M. Alexander Otto, PA, MMS

Liver transplant might be the next big thing for extensive hepatic metastases in colorectal cancer, according to an editorial published in JAMA Surgery .

“Many centers around the world, including our own, [have] started offering liver transplant to patients with colorectal liver metastases,” write Ralph Quillin III, MD, and Shimul Shah, MD, liver transplant surgeons at the University of Cincinnati.

However, they admit that the concept is controversial. “One need only to go to a tumor board to hear critics of the concept of liver transplant for isolated colorectal liver metastases,” the pair write, adding that opponents might argue that transplant patients could have done as well with chemotherapy.

There’s also the problem of deceased donor organ scarcity, Dr. Quillin and Dr. Shah acknowledge.

Nevertheless, the editorial is effusive about a new comparative effectiveness study that it accompanies in JAMA Surgery from a team at the Oslo University Hospital, led by Svein Dueland, MD, PhD.

The new study shows that for select patients with liver metastases, the 5-year survival rate with transplant is higher than for patients who receive standard of care – portal vein embolization (PVE) and surgical resection.

“[Dr.] Dueland et al. have laid the groundwork for the world to follow and took a concept from being experimental to possibly standard of care: liver transplant for colorectal liver metastases with heavy tumor burden,” the editorialists declare.

Using data from their hospital, the Oslo team compared 50 patients who had colorectal cancer liver metastases from previous liver transplant studies (2006-2019) with a retrospective cohort of 53 patients (2006-2015) from studies with similar selection criteria who underwent PVE with the intent to perform liver resection.

Patients with a high liver-only metastatic load had nine or more tumors, or the largest of their tumors had a diameter of at least 5.5 cm. Among 29 such patients treated with liver transplant, the 5-year overall survival (OS) rate was 33.4%, and the median OS was 40.5 months. Among eight such patients treated with PVE and liver resection, the 5-year OS rate was 12.5%, and the median OS was 29.8 months.

The OS among patients with a high metastatic load who received a transplant may be unprecedented, according to the investigators.

The Oslo team “should be commended for a very aggressive surgical approach” for patients whom “many would deem unresectable and palliative from the start,” comment Dr. Quillin and Dr. Shah.
 

Refining patient selection

In the past, finding the ideal candidate with extensive colorectal liver metastases for liver transplant was like “discovering the proverbial needle in the haystack,” Dr. Quillin and Dr. Shah say. Critics have said the impressive outcomes reported in past studies reflect extreme patient selection.

The new study results make selection easier and may expand the transplant patient population.

The patients in the study had no extrahepatic metastases, and their primary colorectal tumors had been resected. Such patients may represent an expanded transplant population. They were younger than 72 years, and their performance status score was 0-1. They had undergone standard-of-care chemotherapy before their liver procedures.

The high-burden transplant patients were all judged to have nonresectable tumors by the university’s tumor board; 14 of 29 had 16 or more liver lesions.

The maximum number of tumors in the PVE group was 15, so these patients were expected to live longer, owing to the fact that survival is longer for colorectal cancer patients who have fewer liver metastases. However, as noted above, that’s not how it worked out.
 

Different story for low liver burdens

The Oslo investigators caution that, despite the findings, liver transplant for colorectal liver metastases “should still be considered a work in progress.”

The Oslo team says that to avoid “the futile use of liver grafts,” prospective research is needed to clearly identify colorectal liver metastases patients “who would benefit the most” from transplant.

Patients with extensive nonresectable metastases seem to be high on the list, but there might also be a role in resectable disease, say the study authors. One scenario, for instance, would be one in which PVE fails to expand the liver enough to allow resection; this was the case in 15 of the 53 PVE patients in the study.

As for patients with low liver tumor burden, transplant didn’t seem to offer much long-term survival benefit; 5-year OS was 72.4% among 21 low-burden transplant patients, vs. 69.3% among 23 who underwent PVE and resection.

Right-sided disease – having a primary tumor in the ascending colon, a known predictor of worse outcomes – might also prove to be a contraindication. The median OS after liver transplant was 12.2 months among patients with right-sided primaries and high-burden liver metastases. No such patients were alive at 5 years. On the other hand, the median OS was 59.9 months, and the 5-year OS was 45.3% among high-burden patients with left-sided primaries.
 

A call for a consortium

In a second editorial, Yuman Fong, MD, of the City of Hope Medical Center, Duarte, Calif., is less enthusiastic than the pair from Cincinnati. He calls the data “intriguing” but emphasizes that “we must recognize that cadaveric livers for transplant remain a finite resource,” and about 1,000 people die annually while on the waiting list in the United States.

The Cincinnati editorialists call for a multicenter consortium “for the cancer community to increase our understanding of this indication” and “pave the way for liver transplant as an option for colorectal liver metastases, just like we have for hepatocellular carcinoma, unresectable hilar cholangiocarcinoma, and metastatic neuroendocrine tumor.”

The investigators note that survival with transplant might be better because liver resection leaves behind microscopic disease that leads to liver recurrence. Most of the transplant patients in the study also experienced relapse, but recurrence after transplant tends to occur in the lungs with small, slow-growing lesions that are amenable to resection.

The study was funded by Oslo University Hospital, the Norwegian Cancer Society, and the South-Eastern Norway Regional Health Authority. The investigators and the editorialists in Cincinnati have disclosed no relevant financial relationships. Dr. Fong is a consultant for Medtronic and Johnson & Johnson and has received royalties from Merck and Imugene.

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

Liver transplant might be the next big thing for extensive hepatic metastases in colorectal cancer, according to an editorial published in JAMA Surgery .

“Many centers around the world, including our own, [have] started offering liver transplant to patients with colorectal liver metastases,” write Ralph Quillin III, MD, and Shimul Shah, MD, liver transplant surgeons at the University of Cincinnati.

However, they admit that the concept is controversial. “One need only to go to a tumor board to hear critics of the concept of liver transplant for isolated colorectal liver metastases,” the pair write, adding that opponents might argue that transplant patients could have done as well with chemotherapy.

There’s also the problem of deceased donor organ scarcity, Dr. Quillin and Dr. Shah acknowledge.

Nevertheless, the editorial is effusive about a new comparative effectiveness study that it accompanies in JAMA Surgery from a team at the Oslo University Hospital, led by Svein Dueland, MD, PhD.

The new study shows that for select patients with liver metastases, the 5-year survival rate with transplant is higher than for patients who receive standard of care – portal vein embolization (PVE) and surgical resection.

“[Dr.] Dueland et al. have laid the groundwork for the world to follow and took a concept from being experimental to possibly standard of care: liver transplant for colorectal liver metastases with heavy tumor burden,” the editorialists declare.

Using data from their hospital, the Oslo team compared 50 patients who had colorectal cancer liver metastases from previous liver transplant studies (2006-2019) with a retrospective cohort of 53 patients (2006-2015) from studies with similar selection criteria who underwent PVE with the intent to perform liver resection.

Patients with a high liver-only metastatic load had nine or more tumors, or the largest of their tumors had a diameter of at least 5.5 cm. Among 29 such patients treated with liver transplant, the 5-year overall survival (OS) rate was 33.4%, and the median OS was 40.5 months. Among eight such patients treated with PVE and liver resection, the 5-year OS rate was 12.5%, and the median OS was 29.8 months.

The OS among patients with a high metastatic load who received a transplant may be unprecedented, according to the investigators.

The Oslo team “should be commended for a very aggressive surgical approach” for patients whom “many would deem unresectable and palliative from the start,” comment Dr. Quillin and Dr. Shah.
 

Refining patient selection

In the past, finding the ideal candidate with extensive colorectal liver metastases for liver transplant was like “discovering the proverbial needle in the haystack,” Dr. Quillin and Dr. Shah say. Critics have said the impressive outcomes reported in past studies reflect extreme patient selection.

The new study results make selection easier and may expand the transplant patient population.

The patients in the study had no extrahepatic metastases, and their primary colorectal tumors had been resected. Such patients may represent an expanded transplant population. They were younger than 72 years, and their performance status score was 0-1. They had undergone standard-of-care chemotherapy before their liver procedures.

The high-burden transplant patients were all judged to have nonresectable tumors by the university’s tumor board; 14 of 29 had 16 or more liver lesions.

The maximum number of tumors in the PVE group was 15, so these patients were expected to live longer, owing to the fact that survival is longer for colorectal cancer patients who have fewer liver metastases. However, as noted above, that’s not how it worked out.
 

Different story for low liver burdens

The Oslo investigators caution that, despite the findings, liver transplant for colorectal liver metastases “should still be considered a work in progress.”

The Oslo team says that to avoid “the futile use of liver grafts,” prospective research is needed to clearly identify colorectal liver metastases patients “who would benefit the most” from transplant.

Patients with extensive nonresectable metastases seem to be high on the list, but there might also be a role in resectable disease, say the study authors. One scenario, for instance, would be one in which PVE fails to expand the liver enough to allow resection; this was the case in 15 of the 53 PVE patients in the study.

As for patients with low liver tumor burden, transplant didn’t seem to offer much long-term survival benefit; 5-year OS was 72.4% among 21 low-burden transplant patients, vs. 69.3% among 23 who underwent PVE and resection.

Right-sided disease – having a primary tumor in the ascending colon, a known predictor of worse outcomes – might also prove to be a contraindication. The median OS after liver transplant was 12.2 months among patients with right-sided primaries and high-burden liver metastases. No such patients were alive at 5 years. On the other hand, the median OS was 59.9 months, and the 5-year OS was 45.3% among high-burden patients with left-sided primaries.
 

A call for a consortium

In a second editorial, Yuman Fong, MD, of the City of Hope Medical Center, Duarte, Calif., is less enthusiastic than the pair from Cincinnati. He calls the data “intriguing” but emphasizes that “we must recognize that cadaveric livers for transplant remain a finite resource,” and about 1,000 people die annually while on the waiting list in the United States.

The Cincinnati editorialists call for a multicenter consortium “for the cancer community to increase our understanding of this indication” and “pave the way for liver transplant as an option for colorectal liver metastases, just like we have for hepatocellular carcinoma, unresectable hilar cholangiocarcinoma, and metastatic neuroendocrine tumor.”

The investigators note that survival with transplant might be better because liver resection leaves behind microscopic disease that leads to liver recurrence. Most of the transplant patients in the study also experienced relapse, but recurrence after transplant tends to occur in the lungs with small, slow-growing lesions that are amenable to resection.

The study was funded by Oslo University Hospital, the Norwegian Cancer Society, and the South-Eastern Norway Regional Health Authority. The investigators and the editorialists in Cincinnati have disclosed no relevant financial relationships. Dr. Fong is a consultant for Medtronic and Johnson & Johnson and has received royalties from Merck and Imugene.

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

Liver transplant might be the next big thing for extensive hepatic metastases in colorectal cancer, according to an editorial published in JAMA Surgery .

“Many centers around the world, including our own, [have] started offering liver transplant to patients with colorectal liver metastases,” write Ralph Quillin III, MD, and Shimul Shah, MD, liver transplant surgeons at the University of Cincinnati.

However, they admit that the concept is controversial. “One need only to go to a tumor board to hear critics of the concept of liver transplant for isolated colorectal liver metastases,” the pair write, adding that opponents might argue that transplant patients could have done as well with chemotherapy.

There’s also the problem of deceased donor organ scarcity, Dr. Quillin and Dr. Shah acknowledge.

Nevertheless, the editorial is effusive about a new comparative effectiveness study that it accompanies in JAMA Surgery from a team at the Oslo University Hospital, led by Svein Dueland, MD, PhD.

The new study shows that for select patients with liver metastases, the 5-year survival rate with transplant is higher than for patients who receive standard of care – portal vein embolization (PVE) and surgical resection.

“[Dr.] Dueland et al. have laid the groundwork for the world to follow and took a concept from being experimental to possibly standard of care: liver transplant for colorectal liver metastases with heavy tumor burden,” the editorialists declare.

Using data from their hospital, the Oslo team compared 50 patients who had colorectal cancer liver metastases from previous liver transplant studies (2006-2019) with a retrospective cohort of 53 patients (2006-2015) from studies with similar selection criteria who underwent PVE with the intent to perform liver resection.

Patients with a high liver-only metastatic load had nine or more tumors, or the largest of their tumors had a diameter of at least 5.5 cm. Among 29 such patients treated with liver transplant, the 5-year overall survival (OS) rate was 33.4%, and the median OS was 40.5 months. Among eight such patients treated with PVE and liver resection, the 5-year OS rate was 12.5%, and the median OS was 29.8 months.

The OS among patients with a high metastatic load who received a transplant may be unprecedented, according to the investigators.

The Oslo team “should be commended for a very aggressive surgical approach” for patients whom “many would deem unresectable and palliative from the start,” comment Dr. Quillin and Dr. Shah.
 

Refining patient selection

In the past, finding the ideal candidate with extensive colorectal liver metastases for liver transplant was like “discovering the proverbial needle in the haystack,” Dr. Quillin and Dr. Shah say. Critics have said the impressive outcomes reported in past studies reflect extreme patient selection.

The new study results make selection easier and may expand the transplant patient population.

The patients in the study had no extrahepatic metastases, and their primary colorectal tumors had been resected. Such patients may represent an expanded transplant population. They were younger than 72 years, and their performance status score was 0-1. They had undergone standard-of-care chemotherapy before their liver procedures.

The high-burden transplant patients were all judged to have nonresectable tumors by the university’s tumor board; 14 of 29 had 16 or more liver lesions.

The maximum number of tumors in the PVE group was 15, so these patients were expected to live longer, owing to the fact that survival is longer for colorectal cancer patients who have fewer liver metastases. However, as noted above, that’s not how it worked out.
 

Different story for low liver burdens

The Oslo investigators caution that, despite the findings, liver transplant for colorectal liver metastases “should still be considered a work in progress.”

The Oslo team says that to avoid “the futile use of liver grafts,” prospective research is needed to clearly identify colorectal liver metastases patients “who would benefit the most” from transplant.

Patients with extensive nonresectable metastases seem to be high on the list, but there might also be a role in resectable disease, say the study authors. One scenario, for instance, would be one in which PVE fails to expand the liver enough to allow resection; this was the case in 15 of the 53 PVE patients in the study.

As for patients with low liver tumor burden, transplant didn’t seem to offer much long-term survival benefit; 5-year OS was 72.4% among 21 low-burden transplant patients, vs. 69.3% among 23 who underwent PVE and resection.

Right-sided disease – having a primary tumor in the ascending colon, a known predictor of worse outcomes – might also prove to be a contraindication. The median OS after liver transplant was 12.2 months among patients with right-sided primaries and high-burden liver metastases. No such patients were alive at 5 years. On the other hand, the median OS was 59.9 months, and the 5-year OS was 45.3% among high-burden patients with left-sided primaries.
 

A call for a consortium

In a second editorial, Yuman Fong, MD, of the City of Hope Medical Center, Duarte, Calif., is less enthusiastic than the pair from Cincinnati. He calls the data “intriguing” but emphasizes that “we must recognize that cadaveric livers for transplant remain a finite resource,” and about 1,000 people die annually while on the waiting list in the United States.

The Cincinnati editorialists call for a multicenter consortium “for the cancer community to increase our understanding of this indication” and “pave the way for liver transplant as an option for colorectal liver metastases, just like we have for hepatocellular carcinoma, unresectable hilar cholangiocarcinoma, and metastatic neuroendocrine tumor.”

The investigators note that survival with transplant might be better because liver resection leaves behind microscopic disease that leads to liver recurrence. Most of the transplant patients in the study also experienced relapse, but recurrence after transplant tends to occur in the lungs with small, slow-growing lesions that are amenable to resection.

The study was funded by Oslo University Hospital, the Norwegian Cancer Society, and the South-Eastern Norway Regional Health Authority. The investigators and the editorialists in Cincinnati have disclosed no relevant financial relationships. Dr. Fong is a consultant for Medtronic and Johnson & Johnson and has received royalties from Merck and Imugene.

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

For patients with triple-negative breast cancer (TNBC), neoadjuvant carboplatin plus docetaxel yields the same pathologic complete response and survival rates as a standard anthracycline-based neoadjuvant regimen – carboplatin and paclitaxel followed by doxorubicin/cyclophosphamide – but with less toxicity, higher completion rates, and at lower cost.

The results come from a phase 2 trial that involved 100 women. The study was published online in February in Clinical Cancer Research.

The doublet provides a safe, effective alternative for patients who are not candidates for treatment with anthracyclines and should be explored further for neoadjuvant deescalation, according to investigators led by Priyanka Sharma, MD, TNBC specialist and professor at the University of Kansas Medical Center, Westwood.

The trial wasn’t powered to demonstrate noninferiority, so it “probably does not provide enough evidence to state that [taxane/platinum] should replace other regimens,” Dr. Sharma said in an interview.

A proper noninferiority trial would require more than 2,500 participants, she said, adding that such a trial is unlikely, because companies are focused on immunotherapies for neoadjuvant TNBC.

“Our study does, however, provide a very effective alternative for patients and providers who want to use or prefer an anthracycline-sparing neoadjuvant chemotherapy regimen. We are very encouraged” by the findings, Dr. Sharma said.

This is “a provocative study that should make us pause and reevaluate our current approach. Further study of this approach in early-stage TNBC is warranted,” Melinda L. Telli, MD, associate professor of medicine and director of the breast cancer program at Stanford (Calif.) University, said when asked for comment.

Avoiding the risks associated with anthracycline “is great. I would be particularly enthusiastic using this regimen in patients with known increased risk of cardiac toxicity,” said Amy Tiersten, MD, a breast cancer specialist and professor at Mount Sinai Hospital, New York.

Anthracycline-based regimens are the standard of care for neoadjuvant TNBC. They typically include a taxane with or without carboplatin plus an anthracycline/cyclophosphamide combination. The regimen is highly active, but there is a small but serious risk for cardiomyopathy and leukemia with anthracycline/cyclophosphamide. In the current trial, one woman in the anthracycline arm died of secondary acute myeloid leukemia.

Given its tolerability and effectiveness, a taxane/carboplatin doublet might serve as a good backbone for the addition of novel immunotherapies in trials. Dr. Sharma is the principal investigator in one such trial, a phase 2 trial of carboplatin/docetaxel plus pembrolizumab for stage I–III TNBC.
 

Study details

The Neoadjuvant Study of Two Platinum Regimens in Stage I–III Triple Negative Breast Cancer (NeoSTOP) involved 100 women with stage I–III TNBC.

In the experimental arm, 52 women received carboplatin AUC 6 plus docetaxel 75 mg/m² every 21 days for six cycles.

In the standard-of-care anthracycline arm, 48 women received carboplatin AUC 6 every 21 days for four cycles plus paclitaxel 80 mg/m² weekly for 12 weeks, followed by doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for four cycles.

Docetaxel and paclitaxel in the two regimens are interchangeable because they have shown equal efficacy in adjuvant trials, Dr. Sharma said.

At surgery, 54% of women in both arms had a breast/axilla pathologic complete response – the primary endpoint – and 67% in both arms had a residual cancer burden of 0-1. Event-free and overall survival (about 55% at 3 years for both) were similar with the two regimens.

Grade 3/4 adverse events were more common in the anthracycline arm. They included neutropenia, which occurred in 60% of women in the anthracycline arm, vs. 8% with the doublet; and febrile neutropenia, which occurred in 19% with anthracycline, vs. none with the doublet.

The toxicity profile of the anthracycline regimen was comparable to those in previous reports.

Ninety-two percent of the docetaxel/carboplatin group completed all six cycles; 72% of women in the anthracycline arm completed 10 or more doses of paclitaxel, and 85% completed all 4 carboplatin doses.

Mean costs of treatment, patient transportation, and lost productivity were $36,720 in the anthracycline arm, vs. $33,148 with the doublet.

The two arms were well balanced with respect to patient characteristics. The median age was 51 years, 30% of patients had axillary lymph node–positive disease, and 16% had ER/PgR expression of 1% to 10%. Of the study population, 17% carried deleterious BRCA1/2 mutations. Women were enrolled from July 2015 to May 2018. Median follow-up was 38 months.

Of the study population, 17% had stage I disease, so NeoSTOP included a lower-risk population than some neoadjuvant trials. However, there was no significant change in pathologic complete response rates in the two arms after exclusion of women with stage I disease (doublet, 50%; anthracycline, 54%).

The study was funded by the University of Kansas Cancer Center, the Breast Cancer Research Foundation, and the National Institute of General Medical Sciences. The investigators disclosed no relevant financial relationships.

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

For patients with triple-negative breast cancer (TNBC), neoadjuvant carboplatin plus docetaxel yields the same pathologic complete response and survival rates as a standard anthracycline-based neoadjuvant regimen – carboplatin and paclitaxel followed by doxorubicin/cyclophosphamide – but with less toxicity, higher completion rates, and at lower cost.

The results come from a phase 2 trial that involved 100 women. The study was published online in February in Clinical Cancer Research.

The doublet provides a safe, effective alternative for patients who are not candidates for treatment with anthracyclines and should be explored further for neoadjuvant deescalation, according to investigators led by Priyanka Sharma, MD, TNBC specialist and professor at the University of Kansas Medical Center, Westwood.

The trial wasn’t powered to demonstrate noninferiority, so it “probably does not provide enough evidence to state that [taxane/platinum] should replace other regimens,” Dr. Sharma said in an interview.

A proper noninferiority trial would require more than 2,500 participants, she said, adding that such a trial is unlikely, because companies are focused on immunotherapies for neoadjuvant TNBC.

“Our study does, however, provide a very effective alternative for patients and providers who want to use or prefer an anthracycline-sparing neoadjuvant chemotherapy regimen. We are very encouraged” by the findings, Dr. Sharma said.

This is “a provocative study that should make us pause and reevaluate our current approach. Further study of this approach in early-stage TNBC is warranted,” Melinda L. Telli, MD, associate professor of medicine and director of the breast cancer program at Stanford (Calif.) University, said when asked for comment.

Avoiding the risks associated with anthracycline “is great. I would be particularly enthusiastic using this regimen in patients with known increased risk of cardiac toxicity,” said Amy Tiersten, MD, a breast cancer specialist and professor at Mount Sinai Hospital, New York.

Anthracycline-based regimens are the standard of care for neoadjuvant TNBC. They typically include a taxane with or without carboplatin plus an anthracycline/cyclophosphamide combination. The regimen is highly active, but there is a small but serious risk for cardiomyopathy and leukemia with anthracycline/cyclophosphamide. In the current trial, one woman in the anthracycline arm died of secondary acute myeloid leukemia.

Given its tolerability and effectiveness, a taxane/carboplatin doublet might serve as a good backbone for the addition of novel immunotherapies in trials. Dr. Sharma is the principal investigator in one such trial, a phase 2 trial of carboplatin/docetaxel plus pembrolizumab for stage I–III TNBC.
 

Study details

The Neoadjuvant Study of Two Platinum Regimens in Stage I–III Triple Negative Breast Cancer (NeoSTOP) involved 100 women with stage I–III TNBC.

In the experimental arm, 52 women received carboplatin AUC 6 plus docetaxel 75 mg/m² every 21 days for six cycles.

In the standard-of-care anthracycline arm, 48 women received carboplatin AUC 6 every 21 days for four cycles plus paclitaxel 80 mg/m² weekly for 12 weeks, followed by doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for four cycles.

Docetaxel and paclitaxel in the two regimens are interchangeable because they have shown equal efficacy in adjuvant trials, Dr. Sharma said.

At surgery, 54% of women in both arms had a breast/axilla pathologic complete response – the primary endpoint – and 67% in both arms had a residual cancer burden of 0-1. Event-free and overall survival (about 55% at 3 years for both) were similar with the two regimens.

Grade 3/4 adverse events were more common in the anthracycline arm. They included neutropenia, which occurred in 60% of women in the anthracycline arm, vs. 8% with the doublet; and febrile neutropenia, which occurred in 19% with anthracycline, vs. none with the doublet.

The toxicity profile of the anthracycline regimen was comparable to those in previous reports.

Ninety-two percent of the docetaxel/carboplatin group completed all six cycles; 72% of women in the anthracycline arm completed 10 or more doses of paclitaxel, and 85% completed all 4 carboplatin doses.

Mean costs of treatment, patient transportation, and lost productivity were $36,720 in the anthracycline arm, vs. $33,148 with the doublet.

The two arms were well balanced with respect to patient characteristics. The median age was 51 years, 30% of patients had axillary lymph node–positive disease, and 16% had ER/PgR expression of 1% to 10%. Of the study population, 17% carried deleterious BRCA1/2 mutations. Women were enrolled from July 2015 to May 2018. Median follow-up was 38 months.

Of the study population, 17% had stage I disease, so NeoSTOP included a lower-risk population than some neoadjuvant trials. However, there was no significant change in pathologic complete response rates in the two arms after exclusion of women with stage I disease (doublet, 50%; anthracycline, 54%).

The study was funded by the University of Kansas Cancer Center, the Breast Cancer Research Foundation, and the National Institute of General Medical Sciences. The investigators disclosed no relevant financial relationships.

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

For patients with triple-negative breast cancer (TNBC), neoadjuvant carboplatin plus docetaxel yields the same pathologic complete response and survival rates as a standard anthracycline-based neoadjuvant regimen – carboplatin and paclitaxel followed by doxorubicin/cyclophosphamide – but with less toxicity, higher completion rates, and at lower cost.

The results come from a phase 2 trial that involved 100 women. The study was published online in February in Clinical Cancer Research.

The doublet provides a safe, effective alternative for patients who are not candidates for treatment with anthracyclines and should be explored further for neoadjuvant deescalation, according to investigators led by Priyanka Sharma, MD, TNBC specialist and professor at the University of Kansas Medical Center, Westwood.

The trial wasn’t powered to demonstrate noninferiority, so it “probably does not provide enough evidence to state that [taxane/platinum] should replace other regimens,” Dr. Sharma said in an interview.

A proper noninferiority trial would require more than 2,500 participants, she said, adding that such a trial is unlikely, because companies are focused on immunotherapies for neoadjuvant TNBC.

“Our study does, however, provide a very effective alternative for patients and providers who want to use or prefer an anthracycline-sparing neoadjuvant chemotherapy regimen. We are very encouraged” by the findings, Dr. Sharma said.

This is “a provocative study that should make us pause and reevaluate our current approach. Further study of this approach in early-stage TNBC is warranted,” Melinda L. Telli, MD, associate professor of medicine and director of the breast cancer program at Stanford (Calif.) University, said when asked for comment.

Avoiding the risks associated with anthracycline “is great. I would be particularly enthusiastic using this regimen in patients with known increased risk of cardiac toxicity,” said Amy Tiersten, MD, a breast cancer specialist and professor at Mount Sinai Hospital, New York.

Anthracycline-based regimens are the standard of care for neoadjuvant TNBC. They typically include a taxane with or without carboplatin plus an anthracycline/cyclophosphamide combination. The regimen is highly active, but there is a small but serious risk for cardiomyopathy and leukemia with anthracycline/cyclophosphamide. In the current trial, one woman in the anthracycline arm died of secondary acute myeloid leukemia.

Given its tolerability and effectiveness, a taxane/carboplatin doublet might serve as a good backbone for the addition of novel immunotherapies in trials. Dr. Sharma is the principal investigator in one such trial, a phase 2 trial of carboplatin/docetaxel plus pembrolizumab for stage I–III TNBC.
 

Study details

The Neoadjuvant Study of Two Platinum Regimens in Stage I–III Triple Negative Breast Cancer (NeoSTOP) involved 100 women with stage I–III TNBC.

In the experimental arm, 52 women received carboplatin AUC 6 plus docetaxel 75 mg/m² every 21 days for six cycles.

In the standard-of-care anthracycline arm, 48 women received carboplatin AUC 6 every 21 days for four cycles plus paclitaxel 80 mg/m² weekly for 12 weeks, followed by doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for four cycles.

Docetaxel and paclitaxel in the two regimens are interchangeable because they have shown equal efficacy in adjuvant trials, Dr. Sharma said.

At surgery, 54% of women in both arms had a breast/axilla pathologic complete response – the primary endpoint – and 67% in both arms had a residual cancer burden of 0-1. Event-free and overall survival (about 55% at 3 years for both) were similar with the two regimens.

Grade 3/4 adverse events were more common in the anthracycline arm. They included neutropenia, which occurred in 60% of women in the anthracycline arm, vs. 8% with the doublet; and febrile neutropenia, which occurred in 19% with anthracycline, vs. none with the doublet.

The toxicity profile of the anthracycline regimen was comparable to those in previous reports.

Ninety-two percent of the docetaxel/carboplatin group completed all six cycles; 72% of women in the anthracycline arm completed 10 or more doses of paclitaxel, and 85% completed all 4 carboplatin doses.

Mean costs of treatment, patient transportation, and lost productivity were $36,720 in the anthracycline arm, vs. $33,148 with the doublet.

The two arms were well balanced with respect to patient characteristics. The median age was 51 years, 30% of patients had axillary lymph node–positive disease, and 16% had ER/PgR expression of 1% to 10%. Of the study population, 17% carried deleterious BRCA1/2 mutations. Women were enrolled from July 2015 to May 2018. Median follow-up was 38 months.

Of the study population, 17% had stage I disease, so NeoSTOP included a lower-risk population than some neoadjuvant trials. However, there was no significant change in pathologic complete response rates in the two arms after exclusion of women with stage I disease (doublet, 50%; anthracycline, 54%).

The study was funded by the University of Kansas Cancer Center, the Breast Cancer Research Foundation, and the National Institute of General Medical Sciences. The investigators disclosed no relevant financial relationships.

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

The right colon appears to age faster in Black people than in White people, perhaps explaining the higher prevalence of right-side colon cancer among Black Americans, according to results from a biopsy study.

The findings were published online Dec. 30 in the Journal of the National Cancer Institute.

For the study, investigators analyzed colon biopsy specimens from 128 individuals who underwent routine colorectal screening.

The researchers compared DNA methylation levels in right and left colon biopsy samples from the same patient. They then assigned epigenetic ages to the tissue samples using the Hovarth clock, which estimates tissue age on the basis of DNA methylation.

DNA methylation is influenced by age and environmental exposures. Aberrant DNA methylation is a hallmark of colorectal cancer, the researchers explained.

The epigenetic age of the right colon of the 88 Black patients was 1.51 years ahead of their left colon; the right colon of the 44 White patients was epigenetically 1.93 years younger than their left colon.

The right colon was epigenetically older than the left colon in 60.2% of Black patients; it was younger in more than 70% of White patients.

A unique pattern of DNA hypermethylation was found in the right colon of Black patients.

“Our results provide biological plausibility for the observed relative preponderance of right colon cancer and younger age of onset in African Americans as compared to European Americans,” wrote the investigators, led by Matthew Devall, PhD, a research associate at the Center for Public Health Genomics at the University of Virginia, Charlottesville.

“Side-specific colonic epigenetic aging may be a promising marker to guide interventions to reduce CRC [colorectal cancer] burden,” they suggested.

If these findings are “corroborated in African Americans in future studies, these results could potentially explain racial differences in the site predilection of colorectal cancers,”  Amit Joshi, MBBS, PhD, and Andrew Chan, MD, gastrointestinal molecular epidemiologists at Harvard Medical School, Boston, wrote in an accompanying editorial.

However, “it is not clear if the higher epigenetic aging measured using the Horvath clock ... directly translates to a higher risk of colorectal cancer,” they noted.

Some differences between the Black patients and the White patients in the study could explain the methylation differences, they pointed out. A higher proportion of Black patients smoked (37.5% vs. 15%), and Black patients were younger (median age, 55.5 years, vs. 61.7 years). In addition, the study included more Black women than White women (67% vs. 58%), and body mass indexes were higher for Black patients than White patients (31.36 kg/m² vs 28.29 kg/m²).

“One or more of these factors, or others that were not measured, may be linked to differential methylation in the right compared with left colon,” the editorialists wrote.

Even so, among the Black patients, almost 70% of differentially methylated positions in the right colon were hypermethylated, compared to less than half in the left colon. These included positions previously associated with colorectal cancer, aging, and ancestry, “suggesting a role for genetic variation in contributing to DNA methylation differences in AA right colon,” the investigators said.

"This study’s observations are interesting and important. One additional limitation to consider is how race of the patient was determined, e.g. self-identified or ancestry history. If it was the former, than this study is limited by the fact that individuals who identify as African American may also have European ancestry, similarly European Americans may have African ancestry. As we advance in health disparities research, our work must acknowledge that there is a broad range of degree of European ancestry among Black Americans,” added Byron Cryer, MD, and Sandra Quezada, MD, the cochairs of the AGA Equity Project Advisory Board.

The work was supported the National Cancer Institute Cancer, the Case Comprehensive Cancer Center, and the University of Virginia Cancer Center. The authors and editorialists have disclosed no relevant financial relationships.

AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

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

The right colon appears to age faster in Black people than in White people, perhaps explaining the higher prevalence of right-side colon cancer among Black Americans, according to results from a biopsy study.

The findings were published online Dec. 30 in the Journal of the National Cancer Institute.

For the study, investigators analyzed colon biopsy specimens from 128 individuals who underwent routine colorectal screening.

The researchers compared DNA methylation levels in right and left colon biopsy samples from the same patient. They then assigned epigenetic ages to the tissue samples using the Hovarth clock, which estimates tissue age on the basis of DNA methylation.

DNA methylation is influenced by age and environmental exposures. Aberrant DNA methylation is a hallmark of colorectal cancer, the researchers explained.

The epigenetic age of the right colon of the 88 Black patients was 1.51 years ahead of their left colon; the right colon of the 44 White patients was epigenetically 1.93 years younger than their left colon.

The right colon was epigenetically older than the left colon in 60.2% of Black patients; it was younger in more than 70% of White patients.

A unique pattern of DNA hypermethylation was found in the right colon of Black patients.

“Our results provide biological plausibility for the observed relative preponderance of right colon cancer and younger age of onset in African Americans as compared to European Americans,” wrote the investigators, led by Matthew Devall, PhD, a research associate at the Center for Public Health Genomics at the University of Virginia, Charlottesville.

“Side-specific colonic epigenetic aging may be a promising marker to guide interventions to reduce CRC [colorectal cancer] burden,” they suggested.

If these findings are “corroborated in African Americans in future studies, these results could potentially explain racial differences in the site predilection of colorectal cancers,”  Amit Joshi, MBBS, PhD, and Andrew Chan, MD, gastrointestinal molecular epidemiologists at Harvard Medical School, Boston, wrote in an accompanying editorial.

However, “it is not clear if the higher epigenetic aging measured using the Horvath clock ... directly translates to a higher risk of colorectal cancer,” they noted.

Some differences between the Black patients and the White patients in the study could explain the methylation differences, they pointed out. A higher proportion of Black patients smoked (37.5% vs. 15%), and Black patients were younger (median age, 55.5 years, vs. 61.7 years). In addition, the study included more Black women than White women (67% vs. 58%), and body mass indexes were higher for Black patients than White patients (31.36 kg/m² vs 28.29 kg/m²).

“One or more of these factors, or others that were not measured, may be linked to differential methylation in the right compared with left colon,” the editorialists wrote.

Even so, among the Black patients, almost 70% of differentially methylated positions in the right colon were hypermethylated, compared to less than half in the left colon. These included positions previously associated with colorectal cancer, aging, and ancestry, “suggesting a role for genetic variation in contributing to DNA methylation differences in AA right colon,” the investigators said.

"This study’s observations are interesting and important. One additional limitation to consider is how race of the patient was determined, e.g. self-identified or ancestry history. If it was the former, than this study is limited by the fact that individuals who identify as African American may also have European ancestry, similarly European Americans may have African ancestry. As we advance in health disparities research, our work must acknowledge that there is a broad range of degree of European ancestry among Black Americans,” added Byron Cryer, MD, and Sandra Quezada, MD, the cochairs of the AGA Equity Project Advisory Board.

The work was supported the National Cancer Institute Cancer, the Case Comprehensive Cancer Center, and the University of Virginia Cancer Center. The authors and editorialists have disclosed no relevant financial relationships.

AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

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

The right colon appears to age faster in Black people than in White people, perhaps explaining the higher prevalence of right-side colon cancer among Black Americans, according to results from a biopsy study.

The findings were published online Dec. 30 in the Journal of the National Cancer Institute.

For the study, investigators analyzed colon biopsy specimens from 128 individuals who underwent routine colorectal screening.

The researchers compared DNA methylation levels in right and left colon biopsy samples from the same patient. They then assigned epigenetic ages to the tissue samples using the Hovarth clock, which estimates tissue age on the basis of DNA methylation.

DNA methylation is influenced by age and environmental exposures. Aberrant DNA methylation is a hallmark of colorectal cancer, the researchers explained.

The epigenetic age of the right colon of the 88 Black patients was 1.51 years ahead of their left colon; the right colon of the 44 White patients was epigenetically 1.93 years younger than their left colon.

The right colon was epigenetically older than the left colon in 60.2% of Black patients; it was younger in more than 70% of White patients.

A unique pattern of DNA hypermethylation was found in the right colon of Black patients.

“Our results provide biological plausibility for the observed relative preponderance of right colon cancer and younger age of onset in African Americans as compared to European Americans,” wrote the investigators, led by Matthew Devall, PhD, a research associate at the Center for Public Health Genomics at the University of Virginia, Charlottesville.

“Side-specific colonic epigenetic aging may be a promising marker to guide interventions to reduce CRC [colorectal cancer] burden,” they suggested.

If these findings are “corroborated in African Americans in future studies, these results could potentially explain racial differences in the site predilection of colorectal cancers,”  Amit Joshi, MBBS, PhD, and Andrew Chan, MD, gastrointestinal molecular epidemiologists at Harvard Medical School, Boston, wrote in an accompanying editorial.

However, “it is not clear if the higher epigenetic aging measured using the Horvath clock ... directly translates to a higher risk of colorectal cancer,” they noted.

Some differences between the Black patients and the White patients in the study could explain the methylation differences, they pointed out. A higher proportion of Black patients smoked (37.5% vs. 15%), and Black patients were younger (median age, 55.5 years, vs. 61.7 years). In addition, the study included more Black women than White women (67% vs. 58%), and body mass indexes were higher for Black patients than White patients (31.36 kg/m² vs 28.29 kg/m²).

“One or more of these factors, or others that were not measured, may be linked to differential methylation in the right compared with left colon,” the editorialists wrote.

Even so, among the Black patients, almost 70% of differentially methylated positions in the right colon were hypermethylated, compared to less than half in the left colon. These included positions previously associated with colorectal cancer, aging, and ancestry, “suggesting a role for genetic variation in contributing to DNA methylation differences in AA right colon,” the investigators said.

"This study’s observations are interesting and important. One additional limitation to consider is how race of the patient was determined, e.g. self-identified or ancestry history. If it was the former, than this study is limited by the fact that individuals who identify as African American may also have European ancestry, similarly European Americans may have African ancestry. As we advance in health disparities research, our work must acknowledge that there is a broad range of degree of European ancestry among Black Americans,” added Byron Cryer, MD, and Sandra Quezada, MD, the cochairs of the AGA Equity Project Advisory Board.

The work was supported the National Cancer Institute Cancer, the Case Comprehensive Cancer Center, and the University of Virginia Cancer Center. The authors and editorialists have disclosed no relevant financial relationships.

AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

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

The right colon appears to age faster in Black people than in White people, perhaps explaining the higher prevalence of right-side colon cancer among Black Americans, according to results from a biopsy study.

The findings were published online Dec. 30 in the Journal of the National Cancer Institute.

For the study, investigators analyzed colon biopsy specimens from 128 individuals who underwent routine colorectal screening.

The researchers compared DNA methylation levels in right and left colon biopsy samples from the same patient. They then assigned epigenetic ages to the tissue samples using the Hovarth clock, which estimates tissue age on the basis of DNA methylation.

DNA methylation is influenced by age and environmental exposures. Aberrant DNA methylation is a hallmark of colorectal cancer, the researchers explained.

The epigenetic age of the right colon of the 88 Black patients was 1.51 years ahead of their left colon; the right colon of the 44 White patients was epigenetically 1.93 years younger than their left colon.

The right colon was epigenetically older than the left colon in 60.2% of Black patients; it was younger in more than 70% of White patients.

A unique pattern of DNA hypermethylation was found in the right colon of Black patients.

“Our results provide biological plausibility for the observed relative preponderance of right colon cancer and younger age of onset in African Americans as compared to European Americans,” wrote the investigators, led by Matthew Devall, PhD, a research associate at the Center for Public Health Genomics at the University of Virginia, Charlottesville.

“Side-specific colonic epigenetic aging may be a promising marker to guide interventions to reduce CRC [colorectal cancer] burden,” they suggested.

If these findings are “corroborated in African Americans in future studies, these results could potentially explain racial differences in the site predilection of colorectal cancers,”  Amit Joshi, MBBS, PhD, and Andrew Chan, MD, gastrointestinal molecular epidemiologists at Harvard Medical School, Boston, wrote in an accompanying editorial.

However, “it is not clear if the higher epigenetic aging measured using the Horvath clock ... directly translates to a higher risk of colorectal cancer,” they noted.

Some differences between the Black patients and the White patients in the study could explain the methylation differences, they pointed out. A higher proportion of Black patients smoked (37.5% vs. 15%), and Black patients were younger (median age, 55.5 years, vs. 61.7 years). In addition, the study included more Black women than White women (67% vs. 58%), and body mass indexes were higher for Black patients than White patients (31.36 kg/m² vs 28.29 kg/m²).

“One or more of these factors, or others that were not measured, may be linked to differential methylation in the right compared with left colon,” the editorialists wrote.

Even so, among the Black patients, almost 70% of differentially methylated positions in the right colon were hypermethylated, compared to less than half in the left colon. These included positions previously associated with colorectal cancer, aging, and ancestry, “suggesting a role for genetic variation in contributing to DNA methylation differences in AA right colon,” the investigators said.

The work was supported the National Cancer Institute Cancer, the Case Comprehensive Cancer Center, and the University of Virginia Cancer Center. The authors and editorialists have disclosed no relevant financial relationships.

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

The right colon appears to age faster in Black people than in White people, perhaps explaining the higher prevalence of right-side colon cancer among Black Americans, according to results from a biopsy study.

The findings were published online Dec. 30 in the Journal of the National Cancer Institute.

For the study, investigators analyzed colon biopsy specimens from 128 individuals who underwent routine colorectal screening.

The researchers compared DNA methylation levels in right and left colon biopsy samples from the same patient. They then assigned epigenetic ages to the tissue samples using the Hovarth clock, which estimates tissue age on the basis of DNA methylation.

DNA methylation is influenced by age and environmental exposures. Aberrant DNA methylation is a hallmark of colorectal cancer, the researchers explained.

The epigenetic age of the right colon of the 88 Black patients was 1.51 years ahead of their left colon; the right colon of the 44 White patients was epigenetically 1.93 years younger than their left colon.

The right colon was epigenetically older than the left colon in 60.2% of Black patients; it was younger in more than 70% of White patients.

A unique pattern of DNA hypermethylation was found in the right colon of Black patients.

“Our results provide biological plausibility for the observed relative preponderance of right colon cancer and younger age of onset in African Americans as compared to European Americans,” wrote the investigators, led by Matthew Devall, PhD, a research associate at the Center for Public Health Genomics at the University of Virginia, Charlottesville.

“Side-specific colonic epigenetic aging may be a promising marker to guide interventions to reduce CRC [colorectal cancer] burden,” they suggested.

If these findings are “corroborated in African Americans in future studies, these results could potentially explain racial differences in the site predilection of colorectal cancers,”  Amit Joshi, MBBS, PhD, and Andrew Chan, MD, gastrointestinal molecular epidemiologists at Harvard Medical School, Boston, wrote in an accompanying editorial.

However, “it is not clear if the higher epigenetic aging measured using the Horvath clock ... directly translates to a higher risk of colorectal cancer,” they noted.

Some differences between the Black patients and the White patients in the study could explain the methylation differences, they pointed out. A higher proportion of Black patients smoked (37.5% vs. 15%), and Black patients were younger (median age, 55.5 years, vs. 61.7 years). In addition, the study included more Black women than White women (67% vs. 58%), and body mass indexes were higher for Black patients than White patients (31.36 kg/m² vs 28.29 kg/m²).

“One or more of these factors, or others that were not measured, may be linked to differential methylation in the right compared with left colon,” the editorialists wrote.

Even so, among the Black patients, almost 70% of differentially methylated positions in the right colon were hypermethylated, compared to less than half in the left colon. These included positions previously associated with colorectal cancer, aging, and ancestry, “suggesting a role for genetic variation in contributing to DNA methylation differences in AA right colon,” the investigators said.

The work was supported the National Cancer Institute Cancer, the Case Comprehensive Cancer Center, and the University of Virginia Cancer Center. The authors and editorialists have disclosed no relevant financial relationships.

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

The right colon appears to age faster in Black people than in White people, perhaps explaining the higher prevalence of right-side colon cancer among Black Americans, according to results from a biopsy study.

The findings were published online Dec. 30 in the Journal of the National Cancer Institute.

For the study, investigators analyzed colon biopsy specimens from 128 individuals who underwent routine colorectal screening.

The researchers compared DNA methylation levels in right and left colon biopsy samples from the same patient. They then assigned epigenetic ages to the tissue samples using the Hovarth clock, which estimates tissue age on the basis of DNA methylation.

DNA methylation is influenced by age and environmental exposures. Aberrant DNA methylation is a hallmark of colorectal cancer, the researchers explained.

The epigenetic age of the right colon of the 88 Black patients was 1.51 years ahead of their left colon; the right colon of the 44 White patients was epigenetically 1.93 years younger than their left colon.

The right colon was epigenetically older than the left colon in 60.2% of Black patients; it was younger in more than 70% of White patients.

A unique pattern of DNA hypermethylation was found in the right colon of Black patients.

“Our results provide biological plausibility for the observed relative preponderance of right colon cancer and younger age of onset in African Americans as compared to European Americans,” wrote the investigators, led by Matthew Devall, PhD, a research associate at the Center for Public Health Genomics at the University of Virginia, Charlottesville.

“Side-specific colonic epigenetic aging may be a promising marker to guide interventions to reduce CRC [colorectal cancer] burden,” they suggested.

If these findings are “corroborated in African Americans in future studies, these results could potentially explain racial differences in the site predilection of colorectal cancers,”  Amit Joshi, MBBS, PhD, and Andrew Chan, MD, gastrointestinal molecular epidemiologists at Harvard Medical School, Boston, wrote in an accompanying editorial.

However, “it is not clear if the higher epigenetic aging measured using the Horvath clock ... directly translates to a higher risk of colorectal cancer,” they noted.

Some differences between the Black patients and the White patients in the study could explain the methylation differences, they pointed out. A higher proportion of Black patients smoked (37.5% vs. 15%), and Black patients were younger (median age, 55.5 years, vs. 61.7 years). In addition, the study included more Black women than White women (67% vs. 58%), and body mass indexes were higher for Black patients than White patients (31.36 kg/m² vs 28.29 kg/m²).

“One or more of these factors, or others that were not measured, may be linked to differential methylation in the right compared with left colon,” the editorialists wrote.

Even so, among the Black patients, almost 70% of differentially methylated positions in the right colon were hypermethylated, compared to less than half in the left colon. These included positions previously associated with colorectal cancer, aging, and ancestry, “suggesting a role for genetic variation in contributing to DNA methylation differences in AA right colon,” the investigators said.

The work was supported the National Cancer Institute Cancer, the Case Comprehensive Cancer Center, and the University of Virginia Cancer Center. The authors and editorialists have disclosed no relevant financial relationships.

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

A proposal to lower Medicare Part B reimbursements for 50 physician-administered drugs and biologics to what drug manufacturers receive for them in other wealthy nations seems unlikely to take effect as planned on January 1, 2021. The proposal has been strongly opposed by the pharmaceutical industry as well as oncologists and other physicians who use the products most often.

At least four lawsuits have been filed in US district courts to block the move, including from Regeneron, manufacturer of the ophthalmic biologic aflibercept, the first agent on the list; the Community Oncology Alliance; the Biotechnology Innovation Organization, California Life Sciences Association, and Biocom; and Pharmaceutical Research and Manufacturers of America, the Association of Community Cancer Centers, the Global Colon Cancer Association, and National Infusion Center Association.

The proposal could hit oncologists/hematologists particularly hard because they are the primary prescribers of about 30 of the 50 agents on the list, including mainstay breast, lung, and prostate cancer treatments and newer immunotherapies. In its filing for injunctive relieve, the Community Oncology Alliance, a trade group for community oncologists, said the proposal exposes “the health and safety of cancer patients and other patients with potentially life-threatening diseases to real danger.”
 

Hearings are imminent

Hearings on the proposal, which was published by the Centers for Medicare & Medicaid Services (CMS) on November 27 following an executive order September 13, are scheduled for coming days. The first hearing is scheduled for December 18.

Given the looming implementation date, judges are likely to rule quickly on the motions for injunctive relief, said attorney Rachel Sachs, a health law expert and associate professor at the Washington University School of Law, St. Louis, Missouri. The odds are in plaintiffs’ favor based on procedural and Constitutional grounds. “It’s extremely unlikely to survive” the legal onslaught, she told Medscape Medical News.

Among the many issues raised in court filings, the proposal was released as an interim final rule (IFR), meaning it would take effect outside of the usual process of proposed rule, comment period, revision, then implementation. The law allows for bypassing normal rule-making requirements with an IFR, but they are meant for emergency situations — several have been issued in response to the COVID-19 pandemic — and the government must be able to show that delay would be “impracticable, unnecessary, or contrary to the public interest,” Sachs explained.

In contrast, some form of CMS’s new proposal, dubbed the “Most Favored Nation” (MFN) model for drug reimbursements, has been under consideration by the Trump administration since 2018.

“The way the [Trump] administration rolled this rule out at pretty much the last minute opens them up to greater legal challenges than if they pursued more normal regulatory pathways, which they had the opportunity to do. They are attempting to implement this on a time frame that is unprecedented for as large a change as this is,” said Juliette Cubanski, PhD, deputy director of Medicare policy at the Kaiser Family Foundation, San Francisco, California.
 

Reimbursement less than acquisition costs

In the proposal, CMS sought to offset the higher prices that pharmaceutical companies charge in the United States when compared with other developed nations — the prices are about double on average.

“One of the largest drivers of increasing Medicare spending is the growing prices for physician-administered separately payable Medicare Part B drugs, which have risen an average of 11.5% annually since 2015, with total spending of approximately $30 billion in 2019,” the agency said in a fact sheet. This is due in large part to “lack of competitive market forces on Medicare Part B drug costs,” it added.

The 50 agents covered by the new proposal are the ones Part B spends the most on, almost $3 billion in 2019 for aflibercept alone, followed closely by pembrolizumab, an immunotherapy used in many different cancer types.

A full list of the drugs and biologicals included in the proposal is on page 50 of the IFR.

CMS estimated that its move would cut reimbursements by approximately 65% once fully implemented in 4 years and save $87.8 billion over the 7 years of the proposed model, as well as reduce cost sharing for beneficiaries.

This model puts the onus on providers to negotiate down drug prices with companies to meet proposed reimbursement limits. However, if companies do not lower their prices, acquisition costs could be substantially lower than reimbursements.

Prescribers and their practices would either have to take the financial hit or stop offering the pharmaceuticals, in which case patients would have to do without, try a different option, or seek care elsewhere, including facilities excluded from the proposal: children’s hospitals, critical access hospitals, cancer hospitals, federally qualified health centers, rural health clinics, and extended neoplastic disease care hospitals.

CMS estimates that in the first year of MFN reimbursements, 9% of beneficiaries would forgo MFN therapies, growing to 19% by year 3, figures that were included in cost savings estimates.

The reimbursement cuts are meant to motivate manufactures to lower prices, but “we have not seen this occur with similar efforts in the past, and drug prices have continued to rise,” said American College of Rheumatology President David Karp, MD, PhD, in a press release. Many of the agents on the list are used by rheumatologists.

Under current policy, Medicare Part B prescribers are reimbursed manufactures’ average sales price plus a 6% add-on. Under the new proposal, reimbursements would be pegged to the lowest price charged among nations of the Organization for Economic Co-operation and Development with a gross domestic product per capita of at least 60% of the US price. In addition to the United States, there are 36 other member countries, including Canada, the United Kingdom, Japan, and Germany.

To remove incentives to prescribe more expensive drugs, the 6% add-on would be replaced with a flat add-on payment per dose, pegged at $148.73 for the first quarter of 2021. There is a hardship exemption for providers if the reimbursement cuts are too drastic, but that involves a lot of paperwork.

This article first appeared on Medscape.com.

A proposal to lower Medicare Part B reimbursements for 50 physician-administered drugs and biologics to what drug manufacturers receive for them in other wealthy nations seems unlikely to take effect as planned on January 1, 2021. The proposal has been strongly opposed by the pharmaceutical industry as well as oncologists and other physicians who use the products most often.

At least four lawsuits have been filed in US district courts to block the move, including from Regeneron, manufacturer of the ophthalmic biologic aflibercept, the first agent on the list; the Community Oncology Alliance; the Biotechnology Innovation Organization, California Life Sciences Association, and Biocom; and Pharmaceutical Research and Manufacturers of America, the Association of Community Cancer Centers, the Global Colon Cancer Association, and National Infusion Center Association.

The proposal could hit oncologists/hematologists particularly hard because they are the primary prescribers of about 30 of the 50 agents on the list, including mainstay breast, lung, and prostate cancer treatments and newer immunotherapies. In its filing for injunctive relieve, the Community Oncology Alliance, a trade group for community oncologists, said the proposal exposes “the health and safety of cancer patients and other patients with potentially life-threatening diseases to real danger.”
 

Hearings are imminent

Hearings on the proposal, which was published by the Centers for Medicare & Medicaid Services (CMS) on November 27 following an executive order September 13, are scheduled for coming days. The first hearing is scheduled for December 18.

Given the looming implementation date, judges are likely to rule quickly on the motions for injunctive relief, said attorney Rachel Sachs, a health law expert and associate professor at the Washington University School of Law, St. Louis, Missouri. The odds are in plaintiffs’ favor based on procedural and Constitutional grounds. “It’s extremely unlikely to survive” the legal onslaught, she told Medscape Medical News.

Among the many issues raised in court filings, the proposal was released as an interim final rule (IFR), meaning it would take effect outside of the usual process of proposed rule, comment period, revision, then implementation. The law allows for bypassing normal rule-making requirements with an IFR, but they are meant for emergency situations — several have been issued in response to the COVID-19 pandemic — and the government must be able to show that delay would be “impracticable, unnecessary, or contrary to the public interest,” Sachs explained.

In contrast, some form of CMS’s new proposal, dubbed the “Most Favored Nation” (MFN) model for drug reimbursements, has been under consideration by the Trump administration since 2018.

“The way the [Trump] administration rolled this rule out at pretty much the last minute opens them up to greater legal challenges than if they pursued more normal regulatory pathways, which they had the opportunity to do. They are attempting to implement this on a time frame that is unprecedented for as large a change as this is,” said Juliette Cubanski, PhD, deputy director of Medicare policy at the Kaiser Family Foundation, San Francisco, California.
 

Reimbursement less than acquisition costs

In the proposal, CMS sought to offset the higher prices that pharmaceutical companies charge in the United States when compared with other developed nations — the prices are about double on average.

“One of the largest drivers of increasing Medicare spending is the growing prices for physician-administered separately payable Medicare Part B drugs, which have risen an average of 11.5% annually since 2015, with total spending of approximately $30 billion in 2019,” the agency said in a fact sheet. This is due in large part to “lack of competitive market forces on Medicare Part B drug costs,” it added.

The 50 agents covered by the new proposal are the ones Part B spends the most on, almost $3 billion in 2019 for aflibercept alone, followed closely by pembrolizumab, an immunotherapy used in many different cancer types.

A full list of the drugs and biologicals included in the proposal is on page 50 of the IFR.

CMS estimated that its move would cut reimbursements by approximately 65% once fully implemented in 4 years and save $87.8 billion over the 7 years of the proposed model, as well as reduce cost sharing for beneficiaries.

This model puts the onus on providers to negotiate down drug prices with companies to meet proposed reimbursement limits. However, if companies do not lower their prices, acquisition costs could be substantially lower than reimbursements.

Prescribers and their practices would either have to take the financial hit or stop offering the pharmaceuticals, in which case patients would have to do without, try a different option, or seek care elsewhere, including facilities excluded from the proposal: children’s hospitals, critical access hospitals, cancer hospitals, federally qualified health centers, rural health clinics, and extended neoplastic disease care hospitals.

CMS estimates that in the first year of MFN reimbursements, 9% of beneficiaries would forgo MFN therapies, growing to 19% by year 3, figures that were included in cost savings estimates.

The reimbursement cuts are meant to motivate manufactures to lower prices, but “we have not seen this occur with similar efforts in the past, and drug prices have continued to rise,” said American College of Rheumatology President David Karp, MD, PhD, in a press release. Many of the agents on the list are used by rheumatologists.

Under current policy, Medicare Part B prescribers are reimbursed manufactures’ average sales price plus a 6% add-on. Under the new proposal, reimbursements would be pegged to the lowest price charged among nations of the Organization for Economic Co-operation and Development with a gross domestic product per capita of at least 60% of the US price. In addition to the United States, there are 36 other member countries, including Canada, the United Kingdom, Japan, and Germany.

To remove incentives to prescribe more expensive drugs, the 6% add-on would be replaced with a flat add-on payment per dose, pegged at $148.73 for the first quarter of 2021. There is a hardship exemption for providers if the reimbursement cuts are too drastic, but that involves a lot of paperwork.

This article first appeared on Medscape.com.

A proposal to lower Medicare Part B reimbursements for 50 physician-administered drugs and biologics to what drug manufacturers receive for them in other wealthy nations seems unlikely to take effect as planned on January 1, 2021. The proposal has been strongly opposed by the pharmaceutical industry as well as oncologists and other physicians who use the products most often.

At least four lawsuits have been filed in US district courts to block the move, including from Regeneron, manufacturer of the ophthalmic biologic aflibercept, the first agent on the list; the Community Oncology Alliance; the Biotechnology Innovation Organization, California Life Sciences Association, and Biocom; and Pharmaceutical Research and Manufacturers of America, the Association of Community Cancer Centers, the Global Colon Cancer Association, and National Infusion Center Association.

The proposal could hit oncologists/hematologists particularly hard because they are the primary prescribers of about 30 of the 50 agents on the list, including mainstay breast, lung, and prostate cancer treatments and newer immunotherapies. In its filing for injunctive relieve, the Community Oncology Alliance, a trade group for community oncologists, said the proposal exposes “the health and safety of cancer patients and other patients with potentially life-threatening diseases to real danger.”
 

Hearings are imminent

Hearings on the proposal, which was published by the Centers for Medicare & Medicaid Services (CMS) on November 27 following an executive order September 13, are scheduled for coming days. The first hearing is scheduled for December 18.

Given the looming implementation date, judges are likely to rule quickly on the motions for injunctive relief, said attorney Rachel Sachs, a health law expert and associate professor at the Washington University School of Law, St. Louis, Missouri. The odds are in plaintiffs’ favor based on procedural and Constitutional grounds. “It’s extremely unlikely to survive” the legal onslaught, she told Medscape Medical News.

Among the many issues raised in court filings, the proposal was released as an interim final rule (IFR), meaning it would take effect outside of the usual process of proposed rule, comment period, revision, then implementation. The law allows for bypassing normal rule-making requirements with an IFR, but they are meant for emergency situations — several have been issued in response to the COVID-19 pandemic — and the government must be able to show that delay would be “impracticable, unnecessary, or contrary to the public interest,” Sachs explained.

In contrast, some form of CMS’s new proposal, dubbed the “Most Favored Nation” (MFN) model for drug reimbursements, has been under consideration by the Trump administration since 2018.

“The way the [Trump] administration rolled this rule out at pretty much the last minute opens them up to greater legal challenges than if they pursued more normal regulatory pathways, which they had the opportunity to do. They are attempting to implement this on a time frame that is unprecedented for as large a change as this is,” said Juliette Cubanski, PhD, deputy director of Medicare policy at the Kaiser Family Foundation, San Francisco, California.
 

Reimbursement less than acquisition costs

In the proposal, CMS sought to offset the higher prices that pharmaceutical companies charge in the United States when compared with other developed nations — the prices are about double on average.

“One of the largest drivers of increasing Medicare spending is the growing prices for physician-administered separately payable Medicare Part B drugs, which have risen an average of 11.5% annually since 2015, with total spending of approximately $30 billion in 2019,” the agency said in a fact sheet. This is due in large part to “lack of competitive market forces on Medicare Part B drug costs,” it added.

The 50 agents covered by the new proposal are the ones Part B spends the most on, almost $3 billion in 2019 for aflibercept alone, followed closely by pembrolizumab, an immunotherapy used in many different cancer types.

A full list of the drugs and biologicals included in the proposal is on page 50 of the IFR.

CMS estimated that its move would cut reimbursements by approximately 65% once fully implemented in 4 years and save $87.8 billion over the 7 years of the proposed model, as well as reduce cost sharing for beneficiaries.

This model puts the onus on providers to negotiate down drug prices with companies to meet proposed reimbursement limits. However, if companies do not lower their prices, acquisition costs could be substantially lower than reimbursements.

Prescribers and their practices would either have to take the financial hit or stop offering the pharmaceuticals, in which case patients would have to do without, try a different option, or seek care elsewhere, including facilities excluded from the proposal: children’s hospitals, critical access hospitals, cancer hospitals, federally qualified health centers, rural health clinics, and extended neoplastic disease care hospitals.

CMS estimates that in the first year of MFN reimbursements, 9% of beneficiaries would forgo MFN therapies, growing to 19% by year 3, figures that were included in cost savings estimates.

The reimbursement cuts are meant to motivate manufactures to lower prices, but “we have not seen this occur with similar efforts in the past, and drug prices have continued to rise,” said American College of Rheumatology President David Karp, MD, PhD, in a press release. Many of the agents on the list are used by rheumatologists.

Under current policy, Medicare Part B prescribers are reimbursed manufactures’ average sales price plus a 6% add-on. Under the new proposal, reimbursements would be pegged to the lowest price charged among nations of the Organization for Economic Co-operation and Development with a gross domestic product per capita of at least 60% of the US price. In addition to the United States, there are 36 other member countries, including Canada, the United Kingdom, Japan, and Germany.

To remove incentives to prescribe more expensive drugs, the 6% add-on would be replaced with a flat add-on payment per dose, pegged at $148.73 for the first quarter of 2021. There is a hardship exemption for providers if the reimbursement cuts are too drastic, but that involves a lot of paperwork.

This article first appeared on Medscape.com.

Patients with cancer are at significantly increased risk for COVID-19 and worse outcomes, a new review confirms. It also found that patients with leukemia, non-Hodgkin lymphoma, and lung cancer are at greatest risk.

Blacks with cancer are at even higher risk, and for patients with colorectal cancer and non-Hodgkin lymphoma, the risk is higher for women than for men. (This contrasts with findings in noncancer populations, where men are more at risk from COVID-19 and severe outcomes than women.)

These findings come from a huge review of electronic health records of 73.4 million patients in the United States. They “highlight the need to protect and monitor patients with cancer as part of the strategy to control the pandemic,” the authors wrote.

The review was published online Dec. 10 in JAMA Oncology.

The greater risk for COVID-19 among patients with cancer is well known, but breaking the risk down by cancer type is novel, wrote the investigators, led by Quanqiu Wang, MS, Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University, Cleveland.

Cancer patients are immunocompromised and have more contact with the health care system, which increases their risk for COVID-19. But which bodily systems are affected by cancer seems to matter. In patients with blood cancer, for example, COVID-19 is probably more dangerous, because blood cancer weakens the immune system directly, the authors suggested.

The increased risk for infection and hospitalization with SARS-CoV-2 among Black patients with cancer might be because of biology, but it is more likely because of factors that weren’t captured in the database review. Such factors include social adversity, economic status, access to health care, and lifestyle, the researchers noted.

For this study, the investigators analyzed electronic health records held in the IBM Watson Health Explorys system, which captures about 15% of new cancer diagnoses in the United States.

The analysis found that, as of Aug. 14, 2020, 16,570 patients (0.02%) had been diagnosed with COVID-19; about 1,200 also had been diagnosed with cancer. Of those, 690 were diagnosed with cancer in the previous year, which counted as a recent cancer diagnosis in the analysis. The study included 13 common cancers, including endometrial, kidney, liver, lung, gastrointestinal, prostate, skin, and thyroid cancers, among others.

Patients with any cancer diagnosis (adjusted odds ratio, 1.46) as well as those with a recent cancer diagnosis (aOR, 7.14) had a significantly higher risk for COVID-19 than those without cancer, after adjusting for asthma, cardiovascular diseases, nursing home stays, and other risk factors.

The risk for COVID-19 was highest among patients recently diagnosed with leukemia (aOR, 12.16), non-Hodgkin lymphoma (aOR, 8.54), and lung cancer (aOR 7.66). The risk for COVID-19 was lower for patients with cancers associated with worse prognoses, including pancreatic (aOR, 6.26) and liver (aOR, 6.49) cancer. It was weakest for patients with thyroid cancer (aOR, 3.10; P for all < .001).

Hospitalization was more common in recent cancer patients with COVID-19 than in COVID-19 patients without cancer (47.46% vs. 24.6%), as was COVID-19–related death (14.93% vs. 5.26%). Among cancer patients who did not have COVID-19, 12.39% were hospitalized, and 4.03% died. The findings suggest a synergistic effect between the COVID-19 and cancer, the team noted.

Among patients recently diagnosed with cancer, Black patients – 10.3% of the overall study population – had a significantly higher risk for COVID-19 than White patients. The racial disparity was largest for patients with breast cancer (aOR, 5.44), followed by patients with prostate cancer (aOR, 5.10), colorectal cancer (aOR, 3.30), and lung cancer (aOR, 2.53; P for all < .001).

Hospitalizations were more common among Black patients with cancer and COVID-19 than White patients. There was also a trend toward higher mortality among Black patients (18.52% vs. 13.51%; P = .11)

However, these differences may not be related to race, oncologist Aakash Desai, MBBS, of the Mayo Clinic, Rochester, Minn., and colleagues noted in an accompanying commentary. “Interestingly, a previous study of hospitalized patients with COVID-19 without cancer demonstrated that mortality rates for Black patients were comparable to those for White patients after adjustment for both comorbidities and deprivation index, suggesting that observed differences are mainly owing to societal disparities rather than biology.”

The editorialists also noted that the finding that Black patients with cancer are at greater risk for COVID-19 (aOR, 1.58-5.44, depending on cancer) echoes the findings in the general population. The Centers for Disease Control and Prevention estimates a severalfold increased risk among Black patients. These higher rates may largely be explained by social determinants, they suggested. Such factors include increased burden of comorbidities, crowded living conditions (inner cities, multigenerational homes, etc.), dependence on public transportation or child care, and higher work-related exposures. “Until such societal disparities are accounted for, we cannot presume these findings are caused by any inherent differences among racial groups,” the editorialists wrote.

“Clearly, the haunting spotlight of COVID-19 has dramatically illuminated known U.S. health care and societal disparities,” Dr. Desai and colleagues wrote. “This situation should be a wake-up call that brings much-needed improvements in U.S. equity policies, including but not limited to better health care access. Nothing appears more critical for alleviating these disparate clinical outcomes in this time of crisis and beyond,” they declared.

The study was funded by the National Institutes of Health, the American Cancer Society, and other organizations. The investigators disclosed having no relevant financial relationships.

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

Patients with cancer are at significantly increased risk for COVID-19 and worse outcomes, a new review confirms. It also found that patients with leukemia, non-Hodgkin lymphoma, and lung cancer are at greatest risk.

Blacks with cancer are at even higher risk, and for patients with colorectal cancer and non-Hodgkin lymphoma, the risk is higher for women than for men. (This contrasts with findings in noncancer populations, where men are more at risk from COVID-19 and severe outcomes than women.)

These findings come from a huge review of electronic health records of 73.4 million patients in the United States. They “highlight the need to protect and monitor patients with cancer as part of the strategy to control the pandemic,” the authors wrote.

The review was published online Dec. 10 in JAMA Oncology.

The greater risk for COVID-19 among patients with cancer is well known, but breaking the risk down by cancer type is novel, wrote the investigators, led by Quanqiu Wang, MS, Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University, Cleveland.

Cancer patients are immunocompromised and have more contact with the health care system, which increases their risk for COVID-19. But which bodily systems are affected by cancer seems to matter. In patients with blood cancer, for example, COVID-19 is probably more dangerous, because blood cancer weakens the immune system directly, the authors suggested.

The increased risk for infection and hospitalization with SARS-CoV-2 among Black patients with cancer might be because of biology, but it is more likely because of factors that weren’t captured in the database review. Such factors include social adversity, economic status, access to health care, and lifestyle, the researchers noted.

For this study, the investigators analyzed electronic health records held in the IBM Watson Health Explorys system, which captures about 15% of new cancer diagnoses in the United States.

The analysis found that, as of Aug. 14, 2020, 16,570 patients (0.02%) had been diagnosed with COVID-19; about 1,200 also had been diagnosed with cancer. Of those, 690 were diagnosed with cancer in the previous year, which counted as a recent cancer diagnosis in the analysis. The study included 13 common cancers, including endometrial, kidney, liver, lung, gastrointestinal, prostate, skin, and thyroid cancers, among others.

Patients with any cancer diagnosis (adjusted odds ratio, 1.46) as well as those with a recent cancer diagnosis (aOR, 7.14) had a significantly higher risk for COVID-19 than those without cancer, after adjusting for asthma, cardiovascular diseases, nursing home stays, and other risk factors.

The risk for COVID-19 was highest among patients recently diagnosed with leukemia (aOR, 12.16), non-Hodgkin lymphoma (aOR, 8.54), and lung cancer (aOR 7.66). The risk for COVID-19 was lower for patients with cancers associated with worse prognoses, including pancreatic (aOR, 6.26) and liver (aOR, 6.49) cancer. It was weakest for patients with thyroid cancer (aOR, 3.10; P for all < .001).

Hospitalization was more common in recent cancer patients with COVID-19 than in COVID-19 patients without cancer (47.46% vs. 24.6%), as was COVID-19–related death (14.93% vs. 5.26%). Among cancer patients who did not have COVID-19, 12.39% were hospitalized, and 4.03% died. The findings suggest a synergistic effect between the COVID-19 and cancer, the team noted.

Among patients recently diagnosed with cancer, Black patients – 10.3% of the overall study population – had a significantly higher risk for COVID-19 than White patients. The racial disparity was largest for patients with breast cancer (aOR, 5.44), followed by patients with prostate cancer (aOR, 5.10), colorectal cancer (aOR, 3.30), and lung cancer (aOR, 2.53; P for all < .001).

Hospitalizations were more common among Black patients with cancer and COVID-19 than White patients. There was also a trend toward higher mortality among Black patients (18.52% vs. 13.51%; P = .11)

However, these differences may not be related to race, oncologist Aakash Desai, MBBS, of the Mayo Clinic, Rochester, Minn., and colleagues noted in an accompanying commentary. “Interestingly, a previous study of hospitalized patients with COVID-19 without cancer demonstrated that mortality rates for Black patients were comparable to those for White patients after adjustment for both comorbidities and deprivation index, suggesting that observed differences are mainly owing to societal disparities rather than biology.”

The editorialists also noted that the finding that Black patients with cancer are at greater risk for COVID-19 (aOR, 1.58-5.44, depending on cancer) echoes the findings in the general population. The Centers for Disease Control and Prevention estimates a severalfold increased risk among Black patients. These higher rates may largely be explained by social determinants, they suggested. Such factors include increased burden of comorbidities, crowded living conditions (inner cities, multigenerational homes, etc.), dependence on public transportation or child care, and higher work-related exposures. “Until such societal disparities are accounted for, we cannot presume these findings are caused by any inherent differences among racial groups,” the editorialists wrote.

“Clearly, the haunting spotlight of COVID-19 has dramatically illuminated known U.S. health care and societal disparities,” Dr. Desai and colleagues wrote. “This situation should be a wake-up call that brings much-needed improvements in U.S. equity policies, including but not limited to better health care access. Nothing appears more critical for alleviating these disparate clinical outcomes in this time of crisis and beyond,” they declared.

The study was funded by the National Institutes of Health, the American Cancer Society, and other organizations. The investigators disclosed having no relevant financial relationships.

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

Patients with cancer are at significantly increased risk for COVID-19 and worse outcomes, a new review confirms. It also found that patients with leukemia, non-Hodgkin lymphoma, and lung cancer are at greatest risk.

Blacks with cancer are at even higher risk, and for patients with colorectal cancer and non-Hodgkin lymphoma, the risk is higher for women than for men. (This contrasts with findings in noncancer populations, where men are more at risk from COVID-19 and severe outcomes than women.)

These findings come from a huge review of electronic health records of 73.4 million patients in the United States. They “highlight the need to protect and monitor patients with cancer as part of the strategy to control the pandemic,” the authors wrote.

The review was published online Dec. 10 in JAMA Oncology.

The greater risk for COVID-19 among patients with cancer is well known, but breaking the risk down by cancer type is novel, wrote the investigators, led by Quanqiu Wang, MS, Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University, Cleveland.

Cancer patients are immunocompromised and have more contact with the health care system, which increases their risk for COVID-19. But which bodily systems are affected by cancer seems to matter. In patients with blood cancer, for example, COVID-19 is probably more dangerous, because blood cancer weakens the immune system directly, the authors suggested.

The increased risk for infection and hospitalization with SARS-CoV-2 among Black patients with cancer might be because of biology, but it is more likely because of factors that weren’t captured in the database review. Such factors include social adversity, economic status, access to health care, and lifestyle, the researchers noted.

For this study, the investigators analyzed electronic health records held in the IBM Watson Health Explorys system, which captures about 15% of new cancer diagnoses in the United States.

The analysis found that, as of Aug. 14, 2020, 16,570 patients (0.02%) had been diagnosed with COVID-19; about 1,200 also had been diagnosed with cancer. Of those, 690 were diagnosed with cancer in the previous year, which counted as a recent cancer diagnosis in the analysis. The study included 13 common cancers, including endometrial, kidney, liver, lung, gastrointestinal, prostate, skin, and thyroid cancers, among others.

Patients with any cancer diagnosis (adjusted odds ratio, 1.46) as well as those with a recent cancer diagnosis (aOR, 7.14) had a significantly higher risk for COVID-19 than those without cancer, after adjusting for asthma, cardiovascular diseases, nursing home stays, and other risk factors.

The risk for COVID-19 was highest among patients recently diagnosed with leukemia (aOR, 12.16), non-Hodgkin lymphoma (aOR, 8.54), and lung cancer (aOR 7.66). The risk for COVID-19 was lower for patients with cancers associated with worse prognoses, including pancreatic (aOR, 6.26) and liver (aOR, 6.49) cancer. It was weakest for patients with thyroid cancer (aOR, 3.10; P for all < .001).

Hospitalization was more common in recent cancer patients with COVID-19 than in COVID-19 patients without cancer (47.46% vs. 24.6%), as was COVID-19–related death (14.93% vs. 5.26%). Among cancer patients who did not have COVID-19, 12.39% were hospitalized, and 4.03% died. The findings suggest a synergistic effect between the COVID-19 and cancer, the team noted.

Among patients recently diagnosed with cancer, Black patients – 10.3% of the overall study population – had a significantly higher risk for COVID-19 than White patients. The racial disparity was largest for patients with breast cancer (aOR, 5.44), followed by patients with prostate cancer (aOR, 5.10), colorectal cancer (aOR, 3.30), and lung cancer (aOR, 2.53; P for all < .001).

Hospitalizations were more common among Black patients with cancer and COVID-19 than White patients. There was also a trend toward higher mortality among Black patients (18.52% vs. 13.51%; P = .11)

However, these differences may not be related to race, oncologist Aakash Desai, MBBS, of the Mayo Clinic, Rochester, Minn., and colleagues noted in an accompanying commentary. “Interestingly, a previous study of hospitalized patients with COVID-19 without cancer demonstrated that mortality rates for Black patients were comparable to those for White patients after adjustment for both comorbidities and deprivation index, suggesting that observed differences are mainly owing to societal disparities rather than biology.”

The editorialists also noted that the finding that Black patients with cancer are at greater risk for COVID-19 (aOR, 1.58-5.44, depending on cancer) echoes the findings in the general population. The Centers for Disease Control and Prevention estimates a severalfold increased risk among Black patients. These higher rates may largely be explained by social determinants, they suggested. Such factors include increased burden of comorbidities, crowded living conditions (inner cities, multigenerational homes, etc.), dependence on public transportation or child care, and higher work-related exposures. “Until such societal disparities are accounted for, we cannot presume these findings are caused by any inherent differences among racial groups,” the editorialists wrote.

“Clearly, the haunting spotlight of COVID-19 has dramatically illuminated known U.S. health care and societal disparities,” Dr. Desai and colleagues wrote. “This situation should be a wake-up call that brings much-needed improvements in U.S. equity policies, including but not limited to better health care access. Nothing appears more critical for alleviating these disparate clinical outcomes in this time of crisis and beyond,” they declared.

The study was funded by the National Institutes of Health, the American Cancer Society, and other organizations. The investigators disclosed having no relevant financial relationships.

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