MM) Patients Undergoing an in-Class Transition (iCT) from Parenteral Bortezomib to Oral Ixazomib in the United States (US) MM-6 Study

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BACKGROUND: Randomized clinical trials (RCTs) typically enroll highly selected populations. Oncology RCTs have an average of 16 eligibility criteria (Unger JNCI 2014). Registry analyses indicate that up to ~40% of ‘real-world’ MM patients are ineligible for RCTs based on common criteria (Shah CLML 2017).

PURPOSE: US MM-6 (NCT03173092) is evaluating iCT from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) in MM patients treated at US community oncology centers. Eligibility criteria are less stringent than RCTs, to enroll patients more representative of the real-world MM population.

METHODS: Non-transplant-eligible newly-diagnosed MM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at 22 US community sites (including three Veterans Affairs hospitals) to receive ixazomib-Rd for up to 39 28- day cycles or until progression/toxicity.

DATA ANALYSIS: We reviewed 84 consecutively enrolled patients using standard RCT eligibility criteria. Initially, six criteria were explored to determine the proportion of patients who might have been RCT-ineligible: renal dysfunction, congestive heart failure (CHF), stroke, prior malignancies, chronic obstructive pulmonary disease (COPD), and memory loss. Dosing information was evaluated to determine any correlation between dose modifications and eligibility status.

RESULTS: Based on six criteria, 24/84 patients (29%) may have been RCT-ineligible: 12% (n=10) had renal dysfunction, 7% (n=6) CHF, 6% (n=5) stroke, 5% (n=4) each other prior malignancies and COPD, and 2% (n=2) memory loss; 6% (n=5) had >1 criterion. Among the 24 RCT-ineligible patients, 75% (n=18), 42% (n=10), and 54% (n=13) received the highest starting doses of ixazomib (4mg), lenalidomide (25mg), and dexamethasone (40mg), respectively. Ixazomib, lenalidomide, and dexamethasone dose reductions were required in 29% (n=7), 25% (n=6), and 21% (n=5), respectively (due to adverse events [AEs]: 21% [n=5], 21% [n=5], 4% [n=1]). 50% (n=12) discontinued treatment (consent withdrawal/patient decision, n=7; disease progression, n=2; sufficient response, AE, death, each n=1); n=3/2/2 discontinued ixazomib/lenalidomide/ dexamethasone due to AEs.

IMPLICATIONS: US MM-6 is enrolling real-world, community- based MM patients, including those who may be ineligible for RCTs based on standard inclusion criteria. Our analysis indicates that iCT to ixazomib- Rd appears to be feasible in these RCT-ineligible US MM-6 patients. Further criteria will be analyzed and presented.

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BACKGROUND: Randomized clinical trials (RCTs) typically enroll highly selected populations. Oncology RCTs have an average of 16 eligibility criteria (Unger JNCI 2014). Registry analyses indicate that up to ~40% of ‘real-world’ MM patients are ineligible for RCTs based on common criteria (Shah CLML 2017).

PURPOSE: US MM-6 (NCT03173092) is evaluating iCT from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) in MM patients treated at US community oncology centers. Eligibility criteria are less stringent than RCTs, to enroll patients more representative of the real-world MM population.

METHODS: Non-transplant-eligible newly-diagnosed MM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at 22 US community sites (including three Veterans Affairs hospitals) to receive ixazomib-Rd for up to 39 28- day cycles or until progression/toxicity.

DATA ANALYSIS: We reviewed 84 consecutively enrolled patients using standard RCT eligibility criteria. Initially, six criteria were explored to determine the proportion of patients who might have been RCT-ineligible: renal dysfunction, congestive heart failure (CHF), stroke, prior malignancies, chronic obstructive pulmonary disease (COPD), and memory loss. Dosing information was evaluated to determine any correlation between dose modifications and eligibility status.

RESULTS: Based on six criteria, 24/84 patients (29%) may have been RCT-ineligible: 12% (n=10) had renal dysfunction, 7% (n=6) CHF, 6% (n=5) stroke, 5% (n=4) each other prior malignancies and COPD, and 2% (n=2) memory loss; 6% (n=5) had >1 criterion. Among the 24 RCT-ineligible patients, 75% (n=18), 42% (n=10), and 54% (n=13) received the highest starting doses of ixazomib (4mg), lenalidomide (25mg), and dexamethasone (40mg), respectively. Ixazomib, lenalidomide, and dexamethasone dose reductions were required in 29% (n=7), 25% (n=6), and 21% (n=5), respectively (due to adverse events [AEs]: 21% [n=5], 21% [n=5], 4% [n=1]). 50% (n=12) discontinued treatment (consent withdrawal/patient decision, n=7; disease progression, n=2; sufficient response, AE, death, each n=1); n=3/2/2 discontinued ixazomib/lenalidomide/ dexamethasone due to AEs.

IMPLICATIONS: US MM-6 is enrolling real-world, community- based MM patients, including those who may be ineligible for RCTs based on standard inclusion criteria. Our analysis indicates that iCT to ixazomib- Rd appears to be feasible in these RCT-ineligible US MM-6 patients. Further criteria will be analyzed and presented.

BACKGROUND: Randomized clinical trials (RCTs) typically enroll highly selected populations. Oncology RCTs have an average of 16 eligibility criteria (Unger JNCI 2014). Registry analyses indicate that up to ~40% of ‘real-world’ MM patients are ineligible for RCTs based on common criteria (Shah CLML 2017).

PURPOSE: US MM-6 (NCT03173092) is evaluating iCT from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) in MM patients treated at US community oncology centers. Eligibility criteria are less stringent than RCTs, to enroll patients more representative of the real-world MM population.

METHODS: Non-transplant-eligible newly-diagnosed MM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at 22 US community sites (including three Veterans Affairs hospitals) to receive ixazomib-Rd for up to 39 28- day cycles or until progression/toxicity.

DATA ANALYSIS: We reviewed 84 consecutively enrolled patients using standard RCT eligibility criteria. Initially, six criteria were explored to determine the proportion of patients who might have been RCT-ineligible: renal dysfunction, congestive heart failure (CHF), stroke, prior malignancies, chronic obstructive pulmonary disease (COPD), and memory loss. Dosing information was evaluated to determine any correlation between dose modifications and eligibility status.

RESULTS: Based on six criteria, 24/84 patients (29%) may have been RCT-ineligible: 12% (n=10) had renal dysfunction, 7% (n=6) CHF, 6% (n=5) stroke, 5% (n=4) each other prior malignancies and COPD, and 2% (n=2) memory loss; 6% (n=5) had >1 criterion. Among the 24 RCT-ineligible patients, 75% (n=18), 42% (n=10), and 54% (n=13) received the highest starting doses of ixazomib (4mg), lenalidomide (25mg), and dexamethasone (40mg), respectively. Ixazomib, lenalidomide, and dexamethasone dose reductions were required in 29% (n=7), 25% (n=6), and 21% (n=5), respectively (due to adverse events [AEs]: 21% [n=5], 21% [n=5], 4% [n=1]). 50% (n=12) discontinued treatment (consent withdrawal/patient decision, n=7; disease progression, n=2; sufficient response, AE, death, each n=1); n=3/2/2 discontinued ixazomib/lenalidomide/ dexamethasone due to AEs.

IMPLICATIONS: US MM-6 is enrolling real-world, community- based MM patients, including those who may be ineligible for RCTs based on standard inclusion criteria. Our analysis indicates that iCT to ixazomib- Rd appears to be feasible in these RCT-ineligible US MM-6 patients. Further criteria will be analyzed and presented.

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Hemolytic Anemia Secondary to Methylene Blue Administration in a G6PD Sufficient Patient

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INTRODUCTION: Methylene blue (MB) has recently gained traction as an adjunctive therapy in the management of vasoplegia. Due to risk of inducing oxidative hemolysis its use should be avoided in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency Although rare, drug induced oxidative hemolysis can still occur in patients without G6PD deficiency. In this report, we describe a case of severe oxidative hemolysis in a G6PD sufficient adult following administration of a large dose of MB.

CASE REPORT: A 78-year-old male with a history of coronary artery disease was admitted for coronary artery bypass graft surgery. Patient underwent surgery without any major complications. Post operatively however he developed severe shock refractory to multiple vasopressors and inotropes. A presumptive diagnosis of vasoplegia was made for which the patient was given multiple boluses of MB. Hemodynamics improved thus the patient was started on a MB infusion. Approximately 24 hours later the patient was noted to have an acute drop in his hemoglobin from 9.9 to 8.0 g/dl. He was transfused multiple units of blood with only transient improvements in his hemoglobin. Physical exam and imaging revealed no evidence of bleeding. Additional workup was notable for an LDH of 7222 U/L and an elevated bilirubin raising concern for hemolytic anemia.

Review of his peripheral smear was notable for the presence of numerous bite cells. A diagnosis of oxidative hemolytic anemia secondary to MB administration was made. MB infusion was discontinued and within 48 hours the patient’s LDH normalized and hemoglobin had stabilized. A quantitative G6PD test ordered during the acute hemolytic period and was reported as normal. Due to the possibility of a falsely normal result in the setting of active hemolysis, G6PD testing was repeated two months following discharge and was also normal.

CONCLUSIONS: Methylene blue can be a lifesaving medication in the setting of severe vasoplegia. However, clinicians should be aware of the possibility of inducing severe oxidative hemolytic anemia even in G6PD sufficient patients when giving this agent in large doses. Management of oxidative hemolysis secondary to MB is supportive care with prompt discontinuation resulting in resolution of hemolysis.

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INTRODUCTION: Methylene blue (MB) has recently gained traction as an adjunctive therapy in the management of vasoplegia. Due to risk of inducing oxidative hemolysis its use should be avoided in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency Although rare, drug induced oxidative hemolysis can still occur in patients without G6PD deficiency. In this report, we describe a case of severe oxidative hemolysis in a G6PD sufficient adult following administration of a large dose of MB.

CASE REPORT: A 78-year-old male with a history of coronary artery disease was admitted for coronary artery bypass graft surgery. Patient underwent surgery without any major complications. Post operatively however he developed severe shock refractory to multiple vasopressors and inotropes. A presumptive diagnosis of vasoplegia was made for which the patient was given multiple boluses of MB. Hemodynamics improved thus the patient was started on a MB infusion. Approximately 24 hours later the patient was noted to have an acute drop in his hemoglobin from 9.9 to 8.0 g/dl. He was transfused multiple units of blood with only transient improvements in his hemoglobin. Physical exam and imaging revealed no evidence of bleeding. Additional workup was notable for an LDH of 7222 U/L and an elevated bilirubin raising concern for hemolytic anemia.

Review of his peripheral smear was notable for the presence of numerous bite cells. A diagnosis of oxidative hemolytic anemia secondary to MB administration was made. MB infusion was discontinued and within 48 hours the patient’s LDH normalized and hemoglobin had stabilized. A quantitative G6PD test ordered during the acute hemolytic period and was reported as normal. Due to the possibility of a falsely normal result in the setting of active hemolysis, G6PD testing was repeated two months following discharge and was also normal.

CONCLUSIONS: Methylene blue can be a lifesaving medication in the setting of severe vasoplegia. However, clinicians should be aware of the possibility of inducing severe oxidative hemolytic anemia even in G6PD sufficient patients when giving this agent in large doses. Management of oxidative hemolysis secondary to MB is supportive care with prompt discontinuation resulting in resolution of hemolysis.

INTRODUCTION: Methylene blue (MB) has recently gained traction as an adjunctive therapy in the management of vasoplegia. Due to risk of inducing oxidative hemolysis its use should be avoided in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency Although rare, drug induced oxidative hemolysis can still occur in patients without G6PD deficiency. In this report, we describe a case of severe oxidative hemolysis in a G6PD sufficient adult following administration of a large dose of MB.

CASE REPORT: A 78-year-old male with a history of coronary artery disease was admitted for coronary artery bypass graft surgery. Patient underwent surgery without any major complications. Post operatively however he developed severe shock refractory to multiple vasopressors and inotropes. A presumptive diagnosis of vasoplegia was made for which the patient was given multiple boluses of MB. Hemodynamics improved thus the patient was started on a MB infusion. Approximately 24 hours later the patient was noted to have an acute drop in his hemoglobin from 9.9 to 8.0 g/dl. He was transfused multiple units of blood with only transient improvements in his hemoglobin. Physical exam and imaging revealed no evidence of bleeding. Additional workup was notable for an LDH of 7222 U/L and an elevated bilirubin raising concern for hemolytic anemia.

Review of his peripheral smear was notable for the presence of numerous bite cells. A diagnosis of oxidative hemolytic anemia secondary to MB administration was made. MB infusion was discontinued and within 48 hours the patient’s LDH normalized and hemoglobin had stabilized. A quantitative G6PD test ordered during the acute hemolytic period and was reported as normal. Due to the possibility of a falsely normal result in the setting of active hemolysis, G6PD testing was repeated two months following discharge and was also normal.

CONCLUSIONS: Methylene blue can be a lifesaving medication in the setting of severe vasoplegia. However, clinicians should be aware of the possibility of inducing severe oxidative hemolytic anemia even in G6PD sufficient patients when giving this agent in large doses. Management of oxidative hemolysis secondary to MB is supportive care with prompt discontinuation resulting in resolution of hemolysis.

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Effective Pain Control With Very Low Dose Palliative Radiotherapy for Multiple Myeloma Patients With Osseous Lesions

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BACKGROUND: Osteolytic lesions are present in 75% of multiple myeloma (MM) patients and frequently require palliation with radiation therapy (RT). Case series of MM patients with bone pain undergoing palliative RT suggest doses > 12 Gy (EQD2) provide excellent bone pain relief. However, recent advances in novel biologic agents have significantly improved overall survival and quality of life for MM patients. We hypothesized that lower-dose RT (LDRT, EQD2 < 12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 > 12 Gy) for palliation of painful MM bone lesions.

METHODS: We retrospectively identified MM patients treated with RT for painful bone lesions and stratified by EQD2 < 12Gy versus ≥12Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 71 treated lesions were included: 24 patients (49 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow up was 16.8 months. The median dose of HDRT treatment was 20 Gy (range 8-30 Gy, EQD2 12- 32.5 Gy) versus 4 Gy in the LDRT group (range = 4-8 Gy, EQD2 4.67-9.3 Gy). The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any grade acute toxicity between the HDRT cohort and LDRT cohort (24.5% vs. 9.1%, χ2 P=0.20). Pain recurred in 10% of lesions (12% HDRT versus 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (p=0.91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort and 3 (6.3%) in the HDRT cohort.

CONCLUSIONS: In this study, LDRT effectively palliated painful MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful MM bony lesions.

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BACKGROUND: Osteolytic lesions are present in 75% of multiple myeloma (MM) patients and frequently require palliation with radiation therapy (RT). Case series of MM patients with bone pain undergoing palliative RT suggest doses > 12 Gy (EQD2) provide excellent bone pain relief. However, recent advances in novel biologic agents have significantly improved overall survival and quality of life for MM patients. We hypothesized that lower-dose RT (LDRT, EQD2 < 12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 > 12 Gy) for palliation of painful MM bone lesions.

METHODS: We retrospectively identified MM patients treated with RT for painful bone lesions and stratified by EQD2 < 12Gy versus ≥12Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 71 treated lesions were included: 24 patients (49 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow up was 16.8 months. The median dose of HDRT treatment was 20 Gy (range 8-30 Gy, EQD2 12- 32.5 Gy) versus 4 Gy in the LDRT group (range = 4-8 Gy, EQD2 4.67-9.3 Gy). The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any grade acute toxicity between the HDRT cohort and LDRT cohort (24.5% vs. 9.1%, χ2 P=0.20). Pain recurred in 10% of lesions (12% HDRT versus 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (p=0.91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort and 3 (6.3%) in the HDRT cohort.

CONCLUSIONS: In this study, LDRT effectively palliated painful MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful MM bony lesions.

BACKGROUND: Osteolytic lesions are present in 75% of multiple myeloma (MM) patients and frequently require palliation with radiation therapy (RT). Case series of MM patients with bone pain undergoing palliative RT suggest doses > 12 Gy (EQD2) provide excellent bone pain relief. However, recent advances in novel biologic agents have significantly improved overall survival and quality of life for MM patients. We hypothesized that lower-dose RT (LDRT, EQD2 < 12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 > 12 Gy) for palliation of painful MM bone lesions.

METHODS: We retrospectively identified MM patients treated with RT for painful bone lesions and stratified by EQD2 < 12Gy versus ≥12Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 71 treated lesions were included: 24 patients (49 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow up was 16.8 months. The median dose of HDRT treatment was 20 Gy (range 8-30 Gy, EQD2 12- 32.5 Gy) versus 4 Gy in the LDRT group (range = 4-8 Gy, EQD2 4.67-9.3 Gy). The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any grade acute toxicity between the HDRT cohort and LDRT cohort (24.5% vs. 9.1%, χ2 P=0.20). Pain recurred in 10% of lesions (12% HDRT versus 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (p=0.91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort and 3 (6.3%) in the HDRT cohort.

CONCLUSIONS: In this study, LDRT effectively palliated painful MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful MM bony lesions.

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Central Texas Veterans Health Care System’s Experiences With Hematology Oncology Clinical Trials

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BACKGROUND: Availability of clinical trials for veterans is limited and more clinical trials are needed. Central Texas Veterans Health Care System (CTVHCS) has been actively involved with hematologic oncologic clinical trials over the last 10 years. This poster describes the number and types of hematology/oncology clinical trials that are either active or completed, and the processes of opening clinical trials, identifying patients, and trial management.

METHODS: Locating clinical trials is key to veteran enrollment into active trials and is accomplished through networking at medical meetings and VA work groups. Developing a clinical trial program requires working closely with the research department/foundations and becoming comfortable with the IRB oversight process. Conduct of a clinical trial is a team effort, with individual members having delegated responsibilities of patient care, data collection, and adverse effect reporting to the sponsors and IRB. The CTVHCS Oncology Section has been active in recruiting and enrolling veterans in clinical trials for treatment of many hematologic malignancies and solid tumors.

RESULTS: At the time of this presentation, 49 veterans have been successfully enrolled in 1 of 9 hematology/ oncology clinical trials ranging from phase Ib to phase III from 2011-2020. Advantages to opening clinical trials include academic scholarship, authorship in publications, generating revenue and most importantly to provide state of the art treatment for our cancer patients. We have been able to effectively accrue/enroll patients into clinical trials through a collaborative effort between the research department and our oncology department by identifying open clinical trials that fit our unique patient population and having a team of providers aiding in the management and care of these enrolled veterans.

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BACKGROUND: Availability of clinical trials for veterans is limited and more clinical trials are needed. Central Texas Veterans Health Care System (CTVHCS) has been actively involved with hematologic oncologic clinical trials over the last 10 years. This poster describes the number and types of hematology/oncology clinical trials that are either active or completed, and the processes of opening clinical trials, identifying patients, and trial management.

METHODS: Locating clinical trials is key to veteran enrollment into active trials and is accomplished through networking at medical meetings and VA work groups. Developing a clinical trial program requires working closely with the research department/foundations and becoming comfortable with the IRB oversight process. Conduct of a clinical trial is a team effort, with individual members having delegated responsibilities of patient care, data collection, and adverse effect reporting to the sponsors and IRB. The CTVHCS Oncology Section has been active in recruiting and enrolling veterans in clinical trials for treatment of many hematologic malignancies and solid tumors.

RESULTS: At the time of this presentation, 49 veterans have been successfully enrolled in 1 of 9 hematology/ oncology clinical trials ranging from phase Ib to phase III from 2011-2020. Advantages to opening clinical trials include academic scholarship, authorship in publications, generating revenue and most importantly to provide state of the art treatment for our cancer patients. We have been able to effectively accrue/enroll patients into clinical trials through a collaborative effort between the research department and our oncology department by identifying open clinical trials that fit our unique patient population and having a team of providers aiding in the management and care of these enrolled veterans.

BACKGROUND: Availability of clinical trials for veterans is limited and more clinical trials are needed. Central Texas Veterans Health Care System (CTVHCS) has been actively involved with hematologic oncologic clinical trials over the last 10 years. This poster describes the number and types of hematology/oncology clinical trials that are either active or completed, and the processes of opening clinical trials, identifying patients, and trial management.

METHODS: Locating clinical trials is key to veteran enrollment into active trials and is accomplished through networking at medical meetings and VA work groups. Developing a clinical trial program requires working closely with the research department/foundations and becoming comfortable with the IRB oversight process. Conduct of a clinical trial is a team effort, with individual members having delegated responsibilities of patient care, data collection, and adverse effect reporting to the sponsors and IRB. The CTVHCS Oncology Section has been active in recruiting and enrolling veterans in clinical trials for treatment of many hematologic malignancies and solid tumors.

RESULTS: At the time of this presentation, 49 veterans have been successfully enrolled in 1 of 9 hematology/ oncology clinical trials ranging from phase Ib to phase III from 2011-2020. Advantages to opening clinical trials include academic scholarship, authorship in publications, generating revenue and most importantly to provide state of the art treatment for our cancer patients. We have been able to effectively accrue/enroll patients into clinical trials through a collaborative effort between the research department and our oncology department by identifying open clinical trials that fit our unique patient population and having a team of providers aiding in the management and care of these enrolled veterans.

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Bridging the Gap: Transforming Oncology Care Through Use of Virtual Tumor Boards

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PURPOSE: A quality improvement pilot study was conducted to assess the feasibility of implementing virtual tumor boards (VTBs) to address barriers in cancer care for Veterans at the VA North TexasHealth Care System (VANTHCS) located in Dallas, Texas.

BACKGROUND: The VANTHCS is the second largest VA health care system in the country, serving more than 129,000 veterans with 1.4 million outpatient episodes of care in the FY2017. Cancer is one of the leading causes of these episodes of care. This specific population faces unique needs due to the complexity of cancer care. Multidisciplinary tumor boards (MTBs) can serve as facilitators in augmenting quality cancer care for veterans. Specifically, MTBs have been shown to support diagnostic decision-making, adherence to evidence-based guidelines, as well as enhance collaboration and care coordination. The VANTHCS Cancer Program hosts seven accredited disease-site specific MTBs that meet in a face-to-face conference. However, the COVID-19 pandemic created a gap in continuity cancer care through use of MTBs. Prior to the initiation of this study, no VTBs had previously been implemented.

METHODS: In March 2020, key stakeholders within the cancer program formulated a plan to continue MTBs during the pandemic. A multidisciplinary cancer conference coordinator (MCCC) lead this task utilizing a web-based platform in addition to Biomedical Engineering assistance ensuring appropriate applications were correctly interfaced on all VA Computers to properly support imaging. A Plan-Do-Study-Act was conducted to assess for any changes.

RESULTS: Data were collected and analyzed from January 2, 2020 until July 2, 2020, utilizing a cancer conference tracking tool conducted by the MCCC. A total of 72 MTBs were completed as well as 446 prospective cases were presented. After implementation of VTBs, data showed a 26.8% increase in interdisciplinary attendance rate for MTBs.

CONCLUSION: This innovative pilot study provided a unique approach to meet the demands of the COVID- 19 pandemic as well as showed the feasibility in enhancing quality cancer care. Virtual tumors boards provide an effective tool in improving accessibility through increased participation at MTBs. This may have future implications in which further research is needed including cancer survival and patient satisfaction rates.

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PURPOSE: A quality improvement pilot study was conducted to assess the feasibility of implementing virtual tumor boards (VTBs) to address barriers in cancer care for Veterans at the VA North TexasHealth Care System (VANTHCS) located in Dallas, Texas.

BACKGROUND: The VANTHCS is the second largest VA health care system in the country, serving more than 129,000 veterans with 1.4 million outpatient episodes of care in the FY2017. Cancer is one of the leading causes of these episodes of care. This specific population faces unique needs due to the complexity of cancer care. Multidisciplinary tumor boards (MTBs) can serve as facilitators in augmenting quality cancer care for veterans. Specifically, MTBs have been shown to support diagnostic decision-making, adherence to evidence-based guidelines, as well as enhance collaboration and care coordination. The VANTHCS Cancer Program hosts seven accredited disease-site specific MTBs that meet in a face-to-face conference. However, the COVID-19 pandemic created a gap in continuity cancer care through use of MTBs. Prior to the initiation of this study, no VTBs had previously been implemented.

METHODS: In March 2020, key stakeholders within the cancer program formulated a plan to continue MTBs during the pandemic. A multidisciplinary cancer conference coordinator (MCCC) lead this task utilizing a web-based platform in addition to Biomedical Engineering assistance ensuring appropriate applications were correctly interfaced on all VA Computers to properly support imaging. A Plan-Do-Study-Act was conducted to assess for any changes.

RESULTS: Data were collected and analyzed from January 2, 2020 until July 2, 2020, utilizing a cancer conference tracking tool conducted by the MCCC. A total of 72 MTBs were completed as well as 446 prospective cases were presented. After implementation of VTBs, data showed a 26.8% increase in interdisciplinary attendance rate for MTBs.

CONCLUSION: This innovative pilot study provided a unique approach to meet the demands of the COVID- 19 pandemic as well as showed the feasibility in enhancing quality cancer care. Virtual tumors boards provide an effective tool in improving accessibility through increased participation at MTBs. This may have future implications in which further research is needed including cancer survival and patient satisfaction rates.

PURPOSE: A quality improvement pilot study was conducted to assess the feasibility of implementing virtual tumor boards (VTBs) to address barriers in cancer care for Veterans at the VA North TexasHealth Care System (VANTHCS) located in Dallas, Texas.

BACKGROUND: The VANTHCS is the second largest VA health care system in the country, serving more than 129,000 veterans with 1.4 million outpatient episodes of care in the FY2017. Cancer is one of the leading causes of these episodes of care. This specific population faces unique needs due to the complexity of cancer care. Multidisciplinary tumor boards (MTBs) can serve as facilitators in augmenting quality cancer care for veterans. Specifically, MTBs have been shown to support diagnostic decision-making, adherence to evidence-based guidelines, as well as enhance collaboration and care coordination. The VANTHCS Cancer Program hosts seven accredited disease-site specific MTBs that meet in a face-to-face conference. However, the COVID-19 pandemic created a gap in continuity cancer care through use of MTBs. Prior to the initiation of this study, no VTBs had previously been implemented.

METHODS: In March 2020, key stakeholders within the cancer program formulated a plan to continue MTBs during the pandemic. A multidisciplinary cancer conference coordinator (MCCC) lead this task utilizing a web-based platform in addition to Biomedical Engineering assistance ensuring appropriate applications were correctly interfaced on all VA Computers to properly support imaging. A Plan-Do-Study-Act was conducted to assess for any changes.

RESULTS: Data were collected and analyzed from January 2, 2020 until July 2, 2020, utilizing a cancer conference tracking tool conducted by the MCCC. A total of 72 MTBs were completed as well as 446 prospective cases were presented. After implementation of VTBs, data showed a 26.8% increase in interdisciplinary attendance rate for MTBs.

CONCLUSION: This innovative pilot study provided a unique approach to meet the demands of the COVID- 19 pandemic as well as showed the feasibility in enhancing quality cancer care. Virtual tumors boards provide an effective tool in improving accessibility through increased participation at MTBs. This may have future implications in which further research is needed including cancer survival and patient satisfaction rates.

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Analysis of Oncology Telehealth Services in Veterans Health Administration

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BACKGROUND: The purpose of this work is to assess the current utilization patterns of telehealth for oncology care and identify opportunities for increased utilization for underserved regions. In order to accurately and efficiently obtain this information a national data extraction and analysis was required to better understand the current needs. Approximately 33% of veterans are considered to live in rural America. A significant proportion of cancer patients must travel long distances to access cutting-edge VA cancer care. Some VAMCs provide academic subspecialized oncology care including next generation sequencing (NGS), genetic counseling, opportunities to enroll in clinical trials, and world-renowned clinical expert consultation. These services are not conveniently accessible for veterans therefore requiring a program which supports access to all.

METHODS: Baseline assessment measurements were identified to understand resource supply, demand, and telehealth utilization needs. Data were extracted from VA’s CDW and VSSCs Service Analysis Services cubes. 15 data measures from 8 data sources were pulled for 141 VAMCs spanning in time period from FY18 to March FY20.

Cluster Analysis, k-means clustering method, were used to classify VAMCs into distinct groups to identify facilities with the highest needs for oncology telehealth services. The evolutionary solving method was used to find the minimum sum of squared estimate of errors (SSE) allowing a more diversified approach in cluster assignment. Three cluster analysis were performed which include a combination of three variables specific to oncology staffing, telehealth usage, patient rurality, and community care consults (CCC).

RESULTS: Results show that 30 (21%) VAMCs are categorized as high need for TeleOncology. These facilities have low staff support, high CCC, and low telehealth usage. Of these, 11 (37%) VAMCs have high percent of rural patients. Eleven (8%) of all VAMCs are categorized as having high staff support, low CCC, and high telehealth usage; good hub site candidates for the National TeleOncology Program.

CONCLUSION: VA is expanding the National TeleOncology Program to offer oncology services to underserved VAMCs and Veterans across the United States. Results of this analysis are being applied to determine where to prioritize telehealth services for oncology care and which sites may serve as hubs.

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Correspondence: Kelli Lee (kelli.lee@va.gov)

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Correspondence: Kelli Lee (kelli.lee@va.gov)

Author and Disclosure Information

Correspondence: Kelli Lee (kelli.lee@va.gov)

BACKGROUND: The purpose of this work is to assess the current utilization patterns of telehealth for oncology care and identify opportunities for increased utilization for underserved regions. In order to accurately and efficiently obtain this information a national data extraction and analysis was required to better understand the current needs. Approximately 33% of veterans are considered to live in rural America. A significant proportion of cancer patients must travel long distances to access cutting-edge VA cancer care. Some VAMCs provide academic subspecialized oncology care including next generation sequencing (NGS), genetic counseling, opportunities to enroll in clinical trials, and world-renowned clinical expert consultation. These services are not conveniently accessible for veterans therefore requiring a program which supports access to all.

METHODS: Baseline assessment measurements were identified to understand resource supply, demand, and telehealth utilization needs. Data were extracted from VA’s CDW and VSSCs Service Analysis Services cubes. 15 data measures from 8 data sources were pulled for 141 VAMCs spanning in time period from FY18 to March FY20.

Cluster Analysis, k-means clustering method, were used to classify VAMCs into distinct groups to identify facilities with the highest needs for oncology telehealth services. The evolutionary solving method was used to find the minimum sum of squared estimate of errors (SSE) allowing a more diversified approach in cluster assignment. Three cluster analysis were performed which include a combination of three variables specific to oncology staffing, telehealth usage, patient rurality, and community care consults (CCC).

RESULTS: Results show that 30 (21%) VAMCs are categorized as high need for TeleOncology. These facilities have low staff support, high CCC, and low telehealth usage. Of these, 11 (37%) VAMCs have high percent of rural patients. Eleven (8%) of all VAMCs are categorized as having high staff support, low CCC, and high telehealth usage; good hub site candidates for the National TeleOncology Program.

CONCLUSION: VA is expanding the National TeleOncology Program to offer oncology services to underserved VAMCs and Veterans across the United States. Results of this analysis are being applied to determine where to prioritize telehealth services for oncology care and which sites may serve as hubs.

BACKGROUND: The purpose of this work is to assess the current utilization patterns of telehealth for oncology care and identify opportunities for increased utilization for underserved regions. In order to accurately and efficiently obtain this information a national data extraction and analysis was required to better understand the current needs. Approximately 33% of veterans are considered to live in rural America. A significant proportion of cancer patients must travel long distances to access cutting-edge VA cancer care. Some VAMCs provide academic subspecialized oncology care including next generation sequencing (NGS), genetic counseling, opportunities to enroll in clinical trials, and world-renowned clinical expert consultation. These services are not conveniently accessible for veterans therefore requiring a program which supports access to all.

METHODS: Baseline assessment measurements were identified to understand resource supply, demand, and telehealth utilization needs. Data were extracted from VA’s CDW and VSSCs Service Analysis Services cubes. 15 data measures from 8 data sources were pulled for 141 VAMCs spanning in time period from FY18 to March FY20.

Cluster Analysis, k-means clustering method, were used to classify VAMCs into distinct groups to identify facilities with the highest needs for oncology telehealth services. The evolutionary solving method was used to find the minimum sum of squared estimate of errors (SSE) allowing a more diversified approach in cluster assignment. Three cluster analysis were performed which include a combination of three variables specific to oncology staffing, telehealth usage, patient rurality, and community care consults (CCC).

RESULTS: Results show that 30 (21%) VAMCs are categorized as high need for TeleOncology. These facilities have low staff support, high CCC, and low telehealth usage. Of these, 11 (37%) VAMCs have high percent of rural patients. Eleven (8%) of all VAMCs are categorized as having high staff support, low CCC, and high telehealth usage; good hub site candidates for the National TeleOncology Program.

CONCLUSION: VA is expanding the National TeleOncology Program to offer oncology services to underserved VAMCs and Veterans across the United States. Results of this analysis are being applied to determine where to prioritize telehealth services for oncology care and which sites may serve as hubs.

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