Highlights in advanced non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress are presented by Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California.

Dr West begins by discussing CodeBreak 200, a study comparing sotorasib with docetaxel in previously treated patients with a KRAS G12C mutation. Sotorasib improved progression-free survival, but overall survival data are awaited.

Next, Dr West examines 5-year updates from KEYNOTE-189 and KEYNOTE-407, comparing pembrolizumab with chemotherapy in nonsquamous and squamous disease, respectively. Around two fifths of patients remained alive and disease-free 5 years after stopping treatment.

Dr West then reports on the IPSOS trial, which compared atezolizumab with single-agent chemotherapy in patients who were ineligible for standard chemotherapy. The results suggested that immunotherapy could be used in patients who are usually excluded from trials.

He finishes with two studies in EGFR-mutated disease. ORIENT-3 indicated that the effect of sintilimab could be boosted with a bevacizumab biosimilar. INSIGHT 2 suggested that adding tepotinib to osimertinib may be effective in patients with MET amplification.

--

Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California

Howard (Jack) West, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda

Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck

Highlights in advanced non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress are presented by Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California.

Dr West begins by discussing CodeBreak 200, a study comparing sotorasib with docetaxel in previously treated patients with a KRAS G12C mutation. Sotorasib improved progression-free survival, but overall survival data are awaited.

Next, Dr West examines 5-year updates from KEYNOTE-189 and KEYNOTE-407, comparing pembrolizumab with chemotherapy in nonsquamous and squamous disease, respectively. Around two fifths of patients remained alive and disease-free 5 years after stopping treatment.

Dr West then reports on the IPSOS trial, which compared atezolizumab with single-agent chemotherapy in patients who were ineligible for standard chemotherapy. The results suggested that immunotherapy could be used in patients who are usually excluded from trials.

He finishes with two studies in EGFR-mutated disease. ORIENT-3 indicated that the effect of sintilimab could be boosted with a bevacizumab biosimilar. INSIGHT 2 suggested that adding tepotinib to osimertinib may be effective in patients with MET amplification.

--

Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California

Howard (Jack) West, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda

Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck

Highlights in advanced non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress are presented by Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California.

Dr West begins by discussing CodeBreak 200, a study comparing sotorasib with docetaxel in previously treated patients with a KRAS G12C mutation. Sotorasib improved progression-free survival, but overall survival data are awaited.

Next, Dr West examines 5-year updates from KEYNOTE-189 and KEYNOTE-407, comparing pembrolizumab with chemotherapy in nonsquamous and squamous disease, respectively. Around two fifths of patients remained alive and disease-free 5 years after stopping treatment.

Dr West then reports on the IPSOS trial, which compared atezolizumab with single-agent chemotherapy in patients who were ineligible for standard chemotherapy. The results suggested that immunotherapy could be used in patients who are usually excluded from trials.

He finishes with two studies in EGFR-mutated disease. ORIENT-3 indicated that the effect of sintilimab could be boosted with a bevacizumab biosimilar. INSIGHT 2 suggested that adding tepotinib to osimertinib may be effective in patients with MET amplification.

--

Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California

Howard (Jack) West, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda

Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck

A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.

©Amanda Grandfield/iStockphoto.com

Uphill battle

Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.

“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.

“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.

Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.

“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”

She also informs them about relatively healthy fast-food choices.

“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”

Dr. Brandt and Dr. Contreras report no relevant financial relationships.

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

A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.

©Amanda Grandfield/iStockphoto.com

Uphill battle

Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.

“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.

“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.

Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.

“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”

She also informs them about relatively healthy fast-food choices.

“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”

Dr. Brandt and Dr. Contreras report no relevant financial relationships.

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

A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.

An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.

©Amanda Grandfield/iStockphoto.com

Uphill battle

Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.

“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.

“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.

Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.

“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”

She also informs them about relatively healthy fast-food choices.

“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”

Dr. Brandt and Dr. Contreras report no relevant financial relationships.

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

Transplantation of hearts donated after circulatory death (DCD) is associated with short-term clinical outcomes similar to those of hearts donated after brain death (DBD), except for transient posttransplant right heart dysfunction, a single-center analysis suggests.

The right-heart dysfunction resolved by 3 weeks post transplant, and recipient mortality was similar for those receiving DCD and DBD, which is considered standard of care (SOC).

Furthermore, the median waiting list time was significantly shorter for DCD recipients than for SOC recipients (17 vs. 70 days).

The authors suggest that use of DCD hearts could expand the donor pool by as much as 30%.

“Now that we and others have demonstrated the safety of this technique, I believe it is our obligation as a transplant community to use these organs and not allow them to be wasted,” David A. D’Alessandro, MD, of Massachusetts General Hospital, Boston, told this news organization.

“I will caution that DCD heart transplantation is labor intensive, and there is a learning curve which can potentially put patients at risk,” he added. “It is vitally important, therefore, that we learn from each other’s experiences to flatten this curve.”

The study was published online in the Journal of the American College of Cardiology.
 

Similar outcomes

Dr. D’Alessandro and colleagues compared the hemodynamic and clinical profiles of 47 DCD hearts with 166 SOC hearts implanted at Massachusetts General Hospital between 2016 and 2022. DCD hearts were maintained with use of a proprietary warm perfusion circuit organ care system (OCS, TransMedics).

Baseline characteristics were similar between the groups, except the DCD heart recipients were younger (mean age, 55 vs. 59); they were less likely to be an inpatient at the time of transplant (26% vs. 49%); and they had lower pulmonary vascular resistance (1.73 WU vs. 2.26 WU).

The median time from DCD consent to transplant was significantly shorter than for SOC hearts (17 vs. 70 days). However, there was a higher, though not statistically significant, incidence of severe primary graft dysfunction at 24 hours post transplant with DCD (10.6% vs. SOC 3.6%), leading five DCD recipients (10.6%) and nine SOC recipients (5.4%) to receive venoarterial extracorporeal membrane oxygenation.

Right heart function was significantly impaired in DCD vs. SOC recipients 1 week post transplant, with higher median right atrial pressure (10 mm Hg vs. 7 mm Hg); higher right atrial pressure to pulmonary capillary wedge pressure ratio (0.64 vs. 0.57); and lower pulmonary arterial pulsatility index (1.66 vs. 2.52).

However, by 3 weeks post transplant, right heart function was similar between the groups, as was mortality at 30 days (0 vs. 2%) and 1 year (3% vs. 8%).

Furthermore, hospital length of stay following transplant, intensive care unit length of stay, ICU readmissions, and 30-day readmissions were similar between the groups.

“We and others will continue to push the boundaries of this technique to understand if we can safely extend the warm ischemic time, which could make additional organs available,” Dr. D’Alessandro said. “We will also be exploring additional ways to monitor and assess organ health and viability ex situ and potential avenues of treatment which could repair and optimize organ function.

“A successful DCD heart transplant program requires institutional and team commitment,” he added, “and there are clinical nuances which should be appreciated to minimize patient risks associated with the obligate learning curve.”

Ulrich P. Jorde, MD, of Montefiore Medical Center in New York, author of a related editorial, concluded that heart donation after circulatory death “promises significant expansion of the donor pool and will lead to many lives saved” and that “the current investigation is a timely and important contribution to this effort”.

However, he noted, “it must be acknowledged that donation after cardiac death has evoked significant controversy regarding the ethics of this approach,” particularly when using a technique called normothermic regional perfusion (NRP), in which, after declaration of death and ligation of cerebral vessels, the heart is resuscitated in situ using extracorporeal membrane oxygenation, as opposed to the proprietary warm perfusion OCS used in this study.

“Central to this discussion is the definition of death and its irreversibility,” Dr. Jorde noted. “In contrast to DBD, where brain death protocols are well established and accepted by societies across the globe, DCD protocol rules, e.g., standoff times after complete cessation of circulation, continue to vary even within national jurisdictions. Such variability and incomplete standardization of practice is particularly important when the organ is resuscitated in situ using normothermic regional perfusion.

“The International Society of Heart and Lung Transplantation has recently provided a framework within which donation after cardiac death, with or without the use of NRP, can be conducted to comply with ethical and legal norms and regulations, acknowledging that such norms and regulations may differ between societies,” he wrote. “To advance the field, and to ensure ongoing trust in the transplantation system, it is of critical importance that such discussions are held publicly and transparently.”
 

More ‘dry runs’

“Donor heart allographs are safe for our patients with heart failure if procured and transplanted in an organized and protocolized manner,” Philip J. Spencer, MD, a cardiovascular and transplant surgeon at Mayo Clinic in Rochester, Minn., told this news organization. “As the techniques are adopted globally, our patients will benefit.”

Nevertheless, like Dr. D’Alessandro, he noted that procurement of DCD hearts is more labor intensive. “A program and its patients must be willing to accept a higher number of ‘dry runs,’ which occurs when the team is sent for an organ and the donor does not progress to circulatory death in a time and manner appropriate for safe organ recovery.

“There is no doubt that being open to these organs will increase the patient’s chances of receiving a donor heart in a shorter period of time,” he said. “However, the experience of a dry run, or multiple, can be emotionally and financially stressful for the patient and the program.”

No commercial funding or relevant conflicts of interest were disclosed.

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

Transplantation of hearts donated after circulatory death (DCD) is associated with short-term clinical outcomes similar to those of hearts donated after brain death (DBD), except for transient posttransplant right heart dysfunction, a single-center analysis suggests.

The right-heart dysfunction resolved by 3 weeks post transplant, and recipient mortality was similar for those receiving DCD and DBD, which is considered standard of care (SOC).

Furthermore, the median waiting list time was significantly shorter for DCD recipients than for SOC recipients (17 vs. 70 days).

The authors suggest that use of DCD hearts could expand the donor pool by as much as 30%.

“Now that we and others have demonstrated the safety of this technique, I believe it is our obligation as a transplant community to use these organs and not allow them to be wasted,” David A. D’Alessandro, MD, of Massachusetts General Hospital, Boston, told this news organization.

“I will caution that DCD heart transplantation is labor intensive, and there is a learning curve which can potentially put patients at risk,” he added. “It is vitally important, therefore, that we learn from each other’s experiences to flatten this curve.”

The study was published online in the Journal of the American College of Cardiology.
 

Similar outcomes

Dr. D’Alessandro and colleagues compared the hemodynamic and clinical profiles of 47 DCD hearts with 166 SOC hearts implanted at Massachusetts General Hospital between 2016 and 2022. DCD hearts were maintained with use of a proprietary warm perfusion circuit organ care system (OCS, TransMedics).

Baseline characteristics were similar between the groups, except the DCD heart recipients were younger (mean age, 55 vs. 59); they were less likely to be an inpatient at the time of transplant (26% vs. 49%); and they had lower pulmonary vascular resistance (1.73 WU vs. 2.26 WU).

The median time from DCD consent to transplant was significantly shorter than for SOC hearts (17 vs. 70 days). However, there was a higher, though not statistically significant, incidence of severe primary graft dysfunction at 24 hours post transplant with DCD (10.6% vs. SOC 3.6%), leading five DCD recipients (10.6%) and nine SOC recipients (5.4%) to receive venoarterial extracorporeal membrane oxygenation.

Right heart function was significantly impaired in DCD vs. SOC recipients 1 week post transplant, with higher median right atrial pressure (10 mm Hg vs. 7 mm Hg); higher right atrial pressure to pulmonary capillary wedge pressure ratio (0.64 vs. 0.57); and lower pulmonary arterial pulsatility index (1.66 vs. 2.52).

However, by 3 weeks post transplant, right heart function was similar between the groups, as was mortality at 30 days (0 vs. 2%) and 1 year (3% vs. 8%).

Furthermore, hospital length of stay following transplant, intensive care unit length of stay, ICU readmissions, and 30-day readmissions were similar between the groups.

“We and others will continue to push the boundaries of this technique to understand if we can safely extend the warm ischemic time, which could make additional organs available,” Dr. D’Alessandro said. “We will also be exploring additional ways to monitor and assess organ health and viability ex situ and potential avenues of treatment which could repair and optimize organ function.

“A successful DCD heart transplant program requires institutional and team commitment,” he added, “and there are clinical nuances which should be appreciated to minimize patient risks associated with the obligate learning curve.”

Ulrich P. Jorde, MD, of Montefiore Medical Center in New York, author of a related editorial, concluded that heart donation after circulatory death “promises significant expansion of the donor pool and will lead to many lives saved” and that “the current investigation is a timely and important contribution to this effort”.

However, he noted, “it must be acknowledged that donation after cardiac death has evoked significant controversy regarding the ethics of this approach,” particularly when using a technique called normothermic regional perfusion (NRP), in which, after declaration of death and ligation of cerebral vessels, the heart is resuscitated in situ using extracorporeal membrane oxygenation, as opposed to the proprietary warm perfusion OCS used in this study.

“Central to this discussion is the definition of death and its irreversibility,” Dr. Jorde noted. “In contrast to DBD, where brain death protocols are well established and accepted by societies across the globe, DCD protocol rules, e.g., standoff times after complete cessation of circulation, continue to vary even within national jurisdictions. Such variability and incomplete standardization of practice is particularly important when the organ is resuscitated in situ using normothermic regional perfusion.

“The International Society of Heart and Lung Transplantation has recently provided a framework within which donation after cardiac death, with or without the use of NRP, can be conducted to comply with ethical and legal norms and regulations, acknowledging that such norms and regulations may differ between societies,” he wrote. “To advance the field, and to ensure ongoing trust in the transplantation system, it is of critical importance that such discussions are held publicly and transparently.”
 

More ‘dry runs’

“Donor heart allographs are safe for our patients with heart failure if procured and transplanted in an organized and protocolized manner,” Philip J. Spencer, MD, a cardiovascular and transplant surgeon at Mayo Clinic in Rochester, Minn., told this news organization. “As the techniques are adopted globally, our patients will benefit.”

Nevertheless, like Dr. D’Alessandro, he noted that procurement of DCD hearts is more labor intensive. “A program and its patients must be willing to accept a higher number of ‘dry runs,’ which occurs when the team is sent for an organ and the donor does not progress to circulatory death in a time and manner appropriate for safe organ recovery.

“There is no doubt that being open to these organs will increase the patient’s chances of receiving a donor heart in a shorter period of time,” he said. “However, the experience of a dry run, or multiple, can be emotionally and financially stressful for the patient and the program.”

No commercial funding or relevant conflicts of interest were disclosed.

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

Transplantation of hearts donated after circulatory death (DCD) is associated with short-term clinical outcomes similar to those of hearts donated after brain death (DBD), except for transient posttransplant right heart dysfunction, a single-center analysis suggests.

The right-heart dysfunction resolved by 3 weeks post transplant, and recipient mortality was similar for those receiving DCD and DBD, which is considered standard of care (SOC).

Furthermore, the median waiting list time was significantly shorter for DCD recipients than for SOC recipients (17 vs. 70 days).

The authors suggest that use of DCD hearts could expand the donor pool by as much as 30%.

“Now that we and others have demonstrated the safety of this technique, I believe it is our obligation as a transplant community to use these organs and not allow them to be wasted,” David A. D’Alessandro, MD, of Massachusetts General Hospital, Boston, told this news organization.

“I will caution that DCD heart transplantation is labor intensive, and there is a learning curve which can potentially put patients at risk,” he added. “It is vitally important, therefore, that we learn from each other’s experiences to flatten this curve.”

The study was published online in the Journal of the American College of Cardiology.
 

Similar outcomes

Dr. D’Alessandro and colleagues compared the hemodynamic and clinical profiles of 47 DCD hearts with 166 SOC hearts implanted at Massachusetts General Hospital between 2016 and 2022. DCD hearts were maintained with use of a proprietary warm perfusion circuit organ care system (OCS, TransMedics).

Baseline characteristics were similar between the groups, except the DCD heart recipients were younger (mean age, 55 vs. 59); they were less likely to be an inpatient at the time of transplant (26% vs. 49%); and they had lower pulmonary vascular resistance (1.73 WU vs. 2.26 WU).

The median time from DCD consent to transplant was significantly shorter than for SOC hearts (17 vs. 70 days). However, there was a higher, though not statistically significant, incidence of severe primary graft dysfunction at 24 hours post transplant with DCD (10.6% vs. SOC 3.6%), leading five DCD recipients (10.6%) and nine SOC recipients (5.4%) to receive venoarterial extracorporeal membrane oxygenation.

Right heart function was significantly impaired in DCD vs. SOC recipients 1 week post transplant, with higher median right atrial pressure (10 mm Hg vs. 7 mm Hg); higher right atrial pressure to pulmonary capillary wedge pressure ratio (0.64 vs. 0.57); and lower pulmonary arterial pulsatility index (1.66 vs. 2.52).

However, by 3 weeks post transplant, right heart function was similar between the groups, as was mortality at 30 days (0 vs. 2%) and 1 year (3% vs. 8%).

Furthermore, hospital length of stay following transplant, intensive care unit length of stay, ICU readmissions, and 30-day readmissions were similar between the groups.

“We and others will continue to push the boundaries of this technique to understand if we can safely extend the warm ischemic time, which could make additional organs available,” Dr. D’Alessandro said. “We will also be exploring additional ways to monitor and assess organ health and viability ex situ and potential avenues of treatment which could repair and optimize organ function.

“A successful DCD heart transplant program requires institutional and team commitment,” he added, “and there are clinical nuances which should be appreciated to minimize patient risks associated with the obligate learning curve.”

Ulrich P. Jorde, MD, of Montefiore Medical Center in New York, author of a related editorial, concluded that heart donation after circulatory death “promises significant expansion of the donor pool and will lead to many lives saved” and that “the current investigation is a timely and important contribution to this effort”.

However, he noted, “it must be acknowledged that donation after cardiac death has evoked significant controversy regarding the ethics of this approach,” particularly when using a technique called normothermic regional perfusion (NRP), in which, after declaration of death and ligation of cerebral vessels, the heart is resuscitated in situ using extracorporeal membrane oxygenation, as opposed to the proprietary warm perfusion OCS used in this study.

“Central to this discussion is the definition of death and its irreversibility,” Dr. Jorde noted. “In contrast to DBD, where brain death protocols are well established and accepted by societies across the globe, DCD protocol rules, e.g., standoff times after complete cessation of circulation, continue to vary even within national jurisdictions. Such variability and incomplete standardization of practice is particularly important when the organ is resuscitated in situ using normothermic regional perfusion.

“The International Society of Heart and Lung Transplantation has recently provided a framework within which donation after cardiac death, with or without the use of NRP, can be conducted to comply with ethical and legal norms and regulations, acknowledging that such norms and regulations may differ between societies,” he wrote. “To advance the field, and to ensure ongoing trust in the transplantation system, it is of critical importance that such discussions are held publicly and transparently.”
 

More ‘dry runs’

“Donor heart allographs are safe for our patients with heart failure if procured and transplanted in an organized and protocolized manner,” Philip J. Spencer, MD, a cardiovascular and transplant surgeon at Mayo Clinic in Rochester, Minn., told this news organization. “As the techniques are adopted globally, our patients will benefit.”

Nevertheless, like Dr. D’Alessandro, he noted that procurement of DCD hearts is more labor intensive. “A program and its patients must be willing to accept a higher number of ‘dry runs,’ which occurs when the team is sent for an organ and the donor does not progress to circulatory death in a time and manner appropriate for safe organ recovery.

“There is no doubt that being open to these organs will increase the patient’s chances of receiving a donor heart in a shorter period of time,” he said. “However, the experience of a dry run, or multiple, can be emotionally and financially stressful for the patient and the program.”

No commercial funding or relevant conflicts of interest were disclosed.

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

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.

According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.

To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.

Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.

“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.

To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.

Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.

For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.

Findings showed that:

• The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
• Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
• HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
• Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
• On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
• Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).

“We are underutilizing the HPV vaccine in our clinical settings in the United States and globally,” Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.

“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.

Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.

“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.

“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.

The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.

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

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.

According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.

To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.

Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.

“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.

To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.

Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.

For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.

Findings showed that:

• The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
• Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
• HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
• Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
• On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
• Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).

“We are underutilizing the HPV vaccine in our clinical settings in the United States and globally,” Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.

“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.

Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.

“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.

“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.

The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.

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

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.

According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.

To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.

Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.

“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.

To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.

Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.

For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.

Findings showed that:

• The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
• Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
• HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
• Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
• On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
• Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).

“We are underutilizing the HPV vaccine in our clinical settings in the United States and globally,” Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.

“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.

Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.

“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.

“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.

The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.

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

Starting treatment for alcohol use disorder (AUD) with extended-release naltrexone injections in the emergency department produced a dramatic reduction in alcohol consumption, according to findings presented at the annual meeting of the American College of Emergency Physicians.

The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.

“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”

The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.

Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.

The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.

“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”

On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.

Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.

She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.

“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.

Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.

“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”

Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.

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

Starting treatment for alcohol use disorder (AUD) with extended-release naltrexone injections in the emergency department produced a dramatic reduction in alcohol consumption, according to findings presented at the annual meeting of the American College of Emergency Physicians.

The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.

“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”

The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.

Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.

The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.

“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”

On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.

Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.

She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.

“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.

Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.

“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”

Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.

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

Starting treatment for alcohol use disorder (AUD) with extended-release naltrexone injections in the emergency department produced a dramatic reduction in alcohol consumption, according to findings presented at the annual meeting of the American College of Emergency Physicians.

The results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.

“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”

The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.

Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.

The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.

“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”

On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.

Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.

She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.

“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.

Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.

“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”

Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.

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

Miscarriages are a devastating, if natural, occurrence. Nearly 1 million pregnant people in the United States experience a miscarriage every year, according to the National Advocates for Pregnant Women. New research could lend insight into the causes of some types of early pregnancy loss and maybe one day help prevent miscarriages. 

In the bioengineering breakthrough, scientists created a mouse embryo in a lab without using sperm or eggs. The experimental embryo, called a model, was grown out of stem cells and developed further than any earlier experiments, with a beating heart and the foundation of a brain within a yolk sac, according to the researchers. 

The experiment, while conducted with mouse stem cells, could help explain why some human pregnancies fail. Miscarriages occur in up to 15% of pregnancies confirmed by doctors, according to some studies, and also for many pregnant people before they even knew of the pregnancy. This experiment gives researchers a glimpse of a critical developmental stage for the first time. 

“We are building mouse embryo models, but they have exactly the same principle as real human embryos,” says lead researcher Magdalena Zernicka-Goetz, PhD, professor in mammalian development and stem cell biology at Cambridge (England) University. “That’s why they tell us about real pregnancy.”

With the new mouse models, the researchers can study implantation, the stage when embryos embed themselves in the mother’s body – a stage that’s often difficult for embryos to survive. The same process happens in mouse embryos, which develop very similarly to human embryos at this early stage of life.

Six years ago, researchers from the University of Cambridge and the California Institute of Technology set out to create models that would allow them to study fetal development in three-dimensional form but without the need for human embryos. 

“We are trying to understand the major principles of time and space that have to be fulfilled” to form a successful pregnancy, Dr. Zernicka-Goetz explains. “If those principles are not fulfilled, the pregnancies are terminated, even before women know they’re pregnant.” 

There are limits on using human embryos for research, and previous experiments have tended to replicate only one aspect of development. That led to two-dimensional experiments: flat cells on the bottom of a petri dish that lack the structural organization of real tissue. 

The new models are three-dimensional with beating hearts and the yolk sacs in which embryos feed and grow. The models even progressed to forming the beginning of a brain – a research first. 

The scientists used the foundational cellular “building blocks” called stem cells and managed to get the cells to communicate along a timeline that mimicked natural development, simulating those developmental stages, says Dr. Zernicka-Goetz. Those “building blocks” are actually three types of stem cells: pluripotent stem cells that build body tissue, and two other types of stem cells that build the placenta and the amniotic sac. 

Completing the experiment required the right quantity of each stem cell type. The researchers also needed to understand how those cells exchange information before they can begin to grow. The researchers were able to “decipher the code” of how the cells talk to each other, Dr. Zernicka-Goetz says.

Initially, the three types of stem cells combine, almost like a soup, but when the timing is right, they have to recognize each other and sort themselves. Next, each stem cell type must start building a different structure necessary for fetal development. Dr. Zernicka-Goetz thinks of this construction as the architecture of human tissue. 

With the new technique, researchers can continue investigating the implantation stage and beyond. And they did – tweaking the experiment to create a genetically flawed embryo on purpose.

Dr. Zernicka-Goetz and her team eliminated a certain gene known to regulate how cells establish their own identities. Doing so resulted in the same brain development flaws as in human embryos, providing “a proof of concept” that the experimental models can be used to study other genetic mysteries, she says. 

Scientists are still in the dark about what some genes do, as well as the point when they become critical to brain development. 

“Many genes have very early roles in specifying, for example, the position of the head and also how our brain will function,” Dr. Zernicka-Goetz says. “We can now use this model system to assess the function of those genes.” 

A version of this article first appeared on WebMD.com.

Miscarriages are a devastating, if natural, occurrence. Nearly 1 million pregnant people in the United States experience a miscarriage every year, according to the National Advocates for Pregnant Women. New research could lend insight into the causes of some types of early pregnancy loss and maybe one day help prevent miscarriages. 

In the bioengineering breakthrough, scientists created a mouse embryo in a lab without using sperm or eggs. The experimental embryo, called a model, was grown out of stem cells and developed further than any earlier experiments, with a beating heart and the foundation of a brain within a yolk sac, according to the researchers. 

The experiment, while conducted with mouse stem cells, could help explain why some human pregnancies fail. Miscarriages occur in up to 15% of pregnancies confirmed by doctors, according to some studies, and also for many pregnant people before they even knew of the pregnancy. This experiment gives researchers a glimpse of a critical developmental stage for the first time. 

“We are building mouse embryo models, but they have exactly the same principle as real human embryos,” says lead researcher Magdalena Zernicka-Goetz, PhD, professor in mammalian development and stem cell biology at Cambridge (England) University. “That’s why they tell us about real pregnancy.”

With the new mouse models, the researchers can study implantation, the stage when embryos embed themselves in the mother’s body – a stage that’s often difficult for embryos to survive. The same process happens in mouse embryos, which develop very similarly to human embryos at this early stage of life.

Six years ago, researchers from the University of Cambridge and the California Institute of Technology set out to create models that would allow them to study fetal development in three-dimensional form but without the need for human embryos. 

“We are trying to understand the major principles of time and space that have to be fulfilled” to form a successful pregnancy, Dr. Zernicka-Goetz explains. “If those principles are not fulfilled, the pregnancies are terminated, even before women know they’re pregnant.” 

There are limits on using human embryos for research, and previous experiments have tended to replicate only one aspect of development. That led to two-dimensional experiments: flat cells on the bottom of a petri dish that lack the structural organization of real tissue. 

The new models are three-dimensional with beating hearts and the yolk sacs in which embryos feed and grow. The models even progressed to forming the beginning of a brain – a research first. 

The scientists used the foundational cellular “building blocks” called stem cells and managed to get the cells to communicate along a timeline that mimicked natural development, simulating those developmental stages, says Dr. Zernicka-Goetz. Those “building blocks” are actually three types of stem cells: pluripotent stem cells that build body tissue, and two other types of stem cells that build the placenta and the amniotic sac. 

Completing the experiment required the right quantity of each stem cell type. The researchers also needed to understand how those cells exchange information before they can begin to grow. The researchers were able to “decipher the code” of how the cells talk to each other, Dr. Zernicka-Goetz says.

Initially, the three types of stem cells combine, almost like a soup, but when the timing is right, they have to recognize each other and sort themselves. Next, each stem cell type must start building a different structure necessary for fetal development. Dr. Zernicka-Goetz thinks of this construction as the architecture of human tissue. 

With the new technique, researchers can continue investigating the implantation stage and beyond. And they did – tweaking the experiment to create a genetically flawed embryo on purpose.

Dr. Zernicka-Goetz and her team eliminated a certain gene known to regulate how cells establish their own identities. Doing so resulted in the same brain development flaws as in human embryos, providing “a proof of concept” that the experimental models can be used to study other genetic mysteries, she says. 

Scientists are still in the dark about what some genes do, as well as the point when they become critical to brain development. 

“Many genes have very early roles in specifying, for example, the position of the head and also how our brain will function,” Dr. Zernicka-Goetz says. “We can now use this model system to assess the function of those genes.” 

A version of this article first appeared on WebMD.com.

Miscarriages are a devastating, if natural, occurrence. Nearly 1 million pregnant people in the United States experience a miscarriage every year, according to the National Advocates for Pregnant Women. New research could lend insight into the causes of some types of early pregnancy loss and maybe one day help prevent miscarriages. 

In the bioengineering breakthrough, scientists created a mouse embryo in a lab without using sperm or eggs. The experimental embryo, called a model, was grown out of stem cells and developed further than any earlier experiments, with a beating heart and the foundation of a brain within a yolk sac, according to the researchers. 

The experiment, while conducted with mouse stem cells, could help explain why some human pregnancies fail. Miscarriages occur in up to 15% of pregnancies confirmed by doctors, according to some studies, and also for many pregnant people before they even knew of the pregnancy. This experiment gives researchers a glimpse of a critical developmental stage for the first time. 

“We are building mouse embryo models, but they have exactly the same principle as real human embryos,” says lead researcher Magdalena Zernicka-Goetz, PhD, professor in mammalian development and stem cell biology at Cambridge (England) University. “That’s why they tell us about real pregnancy.”

With the new mouse models, the researchers can study implantation, the stage when embryos embed themselves in the mother’s body – a stage that’s often difficult for embryos to survive. The same process happens in mouse embryos, which develop very similarly to human embryos at this early stage of life.

Six years ago, researchers from the University of Cambridge and the California Institute of Technology set out to create models that would allow them to study fetal development in three-dimensional form but without the need for human embryos. 

“We are trying to understand the major principles of time and space that have to be fulfilled” to form a successful pregnancy, Dr. Zernicka-Goetz explains. “If those principles are not fulfilled, the pregnancies are terminated, even before women know they’re pregnant.” 

There are limits on using human embryos for research, and previous experiments have tended to replicate only one aspect of development. That led to two-dimensional experiments: flat cells on the bottom of a petri dish that lack the structural organization of real tissue. 

The new models are three-dimensional with beating hearts and the yolk sacs in which embryos feed and grow. The models even progressed to forming the beginning of a brain – a research first. 

The scientists used the foundational cellular “building blocks” called stem cells and managed to get the cells to communicate along a timeline that mimicked natural development, simulating those developmental stages, says Dr. Zernicka-Goetz. Those “building blocks” are actually three types of stem cells: pluripotent stem cells that build body tissue, and two other types of stem cells that build the placenta and the amniotic sac. 

Completing the experiment required the right quantity of each stem cell type. The researchers also needed to understand how those cells exchange information before they can begin to grow. The researchers were able to “decipher the code” of how the cells talk to each other, Dr. Zernicka-Goetz says.

Initially, the three types of stem cells combine, almost like a soup, but when the timing is right, they have to recognize each other and sort themselves. Next, each stem cell type must start building a different structure necessary for fetal development. Dr. Zernicka-Goetz thinks of this construction as the architecture of human tissue. 

With the new technique, researchers can continue investigating the implantation stage and beyond. And they did – tweaking the experiment to create a genetically flawed embryo on purpose.

Dr. Zernicka-Goetz and her team eliminated a certain gene known to regulate how cells establish their own identities. Doing so resulted in the same brain development flaws as in human embryos, providing “a proof of concept” that the experimental models can be used to study other genetic mysteries, she says. 

Scientists are still in the dark about what some genes do, as well as the point when they become critical to brain development. 

“Many genes have very early roles in specifying, for example, the position of the head and also how our brain will function,” Dr. Zernicka-Goetz says. “We can now use this model system to assess the function of those genes.” 

A version of this article first appeared on WebMD.com.

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

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

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

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

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

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

Early-onset cancer – often defined as cancers diagnosed in adults younger than age 50 years – is an emerging global epidemic, according to a recent review.

While the rising incidence of early-onset colorectal cancer (CRC) is a well-documented problem, the trend appears to extend far beyond CRC. The authors traced patterns of early-onset cancer diagnoses across 14 different cancer types, including breast, prostate, and thyroid, over the past 3 decades and found increases in many countries.

Among the 14 cancers explored, eight relate to the digestive system, which highlights the potential role diet and the oral and gut microbiome may play in cancer risk, the authors noted.

And many of the factors that appear to influence cancer risk – such as diet, exercise, sleep, and vaccination against HPV and other cancer-causing microorganisms – are modifiable.

“[Our] immediate goals should be to raise awareness of the early-onset cancer epidemic and reduce exposure to [these] risk factors,” authors Tomotaka Ugai, MD, PhD, and Shuji Ogino, MD, PhD, with Harvard School of Public Health, Boston, noted in a joint email.

The paper was published in Nature Reviews Clinical Oncology.

While the rise in cancer screenings has contributed to earlier detection of cancers, a genuine increase in the incidence of some early-onset cancers also appears to be happening.

In the current review, Dr. Ugai, Dr. Ogino, and colleagues reviewed the literature and mapped trends in the incidence of 14 cancer types among 20- to 49-year-old adults in 44 countries between 2002 and 2012.

The authors found that, since the 1990s, the incidence of early-onset cancers in the breast, colorectum, endometrium, esophagus, extrahepatic bile duct, gallbladder, head/neck, kidney, liver, bone marrow, pancreas, prostate, stomach, and thyroid, has increased around the world. Looking at the United States, for instance, the average annual percent changes for kidney cancer was 3.6% in women and 4.1% in men and for multiple myeloma was 2% in women and 3% in men for 2002 to 2012.

This overall trend could reflect increased exposures to risk factors in early life and young adulthood, although “specific effects of individual exposures remain largely unknown,” the authors acknowledged.

Since the mid-20th century, substantial changes have occurred in diet, sleep, smoking, obesity, type 2 diabetes, and environmental exposures – all of which may influence the gut microbiome or interact with our genes to increase the incidence of early-onset cancers, the authors explained. For instance, obesity, smoking, and alcohol are all established risk factors for pancreatic cancer and have been linked with early-onset disease risk as well.

“Cancer is a multifactorial disease, and we are aware of the importance of genetics as a risk factor and screening for early detection, but this paper importantly brings to light the importance of correctable lifestyle habits that may slow the rise of early onset cancers,” oncologist Marleen Meyers, MD, director of the survivorship program at NYU Langone Perlmutter Cancer Center, who wasn’t involved in the review, said in an interview.

Although modifiable factors such as diet and exercise may ease the burden of these cancers, such changes are often difficult to implement, Dr. Meyers added. In addition, understanding the impact that certain factors, such as alcohol, obesity, physical activity, and delayed reproduction play in cancer risk requires more research to tease out, but “there is enough reason at this point to address these risk factors for both personal and public health benefits,” Dr. Meyers said.

Support for this research was provided in part by the U.S. National Institutes of Health, Cancer Research UK, Prevent Cancer Foundation, Japan Society for the Promotion of Science, and the Mishima Kaiun Memorial Foundation. Dr. Ugai, Dr. Ogino, and Dr. Meyers have disclosed no relevant financial relationships.

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

Early-onset cancer – often defined as cancers diagnosed in adults younger than age 50 years – is an emerging global epidemic, according to a recent review.

While the rising incidence of early-onset colorectal cancer (CRC) is a well-documented problem, the trend appears to extend far beyond CRC. The authors traced patterns of early-onset cancer diagnoses across 14 different cancer types, including breast, prostate, and thyroid, over the past 3 decades and found increases in many countries.

Among the 14 cancers explored, eight relate to the digestive system, which highlights the potential role diet and the oral and gut microbiome may play in cancer risk, the authors noted.

And many of the factors that appear to influence cancer risk – such as diet, exercise, sleep, and vaccination against HPV and other cancer-causing microorganisms – are modifiable.

“[Our] immediate goals should be to raise awareness of the early-onset cancer epidemic and reduce exposure to [these] risk factors,” authors Tomotaka Ugai, MD, PhD, and Shuji Ogino, MD, PhD, with Harvard School of Public Health, Boston, noted in a joint email.

The paper was published in Nature Reviews Clinical Oncology.

While the rise in cancer screenings has contributed to earlier detection of cancers, a genuine increase in the incidence of some early-onset cancers also appears to be happening.

In the current review, Dr. Ugai, Dr. Ogino, and colleagues reviewed the literature and mapped trends in the incidence of 14 cancer types among 20- to 49-year-old adults in 44 countries between 2002 and 2012.

The authors found that, since the 1990s, the incidence of early-onset cancers in the breast, colorectum, endometrium, esophagus, extrahepatic bile duct, gallbladder, head/neck, kidney, liver, bone marrow, pancreas, prostate, stomach, and thyroid, has increased around the world. Looking at the United States, for instance, the average annual percent changes for kidney cancer was 3.6% in women and 4.1% in men and for multiple myeloma was 2% in women and 3% in men for 2002 to 2012.

This overall trend could reflect increased exposures to risk factors in early life and young adulthood, although “specific effects of individual exposures remain largely unknown,” the authors acknowledged.

Since the mid-20th century, substantial changes have occurred in diet, sleep, smoking, obesity, type 2 diabetes, and environmental exposures – all of which may influence the gut microbiome or interact with our genes to increase the incidence of early-onset cancers, the authors explained. For instance, obesity, smoking, and alcohol are all established risk factors for pancreatic cancer and have been linked with early-onset disease risk as well.

“Cancer is a multifactorial disease, and we are aware of the importance of genetics as a risk factor and screening for early detection, but this paper importantly brings to light the importance of correctable lifestyle habits that may slow the rise of early onset cancers,” oncologist Marleen Meyers, MD, director of the survivorship program at NYU Langone Perlmutter Cancer Center, who wasn’t involved in the review, said in an interview.

Although modifiable factors such as diet and exercise may ease the burden of these cancers, such changes are often difficult to implement, Dr. Meyers added. In addition, understanding the impact that certain factors, such as alcohol, obesity, physical activity, and delayed reproduction play in cancer risk requires more research to tease out, but “there is enough reason at this point to address these risk factors for both personal and public health benefits,” Dr. Meyers said.

Support for this research was provided in part by the U.S. National Institutes of Health, Cancer Research UK, Prevent Cancer Foundation, Japan Society for the Promotion of Science, and the Mishima Kaiun Memorial Foundation. Dr. Ugai, Dr. Ogino, and Dr. Meyers have disclosed no relevant financial relationships.

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

Early-onset cancer – often defined as cancers diagnosed in adults younger than age 50 years – is an emerging global epidemic, according to a recent review.

While the rising incidence of early-onset colorectal cancer (CRC) is a well-documented problem, the trend appears to extend far beyond CRC. The authors traced patterns of early-onset cancer diagnoses across 14 different cancer types, including breast, prostate, and thyroid, over the past 3 decades and found increases in many countries.

Among the 14 cancers explored, eight relate to the digestive system, which highlights the potential role diet and the oral and gut microbiome may play in cancer risk, the authors noted.

And many of the factors that appear to influence cancer risk – such as diet, exercise, sleep, and vaccination against HPV and other cancer-causing microorganisms – are modifiable.

“[Our] immediate goals should be to raise awareness of the early-onset cancer epidemic and reduce exposure to [these] risk factors,” authors Tomotaka Ugai, MD, PhD, and Shuji Ogino, MD, PhD, with Harvard School of Public Health, Boston, noted in a joint email.

The paper was published in Nature Reviews Clinical Oncology.

While the rise in cancer screenings has contributed to earlier detection of cancers, a genuine increase in the incidence of some early-onset cancers also appears to be happening.

In the current review, Dr. Ugai, Dr. Ogino, and colleagues reviewed the literature and mapped trends in the incidence of 14 cancer types among 20- to 49-year-old adults in 44 countries between 2002 and 2012.

The authors found that, since the 1990s, the incidence of early-onset cancers in the breast, colorectum, endometrium, esophagus, extrahepatic bile duct, gallbladder, head/neck, kidney, liver, bone marrow, pancreas, prostate, stomach, and thyroid, has increased around the world. Looking at the United States, for instance, the average annual percent changes for kidney cancer was 3.6% in women and 4.1% in men and for multiple myeloma was 2% in women and 3% in men for 2002 to 2012.

This overall trend could reflect increased exposures to risk factors in early life and young adulthood, although “specific effects of individual exposures remain largely unknown,” the authors acknowledged.

Since the mid-20th century, substantial changes have occurred in diet, sleep, smoking, obesity, type 2 diabetes, and environmental exposures – all of which may influence the gut microbiome or interact with our genes to increase the incidence of early-onset cancers, the authors explained. For instance, obesity, smoking, and alcohol are all established risk factors for pancreatic cancer and have been linked with early-onset disease risk as well.

“Cancer is a multifactorial disease, and we are aware of the importance of genetics as a risk factor and screening for early detection, but this paper importantly brings to light the importance of correctable lifestyle habits that may slow the rise of early onset cancers,” oncologist Marleen Meyers, MD, director of the survivorship program at NYU Langone Perlmutter Cancer Center, who wasn’t involved in the review, said in an interview.

Although modifiable factors such as diet and exercise may ease the burden of these cancers, such changes are often difficult to implement, Dr. Meyers added. In addition, understanding the impact that certain factors, such as alcohol, obesity, physical activity, and delayed reproduction play in cancer risk requires more research to tease out, but “there is enough reason at this point to address these risk factors for both personal and public health benefits,” Dr. Meyers said.

Support for this research was provided in part by the U.S. National Institutes of Health, Cancer Research UK, Prevent Cancer Foundation, Japan Society for the Promotion of Science, and the Mishima Kaiun Memorial Foundation. Dr. Ugai, Dr. Ogino, and Dr. Meyers have disclosed no relevant financial relationships.

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

Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California, discusses key presentations on early-stage non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress.

He begins by reporting on 2 years of additional follow-up from the ADAURA trial, which looked at osimertinib as adjuvant therapy in patients with resected EGFR-mutated disease. The results raise the question of whether the drug needs to be given indefinitely.

Next, he discusses an analysis of data from the ADAURA trial that looked at longitudinal monitoring of circulating tumor DNA (ctDNA) levels. This revealed that both baseline ctDNA and ctDNA clearance were predictive of later recurrence.

Dr West moves on to a large global study that demonstrated a clear link between air pollution and lung cancer. Pollution was shown to be a tumor promoter of rare driver mutations in normal lung tissue.

After discussing disappointing data from CANOPY-A indicating that adjuvant canakinumab does not improve survival outcomes, he closes with an examination of the PATHFINDER study. This involved more than 6600 patients who were screened for cancer after a single blood test. Although the study identified cancer in 1.4% of participants, the low positive predictive value raises questions over the wider application of this test.

--

Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California

Howard (Jack) West, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda

Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck

Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California, discusses key presentations on early-stage non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress.

He begins by reporting on 2 years of additional follow-up from the ADAURA trial, which looked at osimertinib as adjuvant therapy in patients with resected EGFR-mutated disease. The results raise the question of whether the drug needs to be given indefinitely.

Next, he discusses an analysis of data from the ADAURA trial that looked at longitudinal monitoring of circulating tumor DNA (ctDNA) levels. This revealed that both baseline ctDNA and ctDNA clearance were predictive of later recurrence.

Dr West moves on to a large global study that demonstrated a clear link between air pollution and lung cancer. Pollution was shown to be a tumor promoter of rare driver mutations in normal lung tissue.

After discussing disappointing data from CANOPY-A indicating that adjuvant canakinumab does not improve survival outcomes, he closes with an examination of the PATHFINDER study. This involved more than 6600 patients who were screened for cancer after a single blood test. Although the study identified cancer in 1.4% of participants, the low positive predictive value raises questions over the wider application of this test.

--

Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California

Howard (Jack) West, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda

Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck

Dr Jack West of City of Hope Comprehensive Cancer Center in Duarte, California, discusses key presentations on early-stage non–small lung cancer (NSCLC) from the 2022 European Society for Medical Oncology Congress.

He begins by reporting on 2 years of additional follow-up from the ADAURA trial, which looked at osimertinib as adjuvant therapy in patients with resected EGFR-mutated disease. The results raise the question of whether the drug needs to be given indefinitely.

Next, he discusses an analysis of data from the ADAURA trial that looked at longitudinal monitoring of circulating tumor DNA (ctDNA) levels. This revealed that both baseline ctDNA and ctDNA clearance were predictive of later recurrence.

Dr West moves on to a large global study that demonstrated a clear link between air pollution and lung cancer. Pollution was shown to be a tumor promoter of rare driver mutations in normal lung tissue.

After discussing disappointing data from CANOPY-A indicating that adjuvant canakinumab does not improve survival outcomes, he closes with an examination of the PATHFINDER study. This involved more than 6600 patients who were screened for cancer after a single blood test. Although the study identified cancer in 1.4% of participants, the low positive predictive value raises questions over the wider application of this test.

--

Associate Professor, Department of Medical Oncology, City of Hope Comprehensive Cancer Care, Duarte, California; Medical Director, AccessHope, Los Angeles, California

Howard (Jack) West, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Amgen; AstraZeneca; Eli Lilly; EQRx; Genentech/Roche; Merck; Mirati; Pfizer; Regeneron; Takeda

Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Merck

PARIS – “I thought I was as exhausted, and isolated, and neglected as I could get, and then he came home.”

Those were the words of Kate Washington, PhD, from Sacramento as she gave a moving account of the immense burden she felt as caregiver to her husband with cancer.

She was taking part in the session, “I am FINE: Frustrated * Isolated * Neglected * Emotional,” at the annual meeting of the European Society for Medical Oncology. In that session, speakers assessed the toll of cancer on patients, caregivers, nurses, and doctors.

Dr. Washington, author of “Already Toast: Caregiving and Burnout in America” (Boston: Beacon Press, 2021), explained that she cared for her husband and young family while he was “suffering through two different kinds of lymphoma and really devastating stem cell transplants.”

When her husband was first diagnosed with a rare form of lymphoma in 2015, he was placed on a watch-and-wait protocol. At that point, he seemed fine, Dr. Washington said.

A few months later, he started coughing up blood. After being rushed to the emergency department, doctors found that a slow-growing lung tumor had ruptured.

Three weeks later, he came out of the hospital with a collapsed lung – an effect of his chemotherapy, Dr. Washington said.

But that was hardly the last word. He soon experienced relapse with a “very aggressive” form of his disease, and in 2016, he underwent a stem cell transplant.

“He spent 1½ months in the hospital ... in isolation, not seeing our daughters,” Dr. Washington said. He lost his vision and developed grade 4 graft-versus-host disease, among other problems.

He was alive, just barely, Dr. Washington said.

“As you might imagine, I was pulled between the hospital and the home, taking care of our daughters, who were not seeing him during that time,” she recalled.

But every time someone asked her whether she was okay, she replied: “I am fine.”

“A total lie,” she admitted.

Dr. Washington felt frustrated, not only from the financial strain of out-of-pocket health care costs and lost earnings but also from fast evolving relationships and a feeling of being “unseen and underappreciated.”

Another jarring change: When her husband was discharged from the hospital, Dr. Washington was suddenly thrust into the role of full-time caretaker.

Her husband could not be left alone, his doctor had said. And with two young children, Dr. Washington did not know how she would manage.

The demands of being a full-time caregiver are intense. Caregivers, Dr. Washington explained, can spend 32 hours a week looking after a loved one with cancer.

Like Dr. Washington, most caregivers feel they have no choice but to take on this intense role – one for which they have little or no training or preparation. The nonstop demands leave little time for self-care and can lead to high rates of caregiver injury and illness.

Isolation often creeps in because it can be “hard to ask for help,” she said. About 30% of caregivers report having depression or anxiety, and 21% feel lonely.

“When he was very ill, I found it really difficult to connect with other people and my friends,” Dr. Washington recalled. “I didn’t feel like I could really adequately explain the kind of strain that I was under.”
 

Are patients fine?

Like caregivers, patients often say they are fine when they are not.

The toll cancer takes on patients is immense. Natacha Bolanos Fernandez, from the Lymphoma Coalition Europe, highlighted the physical, mental, and social strain that can affect patients with cancer.

The physical aspects can encompass a host of problems – fatigue, night sweats, weight loss, and the vomiting that accompanies many cancer treatments. Patients may face changes in their mobility and independence as well. The mental side of cancer can include anxiety, depression, and psychological distress, while the social aspects span changing, perhaps strained, relationships with family and friends.

Fatigue, in particular, is an underreported, underdiagnosed, and undertreated problem, Ms. Fernandez noted. According to recent survey data from the Lymphoma Coalition’s Global Patient Survey, 72% of patients reported fatigue. This problem worsened over time, with 59% reporting fatigue after their diagnosis and up to 82% among patients who experienced relapse two or more times.

Fatigue “may be getting worse rather than better over time,” Ms. Fernandez said, and many patients felt that their life had changed completely because of cancer-related fatigue.

To help patients manage, the Lymphoma Coalition has published a report on the impact of cancer-related fatigue and how to improve outcomes. Methods include greater awareness, regular screening, and interventions such as yoga or mindfulness-based cognitive therapy.
 

Are clinicians fine?

Nurses and physicians face challenges caring for patients with cancer.

Although “nurses love their jobs and are extremely committed,” the impact cancer has on a nursing career is often undervalued or “neglected,” said Lena Sharp, RN, PhD, of the Regional Cancer Centre, Stockholm-Gotland.

Burnout, in particular, remains a problem among oncologists and nurses, and it was made worse during the COVID-19 pandemic.

Fatima Cardoso, MD, explained that burnout has an impact on doctors as well as patients because it affects communication with patients and performance. Physicians can, for instance, appear detached, emotional, or tired.

Patients may then feel less inclined to tell their oncologist how they’re feeling, said Dr. Cardoso, director of the breast unit at Champalimaud Clinical Center, Lisbon.

It is important to remember to not just focus on the patient’s disease or treatment but to also ask how they are doing and what is going on in their lives.

Above all, “show that you care,” said Dr. Cardoso.

The Lymphoma Coalition Europe has relationships with Bristol-Myers Squibb, Establishment Labs, Kyowa Kirin, Novartis, Roche, Takeda. Dr. Cardoso has relationships with Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, and other companies. No other relevant financial relationships were reported.

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

PARIS – “I thought I was as exhausted, and isolated, and neglected as I could get, and then he came home.”

Those were the words of Kate Washington, PhD, from Sacramento as she gave a moving account of the immense burden she felt as caregiver to her husband with cancer.

She was taking part in the session, “I am FINE: Frustrated * Isolated * Neglected * Emotional,” at the annual meeting of the European Society for Medical Oncology. In that session, speakers assessed the toll of cancer on patients, caregivers, nurses, and doctors.

Dr. Washington, author of “Already Toast: Caregiving and Burnout in America” (Boston: Beacon Press, 2021), explained that she cared for her husband and young family while he was “suffering through two different kinds of lymphoma and really devastating stem cell transplants.”

When her husband was first diagnosed with a rare form of lymphoma in 2015, he was placed on a watch-and-wait protocol. At that point, he seemed fine, Dr. Washington said.

A few months later, he started coughing up blood. After being rushed to the emergency department, doctors found that a slow-growing lung tumor had ruptured.

Three weeks later, he came out of the hospital with a collapsed lung – an effect of his chemotherapy, Dr. Washington said.

But that was hardly the last word. He soon experienced relapse with a “very aggressive” form of his disease, and in 2016, he underwent a stem cell transplant.

“He spent 1½ months in the hospital ... in isolation, not seeing our daughters,” Dr. Washington said. He lost his vision and developed grade 4 graft-versus-host disease, among other problems.

He was alive, just barely, Dr. Washington said.

“As you might imagine, I was pulled between the hospital and the home, taking care of our daughters, who were not seeing him during that time,” she recalled.

But every time someone asked her whether she was okay, she replied: “I am fine.”

“A total lie,” she admitted.

Dr. Washington felt frustrated, not only from the financial strain of out-of-pocket health care costs and lost earnings but also from fast evolving relationships and a feeling of being “unseen and underappreciated.”

Another jarring change: When her husband was discharged from the hospital, Dr. Washington was suddenly thrust into the role of full-time caretaker.

Her husband could not be left alone, his doctor had said. And with two young children, Dr. Washington did not know how she would manage.

The demands of being a full-time caregiver are intense. Caregivers, Dr. Washington explained, can spend 32 hours a week looking after a loved one with cancer.

Like Dr. Washington, most caregivers feel they have no choice but to take on this intense role – one for which they have little or no training or preparation. The nonstop demands leave little time for self-care and can lead to high rates of caregiver injury and illness.

Isolation often creeps in because it can be “hard to ask for help,” she said. About 30% of caregivers report having depression or anxiety, and 21% feel lonely.

“When he was very ill, I found it really difficult to connect with other people and my friends,” Dr. Washington recalled. “I didn’t feel like I could really adequately explain the kind of strain that I was under.”
 

Are patients fine?

Like caregivers, patients often say they are fine when they are not.

The toll cancer takes on patients is immense. Natacha Bolanos Fernandez, from the Lymphoma Coalition Europe, highlighted the physical, mental, and social strain that can affect patients with cancer.

The physical aspects can encompass a host of problems – fatigue, night sweats, weight loss, and the vomiting that accompanies many cancer treatments. Patients may face changes in their mobility and independence as well. The mental side of cancer can include anxiety, depression, and psychological distress, while the social aspects span changing, perhaps strained, relationships with family and friends.

Fatigue, in particular, is an underreported, underdiagnosed, and undertreated problem, Ms. Fernandez noted. According to recent survey data from the Lymphoma Coalition’s Global Patient Survey, 72% of patients reported fatigue. This problem worsened over time, with 59% reporting fatigue after their diagnosis and up to 82% among patients who experienced relapse two or more times.

Fatigue “may be getting worse rather than better over time,” Ms. Fernandez said, and many patients felt that their life had changed completely because of cancer-related fatigue.

To help patients manage, the Lymphoma Coalition has published a report on the impact of cancer-related fatigue and how to improve outcomes. Methods include greater awareness, regular screening, and interventions such as yoga or mindfulness-based cognitive therapy.
 

Are clinicians fine?

Nurses and physicians face challenges caring for patients with cancer.

Although “nurses love their jobs and are extremely committed,” the impact cancer has on a nursing career is often undervalued or “neglected,” said Lena Sharp, RN, PhD, of the Regional Cancer Centre, Stockholm-Gotland.

Burnout, in particular, remains a problem among oncologists and nurses, and it was made worse during the COVID-19 pandemic.

Fatima Cardoso, MD, explained that burnout has an impact on doctors as well as patients because it affects communication with patients and performance. Physicians can, for instance, appear detached, emotional, or tired.

Patients may then feel less inclined to tell their oncologist how they’re feeling, said Dr. Cardoso, director of the breast unit at Champalimaud Clinical Center, Lisbon.

It is important to remember to not just focus on the patient’s disease or treatment but to also ask how they are doing and what is going on in their lives.

Above all, “show that you care,” said Dr. Cardoso.

The Lymphoma Coalition Europe has relationships with Bristol-Myers Squibb, Establishment Labs, Kyowa Kirin, Novartis, Roche, Takeda. Dr. Cardoso has relationships with Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, and other companies. No other relevant financial relationships were reported.

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

PARIS – “I thought I was as exhausted, and isolated, and neglected as I could get, and then he came home.”

Those were the words of Kate Washington, PhD, from Sacramento as she gave a moving account of the immense burden she felt as caregiver to her husband with cancer.

She was taking part in the session, “I am FINE: Frustrated * Isolated * Neglected * Emotional,” at the annual meeting of the European Society for Medical Oncology. In that session, speakers assessed the toll of cancer on patients, caregivers, nurses, and doctors.

Dr. Washington, author of “Already Toast: Caregiving and Burnout in America” (Boston: Beacon Press, 2021), explained that she cared for her husband and young family while he was “suffering through two different kinds of lymphoma and really devastating stem cell transplants.”

When her husband was first diagnosed with a rare form of lymphoma in 2015, he was placed on a watch-and-wait protocol. At that point, he seemed fine, Dr. Washington said.

A few months later, he started coughing up blood. After being rushed to the emergency department, doctors found that a slow-growing lung tumor had ruptured.

Three weeks later, he came out of the hospital with a collapsed lung – an effect of his chemotherapy, Dr. Washington said.

But that was hardly the last word. He soon experienced relapse with a “very aggressive” form of his disease, and in 2016, he underwent a stem cell transplant.

“He spent 1½ months in the hospital ... in isolation, not seeing our daughters,” Dr. Washington said. He lost his vision and developed grade 4 graft-versus-host disease, among other problems.

He was alive, just barely, Dr. Washington said.

“As you might imagine, I was pulled between the hospital and the home, taking care of our daughters, who were not seeing him during that time,” she recalled.

But every time someone asked her whether she was okay, she replied: “I am fine.”

“A total lie,” she admitted.

Dr. Washington felt frustrated, not only from the financial strain of out-of-pocket health care costs and lost earnings but also from fast evolving relationships and a feeling of being “unseen and underappreciated.”

Another jarring change: When her husband was discharged from the hospital, Dr. Washington was suddenly thrust into the role of full-time caretaker.

Her husband could not be left alone, his doctor had said. And with two young children, Dr. Washington did not know how she would manage.

The demands of being a full-time caregiver are intense. Caregivers, Dr. Washington explained, can spend 32 hours a week looking after a loved one with cancer.

Like Dr. Washington, most caregivers feel they have no choice but to take on this intense role – one for which they have little or no training or preparation. The nonstop demands leave little time for self-care and can lead to high rates of caregiver injury and illness.

Isolation often creeps in because it can be “hard to ask for help,” she said. About 30% of caregivers report having depression or anxiety, and 21% feel lonely.

“When he was very ill, I found it really difficult to connect with other people and my friends,” Dr. Washington recalled. “I didn’t feel like I could really adequately explain the kind of strain that I was under.”
 

Are patients fine?

Like caregivers, patients often say they are fine when they are not.

The toll cancer takes on patients is immense. Natacha Bolanos Fernandez, from the Lymphoma Coalition Europe, highlighted the physical, mental, and social strain that can affect patients with cancer.

The physical aspects can encompass a host of problems – fatigue, night sweats, weight loss, and the vomiting that accompanies many cancer treatments. Patients may face changes in their mobility and independence as well. The mental side of cancer can include anxiety, depression, and psychological distress, while the social aspects span changing, perhaps strained, relationships with family and friends.

Fatigue, in particular, is an underreported, underdiagnosed, and undertreated problem, Ms. Fernandez noted. According to recent survey data from the Lymphoma Coalition’s Global Patient Survey, 72% of patients reported fatigue. This problem worsened over time, with 59% reporting fatigue after their diagnosis and up to 82% among patients who experienced relapse two or more times.

Fatigue “may be getting worse rather than better over time,” Ms. Fernandez said, and many patients felt that their life had changed completely because of cancer-related fatigue.

To help patients manage, the Lymphoma Coalition has published a report on the impact of cancer-related fatigue and how to improve outcomes. Methods include greater awareness, regular screening, and interventions such as yoga or mindfulness-based cognitive therapy.
 

Are clinicians fine?

Nurses and physicians face challenges caring for patients with cancer.

Although “nurses love their jobs and are extremely committed,” the impact cancer has on a nursing career is often undervalued or “neglected,” said Lena Sharp, RN, PhD, of the Regional Cancer Centre, Stockholm-Gotland.

Burnout, in particular, remains a problem among oncologists and nurses, and it was made worse during the COVID-19 pandemic.

Fatima Cardoso, MD, explained that burnout has an impact on doctors as well as patients because it affects communication with patients and performance. Physicians can, for instance, appear detached, emotional, or tired.

Patients may then feel less inclined to tell their oncologist how they’re feeling, said Dr. Cardoso, director of the breast unit at Champalimaud Clinical Center, Lisbon.

It is important to remember to not just focus on the patient’s disease or treatment but to also ask how they are doing and what is going on in their lives.

Above all, “show that you care,” said Dr. Cardoso.

The Lymphoma Coalition Europe has relationships with Bristol-Myers Squibb, Establishment Labs, Kyowa Kirin, Novartis, Roche, Takeda. Dr. Cardoso has relationships with Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, and other companies. No other relevant financial relationships were reported.

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