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Oncotype Score Helps Avoid Unnecessary Radiation in DCIS
SAN ANTONIO — There’s a long-standing concern among oncologists that many women with ductal carcinoma in situ (DCIS), a potential precursor to invasive breast cancer, receive more treatment than they need. The potential for overtreatment largely revolves around the extent of surgery and the use of radiation.
Using the Oncotype DX Breast DCIS Score test, a laboratory test that estimates DCIS recurrence risk, may help identify patients with low-risk DCIS who can safely avoid adjuvant radiation after surgery, according to new research (abstract GS03-01) presented at the San Antonio Breast Cancer Symposium.
Low-risk patients who skipped adjuvant radiotherapy after breast-conserving surgery demonstrated similar 5-year recurrence rates compared with high-risk patients who received adjuvant radiotherapy.
This is the first prospective study to evaluate radiation decisions among patients with DCIS.
Lead author Seema A. Khan, MD, who presented the research, called the findings “reassuring.”
However, “we need larger and better trials” as well as longer follow-up to confirm this less-is-more approach, said Dr. Khan, a breast cancer surgeon and researcher at Northwestern University, Chicago.
Virginia Kaklamani, MD, who moderated the presentation, noted that it is good to finally have prospective data on this topic. And although they are not definitive, “I personally think these results should be used” for counseling, said Dr. Kaklamani, leader of the breast cancer program at UT Health San Antonio.
To reduce the risk for DCIS recurrence or progression to invasive breast cancer, most patients with DCIS undergo breast-conserving surgery followed by adjuvant radiotherapy, Dr. Khan explained. Instead of breast-conserving surgery, about one in four patients opt for mastectomy.
Earlier results from this trial revealed that MRI helped identify patients who can safely receive breast-conserving surgery instead of mastectomy.
The current results assessed whether the Oncotype DX score can guide radiation treatment decisions.
The study included 171 patients with DCIS who had wide local excisions after MRI confirmed that they could forgo more extensive surgery.
Surgical specimens were then sent for testing to determine the DCIS score using the 12-gene Oncotype DX test.
Women who scored < 39 points on the 100-point Oncotype DX scale were considered to be at low risk for recurrence and were advised to skip radiation. Women who scored > 39 were advised to undergo radiation. Overall, 93% of the patients followed the radiation recommendations: 75 of 82 patients (91.4%) deemed as low risk skipped adjuvant radiotherapy and 84 of 89 patients (94.4%) deemed as high risk had radiotherapy.
At a median follow-up of 5 years, 5.1% (4 of 82) of low-risk patients experienced a recurrence vs. 4.5% (4 of 89) of higher-risk patients.
Recurrence rates among patients who followed the radiation recommendations mirrored these overall findings: 5.5% of 75 patients with low-risk DCIS who skipped radiotherapy experienced disease recurrence vs. 4.8% of 84 patients with high-risk DCIS who received radiotherapy.
Age did not appear to affect the outcomes. Among the 33 women younger than 50 years, two experienced a recurrence (4%), both invasive. One occurred in the low-risk group and the other in the higher-risk group. Among the 138 older women, six had recurrences, three in each group, and one recurrence in each was invasive.
In short, “women who skipped radiation based on this score did not experience an excess risk of” ipsilateral recurrence over 5 years, said Dr. Khan.
Overall, the study offers “strong evidence” that the DCIS score might help “prevent excessive treatment for some patients,” she concluded, adding that 10-year outcomes will be reported.
The work was funded by the National Cancer Institute. Dr. Khan has no conflicts of interest. Dr. Kaklamani has extensive industry ties, including being a speaker for Pfizer, Genentech, Novartis, and AstraZeneca.
A version in the article appeared on Medscape.com.
SAN ANTONIO — There’s a long-standing concern among oncologists that many women with ductal carcinoma in situ (DCIS), a potential precursor to invasive breast cancer, receive more treatment than they need. The potential for overtreatment largely revolves around the extent of surgery and the use of radiation.
Using the Oncotype DX Breast DCIS Score test, a laboratory test that estimates DCIS recurrence risk, may help identify patients with low-risk DCIS who can safely avoid adjuvant radiation after surgery, according to new research (abstract GS03-01) presented at the San Antonio Breast Cancer Symposium.
Low-risk patients who skipped adjuvant radiotherapy after breast-conserving surgery demonstrated similar 5-year recurrence rates compared with high-risk patients who received adjuvant radiotherapy.
This is the first prospective study to evaluate radiation decisions among patients with DCIS.
Lead author Seema A. Khan, MD, who presented the research, called the findings “reassuring.”
However, “we need larger and better trials” as well as longer follow-up to confirm this less-is-more approach, said Dr. Khan, a breast cancer surgeon and researcher at Northwestern University, Chicago.
Virginia Kaklamani, MD, who moderated the presentation, noted that it is good to finally have prospective data on this topic. And although they are not definitive, “I personally think these results should be used” for counseling, said Dr. Kaklamani, leader of the breast cancer program at UT Health San Antonio.
To reduce the risk for DCIS recurrence or progression to invasive breast cancer, most patients with DCIS undergo breast-conserving surgery followed by adjuvant radiotherapy, Dr. Khan explained. Instead of breast-conserving surgery, about one in four patients opt for mastectomy.
Earlier results from this trial revealed that MRI helped identify patients who can safely receive breast-conserving surgery instead of mastectomy.
The current results assessed whether the Oncotype DX score can guide radiation treatment decisions.
The study included 171 patients with DCIS who had wide local excisions after MRI confirmed that they could forgo more extensive surgery.
Surgical specimens were then sent for testing to determine the DCIS score using the 12-gene Oncotype DX test.
Women who scored < 39 points on the 100-point Oncotype DX scale were considered to be at low risk for recurrence and were advised to skip radiation. Women who scored > 39 were advised to undergo radiation. Overall, 93% of the patients followed the radiation recommendations: 75 of 82 patients (91.4%) deemed as low risk skipped adjuvant radiotherapy and 84 of 89 patients (94.4%) deemed as high risk had radiotherapy.
At a median follow-up of 5 years, 5.1% (4 of 82) of low-risk patients experienced a recurrence vs. 4.5% (4 of 89) of higher-risk patients.
Recurrence rates among patients who followed the radiation recommendations mirrored these overall findings: 5.5% of 75 patients with low-risk DCIS who skipped radiotherapy experienced disease recurrence vs. 4.8% of 84 patients with high-risk DCIS who received radiotherapy.
Age did not appear to affect the outcomes. Among the 33 women younger than 50 years, two experienced a recurrence (4%), both invasive. One occurred in the low-risk group and the other in the higher-risk group. Among the 138 older women, six had recurrences, three in each group, and one recurrence in each was invasive.
In short, “women who skipped radiation based on this score did not experience an excess risk of” ipsilateral recurrence over 5 years, said Dr. Khan.
Overall, the study offers “strong evidence” that the DCIS score might help “prevent excessive treatment for some patients,” she concluded, adding that 10-year outcomes will be reported.
The work was funded by the National Cancer Institute. Dr. Khan has no conflicts of interest. Dr. Kaklamani has extensive industry ties, including being a speaker for Pfizer, Genentech, Novartis, and AstraZeneca.
A version in the article appeared on Medscape.com.
SAN ANTONIO — There’s a long-standing concern among oncologists that many women with ductal carcinoma in situ (DCIS), a potential precursor to invasive breast cancer, receive more treatment than they need. The potential for overtreatment largely revolves around the extent of surgery and the use of radiation.
Using the Oncotype DX Breast DCIS Score test, a laboratory test that estimates DCIS recurrence risk, may help identify patients with low-risk DCIS who can safely avoid adjuvant radiation after surgery, according to new research (abstract GS03-01) presented at the San Antonio Breast Cancer Symposium.
Low-risk patients who skipped adjuvant radiotherapy after breast-conserving surgery demonstrated similar 5-year recurrence rates compared with high-risk patients who received adjuvant radiotherapy.
This is the first prospective study to evaluate radiation decisions among patients with DCIS.
Lead author Seema A. Khan, MD, who presented the research, called the findings “reassuring.”
However, “we need larger and better trials” as well as longer follow-up to confirm this less-is-more approach, said Dr. Khan, a breast cancer surgeon and researcher at Northwestern University, Chicago.
Virginia Kaklamani, MD, who moderated the presentation, noted that it is good to finally have prospective data on this topic. And although they are not definitive, “I personally think these results should be used” for counseling, said Dr. Kaklamani, leader of the breast cancer program at UT Health San Antonio.
To reduce the risk for DCIS recurrence or progression to invasive breast cancer, most patients with DCIS undergo breast-conserving surgery followed by adjuvant radiotherapy, Dr. Khan explained. Instead of breast-conserving surgery, about one in four patients opt for mastectomy.
Earlier results from this trial revealed that MRI helped identify patients who can safely receive breast-conserving surgery instead of mastectomy.
The current results assessed whether the Oncotype DX score can guide radiation treatment decisions.
The study included 171 patients with DCIS who had wide local excisions after MRI confirmed that they could forgo more extensive surgery.
Surgical specimens were then sent for testing to determine the DCIS score using the 12-gene Oncotype DX test.
Women who scored < 39 points on the 100-point Oncotype DX scale were considered to be at low risk for recurrence and were advised to skip radiation. Women who scored > 39 were advised to undergo radiation. Overall, 93% of the patients followed the radiation recommendations: 75 of 82 patients (91.4%) deemed as low risk skipped adjuvant radiotherapy and 84 of 89 patients (94.4%) deemed as high risk had radiotherapy.
At a median follow-up of 5 years, 5.1% (4 of 82) of low-risk patients experienced a recurrence vs. 4.5% (4 of 89) of higher-risk patients.
Recurrence rates among patients who followed the radiation recommendations mirrored these overall findings: 5.5% of 75 patients with low-risk DCIS who skipped radiotherapy experienced disease recurrence vs. 4.8% of 84 patients with high-risk DCIS who received radiotherapy.
Age did not appear to affect the outcomes. Among the 33 women younger than 50 years, two experienced a recurrence (4%), both invasive. One occurred in the low-risk group and the other in the higher-risk group. Among the 138 older women, six had recurrences, three in each group, and one recurrence in each was invasive.
In short, “women who skipped radiation based on this score did not experience an excess risk of” ipsilateral recurrence over 5 years, said Dr. Khan.
Overall, the study offers “strong evidence” that the DCIS score might help “prevent excessive treatment for some patients,” she concluded, adding that 10-year outcomes will be reported.
The work was funded by the National Cancer Institute. Dr. Khan has no conflicts of interest. Dr. Kaklamani has extensive industry ties, including being a speaker for Pfizer, Genentech, Novartis, and AstraZeneca.
A version in the article appeared on Medscape.com.
FROM SABCS 2023
When to skip regional nodal radiation in breast cancer
SAN ANTONIO — There’s a long-standing debate in breast oncology about what to do when positive axillary lymph nodes turn negative after neoadjuvant chemotherapy.
Currently, it’s about a 50/50 split among oncologists, according to breast cancer surgeon Eleftherios P. Mamounas, MD, medical director of the Comprehensive Breast Program at the Orlando Health Cancer Institute in Florida.
Until now, Dr. Mamounas’s own institution has opted for regional irradiation just to be on the safe side, but he said that’s going to change in the wake of a multicenter trial he presented at the San Antonio Breast Cancer Symposium.
Dr. Mamounas led a team that randomized 1556 women equally to either regional nodal irradiation or no nodal irradiation following surgery, which was lumpectomy in just over half the subjects and mastectomy in the rest.
Women were a median of 52 years old. Almost 60% had T2 disease and the rest were split about evenly between T1 and T3 disease. Nearly a quarter of the tumors were triple-negative, and over half were HER2 positive.
In the regional nodal irradiation arm, women who had mastectomies had chest wall irradiation in addition to regional nodal irradiation, while women who underwent lumpectomies had whole breast irradiation with regional nodal irradiation. In the no-irradiation group, mastectomies were followed by observation and lumpectomies by whole breast irradiation alone.
All the women had positive axillary lymph nodes (N1) on needle biopsies at baseline that were found to be free of cancer at surgery (ypN0) following neoadjuvant chemotherapy. Neoadjuvant therapy consisted of at least 8 weeks of chemotherapy plus anti-HER2 therapy for HER2-positive patients.
Dr. Mamounas and colleagues observed no meaningful differences in outcomes between the two groups: 92.7% of women in the nodal irradiation arm and 91.8% in the no-irradiation arm were free from invasive recurrences 5 years after surgery.
Patients in both groups demonstrated similar 5-year disease-free survival and overall survival. The 5-year disease-free survival was 88.5% without and 88.3% with regional nodal irradiation and 5-year overall survival was 94% without and 93.6% with regional nodal irradiation.
The team did not observe study-related deaths or unexpected toxicities. Overall, 6.5% of patients without regional nodal irradiation developed grade 3 toxicity vs. 10% of patients with irradiation. Grade 4 toxicity was rare, occurring in 0.1% of patients in the no-irradiation group vs. 0.5% in the irradiation group.
The trial answers “a very important question,” according to Kate Lathrop, MD, a breast medical oncologist at UT Health San Antonio, who moderated the presentation.
The trial results were “highly awaited” because “we didn’t have the data to make these” decisions, Dr. Lathrop said.
Knowing these patients do just as well without regional nodal irradiation is “going to change a lot of opinions,” said Dr. Lathrop, because we can avoid subjecting patients to unnecessary toxicity, including lymphedema with regional nodal irradiation as well as problems with breast reconstruction after mastectomy.
Because recurrences can still occur after 5 years, Dr. Mamounas’s team will continue to follow the women, but he believes “it’s very unlikely that long-term distant disease-free survival will change.”
Based on the study, “we will omit” regional nodal irradiation for women who fit the study criteria, Dr. Mamounas said.
When asked if women should ask their doctors about skipping regional nodal irradiation, Dr. Mamounas said “absolutely.”
“I think it requires a discussion at this point,” he explained. “Based on the data, it’s a reasonable conclusion that radiotherapy can be avoided” in many cases, such as in lower-stage women with one initially positive node.
Dr. Mamounas said he thinks patients will be interested in the approach “because they are really looking to avoid radiotherapy” if they can.
The work was funded by the National Cancer Institute. Dr. Mamounas has been a consultant and speaker for Genentech, Merck, and an adviser for TerSera Therapeutics, Biotheranostics Inc., and Sanofi. He owns stock in Moderna. Dr. Lathrop is a consultant for Pfizer, GE Healthcare, and Biotheranostics, and a speaker for Biotheranostics.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — There’s a long-standing debate in breast oncology about what to do when positive axillary lymph nodes turn negative after neoadjuvant chemotherapy.
Currently, it’s about a 50/50 split among oncologists, according to breast cancer surgeon Eleftherios P. Mamounas, MD, medical director of the Comprehensive Breast Program at the Orlando Health Cancer Institute in Florida.
Until now, Dr. Mamounas’s own institution has opted for regional irradiation just to be on the safe side, but he said that’s going to change in the wake of a multicenter trial he presented at the San Antonio Breast Cancer Symposium.
Dr. Mamounas led a team that randomized 1556 women equally to either regional nodal irradiation or no nodal irradiation following surgery, which was lumpectomy in just over half the subjects and mastectomy in the rest.
Women were a median of 52 years old. Almost 60% had T2 disease and the rest were split about evenly between T1 and T3 disease. Nearly a quarter of the tumors were triple-negative, and over half were HER2 positive.
In the regional nodal irradiation arm, women who had mastectomies had chest wall irradiation in addition to regional nodal irradiation, while women who underwent lumpectomies had whole breast irradiation with regional nodal irradiation. In the no-irradiation group, mastectomies were followed by observation and lumpectomies by whole breast irradiation alone.
All the women had positive axillary lymph nodes (N1) on needle biopsies at baseline that were found to be free of cancer at surgery (ypN0) following neoadjuvant chemotherapy. Neoadjuvant therapy consisted of at least 8 weeks of chemotherapy plus anti-HER2 therapy for HER2-positive patients.
Dr. Mamounas and colleagues observed no meaningful differences in outcomes between the two groups: 92.7% of women in the nodal irradiation arm and 91.8% in the no-irradiation arm were free from invasive recurrences 5 years after surgery.
Patients in both groups demonstrated similar 5-year disease-free survival and overall survival. The 5-year disease-free survival was 88.5% without and 88.3% with regional nodal irradiation and 5-year overall survival was 94% without and 93.6% with regional nodal irradiation.
The team did not observe study-related deaths or unexpected toxicities. Overall, 6.5% of patients without regional nodal irradiation developed grade 3 toxicity vs. 10% of patients with irradiation. Grade 4 toxicity was rare, occurring in 0.1% of patients in the no-irradiation group vs. 0.5% in the irradiation group.
The trial answers “a very important question,” according to Kate Lathrop, MD, a breast medical oncologist at UT Health San Antonio, who moderated the presentation.
The trial results were “highly awaited” because “we didn’t have the data to make these” decisions, Dr. Lathrop said.
Knowing these patients do just as well without regional nodal irradiation is “going to change a lot of opinions,” said Dr. Lathrop, because we can avoid subjecting patients to unnecessary toxicity, including lymphedema with regional nodal irradiation as well as problems with breast reconstruction after mastectomy.
Because recurrences can still occur after 5 years, Dr. Mamounas’s team will continue to follow the women, but he believes “it’s very unlikely that long-term distant disease-free survival will change.”
Based on the study, “we will omit” regional nodal irradiation for women who fit the study criteria, Dr. Mamounas said.
When asked if women should ask their doctors about skipping regional nodal irradiation, Dr. Mamounas said “absolutely.”
“I think it requires a discussion at this point,” he explained. “Based on the data, it’s a reasonable conclusion that radiotherapy can be avoided” in many cases, such as in lower-stage women with one initially positive node.
Dr. Mamounas said he thinks patients will be interested in the approach “because they are really looking to avoid radiotherapy” if they can.
The work was funded by the National Cancer Institute. Dr. Mamounas has been a consultant and speaker for Genentech, Merck, and an adviser for TerSera Therapeutics, Biotheranostics Inc., and Sanofi. He owns stock in Moderna. Dr. Lathrop is a consultant for Pfizer, GE Healthcare, and Biotheranostics, and a speaker for Biotheranostics.
A version of this article first appeared on Medscape.com.
SAN ANTONIO — There’s a long-standing debate in breast oncology about what to do when positive axillary lymph nodes turn negative after neoadjuvant chemotherapy.
Currently, it’s about a 50/50 split among oncologists, according to breast cancer surgeon Eleftherios P. Mamounas, MD, medical director of the Comprehensive Breast Program at the Orlando Health Cancer Institute in Florida.
Until now, Dr. Mamounas’s own institution has opted for regional irradiation just to be on the safe side, but he said that’s going to change in the wake of a multicenter trial he presented at the San Antonio Breast Cancer Symposium.
Dr. Mamounas led a team that randomized 1556 women equally to either regional nodal irradiation or no nodal irradiation following surgery, which was lumpectomy in just over half the subjects and mastectomy in the rest.
Women were a median of 52 years old. Almost 60% had T2 disease and the rest were split about evenly between T1 and T3 disease. Nearly a quarter of the tumors were triple-negative, and over half were HER2 positive.
In the regional nodal irradiation arm, women who had mastectomies had chest wall irradiation in addition to regional nodal irradiation, while women who underwent lumpectomies had whole breast irradiation with regional nodal irradiation. In the no-irradiation group, mastectomies were followed by observation and lumpectomies by whole breast irradiation alone.
All the women had positive axillary lymph nodes (N1) on needle biopsies at baseline that were found to be free of cancer at surgery (ypN0) following neoadjuvant chemotherapy. Neoadjuvant therapy consisted of at least 8 weeks of chemotherapy plus anti-HER2 therapy for HER2-positive patients.
Dr. Mamounas and colleagues observed no meaningful differences in outcomes between the two groups: 92.7% of women in the nodal irradiation arm and 91.8% in the no-irradiation arm were free from invasive recurrences 5 years after surgery.
Patients in both groups demonstrated similar 5-year disease-free survival and overall survival. The 5-year disease-free survival was 88.5% without and 88.3% with regional nodal irradiation and 5-year overall survival was 94% without and 93.6% with regional nodal irradiation.
The team did not observe study-related deaths or unexpected toxicities. Overall, 6.5% of patients without regional nodal irradiation developed grade 3 toxicity vs. 10% of patients with irradiation. Grade 4 toxicity was rare, occurring in 0.1% of patients in the no-irradiation group vs. 0.5% in the irradiation group.
The trial answers “a very important question,” according to Kate Lathrop, MD, a breast medical oncologist at UT Health San Antonio, who moderated the presentation.
The trial results were “highly awaited” because “we didn’t have the data to make these” decisions, Dr. Lathrop said.
Knowing these patients do just as well without regional nodal irradiation is “going to change a lot of opinions,” said Dr. Lathrop, because we can avoid subjecting patients to unnecessary toxicity, including lymphedema with regional nodal irradiation as well as problems with breast reconstruction after mastectomy.
Because recurrences can still occur after 5 years, Dr. Mamounas’s team will continue to follow the women, but he believes “it’s very unlikely that long-term distant disease-free survival will change.”
Based on the study, “we will omit” regional nodal irradiation for women who fit the study criteria, Dr. Mamounas said.
When asked if women should ask their doctors about skipping regional nodal irradiation, Dr. Mamounas said “absolutely.”
“I think it requires a discussion at this point,” he explained. “Based on the data, it’s a reasonable conclusion that radiotherapy can be avoided” in many cases, such as in lower-stage women with one initially positive node.
Dr. Mamounas said he thinks patients will be interested in the approach “because they are really looking to avoid radiotherapy” if they can.
The work was funded by the National Cancer Institute. Dr. Mamounas has been a consultant and speaker for Genentech, Merck, and an adviser for TerSera Therapeutics, Biotheranostics Inc., and Sanofi. He owns stock in Moderna. Dr. Lathrop is a consultant for Pfizer, GE Healthcare, and Biotheranostics, and a speaker for Biotheranostics.
A version of this article first appeared on Medscape.com.
AT SABCS 2023
ASCO details how to manage ongoing cancer drug shortage
As of November 30, the US Food and Drug Administration lists 16 commonly used oncology drugs currently in shortage, including methotrexate, capecitabine, vinblastine, carboplatin, and cisplatin, along with another 13 discontinued agents.
The ASCO guidance, which is updated regularly on ASCO’s drug shortage website, covers dozens of clinical situations involving breast, gastrointestinal, genitourinary, gynecologic, thoracic, and head & neck cancers, as well as Hodgkin lymphoma.
The recommendations, published earlier in JCO Oncology Practice, represent the work of a Drug Shortages Advisory Group with over 40 oncologists, ethicists, and patient advocates brought together by ASCO in collaboration with the Society for Gynecologic Oncology.
In the guidance, the advisory group also provides some context about why these shortage issues have persisted, including a paucity of generic options, quality control issues, and reluctance among manufacturers to produce older drugs with slim profit margins.
And “while ASCO continues to work to address the root causes of the shortages, this guidance document aims to support clinicians, as they navigate the complexities of treatment planning amid the drug shortage, and patients with cancer who are already enduring physical and emotional hardships,” the advisory group writes.
The overall message in the guidance: conserve oncology drugs in limited supply to use when needed most.
The recommendations highlight alternative regimens, when available, and what to do in situations when there are no alternatives, advice that has become particularly relevant for the oncology workhorses cisplatin and carboplatin.
More generally, when ranges of acceptable doses and dose frequencies exist for drugs in short supply, clinicians should opt for the lowest dose at the longest interval. Dose rounding and multi-use vials should also be used to eliminate waste, and alternatives should be used whenever possible. If an alternative agent with similar efficacy and safety is available, the agent in limited supply should not be ordered.
In certain settings where no reasonable alternatives to platinum regimens exist, the advisory group recommends patients travel to where platinum agents are available. The group noted this strategy specifically for patients with non–small cell lung cancer or testicular germ cell cancers, but also acknowledged that this option “may cause additional financial toxicity, hardship, and distress.”
Other, more granular advice includes holding carboplatin in reserve for patients with early-stage triple-negative breast cancer on neoadjuvant therapy who don’t respond well to upfront doxorubicin, cyclophosphamide, and pembrolizumab.
In addition to providing strategies to manage the ongoing cancer drug shortages, ASCO advises counseling for patients and clinicians struggling with the “psychological or moral distress” from the ongoing shortages.
“Unfortunately, drug shortages place the patient and the provider in a challenging situation, possibly resulting in inferior outcomes, delayed or denied care, and increased adverse events,” the advisory group writes. “ASCO will continue to respond to the oncology drug shortage crisis through policy and advocacy efforts, provide ethical guidance for allocation and prioritization decisions, and maintain shortage-specific clinical guidance as long as necessary.”
A version of this article appeared on Medscape.com.
As of November 30, the US Food and Drug Administration lists 16 commonly used oncology drugs currently in shortage, including methotrexate, capecitabine, vinblastine, carboplatin, and cisplatin, along with another 13 discontinued agents.
The ASCO guidance, which is updated regularly on ASCO’s drug shortage website, covers dozens of clinical situations involving breast, gastrointestinal, genitourinary, gynecologic, thoracic, and head & neck cancers, as well as Hodgkin lymphoma.
The recommendations, published earlier in JCO Oncology Practice, represent the work of a Drug Shortages Advisory Group with over 40 oncologists, ethicists, and patient advocates brought together by ASCO in collaboration with the Society for Gynecologic Oncology.
In the guidance, the advisory group also provides some context about why these shortage issues have persisted, including a paucity of generic options, quality control issues, and reluctance among manufacturers to produce older drugs with slim profit margins.
And “while ASCO continues to work to address the root causes of the shortages, this guidance document aims to support clinicians, as they navigate the complexities of treatment planning amid the drug shortage, and patients with cancer who are already enduring physical and emotional hardships,” the advisory group writes.
The overall message in the guidance: conserve oncology drugs in limited supply to use when needed most.
The recommendations highlight alternative regimens, when available, and what to do in situations when there are no alternatives, advice that has become particularly relevant for the oncology workhorses cisplatin and carboplatin.
More generally, when ranges of acceptable doses and dose frequencies exist for drugs in short supply, clinicians should opt for the lowest dose at the longest interval. Dose rounding and multi-use vials should also be used to eliminate waste, and alternatives should be used whenever possible. If an alternative agent with similar efficacy and safety is available, the agent in limited supply should not be ordered.
In certain settings where no reasonable alternatives to platinum regimens exist, the advisory group recommends patients travel to where platinum agents are available. The group noted this strategy specifically for patients with non–small cell lung cancer or testicular germ cell cancers, but also acknowledged that this option “may cause additional financial toxicity, hardship, and distress.”
Other, more granular advice includes holding carboplatin in reserve for patients with early-stage triple-negative breast cancer on neoadjuvant therapy who don’t respond well to upfront doxorubicin, cyclophosphamide, and pembrolizumab.
In addition to providing strategies to manage the ongoing cancer drug shortages, ASCO advises counseling for patients and clinicians struggling with the “psychological or moral distress” from the ongoing shortages.
“Unfortunately, drug shortages place the patient and the provider in a challenging situation, possibly resulting in inferior outcomes, delayed or denied care, and increased adverse events,” the advisory group writes. “ASCO will continue to respond to the oncology drug shortage crisis through policy and advocacy efforts, provide ethical guidance for allocation and prioritization decisions, and maintain shortage-specific clinical guidance as long as necessary.”
A version of this article appeared on Medscape.com.
As of November 30, the US Food and Drug Administration lists 16 commonly used oncology drugs currently in shortage, including methotrexate, capecitabine, vinblastine, carboplatin, and cisplatin, along with another 13 discontinued agents.
The ASCO guidance, which is updated regularly on ASCO’s drug shortage website, covers dozens of clinical situations involving breast, gastrointestinal, genitourinary, gynecologic, thoracic, and head & neck cancers, as well as Hodgkin lymphoma.
The recommendations, published earlier in JCO Oncology Practice, represent the work of a Drug Shortages Advisory Group with over 40 oncologists, ethicists, and patient advocates brought together by ASCO in collaboration with the Society for Gynecologic Oncology.
In the guidance, the advisory group also provides some context about why these shortage issues have persisted, including a paucity of generic options, quality control issues, and reluctance among manufacturers to produce older drugs with slim profit margins.
And “while ASCO continues to work to address the root causes of the shortages, this guidance document aims to support clinicians, as they navigate the complexities of treatment planning amid the drug shortage, and patients with cancer who are already enduring physical and emotional hardships,” the advisory group writes.
The overall message in the guidance: conserve oncology drugs in limited supply to use when needed most.
The recommendations highlight alternative regimens, when available, and what to do in situations when there are no alternatives, advice that has become particularly relevant for the oncology workhorses cisplatin and carboplatin.
More generally, when ranges of acceptable doses and dose frequencies exist for drugs in short supply, clinicians should opt for the lowest dose at the longest interval. Dose rounding and multi-use vials should also be used to eliminate waste, and alternatives should be used whenever possible. If an alternative agent with similar efficacy and safety is available, the agent in limited supply should not be ordered.
In certain settings where no reasonable alternatives to platinum regimens exist, the advisory group recommends patients travel to where platinum agents are available. The group noted this strategy specifically for patients with non–small cell lung cancer or testicular germ cell cancers, but also acknowledged that this option “may cause additional financial toxicity, hardship, and distress.”
Other, more granular advice includes holding carboplatin in reserve for patients with early-stage triple-negative breast cancer on neoadjuvant therapy who don’t respond well to upfront doxorubicin, cyclophosphamide, and pembrolizumab.
In addition to providing strategies to manage the ongoing cancer drug shortages, ASCO advises counseling for patients and clinicians struggling with the “psychological or moral distress” from the ongoing shortages.
“Unfortunately, drug shortages place the patient and the provider in a challenging situation, possibly resulting in inferior outcomes, delayed or denied care, and increased adverse events,” the advisory group writes. “ASCO will continue to respond to the oncology drug shortage crisis through policy and advocacy efforts, provide ethical guidance for allocation and prioritization decisions, and maintain shortage-specific clinical guidance as long as necessary.”
A version of this article appeared on Medscape.com.
FROM JCO ONCOLOGY PRACTICE
FDA OKs new agent to block chemotherapy-induced neutropenia
Efbemalenograstim joins other agents already on the U.S. market, including pegfilgrastim (Neulasta), that aim to reduce the incidence of chemotherapy-induced febrile neutropenia.
The approval of efbemalenograstim was based on two randomized trials. The first included 122 women with either metastatic or nonmetastatic breast cancer who were receiving doxorubicin and docetaxel. These patients were randomly assigned to receive either one subcutaneous injection of efbemalenograstim or placebo on the second day of their first chemotherapy cycle. All patients received efbemalenograstim on the second day of cycles two through four.
The mean duration of grade 4 neutropenia in the first cycle was 1.4 days with efbemalenograstim versus 4.3 days with placebo. Only 4.8% of patients who received efbemalenograstim experienced chemotherapy-induced febrile neutropenia, compared with 25.6% who received the placebo.
The new agent went up against pegfilgrastim in the second trial, which included 393 women who received docetaxel and cyclophosphamide as treatment for nonmetastatic breast cancer. These patients were randomly assigned to receive either a single subcutaneous injection of efbemalenograstim or pegfilgrastim on the second day of each cycle.
During the first cycle, patients in both arms of the trial experienced a mean of 0.2 days of grade 4 neutropenia.
The most common side effects associated with efbemalenograstim were nausea, anemia, and thrombocytopenia. Similar to pegfilgrastim’s label, efbemalenograstim’s label warns of possible splenic rupture, respiratory distress syndrome, sickle cell crisis, and other serious adverse events.
The FDA recommends a dose of 20 mg subcutaneous once per chemotherapy cycle.
A version of this article first appeared on Medscape.com.
Efbemalenograstim joins other agents already on the U.S. market, including pegfilgrastim (Neulasta), that aim to reduce the incidence of chemotherapy-induced febrile neutropenia.
The approval of efbemalenograstim was based on two randomized trials. The first included 122 women with either metastatic or nonmetastatic breast cancer who were receiving doxorubicin and docetaxel. These patients were randomly assigned to receive either one subcutaneous injection of efbemalenograstim or placebo on the second day of their first chemotherapy cycle. All patients received efbemalenograstim on the second day of cycles two through four.
The mean duration of grade 4 neutropenia in the first cycle was 1.4 days with efbemalenograstim versus 4.3 days with placebo. Only 4.8% of patients who received efbemalenograstim experienced chemotherapy-induced febrile neutropenia, compared with 25.6% who received the placebo.
The new agent went up against pegfilgrastim in the second trial, which included 393 women who received docetaxel and cyclophosphamide as treatment for nonmetastatic breast cancer. These patients were randomly assigned to receive either a single subcutaneous injection of efbemalenograstim or pegfilgrastim on the second day of each cycle.
During the first cycle, patients in both arms of the trial experienced a mean of 0.2 days of grade 4 neutropenia.
The most common side effects associated with efbemalenograstim were nausea, anemia, and thrombocytopenia. Similar to pegfilgrastim’s label, efbemalenograstim’s label warns of possible splenic rupture, respiratory distress syndrome, sickle cell crisis, and other serious adverse events.
The FDA recommends a dose of 20 mg subcutaneous once per chemotherapy cycle.
A version of this article first appeared on Medscape.com.
Efbemalenograstim joins other agents already on the U.S. market, including pegfilgrastim (Neulasta), that aim to reduce the incidence of chemotherapy-induced febrile neutropenia.
The approval of efbemalenograstim was based on two randomized trials. The first included 122 women with either metastatic or nonmetastatic breast cancer who were receiving doxorubicin and docetaxel. These patients were randomly assigned to receive either one subcutaneous injection of efbemalenograstim or placebo on the second day of their first chemotherapy cycle. All patients received efbemalenograstim on the second day of cycles two through four.
The mean duration of grade 4 neutropenia in the first cycle was 1.4 days with efbemalenograstim versus 4.3 days with placebo. Only 4.8% of patients who received efbemalenograstim experienced chemotherapy-induced febrile neutropenia, compared with 25.6% who received the placebo.
The new agent went up against pegfilgrastim in the second trial, which included 393 women who received docetaxel and cyclophosphamide as treatment for nonmetastatic breast cancer. These patients were randomly assigned to receive either a single subcutaneous injection of efbemalenograstim or pegfilgrastim on the second day of each cycle.
During the first cycle, patients in both arms of the trial experienced a mean of 0.2 days of grade 4 neutropenia.
The most common side effects associated with efbemalenograstim were nausea, anemia, and thrombocytopenia. Similar to pegfilgrastim’s label, efbemalenograstim’s label warns of possible splenic rupture, respiratory distress syndrome, sickle cell crisis, and other serious adverse events.
The FDA recommends a dose of 20 mg subcutaneous once per chemotherapy cycle.
A version of this article first appeared on Medscape.com.
Surgery is falling out of favor in rectal cancer
TOPLINE:
METHODOLOGY:
- The National Comprehensive Cancer Network endorses watchful waiting, instead of surgery, when patients with rectal cancer have a complete clinical response to neoadjuvant therapy, but it’s unclear how often patients and providers opt for this organ preservation approach.
- To find out, investigators reviewed 175,545 adults in the National Cancer Database treated for rectal adenocarcinoma from 2006 to 2020.
- The research team assessed changes in the proportion of patients who were treated with chemotherapy and/or radiation without tumor resection, transanal local excision, or removal of the rectum.
- Patients had a mean age of 63 years, 39.7% were women, 17.4% had stage 1 disease, 24.7% had stage 2A-C disease, and 32.1% had stage 3A-C tumors; tumor stage was unknown in just over a quarter of patients.
TAKEAWAY:
- The absolute annual proportion of organ preservation increased by more than 50% from 18.4% in 2006 to 28.2% in 2020.
- In that time frame, organ preservation increased from 19.5% to 32.5% – a percent increase of about 67% – for patients with stage 2A-C disease, 16.2% to 29.1% – a percent increase of about 80% – for patients with stage 3A-C disease, and 16.5% to 26.6% – a percent increase of about 60% – for those with unknown stages.
- However, the rate of proctectomies increased by 6.1 percentage points, or by about 30%, among patients with stage I rectal cancer – from 20.3% to 26.4%.
- Among patients who did have surgery, the proportion who had complete pathologic responses to neoadjuvant therapy nearly tripled, increasing from 6.5% to 18.8%.
IN PRACTICE:
“This case series shows that rectal cancer is increasingly being managed medically, especially among patients whose treatment historically relied on proctectomy,” the authors concluded. However, protocols to standardize the approach are lacking, which is why “establishing quality standards for organ preservation is a pressing issue that should involve all relevant stakeholders, including patients.”
SOURCE:
The study, led by Anthony Loria, MD, MSCI, of the University of Rochester (N.Y.), was published online in JAMA Oncology.
LIMITATIONS:
The percentage of people who needed surgery for recurrence, patient and facility factors associated with organ preservation, and overall survival outcomes were not addressed.
DISCLOSURES:
No external funding was reported, and the investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The National Comprehensive Cancer Network endorses watchful waiting, instead of surgery, when patients with rectal cancer have a complete clinical response to neoadjuvant therapy, but it’s unclear how often patients and providers opt for this organ preservation approach.
- To find out, investigators reviewed 175,545 adults in the National Cancer Database treated for rectal adenocarcinoma from 2006 to 2020.
- The research team assessed changes in the proportion of patients who were treated with chemotherapy and/or radiation without tumor resection, transanal local excision, or removal of the rectum.
- Patients had a mean age of 63 years, 39.7% were women, 17.4% had stage 1 disease, 24.7% had stage 2A-C disease, and 32.1% had stage 3A-C tumors; tumor stage was unknown in just over a quarter of patients.
TAKEAWAY:
- The absolute annual proportion of organ preservation increased by more than 50% from 18.4% in 2006 to 28.2% in 2020.
- In that time frame, organ preservation increased from 19.5% to 32.5% – a percent increase of about 67% – for patients with stage 2A-C disease, 16.2% to 29.1% – a percent increase of about 80% – for patients with stage 3A-C disease, and 16.5% to 26.6% – a percent increase of about 60% – for those with unknown stages.
- However, the rate of proctectomies increased by 6.1 percentage points, or by about 30%, among patients with stage I rectal cancer – from 20.3% to 26.4%.
- Among patients who did have surgery, the proportion who had complete pathologic responses to neoadjuvant therapy nearly tripled, increasing from 6.5% to 18.8%.
IN PRACTICE:
“This case series shows that rectal cancer is increasingly being managed medically, especially among patients whose treatment historically relied on proctectomy,” the authors concluded. However, protocols to standardize the approach are lacking, which is why “establishing quality standards for organ preservation is a pressing issue that should involve all relevant stakeholders, including patients.”
SOURCE:
The study, led by Anthony Loria, MD, MSCI, of the University of Rochester (N.Y.), was published online in JAMA Oncology.
LIMITATIONS:
The percentage of people who needed surgery for recurrence, patient and facility factors associated with organ preservation, and overall survival outcomes were not addressed.
DISCLOSURES:
No external funding was reported, and the investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The National Comprehensive Cancer Network endorses watchful waiting, instead of surgery, when patients with rectal cancer have a complete clinical response to neoadjuvant therapy, but it’s unclear how often patients and providers opt for this organ preservation approach.
- To find out, investigators reviewed 175,545 adults in the National Cancer Database treated for rectal adenocarcinoma from 2006 to 2020.
- The research team assessed changes in the proportion of patients who were treated with chemotherapy and/or radiation without tumor resection, transanal local excision, or removal of the rectum.
- Patients had a mean age of 63 years, 39.7% were women, 17.4% had stage 1 disease, 24.7% had stage 2A-C disease, and 32.1% had stage 3A-C tumors; tumor stage was unknown in just over a quarter of patients.
TAKEAWAY:
- The absolute annual proportion of organ preservation increased by more than 50% from 18.4% in 2006 to 28.2% in 2020.
- In that time frame, organ preservation increased from 19.5% to 32.5% – a percent increase of about 67% – for patients with stage 2A-C disease, 16.2% to 29.1% – a percent increase of about 80% – for patients with stage 3A-C disease, and 16.5% to 26.6% – a percent increase of about 60% – for those with unknown stages.
- However, the rate of proctectomies increased by 6.1 percentage points, or by about 30%, among patients with stage I rectal cancer – from 20.3% to 26.4%.
- Among patients who did have surgery, the proportion who had complete pathologic responses to neoadjuvant therapy nearly tripled, increasing from 6.5% to 18.8%.
IN PRACTICE:
“This case series shows that rectal cancer is increasingly being managed medically, especially among patients whose treatment historically relied on proctectomy,” the authors concluded. However, protocols to standardize the approach are lacking, which is why “establishing quality standards for organ preservation is a pressing issue that should involve all relevant stakeholders, including patients.”
SOURCE:
The study, led by Anthony Loria, MD, MSCI, of the University of Rochester (N.Y.), was published online in JAMA Oncology.
LIMITATIONS:
The percentage of people who needed surgery for recurrence, patient and facility factors associated with organ preservation, and overall survival outcomes were not addressed.
DISCLOSURES:
No external funding was reported, and the investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Low vitamin D linked to paclitaxel-induced peripheral neuropathy
TOPLINE:
, suggesting that correcting levels before treatment might help prevent the condition.
METHODOLOGY:
- Past studies have suggested an association between vitamin D insufficiency and paclitaxel-induced peripheral neuropathy, a largely untreatable and sometimes permanent side effect of chemotherapy.
- To confirm the association, investigators reviewed data and samples from 1,191 women in the phase 3 SWOG S0221 trial, which compared weekly and biweekly paclitaxel regimens for early-stage breast cancer.
- Using serum samples collected at baseline, the team evaluated the relationship between insufficient vitamin D levels (20 ng/mL or less) before treatment and grade 3 or higher sensory chemotherapy-induced peripheral neuropathy.
TAKEAWAY:
- Overall, 33.3% of the women had insufficient vitamin D levels at baseline, and 16.4% developed grade 3 or worse sensory chemotherapy-induced peripheral neuropathy.
- The incidence of peripheral neuropathy of grade 3 or greater was higher among patients with pretreatment vitamin D insufficiency (20.7% vs. 14.2%; odds ratio, 1.57; P = .005).
- The association grew stronger after adjusting for age and paclitaxel schedule (adjusted OR, 1.65; P = .003), but not after adjusting for race (adjusted OR, 1.39; P = .066).
IN PRACTICE:
The study “confirms that patients with pretreatment vitamin D insufficiency have a higher incidence of [chemotherapy-induced peripheral neuropathy],” the authors concluded. These results also “suggest that vitamin D supplementation in patients with lower levels of vitamin D may reduce peripheral neuropathy, and particularly high-grade peripheral neuropathy, which would improve these patients’ long-term quality of life,” senior researcher Daniel L. Hertz, PharmD, PhD, University of Michigan College of Pharmacy, Ann Arbor, said in a press release.
SOURCE:
The study, led by Ciao-Sin Chen, PharmD, of the University of Michigan, Ann Arbor, was published in the Journal of the National Comprehensive Cancer Network.
LIMITATIONS:
The trial did not collect data on other peripheral neuropathy risk factors, including preexisting peripheral neuropathy and diabetes. The study included a limited number of non-White participants (16%); larger numbers are needed to elucidate a potential interplay between race, vitamin D, and chemotherapy-induced peripheral neuropathy. The researchers also did not collect data on grade 1 and 2 chemotherapy-induced peripheral neuropathy.
DISCLOSURES:
The study was funded by Amgen, the American Cancer Society, and others. The investigators disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, suggesting that correcting levels before treatment might help prevent the condition.
METHODOLOGY:
- Past studies have suggested an association between vitamin D insufficiency and paclitaxel-induced peripheral neuropathy, a largely untreatable and sometimes permanent side effect of chemotherapy.
- To confirm the association, investigators reviewed data and samples from 1,191 women in the phase 3 SWOG S0221 trial, which compared weekly and biweekly paclitaxel regimens for early-stage breast cancer.
- Using serum samples collected at baseline, the team evaluated the relationship between insufficient vitamin D levels (20 ng/mL or less) before treatment and grade 3 or higher sensory chemotherapy-induced peripheral neuropathy.
TAKEAWAY:
- Overall, 33.3% of the women had insufficient vitamin D levels at baseline, and 16.4% developed grade 3 or worse sensory chemotherapy-induced peripheral neuropathy.
- The incidence of peripheral neuropathy of grade 3 or greater was higher among patients with pretreatment vitamin D insufficiency (20.7% vs. 14.2%; odds ratio, 1.57; P = .005).
- The association grew stronger after adjusting for age and paclitaxel schedule (adjusted OR, 1.65; P = .003), but not after adjusting for race (adjusted OR, 1.39; P = .066).
IN PRACTICE:
The study “confirms that patients with pretreatment vitamin D insufficiency have a higher incidence of [chemotherapy-induced peripheral neuropathy],” the authors concluded. These results also “suggest that vitamin D supplementation in patients with lower levels of vitamin D may reduce peripheral neuropathy, and particularly high-grade peripheral neuropathy, which would improve these patients’ long-term quality of life,” senior researcher Daniel L. Hertz, PharmD, PhD, University of Michigan College of Pharmacy, Ann Arbor, said in a press release.
SOURCE:
The study, led by Ciao-Sin Chen, PharmD, of the University of Michigan, Ann Arbor, was published in the Journal of the National Comprehensive Cancer Network.
LIMITATIONS:
The trial did not collect data on other peripheral neuropathy risk factors, including preexisting peripheral neuropathy and diabetes. The study included a limited number of non-White participants (16%); larger numbers are needed to elucidate a potential interplay between race, vitamin D, and chemotherapy-induced peripheral neuropathy. The researchers also did not collect data on grade 1 and 2 chemotherapy-induced peripheral neuropathy.
DISCLOSURES:
The study was funded by Amgen, the American Cancer Society, and others. The investigators disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, suggesting that correcting levels before treatment might help prevent the condition.
METHODOLOGY:
- Past studies have suggested an association between vitamin D insufficiency and paclitaxel-induced peripheral neuropathy, a largely untreatable and sometimes permanent side effect of chemotherapy.
- To confirm the association, investigators reviewed data and samples from 1,191 women in the phase 3 SWOG S0221 trial, which compared weekly and biweekly paclitaxel regimens for early-stage breast cancer.
- Using serum samples collected at baseline, the team evaluated the relationship between insufficient vitamin D levels (20 ng/mL or less) before treatment and grade 3 or higher sensory chemotherapy-induced peripheral neuropathy.
TAKEAWAY:
- Overall, 33.3% of the women had insufficient vitamin D levels at baseline, and 16.4% developed grade 3 or worse sensory chemotherapy-induced peripheral neuropathy.
- The incidence of peripheral neuropathy of grade 3 or greater was higher among patients with pretreatment vitamin D insufficiency (20.7% vs. 14.2%; odds ratio, 1.57; P = .005).
- The association grew stronger after adjusting for age and paclitaxel schedule (adjusted OR, 1.65; P = .003), but not after adjusting for race (adjusted OR, 1.39; P = .066).
IN PRACTICE:
The study “confirms that patients with pretreatment vitamin D insufficiency have a higher incidence of [chemotherapy-induced peripheral neuropathy],” the authors concluded. These results also “suggest that vitamin D supplementation in patients with lower levels of vitamin D may reduce peripheral neuropathy, and particularly high-grade peripheral neuropathy, which would improve these patients’ long-term quality of life,” senior researcher Daniel L. Hertz, PharmD, PhD, University of Michigan College of Pharmacy, Ann Arbor, said in a press release.
SOURCE:
The study, led by Ciao-Sin Chen, PharmD, of the University of Michigan, Ann Arbor, was published in the Journal of the National Comprehensive Cancer Network.
LIMITATIONS:
The trial did not collect data on other peripheral neuropathy risk factors, including preexisting peripheral neuropathy and diabetes. The study included a limited number of non-White participants (16%); larger numbers are needed to elucidate a potential interplay between race, vitamin D, and chemotherapy-induced peripheral neuropathy. The researchers also did not collect data on grade 1 and 2 chemotherapy-induced peripheral neuropathy.
DISCLOSURES:
The study was funded by Amgen, the American Cancer Society, and others. The investigators disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This tool can predict recurrence in rectal cancer watchful waiting
TOPLINE:
for both local regrowth and distant metastasis during watchful waiting.
METHODOLOGY:
- Currently, oncologists do not have a biomarker that can help select patients with rectal cancer for watchful waiting after neoadjuvant chemoradiotherapy as well as help monitor them over time. And about 25% of patients on watchful waiting will eventually relapse.
- The Immunoscore biopsy quantifies the degree of immune infiltration on pretreatment tumor biopsies, looking at the density of CD3- and CD8-positive T cells at baseline, given that greater infiltration has been associated with prolonged treatment response.
- To determine whether the Immunoscore can help select patients for watchful waiting, investigators correlated Immunoscore with time to recurrence in 249 patients with stage I-III rectal cancer who were undergoing watchful waiting after complete clinical responses to neoadjuvant chemoradiotherapy.
- CD3- and CD8-positive T-cell densities were converted into percentiles and then translated into scores of Immunoscore biopsy: low (0%-25%), intermediate (> 25%-70%), and high (> 70%-100%).
TAKEAWAY:
- The Immunoscore biopsy significantly improved predictions of recurrence: 5-year recurrence-free survival was 91.3% among patients with high scores, 62.5% among those with intermediate scores, and 53.1% among those with low scores.
- The Immunoscore was significantly associated with disease-free survival (log-rank P = .0002) and predicted both local regrowth and distant metastasis.
- On multivariate analysis, the Immunoscore’s predictive ability was independent of age, sex, tumor location, cT stage, and cN stage, and was the strongest predictor of time to recurrence (hazard ratio, high vs. low, 6.93; P = .0017).
IN PRACTICE:
This validation study confirms that the Immunoscore biopsy “is an independent parameter predicting time to recurrence” and can help physicians and patients decide whether to opt for watchful waiting, the study authors wrote.
SOURCE:
The study, led by Carine El Sissy of the Laboratory of Integrative Cancer Immunology, Paris, was published Oct. 3 in the Journal of Clinical Oncology.
LIMITATIONS:
Mismatch repair gene expression status was not assessed.
DISCLOSURES:
The work was supported by the L’Institut National de la Santé et de la Recherche Médicale and others. Investigators disclosed patents related to the work and ties to many companies, including Amgen, AstraZeneca, and Merck. One investigator is an employee of Novo Nordisk, and another is employed by Veracyte.
A version of this article first appeared on Medscape.com.
TOPLINE:
for both local regrowth and distant metastasis during watchful waiting.
METHODOLOGY:
- Currently, oncologists do not have a biomarker that can help select patients with rectal cancer for watchful waiting after neoadjuvant chemoradiotherapy as well as help monitor them over time. And about 25% of patients on watchful waiting will eventually relapse.
- The Immunoscore biopsy quantifies the degree of immune infiltration on pretreatment tumor biopsies, looking at the density of CD3- and CD8-positive T cells at baseline, given that greater infiltration has been associated with prolonged treatment response.
- To determine whether the Immunoscore can help select patients for watchful waiting, investigators correlated Immunoscore with time to recurrence in 249 patients with stage I-III rectal cancer who were undergoing watchful waiting after complete clinical responses to neoadjuvant chemoradiotherapy.
- CD3- and CD8-positive T-cell densities were converted into percentiles and then translated into scores of Immunoscore biopsy: low (0%-25%), intermediate (> 25%-70%), and high (> 70%-100%).
TAKEAWAY:
- The Immunoscore biopsy significantly improved predictions of recurrence: 5-year recurrence-free survival was 91.3% among patients with high scores, 62.5% among those with intermediate scores, and 53.1% among those with low scores.
- The Immunoscore was significantly associated with disease-free survival (log-rank P = .0002) and predicted both local regrowth and distant metastasis.
- On multivariate analysis, the Immunoscore’s predictive ability was independent of age, sex, tumor location, cT stage, and cN stage, and was the strongest predictor of time to recurrence (hazard ratio, high vs. low, 6.93; P = .0017).
IN PRACTICE:
This validation study confirms that the Immunoscore biopsy “is an independent parameter predicting time to recurrence” and can help physicians and patients decide whether to opt for watchful waiting, the study authors wrote.
SOURCE:
The study, led by Carine El Sissy of the Laboratory of Integrative Cancer Immunology, Paris, was published Oct. 3 in the Journal of Clinical Oncology.
LIMITATIONS:
Mismatch repair gene expression status was not assessed.
DISCLOSURES:
The work was supported by the L’Institut National de la Santé et de la Recherche Médicale and others. Investigators disclosed patents related to the work and ties to many companies, including Amgen, AstraZeneca, and Merck. One investigator is an employee of Novo Nordisk, and another is employed by Veracyte.
A version of this article first appeared on Medscape.com.
TOPLINE:
for both local regrowth and distant metastasis during watchful waiting.
METHODOLOGY:
- Currently, oncologists do not have a biomarker that can help select patients with rectal cancer for watchful waiting after neoadjuvant chemoradiotherapy as well as help monitor them over time. And about 25% of patients on watchful waiting will eventually relapse.
- The Immunoscore biopsy quantifies the degree of immune infiltration on pretreatment tumor biopsies, looking at the density of CD3- and CD8-positive T cells at baseline, given that greater infiltration has been associated with prolonged treatment response.
- To determine whether the Immunoscore can help select patients for watchful waiting, investigators correlated Immunoscore with time to recurrence in 249 patients with stage I-III rectal cancer who were undergoing watchful waiting after complete clinical responses to neoadjuvant chemoradiotherapy.
- CD3- and CD8-positive T-cell densities were converted into percentiles and then translated into scores of Immunoscore biopsy: low (0%-25%), intermediate (> 25%-70%), and high (> 70%-100%).
TAKEAWAY:
- The Immunoscore biopsy significantly improved predictions of recurrence: 5-year recurrence-free survival was 91.3% among patients with high scores, 62.5% among those with intermediate scores, and 53.1% among those with low scores.
- The Immunoscore was significantly associated with disease-free survival (log-rank P = .0002) and predicted both local regrowth and distant metastasis.
- On multivariate analysis, the Immunoscore’s predictive ability was independent of age, sex, tumor location, cT stage, and cN stage, and was the strongest predictor of time to recurrence (hazard ratio, high vs. low, 6.93; P = .0017).
IN PRACTICE:
This validation study confirms that the Immunoscore biopsy “is an independent parameter predicting time to recurrence” and can help physicians and patients decide whether to opt for watchful waiting, the study authors wrote.
SOURCE:
The study, led by Carine El Sissy of the Laboratory of Integrative Cancer Immunology, Paris, was published Oct. 3 in the Journal of Clinical Oncology.
LIMITATIONS:
Mismatch repair gene expression status was not assessed.
DISCLOSURES:
The work was supported by the L’Institut National de la Santé et de la Recherche Médicale and others. Investigators disclosed patents related to the work and ties to many companies, including Amgen, AstraZeneca, and Merck. One investigator is an employee of Novo Nordisk, and another is employed by Veracyte.
A version of this article first appeared on Medscape.com.
Stripped privileges: An alarming precedent for community oncologists?
, Alliance Cancer Specialists.
The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
The case
On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.
Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.
In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”
Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.
But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.
“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.
Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.
Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.
“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.
“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.
The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.
Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”
Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.
But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.
“There’s no direct precedent” for the move, he said.
Jefferson Health did not respond to requests for comment.
The ruling
U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.
Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.
Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.
However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.
Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business.
Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.
“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.
It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.
She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.
Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.
Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.
“It’s a mess,” he said.
A familiar story
Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.
“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”
The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.
The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.
When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.
Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.
In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.
“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career.
The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
Reverberations around the country
Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.
“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.
Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.
St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.
Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.
The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.
“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.
Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”
The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
The future of community oncology
Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.
Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.
Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.
“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.
A version of this article first appeared on Medscape.com.
, Alliance Cancer Specialists.
The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
The case
On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.
Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.
In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”
Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.
But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.
“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.
Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.
Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.
“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.
“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.
The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.
Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”
Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.
But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.
“There’s no direct precedent” for the move, he said.
Jefferson Health did not respond to requests for comment.
The ruling
U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.
Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.
Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.
However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.
Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business.
Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.
“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.
It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.
She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.
Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.
Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.
“It’s a mess,” he said.
A familiar story
Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.
“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”
The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.
The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.
When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.
Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.
In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.
“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career.
The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
Reverberations around the country
Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.
“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.
Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.
St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.
Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.
The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.
“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.
Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”
The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
The future of community oncology
Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.
Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.
Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.
“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.
A version of this article first appeared on Medscape.com.
, Alliance Cancer Specialists.
The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
The case
On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.
Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.
In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”
Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.
But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.
“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.
Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.
Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.
“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.
“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.
The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.
Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”
Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.
But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.
“There’s no direct precedent” for the move, he said.
Jefferson Health did not respond to requests for comment.
The ruling
U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.
Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.
Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.
However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.
Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business.
Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.
“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.
It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.
She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.
Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.
Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.
“It’s a mess,” he said.
A familiar story
Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.
“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”
The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.
The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.
When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.
Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.
In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.
“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career.
The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
Reverberations around the country
Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.
“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.
Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.
St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.
Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.
The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.
“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.
Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”
The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
The future of community oncology
Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.
Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.
Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.
“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.
A version of this article first appeared on Medscape.com.
FDA OKs ivosidenib for IDH1-mutated myelodysplastic syndromes
The agency also approved the Abbott RealTime IDH1 Assay to test for the mutation.
Almost 4% of the 16,000 people diagnosed with MDS in the United States each year carry an isocitrate dehydrogenase-1 (IDH1) mutation, which increases their risk for poor outcomes, such as transformation to acute myeloid leukemia, Servier explained in a press announcement.
Ivosidenib is an IDH1 inhibitor that has previously been approved for IDH1-mutated AML and locally advanced or metastatic cholangiocarcinoma. The new approval makes it the only targeted therapy approved for relapsed or refractory MDS with the mutation, Servier said.
The FDA approval was based on a phase 1 study in 18 adults aged 61-82 years with IDH1-mutated relapsed or refractory MDS. Patients started at a dose of 500 mg daily in 28-day cycles until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation. Median treatment duration was 9.3 months, and one patient went on to receive a transplant.
Overall survival was a median of 35.7 months. Fifteen patients (83.3%) had an objective response and 7 (38.9%) went into complete remission after a median of 1.9 months of treatment. The median duration of remission had not been reached at data cutoff.
Among the 9 patients dependent on RBC or platelet transfusions at baseline, 6 (66.7%) no longer needed them during any 56-day post-baseline period.
Grade 3/4 adverse events in 5% or more of patients included arthralgia, hypertension, fatigue, mucositis, and leukocytosis.
Labeling carries a boxed warning of potentially fatal differentiation syndrome. Ivosidenib can also cause QTc prolongation.
A version of this article first appeared on Medscape.com.
The agency also approved the Abbott RealTime IDH1 Assay to test for the mutation.
Almost 4% of the 16,000 people diagnosed with MDS in the United States each year carry an isocitrate dehydrogenase-1 (IDH1) mutation, which increases their risk for poor outcomes, such as transformation to acute myeloid leukemia, Servier explained in a press announcement.
Ivosidenib is an IDH1 inhibitor that has previously been approved for IDH1-mutated AML and locally advanced or metastatic cholangiocarcinoma. The new approval makes it the only targeted therapy approved for relapsed or refractory MDS with the mutation, Servier said.
The FDA approval was based on a phase 1 study in 18 adults aged 61-82 years with IDH1-mutated relapsed or refractory MDS. Patients started at a dose of 500 mg daily in 28-day cycles until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation. Median treatment duration was 9.3 months, and one patient went on to receive a transplant.
Overall survival was a median of 35.7 months. Fifteen patients (83.3%) had an objective response and 7 (38.9%) went into complete remission after a median of 1.9 months of treatment. The median duration of remission had not been reached at data cutoff.
Among the 9 patients dependent on RBC or platelet transfusions at baseline, 6 (66.7%) no longer needed them during any 56-day post-baseline period.
Grade 3/4 adverse events in 5% or more of patients included arthralgia, hypertension, fatigue, mucositis, and leukocytosis.
Labeling carries a boxed warning of potentially fatal differentiation syndrome. Ivosidenib can also cause QTc prolongation.
A version of this article first appeared on Medscape.com.
The agency also approved the Abbott RealTime IDH1 Assay to test for the mutation.
Almost 4% of the 16,000 people diagnosed with MDS in the United States each year carry an isocitrate dehydrogenase-1 (IDH1) mutation, which increases their risk for poor outcomes, such as transformation to acute myeloid leukemia, Servier explained in a press announcement.
Ivosidenib is an IDH1 inhibitor that has previously been approved for IDH1-mutated AML and locally advanced or metastatic cholangiocarcinoma. The new approval makes it the only targeted therapy approved for relapsed or refractory MDS with the mutation, Servier said.
The FDA approval was based on a phase 1 study in 18 adults aged 61-82 years with IDH1-mutated relapsed or refractory MDS. Patients started at a dose of 500 mg daily in 28-day cycles until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation. Median treatment duration was 9.3 months, and one patient went on to receive a transplant.
Overall survival was a median of 35.7 months. Fifteen patients (83.3%) had an objective response and 7 (38.9%) went into complete remission after a median of 1.9 months of treatment. The median duration of remission had not been reached at data cutoff.
Among the 9 patients dependent on RBC or platelet transfusions at baseline, 6 (66.7%) no longer needed them during any 56-day post-baseline period.
Grade 3/4 adverse events in 5% or more of patients included arthralgia, hypertension, fatigue, mucositis, and leukocytosis.
Labeling carries a boxed warning of potentially fatal differentiation syndrome. Ivosidenib can also cause QTc prolongation.
A version of this article first appeared on Medscape.com.
Does surgery improve survival in metastatic breast cancer?
TOPLINE:
METHODOLOGY:
- Given conflicting results from prospective trials and improved outcomes reported in retrospective studies, removing the primary tumor in patients with metastatic breast cancer remains common practice but also “controversial,” the authors explained.
- To clarify whether to remove the primary tumor in metastatic breast cancer, investigators performed a meta-analysis of the five randomized clinical trials evaluating the issue.
- The five trials, published from 2015 to 2023, included 1,381 women with de novo metastatic breast cancer; half had their primary tumor removed, half did not.
TAKEAWAY:
- The analysis revealed no overall survival benefit for patients who underwent surgical excision of their primary breast tumor (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.76-1.14).
- Surgery was not associated with an overall survival benefit in subgroup analyses by receptor status, pattern of metastasis (bone vs. viscera or oligometastatic vs nonoligometastatic disease), number of metastatic sites, or location of metastatic lesions.
- The one possible exception: Surgery did appear to improve overall survival in younger, premenopausal women (HR, 0.74; 95% CI 0.58-0.94), but “the lack of uniform definitions and inconsistent trial results suggest that this subgroup analysis should be viewed as exploratory and requiring further validation,” the authors said.
- Breast surgery was associated with improved local progression-free survival (HR, 0.37) but not distant progression-free survival or patient-reported quality of life.
IN PRACTICE:
“We conclude that surgical excision of the primary tumor in case of de novo metastatic breast cancer is not associated with improved patient survival,” with a “potential exception” among younger patients, the authors said. “As such, besides the need to palliate local symptoms, surgery should not be routinely offered to patients with metastatic disease.”
SOURCE:
The work, led by Guillermo Villacampa of the SOLTI Breast Cancer Research Group in Barcelona, was published Sept. 12 in The Oncologist.
LIMITATIONS:
The five trials had various weaknesses, including imbalances in patient characteristics, protocol violations regarding planned and administered treatment, and missing information on associations between surgical margins and outcomes.
DISCLOSURES:
There was no funding for the work. Investigators reported speaker fees, consultant fees, and/or research funding from various companies, including Merck, AstraZeneca, Pfizer, and Novartis.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Given conflicting results from prospective trials and improved outcomes reported in retrospective studies, removing the primary tumor in patients with metastatic breast cancer remains common practice but also “controversial,” the authors explained.
- To clarify whether to remove the primary tumor in metastatic breast cancer, investigators performed a meta-analysis of the five randomized clinical trials evaluating the issue.
- The five trials, published from 2015 to 2023, included 1,381 women with de novo metastatic breast cancer; half had their primary tumor removed, half did not.
TAKEAWAY:
- The analysis revealed no overall survival benefit for patients who underwent surgical excision of their primary breast tumor (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.76-1.14).
- Surgery was not associated with an overall survival benefit in subgroup analyses by receptor status, pattern of metastasis (bone vs. viscera or oligometastatic vs nonoligometastatic disease), number of metastatic sites, or location of metastatic lesions.
- The one possible exception: Surgery did appear to improve overall survival in younger, premenopausal women (HR, 0.74; 95% CI 0.58-0.94), but “the lack of uniform definitions and inconsistent trial results suggest that this subgroup analysis should be viewed as exploratory and requiring further validation,” the authors said.
- Breast surgery was associated with improved local progression-free survival (HR, 0.37) but not distant progression-free survival or patient-reported quality of life.
IN PRACTICE:
“We conclude that surgical excision of the primary tumor in case of de novo metastatic breast cancer is not associated with improved patient survival,” with a “potential exception” among younger patients, the authors said. “As such, besides the need to palliate local symptoms, surgery should not be routinely offered to patients with metastatic disease.”
SOURCE:
The work, led by Guillermo Villacampa of the SOLTI Breast Cancer Research Group in Barcelona, was published Sept. 12 in The Oncologist.
LIMITATIONS:
The five trials had various weaknesses, including imbalances in patient characteristics, protocol violations regarding planned and administered treatment, and missing information on associations between surgical margins and outcomes.
DISCLOSURES:
There was no funding for the work. Investigators reported speaker fees, consultant fees, and/or research funding from various companies, including Merck, AstraZeneca, Pfizer, and Novartis.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Given conflicting results from prospective trials and improved outcomes reported in retrospective studies, removing the primary tumor in patients with metastatic breast cancer remains common practice but also “controversial,” the authors explained.
- To clarify whether to remove the primary tumor in metastatic breast cancer, investigators performed a meta-analysis of the five randomized clinical trials evaluating the issue.
- The five trials, published from 2015 to 2023, included 1,381 women with de novo metastatic breast cancer; half had their primary tumor removed, half did not.
TAKEAWAY:
- The analysis revealed no overall survival benefit for patients who underwent surgical excision of their primary breast tumor (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.76-1.14).
- Surgery was not associated with an overall survival benefit in subgroup analyses by receptor status, pattern of metastasis (bone vs. viscera or oligometastatic vs nonoligometastatic disease), number of metastatic sites, or location of metastatic lesions.
- The one possible exception: Surgery did appear to improve overall survival in younger, premenopausal women (HR, 0.74; 95% CI 0.58-0.94), but “the lack of uniform definitions and inconsistent trial results suggest that this subgroup analysis should be viewed as exploratory and requiring further validation,” the authors said.
- Breast surgery was associated with improved local progression-free survival (HR, 0.37) but not distant progression-free survival or patient-reported quality of life.
IN PRACTICE:
“We conclude that surgical excision of the primary tumor in case of de novo metastatic breast cancer is not associated with improved patient survival,” with a “potential exception” among younger patients, the authors said. “As such, besides the need to palliate local symptoms, surgery should not be routinely offered to patients with metastatic disease.”
SOURCE:
The work, led by Guillermo Villacampa of the SOLTI Breast Cancer Research Group in Barcelona, was published Sept. 12 in The Oncologist.
LIMITATIONS:
The five trials had various weaknesses, including imbalances in patient characteristics, protocol violations regarding planned and administered treatment, and missing information on associations between surgical margins and outcomes.
DISCLOSURES:
There was no funding for the work. Investigators reported speaker fees, consultant fees, and/or research funding from various companies, including Merck, AstraZeneca, Pfizer, and Novartis.
A version of this article first appeared on Medscape.com.