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.

Key clinical point: This study found no evidence of an association between nonsteroidal anti-inflammatory drug (NSAID) use and myelodysplastic syndromes (MDS).

Major finding: No significant association was seen between MDS and use of any NSAID (adjusted odds ratio [aOR], 0.92; 95% confidence interval [CI], 0.68-1.23), aspirin (aOR, 0.87; 95% CI, 0.67-1.14), ibuprofen (aOR, 0.91; 95% CI, 0.64-1.30), or acetaminophen (aOR, 1.29; 95% CI, 0.90-1.84). No association was observed in analyses stratified by sex; however, the direction of the effect between NSAID use and MDS varied by MDS subtype.

Study details: This population-based case-control study included 399 MDS cases and 698 controls using data from the Adults in Minnesota with Myelodysplastic Syndromes Study.

Disclosures: The study was funded by a National Institutes of Health grant. The authors declared no conflicts of interest.

Source: Hubbard AK et al. Leuk Lymphoma. 2021 Jan 8. doi: 10.1080/10428194.2020.

Key clinical point: This study found no evidence of an association between nonsteroidal anti-inflammatory drug (NSAID) use and myelodysplastic syndromes (MDS).

Major finding: No significant association was seen between MDS and use of any NSAID (adjusted odds ratio [aOR], 0.92; 95% confidence interval [CI], 0.68-1.23), aspirin (aOR, 0.87; 95% CI, 0.67-1.14), ibuprofen (aOR, 0.91; 95% CI, 0.64-1.30), or acetaminophen (aOR, 1.29; 95% CI, 0.90-1.84). No association was observed in analyses stratified by sex; however, the direction of the effect between NSAID use and MDS varied by MDS subtype.

Study details: This population-based case-control study included 399 MDS cases and 698 controls using data from the Adults in Minnesota with Myelodysplastic Syndromes Study.

Disclosures: The study was funded by a National Institutes of Health grant. The authors declared no conflicts of interest.

Source: Hubbard AK et al. Leuk Lymphoma. 2021 Jan 8. doi: 10.1080/10428194.2020.

Key clinical point: This study found no evidence of an association between nonsteroidal anti-inflammatory drug (NSAID) use and myelodysplastic syndromes (MDS).

Major finding: No significant association was seen between MDS and use of any NSAID (adjusted odds ratio [aOR], 0.92; 95% confidence interval [CI], 0.68-1.23), aspirin (aOR, 0.87; 95% CI, 0.67-1.14), ibuprofen (aOR, 0.91; 95% CI, 0.64-1.30), or acetaminophen (aOR, 1.29; 95% CI, 0.90-1.84). No association was observed in analyses stratified by sex; however, the direction of the effect between NSAID use and MDS varied by MDS subtype.

Study details: This population-based case-control study included 399 MDS cases and 698 controls using data from the Adults in Minnesota with Myelodysplastic Syndromes Study.

Disclosures: The study was funded by a National Institutes of Health grant. The authors declared no conflicts of interest.

Source: Hubbard AK et al. Leuk Lymphoma. 2021 Jan 8. doi: 10.1080/10428194.2020.

Key clinical point: A study found smoking, history of autoimmune disease and benzene exposure to significant risk factors for de novo myelodysplastic syndromes (MDS). These factors also had a similar yet non-significant association with therapy-related MDS (tMDS).

Major finding:  After adjusting for confounders, former smoking status (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.10-1.93), history of autoimmune disease (OR, 1.34; 95% CI, 0.99-1.82) and benzene exposure (OR, 1.48; 95% CI, 1.00-2.19) were significantly associated with de novo MDS. The risk estimates for these associations were similar in magnitude for tMDS, but non-significant.

Study details: The data come from a case-control study involving 346 de novo MDS cases, 37 tMDS cases and 682 controls matched by age and sex.

Disclosures: The study was funded by the National Institutes of Health. The authors declared no conflicts of interest.

Source: Yarosh R et al. Cancer Causes Control. 2021 Jan 4. doi: 10.1007/s10552-020-01378-x.

Key clinical point: A study found smoking, history of autoimmune disease and benzene exposure to significant risk factors for de novo myelodysplastic syndromes (MDS). These factors also had a similar yet non-significant association with therapy-related MDS (tMDS).

Major finding:  After adjusting for confounders, former smoking status (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.10-1.93), history of autoimmune disease (OR, 1.34; 95% CI, 0.99-1.82) and benzene exposure (OR, 1.48; 95% CI, 1.00-2.19) were significantly associated with de novo MDS. The risk estimates for these associations were similar in magnitude for tMDS, but non-significant.

Study details: The data come from a case-control study involving 346 de novo MDS cases, 37 tMDS cases and 682 controls matched by age and sex.

Disclosures: The study was funded by the National Institutes of Health. The authors declared no conflicts of interest.

Source: Yarosh R et al. Cancer Causes Control. 2021 Jan 4. doi: 10.1007/s10552-020-01378-x.

Key clinical point: A study found smoking, history of autoimmune disease and benzene exposure to significant risk factors for de novo myelodysplastic syndromes (MDS). These factors also had a similar yet non-significant association with therapy-related MDS (tMDS).

Major finding:  After adjusting for confounders, former smoking status (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.10-1.93), history of autoimmune disease (OR, 1.34; 95% CI, 0.99-1.82) and benzene exposure (OR, 1.48; 95% CI, 1.00-2.19) were significantly associated with de novo MDS. The risk estimates for these associations were similar in magnitude for tMDS, but non-significant.

Study details: The data come from a case-control study involving 346 de novo MDS cases, 37 tMDS cases and 682 controls matched by age and sex.

Disclosures: The study was funded by the National Institutes of Health. The authors declared no conflicts of interest.

Source: Yarosh R et al. Cancer Causes Control. 2021 Jan 4. doi: 10.1007/s10552-020-01378-x.

Key clinical point: Myelodysplastic syndrome (MDS) patients treated with hypomethylating agents (HMA), especially those with higher-risk MDS have unmet clinical needs in real-world setting.

Major finding: Median survival was 11.6 months, 18.4 months, and 19.1 months for the higher-risk, intermediate-risk, and unknown-risk groups, respectively. Corresponding median time-to-AML transformation for the 3 groups were 19.3 months, 50.4 months, and 'not reached', respectively.

Study details: The data come from 3,046 MDS patients treated with HMA from the SEER-Medicare database. The patients were categorized as higher-risk, intermediate-risk, and unknown-risk.

Disclosures: The study was sponsored by Novartis. I Sadek and X Cao are employees and stockholders of Novartis.  G Bonifacio was an employee and stockholder of Novartis at the time of the study. EM Stein provided paid consulting services to Novartis. D Latremouille-Viau, S Shi, A Guerin, and EQ Wu are employees of Analysis Group, Inc. which provided paid consulting services to Novartis.

Source: Stein EM et al. Leuk Lymphoma. 2021 Jan 11. doi: 10.1080/10428194.2020.1869959.

Key clinical point: Myelodysplastic syndrome (MDS) patients treated with hypomethylating agents (HMA), especially those with higher-risk MDS have unmet clinical needs in real-world setting.

Major finding: Median survival was 11.6 months, 18.4 months, and 19.1 months for the higher-risk, intermediate-risk, and unknown-risk groups, respectively. Corresponding median time-to-AML transformation for the 3 groups were 19.3 months, 50.4 months, and 'not reached', respectively.

Study details: The data come from 3,046 MDS patients treated with HMA from the SEER-Medicare database. The patients were categorized as higher-risk, intermediate-risk, and unknown-risk.

Disclosures: The study was sponsored by Novartis. I Sadek and X Cao are employees and stockholders of Novartis.  G Bonifacio was an employee and stockholder of Novartis at the time of the study. EM Stein provided paid consulting services to Novartis. D Latremouille-Viau, S Shi, A Guerin, and EQ Wu are employees of Analysis Group, Inc. which provided paid consulting services to Novartis.

Source: Stein EM et al. Leuk Lymphoma. 2021 Jan 11. doi: 10.1080/10428194.2020.1869959.

Key clinical point: Myelodysplastic syndrome (MDS) patients treated with hypomethylating agents (HMA), especially those with higher-risk MDS have unmet clinical needs in real-world setting.

Major finding: Median survival was 11.6 months, 18.4 months, and 19.1 months for the higher-risk, intermediate-risk, and unknown-risk groups, respectively. Corresponding median time-to-AML transformation for the 3 groups were 19.3 months, 50.4 months, and 'not reached', respectively.

Study details: The data come from 3,046 MDS patients treated with HMA from the SEER-Medicare database. The patients were categorized as higher-risk, intermediate-risk, and unknown-risk.

Disclosures: The study was sponsored by Novartis. I Sadek and X Cao are employees and stockholders of Novartis.  G Bonifacio was an employee and stockholder of Novartis at the time of the study. EM Stein provided paid consulting services to Novartis. D Latremouille-Viau, S Shi, A Guerin, and EQ Wu are employees of Analysis Group, Inc. which provided paid consulting services to Novartis.

Source: Stein EM et al. Leuk Lymphoma. 2021 Jan 11. doi: 10.1080/10428194.2020.1869959.