Soliton’s Rapid Acoustic Pulse (RAP) device, which was cleared for tattoo removal in 2019, has received FDA clearance for short-term improvement in the appearance of cellulite.

As described in a press release issued by Soliton, the RAP device emits rapid acoustic pulses (shock waves) that are transmitted through the skin at a rate of up to 100 pulses per second to rupture or “shear” the fibrotic septa. This causes the release of septa, which results in a smoothening of skin dimples. The procedure takes 40-60 minutes to perform.

“This is a novel, noninvasive treatment for cellulite that appears to be safe, with little pain and little downtime,” Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said in an interview. “Further study and experience will determine the efficacy of this device and the optimization of its parameters going forward.”

In clinical trials that were part of the FDA’s 510(k) application process, patients underwent a single, noninvasive treatment that required no anesthesia and caused no unexpected or serious adverse events. The procedure also received strong patient satisfaction ratings, and clinical trial participants rated their average pain score as 2.4 out of 10.

Soliton plans to begin selling the device for both tattoo removal and cellulite treatment in the first half of 2021. “While the technology is broadly the same, the replaceable treatment cartridges [for tattoo removal and cellulite treatment] differ in significant ways,” Dr. Avram said.

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton. He also reported having ownership and/or shareholder interest in Cytrellis.

[email protected]

Soliton’s Rapid Acoustic Pulse (RAP) device, which was cleared for tattoo removal in 2019, has received FDA clearance for short-term improvement in the appearance of cellulite.

As described in a press release issued by Soliton, the RAP device emits rapid acoustic pulses (shock waves) that are transmitted through the skin at a rate of up to 100 pulses per second to rupture or “shear” the fibrotic septa. This causes the release of septa, which results in a smoothening of skin dimples. The procedure takes 40-60 minutes to perform.

“This is a novel, noninvasive treatment for cellulite that appears to be safe, with little pain and little downtime,” Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said in an interview. “Further study and experience will determine the efficacy of this device and the optimization of its parameters going forward.”

In clinical trials that were part of the FDA’s 510(k) application process, patients underwent a single, noninvasive treatment that required no anesthesia and caused no unexpected or serious adverse events. The procedure also received strong patient satisfaction ratings, and clinical trial participants rated their average pain score as 2.4 out of 10.

Soliton plans to begin selling the device for both tattoo removal and cellulite treatment in the first half of 2021. “While the technology is broadly the same, the replaceable treatment cartridges [for tattoo removal and cellulite treatment] differ in significant ways,” Dr. Avram said.

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton. He also reported having ownership and/or shareholder interest in Cytrellis.

[email protected]

Soliton’s Rapid Acoustic Pulse (RAP) device, which was cleared for tattoo removal in 2019, has received FDA clearance for short-term improvement in the appearance of cellulite.

As described in a press release issued by Soliton, the RAP device emits rapid acoustic pulses (shock waves) that are transmitted through the skin at a rate of up to 100 pulses per second to rupture or “shear” the fibrotic septa. This causes the release of septa, which results in a smoothening of skin dimples. The procedure takes 40-60 minutes to perform.

“This is a novel, noninvasive treatment for cellulite that appears to be safe, with little pain and little downtime,” Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said in an interview. “Further study and experience will determine the efficacy of this device and the optimization of its parameters going forward.”

In clinical trials that were part of the FDA’s 510(k) application process, patients underwent a single, noninvasive treatment that required no anesthesia and caused no unexpected or serious adverse events. The procedure also received strong patient satisfaction ratings, and clinical trial participants rated their average pain score as 2.4 out of 10.

Soliton plans to begin selling the device for both tattoo removal and cellulite treatment in the first half of 2021. “While the technology is broadly the same, the replaceable treatment cartridges [for tattoo removal and cellulite treatment] differ in significant ways,” Dr. Avram said.

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton. He also reported having ownership and/or shareholder interest in Cytrellis.

[email protected]

Use of a semiautonomous algorithm to initiate treatment for hypertension emergencies in pregnancy significantly increased the number of individuals treated promptly, based on data from 959 obstetric patients.

Data show poor compliance with the current American College of Obstetricians and Gynecologists recommendations for treatment of acute severe hypertension with no more than 30-60 minutes’ delay; low compliance may be caused by “multiple factors including lack of intravenous access, inadequate health care practitioner or nursing availability, and implicit racial biases,” wrote Courtney Martin, DO, of Loma Linda (Calif.) University School of Medicine and colleagues.

Semiautomated treatment algorithms have been used to improve timely treatment of conditions including myocardial infarction, heart failure, acute stroke, and asthma, but their use in obstetrics to date has been limited, the researchers noted.

In a retrospective cohort study published in Obstetrics & Gynecology, the researchers identified pregnant and postpartum women treated for severe hypertension at a single center between January 2017 and March 2020. A semiautonomous treatment algorithm was implemented between May 2018 and March 2019. The algorithm included vital sign monitoring, blood pressure thresholds for diagnosis of severe hypertension, and automated order sets for recommended first-line antihypertensive therapy. The primary outcomes were treatment with antihypertensive therapy within 15, 30, and 60 minutes of diagnosis. “Severe hypertension was defined as systolic blood pressure 160 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher,” the researchers said.

The study population was divided into three groups; a preimplementation group (373 patients) managed between January 2017 and April 2018, a during-implementation group (334 patients) managed between May 2018 and March 2019, and a postimplementation group (252 patients) managed between April 2019 and March 2020. Patient demographics were similar among all three groups.
 

Timely treatment improves with algorithm

Overall, treatment of severe hypertension within 15 minutes of diagnosis was 36.5% preimplementation, 45.8% during implementation, and 55.6% postimplementation. Severe hypertension treatment within 30 minutes of diagnosis was 65.9% preimplementation, 77.8% during implementation, and 79.0% post implementation. Differences were significant between pre- and post implementation for 15 minutes and 30 minutes, but no significant differences occurred in the patients treated within 60 minutes before and after implementation of the algorithm.

The study findings were limited by several factors, including the inability to separate peer-to-peer education and other training from the impact of the algorithm, as well as a lack of data on the effect of the algorithm on maternal or neonatal outcomes, the researchers noted.

However, the results support the potential of a semiautonomous algorithm to significantly improve adherence to the recommended treatment guidelines for severe hypertension in pregnancy and post partum, they said. Given the expected increase in hypertensive disorders in pregnancy because of the trends in older age and higher obesity rates in pregnant women, “Integration of semiautonomous treatment algorithms similar to ours into routine obstetric practices could help reduce the health care burden and improve clinical outcomes, especially in areas with limited health care resources,” they concluded.
 

Algorithm may reduce disparities

The overall rise in maternal mortality in the United States remains a concern, but “Even more concerning are the disturbing racial disparities that persist across socioeconomic strata,” wrote Alisse Hauspurg, MD, of the University of Pittsburgh in an accompanying editorial. “There is clear evidence that expeditious treatment of obstetric hypertensive emergency reduces the risk of severe morbidities including stroke, eclampsia, and maternal death,” she emphasized, but compliance with the ACOG recommendations to treat severe hypertension within 30-60 minutes of confirmation remains low, she said.

In this study, not only did use of the algorithm reduce time to antihypertensive therapy, but more than 50% of patients were treated for severe hypertension within 15 minutes, and more than 90% within 60 minutes, “which was sustained after the implementation phase,” and aligns with the ACOG recommendations, Dr. Hauspurg said. “Although Martin et al.’s algorithm was limited to the initial management of obstetric hypertensive emergency, it could readily be expanded to follow the full ACOG algorithm for management of hypertension in pregnancy,” she noted.

In addition, Black women are more frequently diagnosed with hypertensive disorders of pregnancy, including severe hypertension, and the algorithm might improve disparities, she said.

“It is plausible that widespread implementation of such a semiautonomous algorithm at hospitals across the country could reduce delays in treatment and prevent hypertension-related morbidities,” said Dr. Hauspurg. “The use of innovative approaches to management of severe hypertension and other obstetric emergencies has the potential to allow provision of more equitable care by overcoming health care practitioner and system biases, which could meaningfully reduce disparities in care and change the trajectory of maternal morbidity and mortality in the United States,” she emphasized.
 

Need to create culture of safety

“Maternal mortality in the United States is the highest among developed nations, and shocking disparities exist in outcomes for non-Hispanic Black and American Indian/Alaskan Native women,” said Lisa Hollier, MD, of Texas Children’s Health Plan in Bellaire. “In a California review of maternal deaths, the greatest quality improvement opportunities were missed diagnosis and ineffective treatment of preeclampsia and related diseases, which occurred in 65% of the cases where women died of preeclampsia/eclampsia,” she said.

The current study “is very timely as more and more states across the nation are participating in the AIM (Alliance for Innovation on Maternal Health) programs to prevent pregnancy-related mortality,” Dr. Hollier noted.

“This study demonstrated a significant association between implementation of the algorithm and an increased percentage of treatment of severe hypertension within 30 minutes,” Dr. Hollier said. “With the implementation of a comprehensive program that included treatment algorithms, the Illinois Perinatal Quality Collaborative improved timely treatment for women with severe high blood pressure, increasing the percentage of patients treated within 60 minutes from 41% at baseline to 79% in the first year of the project.”

The take-home message is that “implementation of the semiautonomous treatment algorithm can address important clinical variation, including delays in appropriate treatment of severe hypertension,” said Dr. Hollier. However, “One of the potential barriers [to use of an algorithm] is the need for accurate, real-time clinical assessment. Resources must be available to ensure appropriate monitoring,” Dr. Hollier noted. “Collaboration and support of implementation of these treatment algorithms must extend through the nursing staff, the physicians, and advanced-practice providers. Medical staff and administrative leaders are essential in creating a culture of safety and continuous process improvement,” she said.

In addition, “long-term follow-up on the implementation of broader quality improvement programs is essential,” Dr. Hollier said. “While implementation of an algorithm can, and did, result in process improvements, assessment of broader implementation of evidence-based bundles, combined with a systematic approach to redesign of multiple related processes needs to occur and include outcomes of severe maternal morbidity and mortality,” she explained.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Neither Dr. Hauspurg nor Dr. Hollier had financial conflicts to disclose.

Use of a semiautonomous algorithm to initiate treatment for hypertension emergencies in pregnancy significantly increased the number of individuals treated promptly, based on data from 959 obstetric patients.

Data show poor compliance with the current American College of Obstetricians and Gynecologists recommendations for treatment of acute severe hypertension with no more than 30-60 minutes’ delay; low compliance may be caused by “multiple factors including lack of intravenous access, inadequate health care practitioner or nursing availability, and implicit racial biases,” wrote Courtney Martin, DO, of Loma Linda (Calif.) University School of Medicine and colleagues.

Semiautomated treatment algorithms have been used to improve timely treatment of conditions including myocardial infarction, heart failure, acute stroke, and asthma, but their use in obstetrics to date has been limited, the researchers noted.

In a retrospective cohort study published in Obstetrics & Gynecology, the researchers identified pregnant and postpartum women treated for severe hypertension at a single center between January 2017 and March 2020. A semiautonomous treatment algorithm was implemented between May 2018 and March 2019. The algorithm included vital sign monitoring, blood pressure thresholds for diagnosis of severe hypertension, and automated order sets for recommended first-line antihypertensive therapy. The primary outcomes were treatment with antihypertensive therapy within 15, 30, and 60 minutes of diagnosis. “Severe hypertension was defined as systolic blood pressure 160 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher,” the researchers said.

The study population was divided into three groups; a preimplementation group (373 patients) managed between January 2017 and April 2018, a during-implementation group (334 patients) managed between May 2018 and March 2019, and a postimplementation group (252 patients) managed between April 2019 and March 2020. Patient demographics were similar among all three groups.
 

Timely treatment improves with algorithm

Overall, treatment of severe hypertension within 15 minutes of diagnosis was 36.5% preimplementation, 45.8% during implementation, and 55.6% postimplementation. Severe hypertension treatment within 30 minutes of diagnosis was 65.9% preimplementation, 77.8% during implementation, and 79.0% post implementation. Differences were significant between pre- and post implementation for 15 minutes and 30 minutes, but no significant differences occurred in the patients treated within 60 minutes before and after implementation of the algorithm.

The study findings were limited by several factors, including the inability to separate peer-to-peer education and other training from the impact of the algorithm, as well as a lack of data on the effect of the algorithm on maternal or neonatal outcomes, the researchers noted.

However, the results support the potential of a semiautonomous algorithm to significantly improve adherence to the recommended treatment guidelines for severe hypertension in pregnancy and post partum, they said. Given the expected increase in hypertensive disorders in pregnancy because of the trends in older age and higher obesity rates in pregnant women, “Integration of semiautonomous treatment algorithms similar to ours into routine obstetric practices could help reduce the health care burden and improve clinical outcomes, especially in areas with limited health care resources,” they concluded.
 

Algorithm may reduce disparities

The overall rise in maternal mortality in the United States remains a concern, but “Even more concerning are the disturbing racial disparities that persist across socioeconomic strata,” wrote Alisse Hauspurg, MD, of the University of Pittsburgh in an accompanying editorial. “There is clear evidence that expeditious treatment of obstetric hypertensive emergency reduces the risk of severe morbidities including stroke, eclampsia, and maternal death,” she emphasized, but compliance with the ACOG recommendations to treat severe hypertension within 30-60 minutes of confirmation remains low, she said.

In this study, not only did use of the algorithm reduce time to antihypertensive therapy, but more than 50% of patients were treated for severe hypertension within 15 minutes, and more than 90% within 60 minutes, “which was sustained after the implementation phase,” and aligns with the ACOG recommendations, Dr. Hauspurg said. “Although Martin et al.’s algorithm was limited to the initial management of obstetric hypertensive emergency, it could readily be expanded to follow the full ACOG algorithm for management of hypertension in pregnancy,” she noted.

In addition, Black women are more frequently diagnosed with hypertensive disorders of pregnancy, including severe hypertension, and the algorithm might improve disparities, she said.

“It is plausible that widespread implementation of such a semiautonomous algorithm at hospitals across the country could reduce delays in treatment and prevent hypertension-related morbidities,” said Dr. Hauspurg. “The use of innovative approaches to management of severe hypertension and other obstetric emergencies has the potential to allow provision of more equitable care by overcoming health care practitioner and system biases, which could meaningfully reduce disparities in care and change the trajectory of maternal morbidity and mortality in the United States,” she emphasized.
 

Need to create culture of safety

“Maternal mortality in the United States is the highest among developed nations, and shocking disparities exist in outcomes for non-Hispanic Black and American Indian/Alaskan Native women,” said Lisa Hollier, MD, of Texas Children’s Health Plan in Bellaire. “In a California review of maternal deaths, the greatest quality improvement opportunities were missed diagnosis and ineffective treatment of preeclampsia and related diseases, which occurred in 65% of the cases where women died of preeclampsia/eclampsia,” she said.

The current study “is very timely as more and more states across the nation are participating in the AIM (Alliance for Innovation on Maternal Health) programs to prevent pregnancy-related mortality,” Dr. Hollier noted.

“This study demonstrated a significant association between implementation of the algorithm and an increased percentage of treatment of severe hypertension within 30 minutes,” Dr. Hollier said. “With the implementation of a comprehensive program that included treatment algorithms, the Illinois Perinatal Quality Collaborative improved timely treatment for women with severe high blood pressure, increasing the percentage of patients treated within 60 minutes from 41% at baseline to 79% in the first year of the project.”

The take-home message is that “implementation of the semiautonomous treatment algorithm can address important clinical variation, including delays in appropriate treatment of severe hypertension,” said Dr. Hollier. However, “One of the potential barriers [to use of an algorithm] is the need for accurate, real-time clinical assessment. Resources must be available to ensure appropriate monitoring,” Dr. Hollier noted. “Collaboration and support of implementation of these treatment algorithms must extend through the nursing staff, the physicians, and advanced-practice providers. Medical staff and administrative leaders are essential in creating a culture of safety and continuous process improvement,” she said.

In addition, “long-term follow-up on the implementation of broader quality improvement programs is essential,” Dr. Hollier said. “While implementation of an algorithm can, and did, result in process improvements, assessment of broader implementation of evidence-based bundles, combined with a systematic approach to redesign of multiple related processes needs to occur and include outcomes of severe maternal morbidity and mortality,” she explained.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Neither Dr. Hauspurg nor Dr. Hollier had financial conflicts to disclose.

Use of a semiautonomous algorithm to initiate treatment for hypertension emergencies in pregnancy significantly increased the number of individuals treated promptly, based on data from 959 obstetric patients.

Data show poor compliance with the current American College of Obstetricians and Gynecologists recommendations for treatment of acute severe hypertension with no more than 30-60 minutes’ delay; low compliance may be caused by “multiple factors including lack of intravenous access, inadequate health care practitioner or nursing availability, and implicit racial biases,” wrote Courtney Martin, DO, of Loma Linda (Calif.) University School of Medicine and colleagues.

Semiautomated treatment algorithms have been used to improve timely treatment of conditions including myocardial infarction, heart failure, acute stroke, and asthma, but their use in obstetrics to date has been limited, the researchers noted.

In a retrospective cohort study published in Obstetrics & Gynecology, the researchers identified pregnant and postpartum women treated for severe hypertension at a single center between January 2017 and March 2020. A semiautonomous treatment algorithm was implemented between May 2018 and March 2019. The algorithm included vital sign monitoring, blood pressure thresholds for diagnosis of severe hypertension, and automated order sets for recommended first-line antihypertensive therapy. The primary outcomes were treatment with antihypertensive therapy within 15, 30, and 60 minutes of diagnosis. “Severe hypertension was defined as systolic blood pressure 160 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher,” the researchers said.

The study population was divided into three groups; a preimplementation group (373 patients) managed between January 2017 and April 2018, a during-implementation group (334 patients) managed between May 2018 and March 2019, and a postimplementation group (252 patients) managed between April 2019 and March 2020. Patient demographics were similar among all three groups.
 

Timely treatment improves with algorithm

Overall, treatment of severe hypertension within 15 minutes of diagnosis was 36.5% preimplementation, 45.8% during implementation, and 55.6% postimplementation. Severe hypertension treatment within 30 minutes of diagnosis was 65.9% preimplementation, 77.8% during implementation, and 79.0% post implementation. Differences were significant between pre- and post implementation for 15 minutes and 30 minutes, but no significant differences occurred in the patients treated within 60 minutes before and after implementation of the algorithm.

The study findings were limited by several factors, including the inability to separate peer-to-peer education and other training from the impact of the algorithm, as well as a lack of data on the effect of the algorithm on maternal or neonatal outcomes, the researchers noted.

However, the results support the potential of a semiautonomous algorithm to significantly improve adherence to the recommended treatment guidelines for severe hypertension in pregnancy and post partum, they said. Given the expected increase in hypertensive disorders in pregnancy because of the trends in older age and higher obesity rates in pregnant women, “Integration of semiautonomous treatment algorithms similar to ours into routine obstetric practices could help reduce the health care burden and improve clinical outcomes, especially in areas with limited health care resources,” they concluded.
 

Algorithm may reduce disparities

The overall rise in maternal mortality in the United States remains a concern, but “Even more concerning are the disturbing racial disparities that persist across socioeconomic strata,” wrote Alisse Hauspurg, MD, of the University of Pittsburgh in an accompanying editorial. “There is clear evidence that expeditious treatment of obstetric hypertensive emergency reduces the risk of severe morbidities including stroke, eclampsia, and maternal death,” she emphasized, but compliance with the ACOG recommendations to treat severe hypertension within 30-60 minutes of confirmation remains low, she said.

In this study, not only did use of the algorithm reduce time to antihypertensive therapy, but more than 50% of patients were treated for severe hypertension within 15 minutes, and more than 90% within 60 minutes, “which was sustained after the implementation phase,” and aligns with the ACOG recommendations, Dr. Hauspurg said. “Although Martin et al.’s algorithm was limited to the initial management of obstetric hypertensive emergency, it could readily be expanded to follow the full ACOG algorithm for management of hypertension in pregnancy,” she noted.

In addition, Black women are more frequently diagnosed with hypertensive disorders of pregnancy, including severe hypertension, and the algorithm might improve disparities, she said.

“It is plausible that widespread implementation of such a semiautonomous algorithm at hospitals across the country could reduce delays in treatment and prevent hypertension-related morbidities,” said Dr. Hauspurg. “The use of innovative approaches to management of severe hypertension and other obstetric emergencies has the potential to allow provision of more equitable care by overcoming health care practitioner and system biases, which could meaningfully reduce disparities in care and change the trajectory of maternal morbidity and mortality in the United States,” she emphasized.
 

Need to create culture of safety

“Maternal mortality in the United States is the highest among developed nations, and shocking disparities exist in outcomes for non-Hispanic Black and American Indian/Alaskan Native women,” said Lisa Hollier, MD, of Texas Children’s Health Plan in Bellaire. “In a California review of maternal deaths, the greatest quality improvement opportunities were missed diagnosis and ineffective treatment of preeclampsia and related diseases, which occurred in 65% of the cases where women died of preeclampsia/eclampsia,” she said.

The current study “is very timely as more and more states across the nation are participating in the AIM (Alliance for Innovation on Maternal Health) programs to prevent pregnancy-related mortality,” Dr. Hollier noted.

“This study demonstrated a significant association between implementation of the algorithm and an increased percentage of treatment of severe hypertension within 30 minutes,” Dr. Hollier said. “With the implementation of a comprehensive program that included treatment algorithms, the Illinois Perinatal Quality Collaborative improved timely treatment for women with severe high blood pressure, increasing the percentage of patients treated within 60 minutes from 41% at baseline to 79% in the first year of the project.”

The take-home message is that “implementation of the semiautonomous treatment algorithm can address important clinical variation, including delays in appropriate treatment of severe hypertension,” said Dr. Hollier. However, “One of the potential barriers [to use of an algorithm] is the need for accurate, real-time clinical assessment. Resources must be available to ensure appropriate monitoring,” Dr. Hollier noted. “Collaboration and support of implementation of these treatment algorithms must extend through the nursing staff, the physicians, and advanced-practice providers. Medical staff and administrative leaders are essential in creating a culture of safety and continuous process improvement,” she said.

In addition, “long-term follow-up on the implementation of broader quality improvement programs is essential,” Dr. Hollier said. “While implementation of an algorithm can, and did, result in process improvements, assessment of broader implementation of evidence-based bundles, combined with a systematic approach to redesign of multiple related processes needs to occur and include outcomes of severe maternal morbidity and mortality,” she explained.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Neither Dr. Hauspurg nor Dr. Hollier had financial conflicts to disclose.

The Janssen/Johnson & Johnson single-dose adenovirus vaccine provides 85% efficacy globally against severe COVID-19 illness, according to the highly anticipated interim phase 3 results announced this morning.

The efficacy against severe disease provided by the Janssen/J&J vaccine held true regardless of age, race/ethnicity, absence or presence of comorbidities, and geography. The 44,000-participant ENSEMBLE study was conducted in the United States, South America, and South Africa.

“The team is very diligently monitoring all the variants that come up, and there are literally thousands of these. We are acting in anticipation of a variant being a potential problem. The South African variant we too acted on right away. So we too are preparing that antigen for testing.

“With data today, we do see that not a single South African, after 28 days post vaccination, ended up needing to go to the hospital, no South African died who was vaccinated.

“We do see that 85%-plus protection in South African against severe disease. That is one of the most exciting results in the dataset today,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development.

The overall efficacy was 66% globally, 72% in the United States, 66% in Latin America, and 57% in South Africa against moderate to severe SARS-CoV-2 28 days post vaccination, officials from the National Institutes of Health and Janssen reported during a media briefing.

But the J&J vaccine has potential advantages over the existing two-dose Pfizer/BioNTech and Moderna mRNA vaccines because it’s single dose and has less stringent storage requirements – only regular refrigeration is needed versus a need to freeze the two-dose Pfizer/BioNTech and Moderna COVID-19 vaccines. The J&J vaccine can be refrigerated for up to 3 months at 36°-46° F (2°-8° C).

But the difference between these just-released efficacy figures and the 94%-95% efficacy provided by the existing Pfizer/BioNTech and Moderna mRNA vaccines generated many questions during the briefing.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the focus should not just be on the overall numbers. “The most important thing from a public health standpoint domestically is to keep people out of the hospital and prevent them from getting severe illness,” he said. “Many in the general public might look at a number and want to know if they get symptomatic disease or not.”

“More important than preventing someone from getting some aches and a sore throat is to prevent people – particularly people who have underlying conditions and the elderly, the ones most susceptible to a severe outcome – [from getting] severe disease,” Dr. Fauci added. Prevention of severe outcomes in a high percentage of individuals “will alleviate so much of the stress, human suffering, and death.”

Dr. Fauci acknowledged that many people will naturally focus on the distinction between 72% efficacy and 94%-95% efficacy. “This could be a messaging challenge [but] you have to make sure people understand the implications.”

It is more complex, he added, than just asking people: “If you go to the door on the left, you get 94% or 95%. If you go to the door to the right, you get 72%. What door do you want to go to?”

Instead, the messaging should be that “this and the other vaccines we have are actually preventing severe disease to a very substantial degree.”
 

Company defends numbers

Janssen defended their efficacy findings, pointing out that it is not a fair comparison.

“The vaccine programs that went a couple of months ago, they ran their studies during different times, when the pandemic was less complex. There were not these variants, and there was not the same level of incidence, which puts pressure on vaccine efficacy,” said Mathai Mammen, MD, PhD, global head of research and development for Janssen.

“So the numbers cannot really be compared, and that does pose a messaging challenge,” he said. “But the reality is, if one was to run the same studies [for the Pfizer and Moderna vaccines] today you would likely see different results.”

Asked if the efficacy figures could affect vaccine hesitancy, National Institutes of Health Director Francis Collins, MD, PhD, said at the announcement that most reluctance among people to get vaccinated against SARS-CoV-2 stems from concerns about safety. “The safety record is extremely good for this vaccine, as it is for the others that have received emergency use authorization.”

Janssen/J&J plans to submit for emergency use authorization from the U.S. Food and Drug Administration next week, at which point the company plans to release more information on side effects, deaths, and patient subpopulation efficacy, and more from the ENSEMBLE trial.

Janssen is aiming to provide 1 billion doses by the end of this year.

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

The Janssen/Johnson & Johnson single-dose adenovirus vaccine provides 85% efficacy globally against severe COVID-19 illness, according to the highly anticipated interim phase 3 results announced this morning.

The efficacy against severe disease provided by the Janssen/J&J vaccine held true regardless of age, race/ethnicity, absence or presence of comorbidities, and geography. The 44,000-participant ENSEMBLE study was conducted in the United States, South America, and South Africa.

“The team is very diligently monitoring all the variants that come up, and there are literally thousands of these. We are acting in anticipation of a variant being a potential problem. The South African variant we too acted on right away. So we too are preparing that antigen for testing.

“With data today, we do see that not a single South African, after 28 days post vaccination, ended up needing to go to the hospital, no South African died who was vaccinated.

“We do see that 85%-plus protection in South African against severe disease. That is one of the most exciting results in the dataset today,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development.

The overall efficacy was 66% globally, 72% in the United States, 66% in Latin America, and 57% in South Africa against moderate to severe SARS-CoV-2 28 days post vaccination, officials from the National Institutes of Health and Janssen reported during a media briefing.

But the J&J vaccine has potential advantages over the existing two-dose Pfizer/BioNTech and Moderna mRNA vaccines because it’s single dose and has less stringent storage requirements – only regular refrigeration is needed versus a need to freeze the two-dose Pfizer/BioNTech and Moderna COVID-19 vaccines. The J&J vaccine can be refrigerated for up to 3 months at 36°-46° F (2°-8° C).

But the difference between these just-released efficacy figures and the 94%-95% efficacy provided by the existing Pfizer/BioNTech and Moderna mRNA vaccines generated many questions during the briefing.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the focus should not just be on the overall numbers. “The most important thing from a public health standpoint domestically is to keep people out of the hospital and prevent them from getting severe illness,” he said. “Many in the general public might look at a number and want to know if they get symptomatic disease or not.”

“More important than preventing someone from getting some aches and a sore throat is to prevent people – particularly people who have underlying conditions and the elderly, the ones most susceptible to a severe outcome – [from getting] severe disease,” Dr. Fauci added. Prevention of severe outcomes in a high percentage of individuals “will alleviate so much of the stress, human suffering, and death.”

Dr. Fauci acknowledged that many people will naturally focus on the distinction between 72% efficacy and 94%-95% efficacy. “This could be a messaging challenge [but] you have to make sure people understand the implications.”

It is more complex, he added, than just asking people: “If you go to the door on the left, you get 94% or 95%. If you go to the door to the right, you get 72%. What door do you want to go to?”

Instead, the messaging should be that “this and the other vaccines we have are actually preventing severe disease to a very substantial degree.”
 

Company defends numbers

Janssen defended their efficacy findings, pointing out that it is not a fair comparison.

“The vaccine programs that went a couple of months ago, they ran their studies during different times, when the pandemic was less complex. There were not these variants, and there was not the same level of incidence, which puts pressure on vaccine efficacy,” said Mathai Mammen, MD, PhD, global head of research and development for Janssen.

“So the numbers cannot really be compared, and that does pose a messaging challenge,” he said. “But the reality is, if one was to run the same studies [for the Pfizer and Moderna vaccines] today you would likely see different results.”

Asked if the efficacy figures could affect vaccine hesitancy, National Institutes of Health Director Francis Collins, MD, PhD, said at the announcement that most reluctance among people to get vaccinated against SARS-CoV-2 stems from concerns about safety. “The safety record is extremely good for this vaccine, as it is for the others that have received emergency use authorization.”

Janssen/J&J plans to submit for emergency use authorization from the U.S. Food and Drug Administration next week, at which point the company plans to release more information on side effects, deaths, and patient subpopulation efficacy, and more from the ENSEMBLE trial.

Janssen is aiming to provide 1 billion doses by the end of this year.

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

The Janssen/Johnson & Johnson single-dose adenovirus vaccine provides 85% efficacy globally against severe COVID-19 illness, according to the highly anticipated interim phase 3 results announced this morning.

The efficacy against severe disease provided by the Janssen/J&J vaccine held true regardless of age, race/ethnicity, absence or presence of comorbidities, and geography. The 44,000-participant ENSEMBLE study was conducted in the United States, South America, and South Africa.

“The team is very diligently monitoring all the variants that come up, and there are literally thousands of these. We are acting in anticipation of a variant being a potential problem. The South African variant we too acted on right away. So we too are preparing that antigen for testing.

“With data today, we do see that not a single South African, after 28 days post vaccination, ended up needing to go to the hospital, no South African died who was vaccinated.

“We do see that 85%-plus protection in South African against severe disease. That is one of the most exciting results in the dataset today,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development.

The overall efficacy was 66% globally, 72% in the United States, 66% in Latin America, and 57% in South Africa against moderate to severe SARS-CoV-2 28 days post vaccination, officials from the National Institutes of Health and Janssen reported during a media briefing.

But the J&J vaccine has potential advantages over the existing two-dose Pfizer/BioNTech and Moderna mRNA vaccines because it’s single dose and has less stringent storage requirements – only regular refrigeration is needed versus a need to freeze the two-dose Pfizer/BioNTech and Moderna COVID-19 vaccines. The J&J vaccine can be refrigerated for up to 3 months at 36°-46° F (2°-8° C).

But the difference between these just-released efficacy figures and the 94%-95% efficacy provided by the existing Pfizer/BioNTech and Moderna mRNA vaccines generated many questions during the briefing.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said the focus should not just be on the overall numbers. “The most important thing from a public health standpoint domestically is to keep people out of the hospital and prevent them from getting severe illness,” he said. “Many in the general public might look at a number and want to know if they get symptomatic disease or not.”

“More important than preventing someone from getting some aches and a sore throat is to prevent people – particularly people who have underlying conditions and the elderly, the ones most susceptible to a severe outcome – [from getting] severe disease,” Dr. Fauci added. Prevention of severe outcomes in a high percentage of individuals “will alleviate so much of the stress, human suffering, and death.”

Dr. Fauci acknowledged that many people will naturally focus on the distinction between 72% efficacy and 94%-95% efficacy. “This could be a messaging challenge [but] you have to make sure people understand the implications.”

It is more complex, he added, than just asking people: “If you go to the door on the left, you get 94% or 95%. If you go to the door to the right, you get 72%. What door do you want to go to?”

Instead, the messaging should be that “this and the other vaccines we have are actually preventing severe disease to a very substantial degree.”
 

Company defends numbers

Janssen defended their efficacy findings, pointing out that it is not a fair comparison.

“The vaccine programs that went a couple of months ago, they ran their studies during different times, when the pandemic was less complex. There were not these variants, and there was not the same level of incidence, which puts pressure on vaccine efficacy,” said Mathai Mammen, MD, PhD, global head of research and development for Janssen.

“So the numbers cannot really be compared, and that does pose a messaging challenge,” he said. “But the reality is, if one was to run the same studies [for the Pfizer and Moderna vaccines] today you would likely see different results.”

Asked if the efficacy figures could affect vaccine hesitancy, National Institutes of Health Director Francis Collins, MD, PhD, said at the announcement that most reluctance among people to get vaccinated against SARS-CoV-2 stems from concerns about safety. “The safety record is extremely good for this vaccine, as it is for the others that have received emergency use authorization.”

Janssen/J&J plans to submit for emergency use authorization from the U.S. Food and Drug Administration next week, at which point the company plans to release more information on side effects, deaths, and patient subpopulation efficacy, and more from the ENSEMBLE trial.

Janssen is aiming to provide 1 billion doses by the end of this year.

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

The relationship between obesity and overweight and breast cancer has some elements of mystery. But this is not one of them: in metastatic breast cancer (MBC), excess body weight does not negatively influence outcomes.

Multiple small studies have demonstrated this point, and now, for the first time, a large multicenter cohort analysis indicates the same.

Using medical records from 18 French comprehensive cancer centers, investigators reviewed body mass index (BMI) and overall survival (OS) data for nearly 13,000 women. The median OS was 47.4 months, and the median follow-up was about the same length of time. The team reports that obesity and overweight “were clearly not associated with prognosis.”

However, underweight was independently associated with worse OS (median, 33 months; hazard ratio, 1.14; 95% confidence interval, 1.02-1.27), report Khalil Saleh, MD, of Gustave Roussy in Villejuif, France, and colleagues.

In short, obesity or overweight had no effect on the primary outcome of OS, but underweight did.

“Underweight should be the subject of clinical attention at the time of diagnosis of MBC, and specific management should be implemented,” said study author Elise Deluche, MD, of CHU de Limoges, in an email to this news organization.

The study was published online Dec. 1 in The Breast.

“It’s really wonderful to have such a large cohort to look at this question,” said Jennifer Ligibel, MD, of the Dana-Farber Cancer Institute, Boston, who was asked for comment.

Is this another case of obesity paradox in cancer (as in renal cell carcinoma and melanoma, where excess weight is tied to better cancer-specific survival)?

No, said Dr. Ligibel: “There’s no hint at all [in this study] that people with obesity and overweight did better. … They just didn’t have worse outcomes.”

The study authors point out that the opposite is true in early-stage breast cancer. In this patient population, excess weight is associated with worse outcomes.

For example, in a 2014 meta-analysis of 82 follow-up studies in early-stage disease, obesity was associated with higher total mortality (relative risk, 1.41) and breast cancer–specific mortality (RR, 1.35) as compared to normal weight.

Why is there such a contrast between early- and late-stage disease?

“I don’t think we know exactly,” answered Dr. Ligibel. “It may be that, with breast cancer, as disease progresses, the pathways through which lifestyle may impact breast cancer may become less important.

“Obesity and overweight are associated with cancer risk in general,” said Dr. Ligibel, citing more than a dozen malignancies, including breast cancer.

But there is also an age element. Overweight or obesity is an independent predictor of breast cancer risk in postmenopausal women, but in premenopausal women, it appears to be protective. “Historically, there has been a lower risk of hormone receptor–positive breast cancer in women with obesity at younger ages that we don’t completely understand,” Dr. Ligibel noted.

That age-based difference is a conundrum, said Dr. Ligibel: “People have been trying to figure that out for a long time.”

Dr. Ligibel summarized as follows:

“There is a clear relationship between obesity and the risk of developing breast cancer; there is a clear relationship in early breast cancer that obesity is related to an increased risk of occurrence and mortality. What we are seeing from this study is that, by the time you get to metastatic breast cancer, body weight does not seem to play as important a role.”
 

More study details

The findings come from the French National Epidemiological Strategy and Medical Economics–Metastatic Breast Cancer observational cohort, which includes 22,000-plus consecutive patients who were newly diagnosed with metastatic disease between 2008 and 2016.

A total of 12,999 women for whom BMI data were available when they were diagnosed with metastatic breast cancer were selected for analysis. They were divided into four groups, according to World Health Organization classification: underweight (BMI <18.5 kg/m²), normal weight (18.5-24.9), overweight (25.0-29.9), and obese (≥30.0).

A total of 20% of women were obese, which is a much lower percentage than the 40%-50% that would be expected in a comparable American cohort, said Dr. Ligibel. Also, 5% of the French cohort was underweight.

Multivariate Cox analyses were carried out for OS and for first-line progression-free survival (PFS).

As noted above, underweight was independently associated with a worse OS. It was also tied to worse first-line PFS (HR, 1.11; 95% CI, 1.01-1.22). Overweight or obesity had no effect.

“Patients with a low BMI had more visceral metastases and a greater number of metastatic sites,” pointed out study author Dr. Deluche. “We attribute the fat loss in patients with metastatic breast cancer to aggressive tumor behavior with a higher energy requirement.”

The study authors also observe that in early-stage breast cancer, underweight is not associated with overall or breast cancer–specific survival. “Underweight at metastatic diagnosis seems to have a different significance and impact,” they write. The French team also observes that, in other cancers, underweight is also an adverse prognostic factor and has been associated with a higher risk for death.

The study authors acknowledge that BMI has limitations as a measure of body type. “BMI alone cannot estimate a woman’s muscle mass and adiposity,” they observe. The suggestion is that, among women with a similar BMI, some might be muscular, whereas others might have more body fat.

Multiple study authors report financial ties to industry, including pharmaceutical companies with drugs used in breast cancer. The database used in the study receives financial support from AstraZeneca, Daiichi Sankyo, Eisai, MSD, Pfizer, and Roche. Dr. Ligibel reports no relevant financial relationships.

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

The relationship between obesity and overweight and breast cancer has some elements of mystery. But this is not one of them: in metastatic breast cancer (MBC), excess body weight does not negatively influence outcomes.

Multiple small studies have demonstrated this point, and now, for the first time, a large multicenter cohort analysis indicates the same.

Using medical records from 18 French comprehensive cancer centers, investigators reviewed body mass index (BMI) and overall survival (OS) data for nearly 13,000 women. The median OS was 47.4 months, and the median follow-up was about the same length of time. The team reports that obesity and overweight “were clearly not associated with prognosis.”

However, underweight was independently associated with worse OS (median, 33 months; hazard ratio, 1.14; 95% confidence interval, 1.02-1.27), report Khalil Saleh, MD, of Gustave Roussy in Villejuif, France, and colleagues.

In short, obesity or overweight had no effect on the primary outcome of OS, but underweight did.

“Underweight should be the subject of clinical attention at the time of diagnosis of MBC, and specific management should be implemented,” said study author Elise Deluche, MD, of CHU de Limoges, in an email to this news organization.

The study was published online Dec. 1 in The Breast.

“It’s really wonderful to have such a large cohort to look at this question,” said Jennifer Ligibel, MD, of the Dana-Farber Cancer Institute, Boston, who was asked for comment.

Is this another case of obesity paradox in cancer (as in renal cell carcinoma and melanoma, where excess weight is tied to better cancer-specific survival)?

No, said Dr. Ligibel: “There’s no hint at all [in this study] that people with obesity and overweight did better. … They just didn’t have worse outcomes.”

The study authors point out that the opposite is true in early-stage breast cancer. In this patient population, excess weight is associated with worse outcomes.

For example, in a 2014 meta-analysis of 82 follow-up studies in early-stage disease, obesity was associated with higher total mortality (relative risk, 1.41) and breast cancer–specific mortality (RR, 1.35) as compared to normal weight.

Why is there such a contrast between early- and late-stage disease?

“I don’t think we know exactly,” answered Dr. Ligibel. “It may be that, with breast cancer, as disease progresses, the pathways through which lifestyle may impact breast cancer may become less important.

“Obesity and overweight are associated with cancer risk in general,” said Dr. Ligibel, citing more than a dozen malignancies, including breast cancer.

But there is also an age element. Overweight or obesity is an independent predictor of breast cancer risk in postmenopausal women, but in premenopausal women, it appears to be protective. “Historically, there has been a lower risk of hormone receptor–positive breast cancer in women with obesity at younger ages that we don’t completely understand,” Dr. Ligibel noted.

That age-based difference is a conundrum, said Dr. Ligibel: “People have been trying to figure that out for a long time.”

Dr. Ligibel summarized as follows:

“There is a clear relationship between obesity and the risk of developing breast cancer; there is a clear relationship in early breast cancer that obesity is related to an increased risk of occurrence and mortality. What we are seeing from this study is that, by the time you get to metastatic breast cancer, body weight does not seem to play as important a role.”
 

More study details

The findings come from the French National Epidemiological Strategy and Medical Economics–Metastatic Breast Cancer observational cohort, which includes 22,000-plus consecutive patients who were newly diagnosed with metastatic disease between 2008 and 2016.

A total of 12,999 women for whom BMI data were available when they were diagnosed with metastatic breast cancer were selected for analysis. They were divided into four groups, according to World Health Organization classification: underweight (BMI <18.5 kg/m²), normal weight (18.5-24.9), overweight (25.0-29.9), and obese (≥30.0).

A total of 20% of women were obese, which is a much lower percentage than the 40%-50% that would be expected in a comparable American cohort, said Dr. Ligibel. Also, 5% of the French cohort was underweight.

Multivariate Cox analyses were carried out for OS and for first-line progression-free survival (PFS).

As noted above, underweight was independently associated with a worse OS. It was also tied to worse first-line PFS (HR, 1.11; 95% CI, 1.01-1.22). Overweight or obesity had no effect.

“Patients with a low BMI had more visceral metastases and a greater number of metastatic sites,” pointed out study author Dr. Deluche. “We attribute the fat loss in patients with metastatic breast cancer to aggressive tumor behavior with a higher energy requirement.”

The study authors also observe that in early-stage breast cancer, underweight is not associated with overall or breast cancer–specific survival. “Underweight at metastatic diagnosis seems to have a different significance and impact,” they write. The French team also observes that, in other cancers, underweight is also an adverse prognostic factor and has been associated with a higher risk for death.

The study authors acknowledge that BMI has limitations as a measure of body type. “BMI alone cannot estimate a woman’s muscle mass and adiposity,” they observe. The suggestion is that, among women with a similar BMI, some might be muscular, whereas others might have more body fat.

Multiple study authors report financial ties to industry, including pharmaceutical companies with drugs used in breast cancer. The database used in the study receives financial support from AstraZeneca, Daiichi Sankyo, Eisai, MSD, Pfizer, and Roche. Dr. Ligibel reports no relevant financial relationships.

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

The relationship between obesity and overweight and breast cancer has some elements of mystery. But this is not one of them: in metastatic breast cancer (MBC), excess body weight does not negatively influence outcomes.

Multiple small studies have demonstrated this point, and now, for the first time, a large multicenter cohort analysis indicates the same.

Using medical records from 18 French comprehensive cancer centers, investigators reviewed body mass index (BMI) and overall survival (OS) data for nearly 13,000 women. The median OS was 47.4 months, and the median follow-up was about the same length of time. The team reports that obesity and overweight “were clearly not associated with prognosis.”

However, underweight was independently associated with worse OS (median, 33 months; hazard ratio, 1.14; 95% confidence interval, 1.02-1.27), report Khalil Saleh, MD, of Gustave Roussy in Villejuif, France, and colleagues.

In short, obesity or overweight had no effect on the primary outcome of OS, but underweight did.

“Underweight should be the subject of clinical attention at the time of diagnosis of MBC, and specific management should be implemented,” said study author Elise Deluche, MD, of CHU de Limoges, in an email to this news organization.

The study was published online Dec. 1 in The Breast.

“It’s really wonderful to have such a large cohort to look at this question,” said Jennifer Ligibel, MD, of the Dana-Farber Cancer Institute, Boston, who was asked for comment.

Is this another case of obesity paradox in cancer (as in renal cell carcinoma and melanoma, where excess weight is tied to better cancer-specific survival)?

No, said Dr. Ligibel: “There’s no hint at all [in this study] that people with obesity and overweight did better. … They just didn’t have worse outcomes.”

The study authors point out that the opposite is true in early-stage breast cancer. In this patient population, excess weight is associated with worse outcomes.

For example, in a 2014 meta-analysis of 82 follow-up studies in early-stage disease, obesity was associated with higher total mortality (relative risk, 1.41) and breast cancer–specific mortality (RR, 1.35) as compared to normal weight.

Why is there such a contrast between early- and late-stage disease?

“I don’t think we know exactly,” answered Dr. Ligibel. “It may be that, with breast cancer, as disease progresses, the pathways through which lifestyle may impact breast cancer may become less important.

“Obesity and overweight are associated with cancer risk in general,” said Dr. Ligibel, citing more than a dozen malignancies, including breast cancer.

But there is also an age element. Overweight or obesity is an independent predictor of breast cancer risk in postmenopausal women, but in premenopausal women, it appears to be protective. “Historically, there has been a lower risk of hormone receptor–positive breast cancer in women with obesity at younger ages that we don’t completely understand,” Dr. Ligibel noted.

That age-based difference is a conundrum, said Dr. Ligibel: “People have been trying to figure that out for a long time.”

Dr. Ligibel summarized as follows:

“There is a clear relationship between obesity and the risk of developing breast cancer; there is a clear relationship in early breast cancer that obesity is related to an increased risk of occurrence and mortality. What we are seeing from this study is that, by the time you get to metastatic breast cancer, body weight does not seem to play as important a role.”
 

More study details

The findings come from the French National Epidemiological Strategy and Medical Economics–Metastatic Breast Cancer observational cohort, which includes 22,000-plus consecutive patients who were newly diagnosed with metastatic disease between 2008 and 2016.

A total of 12,999 women for whom BMI data were available when they were diagnosed with metastatic breast cancer were selected for analysis. They were divided into four groups, according to World Health Organization classification: underweight (BMI <18.5 kg/m²), normal weight (18.5-24.9), overweight (25.0-29.9), and obese (≥30.0).

A total of 20% of women were obese, which is a much lower percentage than the 40%-50% that would be expected in a comparable American cohort, said Dr. Ligibel. Also, 5% of the French cohort was underweight.

Multivariate Cox analyses were carried out for OS and for first-line progression-free survival (PFS).

As noted above, underweight was independently associated with a worse OS. It was also tied to worse first-line PFS (HR, 1.11; 95% CI, 1.01-1.22). Overweight or obesity had no effect.

“Patients with a low BMI had more visceral metastases and a greater number of metastatic sites,” pointed out study author Dr. Deluche. “We attribute the fat loss in patients with metastatic breast cancer to aggressive tumor behavior with a higher energy requirement.”

The study authors also observe that in early-stage breast cancer, underweight is not associated with overall or breast cancer–specific survival. “Underweight at metastatic diagnosis seems to have a different significance and impact,” they write. The French team also observes that, in other cancers, underweight is also an adverse prognostic factor and has been associated with a higher risk for death.

The study authors acknowledge that BMI has limitations as a measure of body type. “BMI alone cannot estimate a woman’s muscle mass and adiposity,” they observe. The suggestion is that, among women with a similar BMI, some might be muscular, whereas others might have more body fat.

Multiple study authors report financial ties to industry, including pharmaceutical companies with drugs used in breast cancer. The database used in the study receives financial support from AstraZeneca, Daiichi Sankyo, Eisai, MSD, Pfizer, and Roche. Dr. Ligibel reports no relevant financial relationships.

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

Dramatic changes in the use of radiotherapy for cancer were seen during the first wave of the COVID-19 pandemic in England. Some radiotherapy regimens were shortened, but others were intensified, suggesting that they were being used as a replacement for surgery.

The findings come from an analysis of National Health Service data in England, which also indicated that overall there was a reduction in the amount of radiotherapy delivered.

“Radiotherapy is a very important treatment option for cancer, and our study shows that, across the English NHS, there was a rapid shift in how radiotherapy was used,” said lead author Katie Spencer, PhD, faculty of medicine and health, University of Leeds (England).

“It is impressive to see that the data closely follow the guidelines published at the start of the pandemic,” she said. For instance, for patients with breast and colorectal cancers, treatment regimens were shorter and more intensive, whereas for patients with prostate cancer, treatments were delayed to reduce exposure to COVID-19.

“In other cases, such as head and neck cancers and anal cancers, we saw that the number of radiotherapy treatments hardly changed during the first wave. This was really reassuring, as we know that it is vital that these treatments are not delayed,” Dr. Spencer added.

The study was published online in The Lancet Oncology on Jan. 22 (doi: 10.1016/S1470-2045[20]30743-9).

Researchers examined data from the National Radiotherapy Dataset on all radiotherapy delivered for cancer in the NHS in England between Feb. 4, 2019, and June 28, 2020.

On interrupted time-series analysis, the introduction of lockdown in response to the COVID-19 pandemic was associated with a significant reduction in both radiotherapy courses and attendances (P < .0001).

Overall, the team estimated that there were 3,263 fewer radiotherapy treatment courses and 119,050 fewer attendances than would have taken place had the pandemic not occurred.

The largest reduction in treatment courses was seen for prostate cancer, with a 77% reduction in April 2020 in comparison with April 2019, and in nonmelanoma skin cancer, for which there was a decrease of 72.4% over the same period.

There were, however, marked increases in the number of radiotherapy courses given for some disorders in April 2020 in comparison with April 2019. Radiotherapy for bladder cancer increased by 64.2%; for esophageal cancer, it increased by 41.2%; and for rectal cancer, it increased by 36.3%.

This likely reflects the fact that, during the pandemic, “surgical capacity dropped dramatically,” Dr. Spencer said in an interview.

“To try to mitigate the consequences of that, working with their multidisciplinary teams, doctors increased the use of radiotherapy to provide a timely alternative curative treatment and help mitigate the consequences of not having access to surgery,” she said.

“This is a cohort of patients who would otherwise have had their treatment delayed, and we know that’s detrimental, so having an alternative strategy that, in specific cases, can offer similar outcomes is fantastic,” she added.

The analysis shows the “incredible speed with which radiotherapy services within the NHS were able to adapt their treatment patterns to help protect patients with cancer whilst coping with reduced surgical capacity due to the global pandemic,” coauthor Tom Roques, MD, medical director of professional practice for clinical oncology at the Royal College of Radiologists, commented in a statement.
 

Shorter radiotherapy regimen for breast cancer

In addition to the pandemic, two other events led to changes in the way that radiotherapy was delivered in the period analyzed.

One was the publication in April 2020 of the FAST-Forward trial of radiotherapy for breast cancer. This showed that radiotherapy with 26 Gy in 5 fractions administered over 1 week following primary surgery for early breast cancer was noninferior to the standard 40 Gy delivered in 15 fractions over 3 weeks.

These results led to immediate changes in practice, and quick implementation across the NHS “massively freed up capacity in terms of the number of fractions being delivered but also really helped to keep patients safe by ensuring they were only visiting the hospital on 5 occasions instead of the standard 15,” Spencer said.

Indeed, the analysis showed that the proportion of all breast radiotherapy courses given as the ultrahypofractionated regimen of 26 Gy in five fractions increased from 0.2% in April 2019 to 60.0% in April 2020 (P < .0001), which the authors noted “contributed to the substantial reduction” in radiotherapy attendances.

The other event occurred in March 2020, when NHS England “dramatically changed commissioning” from a tariff-based system in which radiotherapy was paid for every fraction delivered to a “payment that reflects the amount of money that was spent the previous year.

“That supported radiotherapy providers to do what was necessary to continue to deliver the best possible care to patients with cancer despite COVID,” Dr. Spencer added. “We saw this in our study, with doctors shortening radiotherapy courses to keep patients safe and departments running.”

The question now is whether the changes resulting from these two events will be maintained once the COVID-19 pandemic lifts.

What will happen to radiotherapy service commissioning beyond the end of the financial year is currently “unclear,” Dr. Spencer commented.

“There’s strong clinical support for continuing to use the shorter treatment courses in breast cancer, although it’s hard to know how any change in commissioning and reduction in COVID risk will influence their use over the next year and beyond,” she said.

“The data we used in this study, that Public Health England collect, will be really valuable in helping us to assess this in future,” Dr. Spencer said.
 

Radiotherapy remains reduced

Dr. Spencer taid that, “whilst in April and May 2020 we saw that the fall in radiotherapy was in cancers where it›s safe to delay treatment, in June we could see that radiotherapy activity was not back up to where it was previously, and that was across a wider range of cancers.

“This looks likely to be because of a fall in the number of people being diagnosed with cancer,” she said.

“The pandemic continues to cause severe disruption for cancer diagnosis and some national screening programs,” she commented. “This has meant that fewer patients were diagnosed with cancer during the first wave of the pandemic, and this is likely to have led to the persistent fall in treatments we are seeing.”

By November 2020, some referral pathways were back up to the volume of patients that was seen before the pandemic, but “it’s very variable across different diagnoses.”

The fear is that the resurgence of COVID-19 over the past month has made the situation worse, which is “very worrying,” Dr. Spencer said.

No funding for the study was declared. The authors disclosed no relevant financial relationships.

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

Dramatic changes in the use of radiotherapy for cancer were seen during the first wave of the COVID-19 pandemic in England. Some radiotherapy regimens were shortened, but others were intensified, suggesting that they were being used as a replacement for surgery.

The findings come from an analysis of National Health Service data in England, which also indicated that overall there was a reduction in the amount of radiotherapy delivered.

“Radiotherapy is a very important treatment option for cancer, and our study shows that, across the English NHS, there was a rapid shift in how radiotherapy was used,” said lead author Katie Spencer, PhD, faculty of medicine and health, University of Leeds (England).

“It is impressive to see that the data closely follow the guidelines published at the start of the pandemic,” she said. For instance, for patients with breast and colorectal cancers, treatment regimens were shorter and more intensive, whereas for patients with prostate cancer, treatments were delayed to reduce exposure to COVID-19.

“In other cases, such as head and neck cancers and anal cancers, we saw that the number of radiotherapy treatments hardly changed during the first wave. This was really reassuring, as we know that it is vital that these treatments are not delayed,” Dr. Spencer added.

The study was published online in The Lancet Oncology on Jan. 22 (doi: 10.1016/S1470-2045[20]30743-9).

Researchers examined data from the National Radiotherapy Dataset on all radiotherapy delivered for cancer in the NHS in England between Feb. 4, 2019, and June 28, 2020.

On interrupted time-series analysis, the introduction of lockdown in response to the COVID-19 pandemic was associated with a significant reduction in both radiotherapy courses and attendances (P < .0001).

Overall, the team estimated that there were 3,263 fewer radiotherapy treatment courses and 119,050 fewer attendances than would have taken place had the pandemic not occurred.

The largest reduction in treatment courses was seen for prostate cancer, with a 77% reduction in April 2020 in comparison with April 2019, and in nonmelanoma skin cancer, for which there was a decrease of 72.4% over the same period.

There were, however, marked increases in the number of radiotherapy courses given for some disorders in April 2020 in comparison with April 2019. Radiotherapy for bladder cancer increased by 64.2%; for esophageal cancer, it increased by 41.2%; and for rectal cancer, it increased by 36.3%.

This likely reflects the fact that, during the pandemic, “surgical capacity dropped dramatically,” Dr. Spencer said in an interview.

“To try to mitigate the consequences of that, working with their multidisciplinary teams, doctors increased the use of radiotherapy to provide a timely alternative curative treatment and help mitigate the consequences of not having access to surgery,” she said.

“This is a cohort of patients who would otherwise have had their treatment delayed, and we know that’s detrimental, so having an alternative strategy that, in specific cases, can offer similar outcomes is fantastic,” she added.

The analysis shows the “incredible speed with which radiotherapy services within the NHS were able to adapt their treatment patterns to help protect patients with cancer whilst coping with reduced surgical capacity due to the global pandemic,” coauthor Tom Roques, MD, medical director of professional practice for clinical oncology at the Royal College of Radiologists, commented in a statement.
 

Shorter radiotherapy regimen for breast cancer

In addition to the pandemic, two other events led to changes in the way that radiotherapy was delivered in the period analyzed.

One was the publication in April 2020 of the FAST-Forward trial of radiotherapy for breast cancer. This showed that radiotherapy with 26 Gy in 5 fractions administered over 1 week following primary surgery for early breast cancer was noninferior to the standard 40 Gy delivered in 15 fractions over 3 weeks.

These results led to immediate changes in practice, and quick implementation across the NHS “massively freed up capacity in terms of the number of fractions being delivered but also really helped to keep patients safe by ensuring they were only visiting the hospital on 5 occasions instead of the standard 15,” Spencer said.

Indeed, the analysis showed that the proportion of all breast radiotherapy courses given as the ultrahypofractionated regimen of 26 Gy in five fractions increased from 0.2% in April 2019 to 60.0% in April 2020 (P < .0001), which the authors noted “contributed to the substantial reduction” in radiotherapy attendances.

The other event occurred in March 2020, when NHS England “dramatically changed commissioning” from a tariff-based system in which radiotherapy was paid for every fraction delivered to a “payment that reflects the amount of money that was spent the previous year.

“That supported radiotherapy providers to do what was necessary to continue to deliver the best possible care to patients with cancer despite COVID,” Dr. Spencer added. “We saw this in our study, with doctors shortening radiotherapy courses to keep patients safe and departments running.”

The question now is whether the changes resulting from these two events will be maintained once the COVID-19 pandemic lifts.

What will happen to radiotherapy service commissioning beyond the end of the financial year is currently “unclear,” Dr. Spencer commented.

“There’s strong clinical support for continuing to use the shorter treatment courses in breast cancer, although it’s hard to know how any change in commissioning and reduction in COVID risk will influence their use over the next year and beyond,” she said.

“The data we used in this study, that Public Health England collect, will be really valuable in helping us to assess this in future,” Dr. Spencer said.
 

Radiotherapy remains reduced

Dr. Spencer taid that, “whilst in April and May 2020 we saw that the fall in radiotherapy was in cancers where it›s safe to delay treatment, in June we could see that radiotherapy activity was not back up to where it was previously, and that was across a wider range of cancers.

“This looks likely to be because of a fall in the number of people being diagnosed with cancer,” she said.

“The pandemic continues to cause severe disruption for cancer diagnosis and some national screening programs,” she commented. “This has meant that fewer patients were diagnosed with cancer during the first wave of the pandemic, and this is likely to have led to the persistent fall in treatments we are seeing.”

By November 2020, some referral pathways were back up to the volume of patients that was seen before the pandemic, but “it’s very variable across different diagnoses.”

The fear is that the resurgence of COVID-19 over the past month has made the situation worse, which is “very worrying,” Dr. Spencer said.

No funding for the study was declared. The authors disclosed no relevant financial relationships.

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

Dramatic changes in the use of radiotherapy for cancer were seen during the first wave of the COVID-19 pandemic in England. Some radiotherapy regimens were shortened, but others were intensified, suggesting that they were being used as a replacement for surgery.

The findings come from an analysis of National Health Service data in England, which also indicated that overall there was a reduction in the amount of radiotherapy delivered.

“Radiotherapy is a very important treatment option for cancer, and our study shows that, across the English NHS, there was a rapid shift in how radiotherapy was used,” said lead author Katie Spencer, PhD, faculty of medicine and health, University of Leeds (England).

“It is impressive to see that the data closely follow the guidelines published at the start of the pandemic,” she said. For instance, for patients with breast and colorectal cancers, treatment regimens were shorter and more intensive, whereas for patients with prostate cancer, treatments were delayed to reduce exposure to COVID-19.

“In other cases, such as head and neck cancers and anal cancers, we saw that the number of radiotherapy treatments hardly changed during the first wave. This was really reassuring, as we know that it is vital that these treatments are not delayed,” Dr. Spencer added.

The study was published online in The Lancet Oncology on Jan. 22 (doi: 10.1016/S1470-2045[20]30743-9).

Researchers examined data from the National Radiotherapy Dataset on all radiotherapy delivered for cancer in the NHS in England between Feb. 4, 2019, and June 28, 2020.

On interrupted time-series analysis, the introduction of lockdown in response to the COVID-19 pandemic was associated with a significant reduction in both radiotherapy courses and attendances (P < .0001).

Overall, the team estimated that there were 3,263 fewer radiotherapy treatment courses and 119,050 fewer attendances than would have taken place had the pandemic not occurred.

The largest reduction in treatment courses was seen for prostate cancer, with a 77% reduction in April 2020 in comparison with April 2019, and in nonmelanoma skin cancer, for which there was a decrease of 72.4% over the same period.

There were, however, marked increases in the number of radiotherapy courses given for some disorders in April 2020 in comparison with April 2019. Radiotherapy for bladder cancer increased by 64.2%; for esophageal cancer, it increased by 41.2%; and for rectal cancer, it increased by 36.3%.

This likely reflects the fact that, during the pandemic, “surgical capacity dropped dramatically,” Dr. Spencer said in an interview.

“To try to mitigate the consequences of that, working with their multidisciplinary teams, doctors increased the use of radiotherapy to provide a timely alternative curative treatment and help mitigate the consequences of not having access to surgery,” she said.

“This is a cohort of patients who would otherwise have had their treatment delayed, and we know that’s detrimental, so having an alternative strategy that, in specific cases, can offer similar outcomes is fantastic,” she added.

The analysis shows the “incredible speed with which radiotherapy services within the NHS were able to adapt their treatment patterns to help protect patients with cancer whilst coping with reduced surgical capacity due to the global pandemic,” coauthor Tom Roques, MD, medical director of professional practice for clinical oncology at the Royal College of Radiologists, commented in a statement.
 

Shorter radiotherapy regimen for breast cancer

In addition to the pandemic, two other events led to changes in the way that radiotherapy was delivered in the period analyzed.

One was the publication in April 2020 of the FAST-Forward trial of radiotherapy for breast cancer. This showed that radiotherapy with 26 Gy in 5 fractions administered over 1 week following primary surgery for early breast cancer was noninferior to the standard 40 Gy delivered in 15 fractions over 3 weeks.

These results led to immediate changes in practice, and quick implementation across the NHS “massively freed up capacity in terms of the number of fractions being delivered but also really helped to keep patients safe by ensuring they were only visiting the hospital on 5 occasions instead of the standard 15,” Spencer said.

Indeed, the analysis showed that the proportion of all breast radiotherapy courses given as the ultrahypofractionated regimen of 26 Gy in five fractions increased from 0.2% in April 2019 to 60.0% in April 2020 (P < .0001), which the authors noted “contributed to the substantial reduction” in radiotherapy attendances.

The other event occurred in March 2020, when NHS England “dramatically changed commissioning” from a tariff-based system in which radiotherapy was paid for every fraction delivered to a “payment that reflects the amount of money that was spent the previous year.

“That supported radiotherapy providers to do what was necessary to continue to deliver the best possible care to patients with cancer despite COVID,” Dr. Spencer added. “We saw this in our study, with doctors shortening radiotherapy courses to keep patients safe and departments running.”

The question now is whether the changes resulting from these two events will be maintained once the COVID-19 pandemic lifts.

What will happen to radiotherapy service commissioning beyond the end of the financial year is currently “unclear,” Dr. Spencer commented.

“There’s strong clinical support for continuing to use the shorter treatment courses in breast cancer, although it’s hard to know how any change in commissioning and reduction in COVID risk will influence their use over the next year and beyond,” she said.

“The data we used in this study, that Public Health England collect, will be really valuable in helping us to assess this in future,” Dr. Spencer said.
 

Radiotherapy remains reduced

Dr. Spencer taid that, “whilst in April and May 2020 we saw that the fall in radiotherapy was in cancers where it›s safe to delay treatment, in June we could see that radiotherapy activity was not back up to where it was previously, and that was across a wider range of cancers.

“This looks likely to be because of a fall in the number of people being diagnosed with cancer,” she said.

“The pandemic continues to cause severe disruption for cancer diagnosis and some national screening programs,” she commented. “This has meant that fewer patients were diagnosed with cancer during the first wave of the pandemic, and this is likely to have led to the persistent fall in treatments we are seeing.”

By November 2020, some referral pathways were back up to the volume of patients that was seen before the pandemic, but “it’s very variable across different diagnoses.”

The fear is that the resurgence of COVID-19 over the past month has made the situation worse, which is “very worrying,” Dr. Spencer said.

No funding for the study was declared. The authors disclosed no relevant financial relationships.

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

Dear colleagues,

I’m pleased to introduce the winter edition of The New Gastroenterologist – the first issue of 2021! The start of the new year has been very much anticipated because many hope that this year will bring some resolution to the challenges we faced in 2020.

With the pandemic came the widespread use of telemedicine, a feature of patient care that is likely here to stay. As physicians, it is imperative that we understand the legal implications of virtual medicine. Experienced medical malpractice lawyers Ashton Hyde and Grace Johnson (Younker Hyde Macfarlane) offer advice on this rapidly evolving realm of medicine.

Early career gastroenterologists often fall victim to self-doubt in a phenomenon referred to as impostor syndrome. Dr. Kimberly Brown (Wayne State University) discusses this important topic: what it is, how to recognize it, and how to mitigate it. One way to temper the effects of impostor syndrome is utilizing the art of coaching. Dr. Ami N. Shah (Rush) takes us through her journey and reviews the personal and professional benefits of implementing coaching in medicine.

Consults about feedings tubes can be daunting because experience with the placement and management of feeding tubes can be limited during training. This quarter’s “In Focus” article, written by Dr. John Fang and Dr. Gregory Toy (University of Utah) reviews the indications for placement, type of tubes available, and common complications and how to troubleshoot them. This is an absolute must-read for any new gastroenterologist.

How do you approach the patient who shows up for an open access endoscopy, but a quick chart review leads you to the realization that the procedure, is in fact, not indicated? There tends to be a lot of inertia which prevents cancellation of cases like this because the patient is already in the endoscopy suite, prepped, and has planned for this procedure in the preceding weeks or months. Dr. Laurel R. Fisher (University of Pennsylvania) unpacks the ethical considerations of this familiar scenario in this fantastic addition to our ethics case series.

In our postfellowship pathways section, Dr. Rena Yadlapati (University of California San Diego) and Dr. Kelli DeLay (University of Colorado) guide us through the path to becoming an esophagologist. In the DHPA Private Practice Perspectives article this quarter, Dr. Nadeem Baig (Allied Digestive Care) and Kevin Harlen (Capital Digestive Care) explain how clinical productivity is measured and how this translates into compensation in practice.

A silver lining of the pandemic is the way in which social media has been used to connect colleagues around the world in fostering medical education. Dr. Sultan Mahmood (State University of New York at Buffalo), Dr. Atoosa Rabiee (Washington DC VA Medical Center), Dr. Sunil Amin (University of Miami), Dr. Allon Kahn (Mayo Clinic Scottsdale), and Dr. Ijlal Akbar Ali (University of Oklahoma) discuss the inception of @GIJournal, a Twitter-based online journal club, and how it has gained popularity in recent months.

The AGA launched a new podcast, “Small Talk, Big Topics,” geared toward trainees and early career gastroenterologists, and through a brief question and answer session, we get to know the hosts: Dr. Matthew Whitson (Zucker School of Medicine at Hofstra-Northwell), Dr. Nina Nandy (Presbyterian Medical Group), and Dr. C.S. Tse (Brown University).

Lastly, I’d like to take a moment to recognize Lora McGlade, who has been instrumental in The New Gastroenterologist as the Medical Communications Editor for our publisher, Frontline. She assumed a new role at the end of last year, and I cannot thank her enough for her contributions in making this publication a success.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.
 

Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

I’m pleased to introduce the winter edition of The New Gastroenterologist – the first issue of 2021! The start of the new year has been very much anticipated because many hope that this year will bring some resolution to the challenges we faced in 2020.

With the pandemic came the widespread use of telemedicine, a feature of patient care that is likely here to stay. As physicians, it is imperative that we understand the legal implications of virtual medicine. Experienced medical malpractice lawyers Ashton Hyde and Grace Johnson (Younker Hyde Macfarlane) offer advice on this rapidly evolving realm of medicine.

Early career gastroenterologists often fall victim to self-doubt in a phenomenon referred to as impostor syndrome. Dr. Kimberly Brown (Wayne State University) discusses this important topic: what it is, how to recognize it, and how to mitigate it. One way to temper the effects of impostor syndrome is utilizing the art of coaching. Dr. Ami N. Shah (Rush) takes us through her journey and reviews the personal and professional benefits of implementing coaching in medicine.

Consults about feedings tubes can be daunting because experience with the placement and management of feeding tubes can be limited during training. This quarter’s “In Focus” article, written by Dr. John Fang and Dr. Gregory Toy (University of Utah) reviews the indications for placement, type of tubes available, and common complications and how to troubleshoot them. This is an absolute must-read for any new gastroenterologist.

How do you approach the patient who shows up for an open access endoscopy, but a quick chart review leads you to the realization that the procedure, is in fact, not indicated? There tends to be a lot of inertia which prevents cancellation of cases like this because the patient is already in the endoscopy suite, prepped, and has planned for this procedure in the preceding weeks or months. Dr. Laurel R. Fisher (University of Pennsylvania) unpacks the ethical considerations of this familiar scenario in this fantastic addition to our ethics case series.

In our postfellowship pathways section, Dr. Rena Yadlapati (University of California San Diego) and Dr. Kelli DeLay (University of Colorado) guide us through the path to becoming an esophagologist. In the DHPA Private Practice Perspectives article this quarter, Dr. Nadeem Baig (Allied Digestive Care) and Kevin Harlen (Capital Digestive Care) explain how clinical productivity is measured and how this translates into compensation in practice.

A silver lining of the pandemic is the way in which social media has been used to connect colleagues around the world in fostering medical education. Dr. Sultan Mahmood (State University of New York at Buffalo), Dr. Atoosa Rabiee (Washington DC VA Medical Center), Dr. Sunil Amin (University of Miami), Dr. Allon Kahn (Mayo Clinic Scottsdale), and Dr. Ijlal Akbar Ali (University of Oklahoma) discuss the inception of @GIJournal, a Twitter-based online journal club, and how it has gained popularity in recent months.

The AGA launched a new podcast, “Small Talk, Big Topics,” geared toward trainees and early career gastroenterologists, and through a brief question and answer session, we get to know the hosts: Dr. Matthew Whitson (Zucker School of Medicine at Hofstra-Northwell), Dr. Nina Nandy (Presbyterian Medical Group), and Dr. C.S. Tse (Brown University).

Lastly, I’d like to take a moment to recognize Lora McGlade, who has been instrumental in The New Gastroenterologist as the Medical Communications Editor for our publisher, Frontline. She assumed a new role at the end of last year, and I cannot thank her enough for her contributions in making this publication a success.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.
 

Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

I’m pleased to introduce the winter edition of The New Gastroenterologist – the first issue of 2021! The start of the new year has been very much anticipated because many hope that this year will bring some resolution to the challenges we faced in 2020.

With the pandemic came the widespread use of telemedicine, a feature of patient care that is likely here to stay. As physicians, it is imperative that we understand the legal implications of virtual medicine. Experienced medical malpractice lawyers Ashton Hyde and Grace Johnson (Younker Hyde Macfarlane) offer advice on this rapidly evolving realm of medicine.

Early career gastroenterologists often fall victim to self-doubt in a phenomenon referred to as impostor syndrome. Dr. Kimberly Brown (Wayne State University) discusses this important topic: what it is, how to recognize it, and how to mitigate it. One way to temper the effects of impostor syndrome is utilizing the art of coaching. Dr. Ami N. Shah (Rush) takes us through her journey and reviews the personal and professional benefits of implementing coaching in medicine.

Consults about feedings tubes can be daunting because experience with the placement and management of feeding tubes can be limited during training. This quarter’s “In Focus” article, written by Dr. John Fang and Dr. Gregory Toy (University of Utah) reviews the indications for placement, type of tubes available, and common complications and how to troubleshoot them. This is an absolute must-read for any new gastroenterologist.

How do you approach the patient who shows up for an open access endoscopy, but a quick chart review leads you to the realization that the procedure, is in fact, not indicated? There tends to be a lot of inertia which prevents cancellation of cases like this because the patient is already in the endoscopy suite, prepped, and has planned for this procedure in the preceding weeks or months. Dr. Laurel R. Fisher (University of Pennsylvania) unpacks the ethical considerations of this familiar scenario in this fantastic addition to our ethics case series.

In our postfellowship pathways section, Dr. Rena Yadlapati (University of California San Diego) and Dr. Kelli DeLay (University of Colorado) guide us through the path to becoming an esophagologist. In the DHPA Private Practice Perspectives article this quarter, Dr. Nadeem Baig (Allied Digestive Care) and Kevin Harlen (Capital Digestive Care) explain how clinical productivity is measured and how this translates into compensation in practice.

A silver lining of the pandemic is the way in which social media has been used to connect colleagues around the world in fostering medical education. Dr. Sultan Mahmood (State University of New York at Buffalo), Dr. Atoosa Rabiee (Washington DC VA Medical Center), Dr. Sunil Amin (University of Miami), Dr. Allon Kahn (Mayo Clinic Scottsdale), and Dr. Ijlal Akbar Ali (University of Oklahoma) discuss the inception of @GIJournal, a Twitter-based online journal club, and how it has gained popularity in recent months.

The AGA launched a new podcast, “Small Talk, Big Topics,” geared toward trainees and early career gastroenterologists, and through a brief question and answer session, we get to know the hosts: Dr. Matthew Whitson (Zucker School of Medicine at Hofstra-Northwell), Dr. Nina Nandy (Presbyterian Medical Group), and Dr. C.S. Tse (Brown University).

Lastly, I’d like to take a moment to recognize Lora McGlade, who has been instrumental in The New Gastroenterologist as the Medical Communications Editor for our publisher, Frontline. She assumed a new role at the end of last year, and I cannot thank her enough for her contributions in making this publication a success.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.
 

Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Key clinical point: Information of the flow cytometry immunophenotyping (FCI) data during therapy combined with the hematological response can help physicians identify patients with myelodysplastic syndrome (MDS) with a higher probability of maintaining a good quality of response to 5-azacitidine (AZA) therapy for a longer period of time.

Major finding: After a median of 6 cycles of AZA, an FCI improvement was found in 41% of patients, and this finding correlated with a better clinical response (P less than .001). FCI improvement correlated with hematological improvement (HI), and the probability of maintaining a clinical response at 12 cycles of AZA was twice as large (67%) for those who achieved an HI and an FCI improvement after 6 cycles of AZA compared with patients who only achieved an HI (33%).

Study details: The data come from a study of 81 patients diagnosed with MDS in 5 European centers.

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Source: Subirá D et al. Ann Hematol. 2021 Jan 9. doi: 10.1007/s00277-021-04411-4.

Key clinical point: Information of the flow cytometry immunophenotyping (FCI) data during therapy combined with the hematological response can help physicians identify patients with myelodysplastic syndrome (MDS) with a higher probability of maintaining a good quality of response to 5-azacitidine (AZA) therapy for a longer period of time.

Major finding: After a median of 6 cycles of AZA, an FCI improvement was found in 41% of patients, and this finding correlated with a better clinical response (P less than .001). FCI improvement correlated with hematological improvement (HI), and the probability of maintaining a clinical response at 12 cycles of AZA was twice as large (67%) for those who achieved an HI and an FCI improvement after 6 cycles of AZA compared with patients who only achieved an HI (33%).

Study details: The data come from a study of 81 patients diagnosed with MDS in 5 European centers.

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Source: Subirá D et al. Ann Hematol. 2021 Jan 9. doi: 10.1007/s00277-021-04411-4.

Key clinical point: Information of the flow cytometry immunophenotyping (FCI) data during therapy combined with the hematological response can help physicians identify patients with myelodysplastic syndrome (MDS) with a higher probability of maintaining a good quality of response to 5-azacitidine (AZA) therapy for a longer period of time.

Major finding: After a median of 6 cycles of AZA, an FCI improvement was found in 41% of patients, and this finding correlated with a better clinical response (P less than .001). FCI improvement correlated with hematological improvement (HI), and the probability of maintaining a clinical response at 12 cycles of AZA was twice as large (67%) for those who achieved an HI and an FCI improvement after 6 cycles of AZA compared with patients who only achieved an HI (33%).

Study details: The data come from a study of 81 patients diagnosed with MDS in 5 European centers.

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Source: Subirá D et al. Ann Hematol. 2021 Jan 9. doi: 10.1007/s00277-021-04411-4.

Key clinical point: Plerixafor in combination with granulocyte colony-stimulating factor (G-CSF) and azacitidine appears tolerable when given over 5 days and has encouraging response rates in patients with myelodysplastic syndromes (MDS).

Major finding: Two complete responses and 6 marrow responses were seen for an overall response rate (ORR) of 36% in evaluable patients. The ORR for patients receiving plerixafor (any dose), G-CSF, and azacitidine was 53%. Blast mobilization during treatment correlated with response, with patients that mobilized greater than 2-fold having an ORR of 60% vs. 17% for those that did not (P = .035).

Study details: The data come from an open-label, phase 1 study of 28 MDS patients treated with plerixafor, G-CSF, and azacitidine with a standard 3 + 3 design with 3 dose escalation cohorts of plerixafor 320 mg/kg/day, 440 mg/kg/day, and 560 mg/kg/day.

Disclosures: The study was supported by the American Society of Hematology Clinical Research Training Institute. Four of the authors reported receiving honoraria from Sanofi and 1 received honoraria from Bristol Myers Squibb.

Source: Huselton E et al. Leuk Lymphoma. 2021 Jan 19. doi: 10.1080/10428194.2021.

Key clinical point: Plerixafor in combination with granulocyte colony-stimulating factor (G-CSF) and azacitidine appears tolerable when given over 5 days and has encouraging response rates in patients with myelodysplastic syndromes (MDS).

Major finding: Two complete responses and 6 marrow responses were seen for an overall response rate (ORR) of 36% in evaluable patients. The ORR for patients receiving plerixafor (any dose), G-CSF, and azacitidine was 53%. Blast mobilization during treatment correlated with response, with patients that mobilized greater than 2-fold having an ORR of 60% vs. 17% for those that did not (P = .035).

Study details: The data come from an open-label, phase 1 study of 28 MDS patients treated with plerixafor, G-CSF, and azacitidine with a standard 3 + 3 design with 3 dose escalation cohorts of plerixafor 320 mg/kg/day, 440 mg/kg/day, and 560 mg/kg/day.

Disclosures: The study was supported by the American Society of Hematology Clinical Research Training Institute. Four of the authors reported receiving honoraria from Sanofi and 1 received honoraria from Bristol Myers Squibb.

Source: Huselton E et al. Leuk Lymphoma. 2021 Jan 19. doi: 10.1080/10428194.2021.

Key clinical point: Plerixafor in combination with granulocyte colony-stimulating factor (G-CSF) and azacitidine appears tolerable when given over 5 days and has encouraging response rates in patients with myelodysplastic syndromes (MDS).

Major finding: Two complete responses and 6 marrow responses were seen for an overall response rate (ORR) of 36% in evaluable patients. The ORR for patients receiving plerixafor (any dose), G-CSF, and azacitidine was 53%. Blast mobilization during treatment correlated with response, with patients that mobilized greater than 2-fold having an ORR of 60% vs. 17% for those that did not (P = .035).

Study details: The data come from an open-label, phase 1 study of 28 MDS patients treated with plerixafor, G-CSF, and azacitidine with a standard 3 + 3 design with 3 dose escalation cohorts of plerixafor 320 mg/kg/day, 440 mg/kg/day, and 560 mg/kg/day.

Disclosures: The study was supported by the American Society of Hematology Clinical Research Training Institute. Four of the authors reported receiving honoraria from Sanofi and 1 received honoraria from Bristol Myers Squibb.

Source: Huselton E et al. Leuk Lymphoma. 2021 Jan 19. doi: 10.1080/10428194.2021.

Key clinical point: The addition of lenalidomide (LEN) to epoetin (EPO) alfa offers a superior probability of clinically meaningful and highly durable erythroid response vs. LEN alone in patients with lower-risk, non-del (5q) myelodysplastic syndromes (MDS) who have anemia that is refractory to recombinant erythropoietin.

Major finding: After 4 cycles of treatment, major erythroid response was significantly higher with the combination of LEN and erythropoietin vs. LEN alone (28.3% vs. 11.5%; P = .004). Responses to the combined treatment were highly durable with a median major erythroid response duration of 23.8 months in the combined therapy cohort vs. 13 months in the LEN cohort.

Study details: In this phase 3 US intergroup trial, 195 patients with MDS and anemia were randomly assigned to receive LEN and EPO alfa (n = 99) or LEN alone (n = 96) following stratification by serum erythropoietin concentration and prior erythropoietin treatment.

Disclosures: The study was supported by the ECOG-ACRIN Cancer Research Group Study, the National Cancer Institute (NCI) of the National Institutes of Health, and NCI. The authors reported ties with various pharmaceutical companies.

Source: List AF et al. J Clin Oncol. 2021 Jan 13. doi: 10.1200/JCO.20.01691.

Key clinical point: The addition of lenalidomide (LEN) to epoetin (EPO) alfa offers a superior probability of clinically meaningful and highly durable erythroid response vs. LEN alone in patients with lower-risk, non-del (5q) myelodysplastic syndromes (MDS) who have anemia that is refractory to recombinant erythropoietin.

Major finding: After 4 cycles of treatment, major erythroid response was significantly higher with the combination of LEN and erythropoietin vs. LEN alone (28.3% vs. 11.5%; P = .004). Responses to the combined treatment were highly durable with a median major erythroid response duration of 23.8 months in the combined therapy cohort vs. 13 months in the LEN cohort.

Study details: In this phase 3 US intergroup trial, 195 patients with MDS and anemia were randomly assigned to receive LEN and EPO alfa (n = 99) or LEN alone (n = 96) following stratification by serum erythropoietin concentration and prior erythropoietin treatment.

Disclosures: The study was supported by the ECOG-ACRIN Cancer Research Group Study, the National Cancer Institute (NCI) of the National Institutes of Health, and NCI. The authors reported ties with various pharmaceutical companies.

Source: List AF et al. J Clin Oncol. 2021 Jan 13. doi: 10.1200/JCO.20.01691.

Key clinical point: The addition of lenalidomide (LEN) to epoetin (EPO) alfa offers a superior probability of clinically meaningful and highly durable erythroid response vs. LEN alone in patients with lower-risk, non-del (5q) myelodysplastic syndromes (MDS) who have anemia that is refractory to recombinant erythropoietin.

Major finding: After 4 cycles of treatment, major erythroid response was significantly higher with the combination of LEN and erythropoietin vs. LEN alone (28.3% vs. 11.5%; P = .004). Responses to the combined treatment were highly durable with a median major erythroid response duration of 23.8 months in the combined therapy cohort vs. 13 months in the LEN cohort.

Study details: In this phase 3 US intergroup trial, 195 patients with MDS and anemia were randomly assigned to receive LEN and EPO alfa (n = 99) or LEN alone (n = 96) following stratification by serum erythropoietin concentration and prior erythropoietin treatment.

Disclosures: The study was supported by the ECOG-ACRIN Cancer Research Group Study, the National Cancer Institute (NCI) of the National Institutes of Health, and NCI. The authors reported ties with various pharmaceutical companies.

Source: List AF et al. J Clin Oncol. 2021 Jan 13. doi: 10.1200/JCO.20.01691.

The United States is facing a “Category 5” storm as coronavirus variants begin to spread across the country, one of the nation’s top infectious disease experts said Sunday.

“We are going to see something like we have not seen yet in this country,” Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said on NBC’s Meet the Press.

The United States has reported 467 cases of the coronavirus variant first identified in the United Kingdom, across 32 states, according to the CDC variant tracker. The United States has also reported three cases of the variant first identified in South Africa in South Carolina and Maryland. One case of the variant first identified in Brazil has been found in Minnesota.

Although overall COVID-19 cases and hospitalizations have declined during the past few weeks, another storm is brewing on the horizon with the variants, Dr. Osterholm told host Chuck Todd. The U.K. variant will likely cause a surge in COVID-19 cases during the next 6-14 weeks, he said. “You and I are sitting on this beach where it’s 70 degrees, perfectly blue skies, gentle breeze. But I see that hurricane 5, Category 5 or higher, 450 miles offshore. And telling people to evacuate on that nice blue sky day is going to be hard. But I can also tell you that hurricane is coming.”

Dr. Osterholm urged federal and state officials to vaccinate as many people as possible to reduce the oncoming storm. The United States has distributed 49.9 million doses and administered 31.1 million doses, according to the latest CDC data updated Sunday, including 25.2 million first doses and 5.6 million second doses.

Doling out more doses to older Americans, rather than holding onto the second dose of the two-shot regimen, is an urgent decision, Dr. Osterholm said.

“I think right now, in advance of this surge, we need to get as many one doses in as many people over 65 as we possibly can to reduce serious illnesses and deaths that are going to occur over the weeks ahead,” he said.

The U.K. variant will likely become the dominant coronavirus strain in the United States in coming weeks, Dr. Osterholm said, adding that COVID-19 vaccines should be able to protect against it. In the meantime, however, he’s worried that the variant will cause more infections and deaths until more people get vaccinated.

“What we have to do now is also anticipate this and understand that we’re going to have change quickly,” he said. “As fast as we’re opening restaurants, we’re likely going to be closing them in the near term.”

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

The United States is facing a “Category 5” storm as coronavirus variants begin to spread across the country, one of the nation’s top infectious disease experts said Sunday.

“We are going to see something like we have not seen yet in this country,” Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said on NBC’s Meet the Press.

The United States has reported 467 cases of the coronavirus variant first identified in the United Kingdom, across 32 states, according to the CDC variant tracker. The United States has also reported three cases of the variant first identified in South Africa in South Carolina and Maryland. One case of the variant first identified in Brazil has been found in Minnesota.

Although overall COVID-19 cases and hospitalizations have declined during the past few weeks, another storm is brewing on the horizon with the variants, Dr. Osterholm told host Chuck Todd. The U.K. variant will likely cause a surge in COVID-19 cases during the next 6-14 weeks, he said. “You and I are sitting on this beach where it’s 70 degrees, perfectly blue skies, gentle breeze. But I see that hurricane 5, Category 5 or higher, 450 miles offshore. And telling people to evacuate on that nice blue sky day is going to be hard. But I can also tell you that hurricane is coming.”

Dr. Osterholm urged federal and state officials to vaccinate as many people as possible to reduce the oncoming storm. The United States has distributed 49.9 million doses and administered 31.1 million doses, according to the latest CDC data updated Sunday, including 25.2 million first doses and 5.6 million second doses.

Doling out more doses to older Americans, rather than holding onto the second dose of the two-shot regimen, is an urgent decision, Dr. Osterholm said.

“I think right now, in advance of this surge, we need to get as many one doses in as many people over 65 as we possibly can to reduce serious illnesses and deaths that are going to occur over the weeks ahead,” he said.

The U.K. variant will likely become the dominant coronavirus strain in the United States in coming weeks, Dr. Osterholm said, adding that COVID-19 vaccines should be able to protect against it. In the meantime, however, he’s worried that the variant will cause more infections and deaths until more people get vaccinated.

“What we have to do now is also anticipate this and understand that we’re going to have change quickly,” he said. “As fast as we’re opening restaurants, we’re likely going to be closing them in the near term.”

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

The United States is facing a “Category 5” storm as coronavirus variants begin to spread across the country, one of the nation’s top infectious disease experts said Sunday.

“We are going to see something like we have not seen yet in this country,” Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, said on NBC’s Meet the Press.

The United States has reported 467 cases of the coronavirus variant first identified in the United Kingdom, across 32 states, according to the CDC variant tracker. The United States has also reported three cases of the variant first identified in South Africa in South Carolina and Maryland. One case of the variant first identified in Brazil has been found in Minnesota.

Although overall COVID-19 cases and hospitalizations have declined during the past few weeks, another storm is brewing on the horizon with the variants, Dr. Osterholm told host Chuck Todd. The U.K. variant will likely cause a surge in COVID-19 cases during the next 6-14 weeks, he said. “You and I are sitting on this beach where it’s 70 degrees, perfectly blue skies, gentle breeze. But I see that hurricane 5, Category 5 or higher, 450 miles offshore. And telling people to evacuate on that nice blue sky day is going to be hard. But I can also tell you that hurricane is coming.”

Dr. Osterholm urged federal and state officials to vaccinate as many people as possible to reduce the oncoming storm. The United States has distributed 49.9 million doses and administered 31.1 million doses, according to the latest CDC data updated Sunday, including 25.2 million first doses and 5.6 million second doses.

Doling out more doses to older Americans, rather than holding onto the second dose of the two-shot regimen, is an urgent decision, Dr. Osterholm said.

“I think right now, in advance of this surge, we need to get as many one doses in as many people over 65 as we possibly can to reduce serious illnesses and deaths that are going to occur over the weeks ahead,” he said.

The U.K. variant will likely become the dominant coronavirus strain in the United States in coming weeks, Dr. Osterholm said, adding that COVID-19 vaccines should be able to protect against it. In the meantime, however, he’s worried that the variant will cause more infections and deaths until more people get vaccinated.

“What we have to do now is also anticipate this and understand that we’re going to have change quickly,” he said. “As fast as we’re opening restaurants, we’re likely going to be closing them in the near term.”

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