Cancer

A suspicion from retrospective data has now been confirmed by a prospective clinical trial: Adding panitumumab (Vectibix) to standard chemotherapy in left-sided RAS wild-type metastatic colorectal cancer (mCRC) is more effective than adding bevacizumab (Avastin).

Patients treated with panitumumab alongside chemotherapy saw a 16% improvement in overall survival versus those given bevacizumab after a median follow-up of over 5 years.

The overall survival benefit rose to 18% in those with left-sided tumors.

However, there was no difference in overall survival between the two treatment groups in the small subgroup of patients with right-sided primary tumors.

These findings come from the PARADIGM trial conducted in Japan.

The results were presented during a plenary session at the annual meeting of the American Society of Clinical Oncology.

“If gene testing shows that a tumor is RAS wild-type, the choice of initial treatment with panitumumab plus mFOLFOX6 chemotherapy is superior ... for those people with left-sided tumors,” said lead researcher Takayuki Yoshino, MD, PhD, department of gastrointestinal oncology, National Cancer Center Hospital East, Chiba, Japan, in an ASCO press release.

“It has long been believed that the sequence of metastatic colorectal cancer treatment does not matter as long as patients had access to the drugs at some point, which has now been disproven,” he noted.

Dr. Yoshino added in a press conference about the trial that the results establish “a standard first-line combination regimen for patients with RAS wild-type, left-sided mCRC.”

This is the “longest survival ever reported in a first-line unresectable metastatic colorectal cancer prospective phase 3 trial,” commented Cathy Eng, MD, ASCO Expert in gastrointestinal cancers.

The findings “emphasize the importance of taking into account sidedness, as well as including comprehensive biomarker testing,” she said.

Dr. Eng underlined that this is especially the case for RAS gene status testing, “which is critical for all colorectal cancer patients at the time of diagnosis of metastatic disease.”

These results are of particular relevance in the United States, where the choice between an anti-EGFR or anti-VEGF antibody for the treatment of mCRC has been an area of “controversy” because of the lack of supporting data.

Panitumumab is a human monoclonal antibody that targets EGFR. It was approved in 2006 for use in mCRC by the U.S. Food and Drug Administration and also approved in 2014 for use in combination with FOLFOX for the first-line treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) mCRC, having previously been shown to be equally effective as cetuximab (another EGFR inhibitor) in this population.

In contrast, bevacizumab is a monoclonal antibody that targets the VEGF receptor. It was approved by the FDA for use in mCRC in 2004 in combination with intravenous 5-fluorouracil–based chemotherapy.

Dr. Yoshino explained that around 36% of patients with CRC have metastatic tumors at diagnosis and that adding an anti-EGFR or anti-VEGF antibody to chemotherapy improves overall survival in these patients by up to 30 months.

There has been “accumulating” evidence from retrospective studies suggesting that patients with RAS wild-type mCRC whose primary tumor is on the left side, which accounts for approximately 35% of mCRC cases, have a longer survival benefit with an anti-EGFR antibody, he commented.

Despite this, both antibody types continue to be used in these patients, he added.

PARADIGM was the first prospective trial to compare the two antibody types. Patients were randomized to receive either panitumumab or bevacizumab plus the combination chemotherapy regimen modified FOLFOX6 (mFOLFOX6).

The trial involved 823 Japanese patients with previously untreated wild-type mCRC with unresectable disease. Most patients had left-sided primary tumors (312 of 400 patients in the panitumumab group, and 292 of 402 patients in the bevacizumab group).  

After a median follow-up of 61 months, panitumumab was associated with a significant improvement in overall survival in the overall study population, at a hazard ratio of 0.84 (P = .030, with the boundary of significance set at P < .05).

In addition, panitumumab was associated with a significant improvement in overall survival in the large subgroup of patients with left-sided primary tumors, at 37.9 versus 34.3 months, or a hazard ratio of 0.82 (P = .031).

However, there was no significant difference in overall survival between the two treatment groups in the smaller subgroup of patients with right-sided tumors, at a hazard ratio of 1.09.

Median progression-free survival was no different between the panitumumab and bevacizumab groups, at 13.7 versus 13.2 months in patients with a left-sided tumor and 12.9 versus 12.0 months in the overall cohort.

There was, however, a difference in response rates in left-sided patients between those receiving the two antibodies, at 80.2% with panitumumab versus 68.6% with bevacizumab, and in curative resection rates, at 18.3% and 11.6%, respectively.

These results demonstrate the “superiority of first-line panitumumab versus bevacizumab in combination with mFOLFOX6 in the left-sided and overall populations,” Dr. Yoshino concluded.

He also highlighted that the team has undertaken a large-scale biomarker analysis of pre- and posttreatment plasma and tissue samples from patients in the PARADIGM study to identify potential biomarkers of treatment response.

At the plenary session, discussant for this abstract Chiara Cremolini, MD, PhD, professor of medical oncology, Pisa (Italy) University Hospital, commented that “location matters” when it comes to mCRC tumors.

Dr. Cremolini pointed out that the separation of the survival curves at 28 months suggests that the 40% of patients with left-sided tumors who survived only up until that time point receive an equal benefit from panitumumab and bevacizumab.

In contrast, the remainder who survived for longer showed better outcomes with panitumumab.

Overall, she said, in her opinion and based on the findings from other studies, the current results support the use of panitumumab plus mFOLFOX6 as first-line therapy in patients with microsatellite stable RAS wild-type and with BRAF wild-type left-sided mCRC.

Dr. Cremolini emphasized that patients should be warned that, if they opt for doublet chemotherapy plus bevacizumab, they could face a median 3.6-month loss in overall survival, as well as poorer treatment activity.

However, patients with high microsatellite instability should receive immunotherapy up front, she added, while those with BRAF mutations should be given FOLFOX upfront plus bevacizumab, followed by encorafenib plus cetuximab in the case of progression.

Dr. Cremolini ended by noting that there has, as yet, been no prospective comparison of doublet chemotherapy plus an anti-EGFR antibody with triplet chemotherapy plus bevacizumab in this population.

The study was funded by Takeda. Dr. Yoshino has reported relationships with Bayer Yakuhin, Chugai Pharmaceutical, Merck, and MSD. Dr. Eng has reported relationships with Bayer Health, Gilead/Forty Seven, GlaxoSmithKline, Hookipa Biotech, Mirati Therapeutics, Natera, Pfizer, Elevar, Fruquitinib, Merck, and Pfizer.

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

A suspicion from retrospective data has now been confirmed by a prospective clinical trial: Adding panitumumab (Vectibix) to standard chemotherapy in left-sided RAS wild-type metastatic colorectal cancer (mCRC) is more effective than adding bevacizumab (Avastin).

Patients treated with panitumumab alongside chemotherapy saw a 16% improvement in overall survival versus those given bevacizumab after a median follow-up of over 5 years.

The overall survival benefit rose to 18% in those with left-sided tumors.

However, there was no difference in overall survival between the two treatment groups in the small subgroup of patients with right-sided primary tumors.

These findings come from the PARADIGM trial conducted in Japan.

The results were presented during a plenary session at the annual meeting of the American Society of Clinical Oncology.

“If gene testing shows that a tumor is RAS wild-type, the choice of initial treatment with panitumumab plus mFOLFOX6 chemotherapy is superior ... for those people with left-sided tumors,” said lead researcher Takayuki Yoshino, MD, PhD, department of gastrointestinal oncology, National Cancer Center Hospital East, Chiba, Japan, in an ASCO press release.

“It has long been believed that the sequence of metastatic colorectal cancer treatment does not matter as long as patients had access to the drugs at some point, which has now been disproven,” he noted.

Dr. Yoshino added in a press conference about the trial that the results establish “a standard first-line combination regimen for patients with RAS wild-type, left-sided mCRC.”

This is the “longest survival ever reported in a first-line unresectable metastatic colorectal cancer prospective phase 3 trial,” commented Cathy Eng, MD, ASCO Expert in gastrointestinal cancers.

The findings “emphasize the importance of taking into account sidedness, as well as including comprehensive biomarker testing,” she said.

Dr. Eng underlined that this is especially the case for RAS gene status testing, “which is critical for all colorectal cancer patients at the time of diagnosis of metastatic disease.”

These results are of particular relevance in the United States, where the choice between an anti-EGFR or anti-VEGF antibody for the treatment of mCRC has been an area of “controversy” because of the lack of supporting data.

Panitumumab is a human monoclonal antibody that targets EGFR. It was approved in 2006 for use in mCRC by the U.S. Food and Drug Administration and also approved in 2014 for use in combination with FOLFOX for the first-line treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) mCRC, having previously been shown to be equally effective as cetuximab (another EGFR inhibitor) in this population.

In contrast, bevacizumab is a monoclonal antibody that targets the VEGF receptor. It was approved by the FDA for use in mCRC in 2004 in combination with intravenous 5-fluorouracil–based chemotherapy.

Dr. Yoshino explained that around 36% of patients with CRC have metastatic tumors at diagnosis and that adding an anti-EGFR or anti-VEGF antibody to chemotherapy improves overall survival in these patients by up to 30 months.

There has been “accumulating” evidence from retrospective studies suggesting that patients with RAS wild-type mCRC whose primary tumor is on the left side, which accounts for approximately 35% of mCRC cases, have a longer survival benefit with an anti-EGFR antibody, he commented.

Despite this, both antibody types continue to be used in these patients, he added.

PARADIGM was the first prospective trial to compare the two antibody types. Patients were randomized to receive either panitumumab or bevacizumab plus the combination chemotherapy regimen modified FOLFOX6 (mFOLFOX6).

The trial involved 823 Japanese patients with previously untreated wild-type mCRC with unresectable disease. Most patients had left-sided primary tumors (312 of 400 patients in the panitumumab group, and 292 of 402 patients in the bevacizumab group).  

After a median follow-up of 61 months, panitumumab was associated with a significant improvement in overall survival in the overall study population, at a hazard ratio of 0.84 (P = .030, with the boundary of significance set at P < .05).

In addition, panitumumab was associated with a significant improvement in overall survival in the large subgroup of patients with left-sided primary tumors, at 37.9 versus 34.3 months, or a hazard ratio of 0.82 (P = .031).

However, there was no significant difference in overall survival between the two treatment groups in the smaller subgroup of patients with right-sided tumors, at a hazard ratio of 1.09.

Median progression-free survival was no different between the panitumumab and bevacizumab groups, at 13.7 versus 13.2 months in patients with a left-sided tumor and 12.9 versus 12.0 months in the overall cohort.

There was, however, a difference in response rates in left-sided patients between those receiving the two antibodies, at 80.2% with panitumumab versus 68.6% with bevacizumab, and in curative resection rates, at 18.3% and 11.6%, respectively.

These results demonstrate the “superiority of first-line panitumumab versus bevacizumab in combination with mFOLFOX6 in the left-sided and overall populations,” Dr. Yoshino concluded.

He also highlighted that the team has undertaken a large-scale biomarker analysis of pre- and posttreatment plasma and tissue samples from patients in the PARADIGM study to identify potential biomarkers of treatment response.

At the plenary session, discussant for this abstract Chiara Cremolini, MD, PhD, professor of medical oncology, Pisa (Italy) University Hospital, commented that “location matters” when it comes to mCRC tumors.

Dr. Cremolini pointed out that the separation of the survival curves at 28 months suggests that the 40% of patients with left-sided tumors who survived only up until that time point receive an equal benefit from panitumumab and bevacizumab.

In contrast, the remainder who survived for longer showed better outcomes with panitumumab.

Overall, she said, in her opinion and based on the findings from other studies, the current results support the use of panitumumab plus mFOLFOX6 as first-line therapy in patients with microsatellite stable RAS wild-type and with BRAF wild-type left-sided mCRC.

Dr. Cremolini emphasized that patients should be warned that, if they opt for doublet chemotherapy plus bevacizumab, they could face a median 3.6-month loss in overall survival, as well as poorer treatment activity.

However, patients with high microsatellite instability should receive immunotherapy up front, she added, while those with BRAF mutations should be given FOLFOX upfront plus bevacizumab, followed by encorafenib plus cetuximab in the case of progression.

Dr. Cremolini ended by noting that there has, as yet, been no prospective comparison of doublet chemotherapy plus an anti-EGFR antibody with triplet chemotherapy plus bevacizumab in this population.

The study was funded by Takeda. Dr. Yoshino has reported relationships with Bayer Yakuhin, Chugai Pharmaceutical, Merck, and MSD. Dr. Eng has reported relationships with Bayer Health, Gilead/Forty Seven, GlaxoSmithKline, Hookipa Biotech, Mirati Therapeutics, Natera, Pfizer, Elevar, Fruquitinib, Merck, and Pfizer.

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

A suspicion from retrospective data has now been confirmed by a prospective clinical trial: Adding panitumumab (Vectibix) to standard chemotherapy in left-sided RAS wild-type metastatic colorectal cancer (mCRC) is more effective than adding bevacizumab (Avastin).

Patients treated with panitumumab alongside chemotherapy saw a 16% improvement in overall survival versus those given bevacizumab after a median follow-up of over 5 years.

The overall survival benefit rose to 18% in those with left-sided tumors.

However, there was no difference in overall survival between the two treatment groups in the small subgroup of patients with right-sided primary tumors.

These findings come from the PARADIGM trial conducted in Japan.

The results were presented during a plenary session at the annual meeting of the American Society of Clinical Oncology.

“If gene testing shows that a tumor is RAS wild-type, the choice of initial treatment with panitumumab plus mFOLFOX6 chemotherapy is superior ... for those people with left-sided tumors,” said lead researcher Takayuki Yoshino, MD, PhD, department of gastrointestinal oncology, National Cancer Center Hospital East, Chiba, Japan, in an ASCO press release.

“It has long been believed that the sequence of metastatic colorectal cancer treatment does not matter as long as patients had access to the drugs at some point, which has now been disproven,” he noted.

Dr. Yoshino added in a press conference about the trial that the results establish “a standard first-line combination regimen for patients with RAS wild-type, left-sided mCRC.”

This is the “longest survival ever reported in a first-line unresectable metastatic colorectal cancer prospective phase 3 trial,” commented Cathy Eng, MD, ASCO Expert in gastrointestinal cancers.

The findings “emphasize the importance of taking into account sidedness, as well as including comprehensive biomarker testing,” she said.

Dr. Eng underlined that this is especially the case for RAS gene status testing, “which is critical for all colorectal cancer patients at the time of diagnosis of metastatic disease.”

These results are of particular relevance in the United States, where the choice between an anti-EGFR or anti-VEGF antibody for the treatment of mCRC has been an area of “controversy” because of the lack of supporting data.

Panitumumab is a human monoclonal antibody that targets EGFR. It was approved in 2006 for use in mCRC by the U.S. Food and Drug Administration and also approved in 2014 for use in combination with FOLFOX for the first-line treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) mCRC, having previously been shown to be equally effective as cetuximab (another EGFR inhibitor) in this population.

In contrast, bevacizumab is a monoclonal antibody that targets the VEGF receptor. It was approved by the FDA for use in mCRC in 2004 in combination with intravenous 5-fluorouracil–based chemotherapy.

Dr. Yoshino explained that around 36% of patients with CRC have metastatic tumors at diagnosis and that adding an anti-EGFR or anti-VEGF antibody to chemotherapy improves overall survival in these patients by up to 30 months.

There has been “accumulating” evidence from retrospective studies suggesting that patients with RAS wild-type mCRC whose primary tumor is on the left side, which accounts for approximately 35% of mCRC cases, have a longer survival benefit with an anti-EGFR antibody, he commented.

Despite this, both antibody types continue to be used in these patients, he added.

PARADIGM was the first prospective trial to compare the two antibody types. Patients were randomized to receive either panitumumab or bevacizumab plus the combination chemotherapy regimen modified FOLFOX6 (mFOLFOX6).

The trial involved 823 Japanese patients with previously untreated wild-type mCRC with unresectable disease. Most patients had left-sided primary tumors (312 of 400 patients in the panitumumab group, and 292 of 402 patients in the bevacizumab group).  

After a median follow-up of 61 months, panitumumab was associated with a significant improvement in overall survival in the overall study population, at a hazard ratio of 0.84 (P = .030, with the boundary of significance set at P < .05).

In addition, panitumumab was associated with a significant improvement in overall survival in the large subgroup of patients with left-sided primary tumors, at 37.9 versus 34.3 months, or a hazard ratio of 0.82 (P = .031).

However, there was no significant difference in overall survival between the two treatment groups in the smaller subgroup of patients with right-sided tumors, at a hazard ratio of 1.09.

Median progression-free survival was no different between the panitumumab and bevacizumab groups, at 13.7 versus 13.2 months in patients with a left-sided tumor and 12.9 versus 12.0 months in the overall cohort.

There was, however, a difference in response rates in left-sided patients between those receiving the two antibodies, at 80.2% with panitumumab versus 68.6% with bevacizumab, and in curative resection rates, at 18.3% and 11.6%, respectively.

These results demonstrate the “superiority of first-line panitumumab versus bevacizumab in combination with mFOLFOX6 in the left-sided and overall populations,” Dr. Yoshino concluded.

He also highlighted that the team has undertaken a large-scale biomarker analysis of pre- and posttreatment plasma and tissue samples from patients in the PARADIGM study to identify potential biomarkers of treatment response.

At the plenary session, discussant for this abstract Chiara Cremolini, MD, PhD, professor of medical oncology, Pisa (Italy) University Hospital, commented that “location matters” when it comes to mCRC tumors.

Dr. Cremolini pointed out that the separation of the survival curves at 28 months suggests that the 40% of patients with left-sided tumors who survived only up until that time point receive an equal benefit from panitumumab and bevacizumab.

In contrast, the remainder who survived for longer showed better outcomes with panitumumab.

Overall, she said, in her opinion and based on the findings from other studies, the current results support the use of panitumumab plus mFOLFOX6 as first-line therapy in patients with microsatellite stable RAS wild-type and with BRAF wild-type left-sided mCRC.

Dr. Cremolini emphasized that patients should be warned that, if they opt for doublet chemotherapy plus bevacizumab, they could face a median 3.6-month loss in overall survival, as well as poorer treatment activity.

However, patients with high microsatellite instability should receive immunotherapy up front, she added, while those with BRAF mutations should be given FOLFOX upfront plus bevacizumab, followed by encorafenib plus cetuximab in the case of progression.

Dr. Cremolini ended by noting that there has, as yet, been no prospective comparison of doublet chemotherapy plus an anti-EGFR antibody with triplet chemotherapy plus bevacizumab in this population.

The study was funded by Takeda. Dr. Yoshino has reported relationships with Bayer Yakuhin, Chugai Pharmaceutical, Merck, and MSD. Dr. Eng has reported relationships with Bayer Health, Gilead/Forty Seven, GlaxoSmithKline, Hookipa Biotech, Mirati Therapeutics, Natera, Pfizer, Elevar, Fruquitinib, Merck, and Pfizer.

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

A cohort study has found increases in mortality rates among women with non-endometrioid uterine carcinoma, despite incident rates that have stabilized. After correction with hysterectomy, mortality risk was about doubled for Black women, compared with White women, and these results could not be explained by differences in cancer subtype or cancer stage at diagnosis. Non-endometroid uterine carcinoma represents 15%-20% of uterine cancers diagnosed and carries a worse prognosis.

“We do not know why non-endometrioid subtypes are disproportionately increasing among all women, nor do we understand why they are so much more common among non-Hispanic Black women. We need more research to identify risk factors and exposures more specifically associated with non-endometrioid cancers to better understand the strong increases in this subtype among all women and the particularly high rates and recent increases in non-Hispanic black women,” said lead author Megan Clarke, PhD, MHS, the study’s lead author and a cancer epidemiologist with the National Cancer Institute.

The study was published online in JAMA Oncology.

“Physicians should be aware that both incidence and mortality rates of non-endometrioid cancers are on the rise. Because these subtypes are rarer than endometrioid uterine cancers, physicians may be less familiar with diagnosing and treating these aggressive types of cancers. Increasing awareness among clinicians and patients regarding the signs and symptoms of uterine cancer (such as postmenopausal bleeding) and the differences in histologic subtypes among racial and ethnic groups may promote earlier diagnosis and timely referral to appropriate treatment,” Dr. Clarke said.

Previous studies based on death certificates found increased mortality, especially in Black women, but they were limited by an inability to link mortality to tumor characteristics. To address this, the researchers linked mortality data to records of 208,587 women diagnosed with uterine cancer between 2000 and 2017, drawn from the U.S. Surveillance, Epidemiology, and End Results (SEER) Program.

Black women represented 9.7% of cases, but they suffered 17.7% of uterine cancer deaths. Overall, mortality from uterine corpus cancer increased by 1.8% per year (95% confidence interval, 1.5%-2.9%). Non-endometroid cancers increased at 2.7% per year (95% CI, 1.8%-3.6%), and this was higher in Asian (3.4%; 95% CI, 0.3%-6.6%), Black (3.5%; 95% CI, 2.2%-4.9%), Hispanic (6.7%; 95% CI, 1.9%-11.8%), and White women (1.5%; 95% CI, 0.6%-2.4%).

Mortality increased 1.8% per year overall for uterine cancer and 2.7% per year for non-endometrioid uterine cancer. There was no increase in mortality seen in endometrioid cancers.

“The concerning rise in deaths from non-endometrioid cancers warrants clinical attention. Our findings suggest that there may be several factors contributing to racial disparities in uterine cancer mortality. Higher mortality rates among non-Hispanic Black women are partly attributable to higher incidence of tumors with aggressive subtypes and advanced stages. However, non-Hispanic Black women in our study who were diagnosed with less aggressive subtypes and early-stage disease also had the highest mortality rates,” said Dr. Clarke.

That suggests that inequities of treatment and high-quality care may be at least partly to blame, since those factors are known to contribute to differences in uterine cancer outcomes. “Other factors including comorbidities, health care facility characteristics, treatment preferences and adherence, patient and provider communication, provider bias, discrimination and structural racism, and potential biologic differences in response to treatment need to be better understood in terms of how they influence racial disparities,” Dr. Clarke said.

Dr. Clarke reported no relevant disclosures.

A cohort study has found increases in mortality rates among women with non-endometrioid uterine carcinoma, despite incident rates that have stabilized. After correction with hysterectomy, mortality risk was about doubled for Black women, compared with White women, and these results could not be explained by differences in cancer subtype or cancer stage at diagnosis. Non-endometroid uterine carcinoma represents 15%-20% of uterine cancers diagnosed and carries a worse prognosis.

“We do not know why non-endometrioid subtypes are disproportionately increasing among all women, nor do we understand why they are so much more common among non-Hispanic Black women. We need more research to identify risk factors and exposures more specifically associated with non-endometrioid cancers to better understand the strong increases in this subtype among all women and the particularly high rates and recent increases in non-Hispanic black women,” said lead author Megan Clarke, PhD, MHS, the study’s lead author and a cancer epidemiologist with the National Cancer Institute.

The study was published online in JAMA Oncology.

“Physicians should be aware that both incidence and mortality rates of non-endometrioid cancers are on the rise. Because these subtypes are rarer than endometrioid uterine cancers, physicians may be less familiar with diagnosing and treating these aggressive types of cancers. Increasing awareness among clinicians and patients regarding the signs and symptoms of uterine cancer (such as postmenopausal bleeding) and the differences in histologic subtypes among racial and ethnic groups may promote earlier diagnosis and timely referral to appropriate treatment,” Dr. Clarke said.

Previous studies based on death certificates found increased mortality, especially in Black women, but they were limited by an inability to link mortality to tumor characteristics. To address this, the researchers linked mortality data to records of 208,587 women diagnosed with uterine cancer between 2000 and 2017, drawn from the U.S. Surveillance, Epidemiology, and End Results (SEER) Program.

Black women represented 9.7% of cases, but they suffered 17.7% of uterine cancer deaths. Overall, mortality from uterine corpus cancer increased by 1.8% per year (95% confidence interval, 1.5%-2.9%). Non-endometroid cancers increased at 2.7% per year (95% CI, 1.8%-3.6%), and this was higher in Asian (3.4%; 95% CI, 0.3%-6.6%), Black (3.5%; 95% CI, 2.2%-4.9%), Hispanic (6.7%; 95% CI, 1.9%-11.8%), and White women (1.5%; 95% CI, 0.6%-2.4%).

Mortality increased 1.8% per year overall for uterine cancer and 2.7% per year for non-endometrioid uterine cancer. There was no increase in mortality seen in endometrioid cancers.

“The concerning rise in deaths from non-endometrioid cancers warrants clinical attention. Our findings suggest that there may be several factors contributing to racial disparities in uterine cancer mortality. Higher mortality rates among non-Hispanic Black women are partly attributable to higher incidence of tumors with aggressive subtypes and advanced stages. However, non-Hispanic Black women in our study who were diagnosed with less aggressive subtypes and early-stage disease also had the highest mortality rates,” said Dr. Clarke.

That suggests that inequities of treatment and high-quality care may be at least partly to blame, since those factors are known to contribute to differences in uterine cancer outcomes. “Other factors including comorbidities, health care facility characteristics, treatment preferences and adherence, patient and provider communication, provider bias, discrimination and structural racism, and potential biologic differences in response to treatment need to be better understood in terms of how they influence racial disparities,” Dr. Clarke said.

Dr. Clarke reported no relevant disclosures.

A cohort study has found increases in mortality rates among women with non-endometrioid uterine carcinoma, despite incident rates that have stabilized. After correction with hysterectomy, mortality risk was about doubled for Black women, compared with White women, and these results could not be explained by differences in cancer subtype or cancer stage at diagnosis. Non-endometroid uterine carcinoma represents 15%-20% of uterine cancers diagnosed and carries a worse prognosis.

“We do not know why non-endometrioid subtypes are disproportionately increasing among all women, nor do we understand why they are so much more common among non-Hispanic Black women. We need more research to identify risk factors and exposures more specifically associated with non-endometrioid cancers to better understand the strong increases in this subtype among all women and the particularly high rates and recent increases in non-Hispanic black women,” said lead author Megan Clarke, PhD, MHS, the study’s lead author and a cancer epidemiologist with the National Cancer Institute.

The study was published online in JAMA Oncology.

“Physicians should be aware that both incidence and mortality rates of non-endometrioid cancers are on the rise. Because these subtypes are rarer than endometrioid uterine cancers, physicians may be less familiar with diagnosing and treating these aggressive types of cancers. Increasing awareness among clinicians and patients regarding the signs and symptoms of uterine cancer (such as postmenopausal bleeding) and the differences in histologic subtypes among racial and ethnic groups may promote earlier diagnosis and timely referral to appropriate treatment,” Dr. Clarke said.

Previous studies based on death certificates found increased mortality, especially in Black women, but they were limited by an inability to link mortality to tumor characteristics. To address this, the researchers linked mortality data to records of 208,587 women diagnosed with uterine cancer between 2000 and 2017, drawn from the U.S. Surveillance, Epidemiology, and End Results (SEER) Program.

Black women represented 9.7% of cases, but they suffered 17.7% of uterine cancer deaths. Overall, mortality from uterine corpus cancer increased by 1.8% per year (95% confidence interval, 1.5%-2.9%). Non-endometroid cancers increased at 2.7% per year (95% CI, 1.8%-3.6%), and this was higher in Asian (3.4%; 95% CI, 0.3%-6.6%), Black (3.5%; 95% CI, 2.2%-4.9%), Hispanic (6.7%; 95% CI, 1.9%-11.8%), and White women (1.5%; 95% CI, 0.6%-2.4%).

Mortality increased 1.8% per year overall for uterine cancer and 2.7% per year for non-endometrioid uterine cancer. There was no increase in mortality seen in endometrioid cancers.

“The concerning rise in deaths from non-endometrioid cancers warrants clinical attention. Our findings suggest that there may be several factors contributing to racial disparities in uterine cancer mortality. Higher mortality rates among non-Hispanic Black women are partly attributable to higher incidence of tumors with aggressive subtypes and advanced stages. However, non-Hispanic Black women in our study who were diagnosed with less aggressive subtypes and early-stage disease also had the highest mortality rates,” said Dr. Clarke.

That suggests that inequities of treatment and high-quality care may be at least partly to blame, since those factors are known to contribute to differences in uterine cancer outcomes. “Other factors including comorbidities, health care facility characteristics, treatment preferences and adherence, patient and provider communication, provider bias, discrimination and structural racism, and potential biologic differences in response to treatment need to be better understood in terms of how they influence racial disparities,” Dr. Clarke said.

Dr. Clarke reported no relevant disclosures.

In the largest investigation into the issue to date, metformin did not improve survival of patients with high-risk, operable breast cancer when added to standard adjuvant treatments.

Metformin, a common option for patients with type 2 diabetes, had previously been shown in observational studies to be associated with improved survival of cancer patients. Those studies mostly involved older patients with cancer who also had diabetes.

These findings have led to trials of the use of metformin for patients with cancer who do not have diabetes, but two lung cancer trials found no effect on survival.

Now this latest trial in breast cancer, which included 3,649 patients with hormone receptor–positive or –negative disease – who did not have diabetes – also found that metformin had no effect on survival.

These results “tell us that metformin is not effective against the most common types of breast cancer and any off-label use [of] this drug for the treatment of these common types of breast cancer should be stopped,” lead investigator and medical oncologist Pamela Goodwin, MD, a breast cancer researcher at the Lunenfeld-Tanenbaum Research Institute in Toronto, said in a press release.

The negative results “underscore the need for well-conducted randomized trials” before observational studies are put into practice, Dr. Goodwin and her team said.

However, the investigators cautioned against extrapolating their results to patients with diabetes, noting that “because metformin is effective in type 2 diabetes, the results ... should not affect the use of metformin” in breast cancer patients who have diabetes.

The study was published online in JAMA.

Patients were enrolled from 2010 to 2013 while undergoing adjuvant treatment – chemotherapy, radiotherapy, hormone therapy, and/or others – following complete resection of T1-3, N0-3 tumors. They were almost exclusively women (mean age, 52.4 years), and almost 90% were non-Hispanic White. They were primarily from the United States and Canada, with some patients from the United Kingdom and Switzerland.

Patients were randomly assigned equally to receive either metformin 850 mg twice daily or placebo for 5 years. Median follow-up was about 8 years.

Among 2,533 patients with estrogen receptor– and/or progesterone receptor–positive disease, the incidence of invasive disease–free survival events was 2.78 per 100 patient-years in the metformin group, vs. 2.74 per 100 patient-years in the placebo arm (hazard ratio [HR], 1.01, P = .93). There were 1.46 deaths per 100 patient-years with metformin, vs. 1.32 with placebo (HR, 1.10, P = .47).

Metformin was stopped early at about 3 years for the 1,116 hormone receptor–negative patients after futility was declared on interim analysis. The incidence of invasive disease–free survival events was 3.58 with metformin, vs. 3.60 with placebo per 100 patient-years (HR, 1.01, P = .92). There were 1.91 deaths per 100 patient-years in the metformin arm, vs. 2.15 in the group that received placebo (HR, 0.89, P = .46).

However, the findings were different and suggested a signal among the small subset of patients (17% of the total) who had HER2-positive disease. There were 1.93 disease-free survival events with metformin per 100 patient-years, vs. 3.05 events with placebo (HR, 0.64, P = .03), and 0.78 deaths in the metformin arm, vs. 1.43 deaths per 100 patient-years in the placebo arm (HR, 0.54, P = .04).

The benefit seen in this HER2-postive subgroup was limited to patients with any C allele of the rs11212617 single-nucleotide variant.

This was an exploratory analysis, so the results need to be confirmed in a randomized trial, but it’s possible that metformin “could provide an additional treatment option for HER2-positive breast cancer,” Dr. Goodwin said.

Grade 3 or higher adverse events were more common with metformin (21.5% vs. 17.5%). The most common such events were hypertension (2.4% vs. 1.9%), irregular menses (1.5% vs. 1.4%), and diarrhea (1.9% vs. 0.8%).

The study was conducted by the Canadian Cancer Trials Group and was funded by the Canadian Cancer Society, the National Cancer Institute, and others. Dr. Goodwin has disclosed no relevant financial relationships. Several coauthors reported ties to Pfizer, Eli Lilly, Roche, and a number of other companies. One coauthor is an AstraZeneca employee.

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

In the largest investigation into the issue to date, metformin did not improve survival of patients with high-risk, operable breast cancer when added to standard adjuvant treatments.

Metformin, a common option for patients with type 2 diabetes, had previously been shown in observational studies to be associated with improved survival of cancer patients. Those studies mostly involved older patients with cancer who also had diabetes.

These findings have led to trials of the use of metformin for patients with cancer who do not have diabetes, but two lung cancer trials found no effect on survival.

Now this latest trial in breast cancer, which included 3,649 patients with hormone receptor–positive or –negative disease – who did not have diabetes – also found that metformin had no effect on survival.

These results “tell us that metformin is not effective against the most common types of breast cancer and any off-label use [of] this drug for the treatment of these common types of breast cancer should be stopped,” lead investigator and medical oncologist Pamela Goodwin, MD, a breast cancer researcher at the Lunenfeld-Tanenbaum Research Institute in Toronto, said in a press release.

The negative results “underscore the need for well-conducted randomized trials” before observational studies are put into practice, Dr. Goodwin and her team said.

However, the investigators cautioned against extrapolating their results to patients with diabetes, noting that “because metformin is effective in type 2 diabetes, the results ... should not affect the use of metformin” in breast cancer patients who have diabetes.

The study was published online in JAMA.

Patients were enrolled from 2010 to 2013 while undergoing adjuvant treatment – chemotherapy, radiotherapy, hormone therapy, and/or others – following complete resection of T1-3, N0-3 tumors. They were almost exclusively women (mean age, 52.4 years), and almost 90% were non-Hispanic White. They were primarily from the United States and Canada, with some patients from the United Kingdom and Switzerland.

Patients were randomly assigned equally to receive either metformin 850 mg twice daily or placebo for 5 years. Median follow-up was about 8 years.

Among 2,533 patients with estrogen receptor– and/or progesterone receptor–positive disease, the incidence of invasive disease–free survival events was 2.78 per 100 patient-years in the metformin group, vs. 2.74 per 100 patient-years in the placebo arm (hazard ratio [HR], 1.01, P = .93). There were 1.46 deaths per 100 patient-years with metformin, vs. 1.32 with placebo (HR, 1.10, P = .47).

Metformin was stopped early at about 3 years for the 1,116 hormone receptor–negative patients after futility was declared on interim analysis. The incidence of invasive disease–free survival events was 3.58 with metformin, vs. 3.60 with placebo per 100 patient-years (HR, 1.01, P = .92). There were 1.91 deaths per 100 patient-years in the metformin arm, vs. 2.15 in the group that received placebo (HR, 0.89, P = .46).

However, the findings were different and suggested a signal among the small subset of patients (17% of the total) who had HER2-positive disease. There were 1.93 disease-free survival events with metformin per 100 patient-years, vs. 3.05 events with placebo (HR, 0.64, P = .03), and 0.78 deaths in the metformin arm, vs. 1.43 deaths per 100 patient-years in the placebo arm (HR, 0.54, P = .04).

The benefit seen in this HER2-postive subgroup was limited to patients with any C allele of the rs11212617 single-nucleotide variant.

This was an exploratory analysis, so the results need to be confirmed in a randomized trial, but it’s possible that metformin “could provide an additional treatment option for HER2-positive breast cancer,” Dr. Goodwin said.

Grade 3 or higher adverse events were more common with metformin (21.5% vs. 17.5%). The most common such events were hypertension (2.4% vs. 1.9%), irregular menses (1.5% vs. 1.4%), and diarrhea (1.9% vs. 0.8%).

The study was conducted by the Canadian Cancer Trials Group and was funded by the Canadian Cancer Society, the National Cancer Institute, and others. Dr. Goodwin has disclosed no relevant financial relationships. Several coauthors reported ties to Pfizer, Eli Lilly, Roche, and a number of other companies. One coauthor is an AstraZeneca employee.

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

In the largest investigation into the issue to date, metformin did not improve survival of patients with high-risk, operable breast cancer when added to standard adjuvant treatments.

Metformin, a common option for patients with type 2 diabetes, had previously been shown in observational studies to be associated with improved survival of cancer patients. Those studies mostly involved older patients with cancer who also had diabetes.

These findings have led to trials of the use of metformin for patients with cancer who do not have diabetes, but two lung cancer trials found no effect on survival.

Now this latest trial in breast cancer, which included 3,649 patients with hormone receptor–positive or –negative disease – who did not have diabetes – also found that metformin had no effect on survival.

These results “tell us that metformin is not effective against the most common types of breast cancer and any off-label use [of] this drug for the treatment of these common types of breast cancer should be stopped,” lead investigator and medical oncologist Pamela Goodwin, MD, a breast cancer researcher at the Lunenfeld-Tanenbaum Research Institute in Toronto, said in a press release.

The negative results “underscore the need for well-conducted randomized trials” before observational studies are put into practice, Dr. Goodwin and her team said.

However, the investigators cautioned against extrapolating their results to patients with diabetes, noting that “because metformin is effective in type 2 diabetes, the results ... should not affect the use of metformin” in breast cancer patients who have diabetes.

The study was published online in JAMA.

Patients were enrolled from 2010 to 2013 while undergoing adjuvant treatment – chemotherapy, radiotherapy, hormone therapy, and/or others – following complete resection of T1-3, N0-3 tumors. They were almost exclusively women (mean age, 52.4 years), and almost 90% were non-Hispanic White. They were primarily from the United States and Canada, with some patients from the United Kingdom and Switzerland.

Patients were randomly assigned equally to receive either metformin 850 mg twice daily or placebo for 5 years. Median follow-up was about 8 years.

Among 2,533 patients with estrogen receptor– and/or progesterone receptor–positive disease, the incidence of invasive disease–free survival events was 2.78 per 100 patient-years in the metformin group, vs. 2.74 per 100 patient-years in the placebo arm (hazard ratio [HR], 1.01, P = .93). There were 1.46 deaths per 100 patient-years with metformin, vs. 1.32 with placebo (HR, 1.10, P = .47).

Metformin was stopped early at about 3 years for the 1,116 hormone receptor–negative patients after futility was declared on interim analysis. The incidence of invasive disease–free survival events was 3.58 with metformin, vs. 3.60 with placebo per 100 patient-years (HR, 1.01, P = .92). There were 1.91 deaths per 100 patient-years in the metformin arm, vs. 2.15 in the group that received placebo (HR, 0.89, P = .46).

However, the findings were different and suggested a signal among the small subset of patients (17% of the total) who had HER2-positive disease. There were 1.93 disease-free survival events with metformin per 100 patient-years, vs. 3.05 events with placebo (HR, 0.64, P = .03), and 0.78 deaths in the metformin arm, vs. 1.43 deaths per 100 patient-years in the placebo arm (HR, 0.54, P = .04).

The benefit seen in this HER2-postive subgroup was limited to patients with any C allele of the rs11212617 single-nucleotide variant.

This was an exploratory analysis, so the results need to be confirmed in a randomized trial, but it’s possible that metformin “could provide an additional treatment option for HER2-positive breast cancer,” Dr. Goodwin said.

Grade 3 or higher adverse events were more common with metformin (21.5% vs. 17.5%). The most common such events were hypertension (2.4% vs. 1.9%), irregular menses (1.5% vs. 1.4%), and diarrhea (1.9% vs. 0.8%).

The study was conducted by the Canadian Cancer Trials Group and was funded by the Canadian Cancer Society, the National Cancer Institute, and others. Dr. Goodwin has disclosed no relevant financial relationships. Several coauthors reported ties to Pfizer, Eli Lilly, Roche, and a number of other companies. One coauthor is an AstraZeneca employee.

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

Some smokers might not get lung cancer because of their DNA, researchers report in a new study.

These people have genes that help limit mutations to DNA that would turn cells malignant and make them grow into tumors, the researchers say.

Scientists have long suspected that smoking leads to lung cancer by triggering DNA mutations in healthy cells. But it was hard for them to identify the mutations in healthy cells that might help predict future cancer risk, Jan Vijg, PhD, a senior author of the study and researcher at the University School of Medicine, Shanghai, China, said in a statement.

His team used a process called single-cell whole genome sequencing to examine cells lining the lungs of 19 smokers and 14 nonsmokers ranging in age from their pre-teens to their mid-80s. The cells came from patients who had tissue samples collected from their lungs during diagnostic testing unrelated to cancer. The scientists reported their findings in Nature Genetics.

The researchers specifically looked at cells lining the lungs because these cells can survive for years and build up mutations over time that are linked to aging and smoking.

“Of all the lung’s cell types, these are among the most likely to become cancerous,” says Simon Spivack, MD, a senior author of the study and professor at the Albert Einstein College of Medicine, New York.

Smokers had far more gene mutations that can cause lung cancer than nonsmokers, the analysis found.

“This experimentally confirms that smoking increases lung cancer risk by increasing the frequency of mutations, as previously hypothesized,” says Dr. Spivack. “This is likely one reason why so few nonsmokers get lung cancer, while 10 to 20 percent of lifelong smokers do.”

Among the smokers, people had smoked a maximum of 116 pack-years. A pack-year is the equivalent of smoking one pack a day for a year. The number of mutations detected in smokers’ lung cells increased in direct proportion to the number of pack-years they smoked.

But after 23 pack-years, the lung cells in smokers didn’t appear to add more mutations, the researchers report, suggesting that some people’s genes might make them more likely to fight mutations.

“The heaviest smokers did not have the highest mutation burden,” says Dr. Spivack. “Our data suggest that these individuals may have survived for so long in spite of their heavy smoking because they managed to suppress further mutation accumulation.”

While it’s possible these findings could one day help doctors come up with better ways to screen for lung cancer and treat the disease, that’s still a long way off. Many more lab tests and larger studies will be needed to better pinpoint which smokers might be more prone to lung cancer and why.

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

Some smokers might not get lung cancer because of their DNA, researchers report in a new study.

These people have genes that help limit mutations to DNA that would turn cells malignant and make them grow into tumors, the researchers say.

Scientists have long suspected that smoking leads to lung cancer by triggering DNA mutations in healthy cells. But it was hard for them to identify the mutations in healthy cells that might help predict future cancer risk, Jan Vijg, PhD, a senior author of the study and researcher at the University School of Medicine, Shanghai, China, said in a statement.

His team used a process called single-cell whole genome sequencing to examine cells lining the lungs of 19 smokers and 14 nonsmokers ranging in age from their pre-teens to their mid-80s. The cells came from patients who had tissue samples collected from their lungs during diagnostic testing unrelated to cancer. The scientists reported their findings in Nature Genetics.

The researchers specifically looked at cells lining the lungs because these cells can survive for years and build up mutations over time that are linked to aging and smoking.

“Of all the lung’s cell types, these are among the most likely to become cancerous,” says Simon Spivack, MD, a senior author of the study and professor at the Albert Einstein College of Medicine, New York.

Smokers had far more gene mutations that can cause lung cancer than nonsmokers, the analysis found.

“This experimentally confirms that smoking increases lung cancer risk by increasing the frequency of mutations, as previously hypothesized,” says Dr. Spivack. “This is likely one reason why so few nonsmokers get lung cancer, while 10 to 20 percent of lifelong smokers do.”

Among the smokers, people had smoked a maximum of 116 pack-years. A pack-year is the equivalent of smoking one pack a day for a year. The number of mutations detected in smokers’ lung cells increased in direct proportion to the number of pack-years they smoked.

But after 23 pack-years, the lung cells in smokers didn’t appear to add more mutations, the researchers report, suggesting that some people’s genes might make them more likely to fight mutations.

“The heaviest smokers did not have the highest mutation burden,” says Dr. Spivack. “Our data suggest that these individuals may have survived for so long in spite of their heavy smoking because they managed to suppress further mutation accumulation.”

While it’s possible these findings could one day help doctors come up with better ways to screen for lung cancer and treat the disease, that’s still a long way off. Many more lab tests and larger studies will be needed to better pinpoint which smokers might be more prone to lung cancer and why.

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

Some smokers might not get lung cancer because of their DNA, researchers report in a new study.

These people have genes that help limit mutations to DNA that would turn cells malignant and make them grow into tumors, the researchers say.

Scientists have long suspected that smoking leads to lung cancer by triggering DNA mutations in healthy cells. But it was hard for them to identify the mutations in healthy cells that might help predict future cancer risk, Jan Vijg, PhD, a senior author of the study and researcher at the University School of Medicine, Shanghai, China, said in a statement.

His team used a process called single-cell whole genome sequencing to examine cells lining the lungs of 19 smokers and 14 nonsmokers ranging in age from their pre-teens to their mid-80s. The cells came from patients who had tissue samples collected from their lungs during diagnostic testing unrelated to cancer. The scientists reported their findings in Nature Genetics.

The researchers specifically looked at cells lining the lungs because these cells can survive for years and build up mutations over time that are linked to aging and smoking.

“Of all the lung’s cell types, these are among the most likely to become cancerous,” says Simon Spivack, MD, a senior author of the study and professor at the Albert Einstein College of Medicine, New York.

Smokers had far more gene mutations that can cause lung cancer than nonsmokers, the analysis found.

“This experimentally confirms that smoking increases lung cancer risk by increasing the frequency of mutations, as previously hypothesized,” says Dr. Spivack. “This is likely one reason why so few nonsmokers get lung cancer, while 10 to 20 percent of lifelong smokers do.”

Among the smokers, people had smoked a maximum of 116 pack-years. A pack-year is the equivalent of smoking one pack a day for a year. The number of mutations detected in smokers’ lung cells increased in direct proportion to the number of pack-years they smoked.

But after 23 pack-years, the lung cells in smokers didn’t appear to add more mutations, the researchers report, suggesting that some people’s genes might make them more likely to fight mutations.

“The heaviest smokers did not have the highest mutation burden,” says Dr. Spivack. “Our data suggest that these individuals may have survived for so long in spite of their heavy smoking because they managed to suppress further mutation accumulation.”

While it’s possible these findings could one day help doctors come up with better ways to screen for lung cancer and treat the disease, that’s still a long way off. Many more lab tests and larger studies will be needed to better pinpoint which smokers might be more prone to lung cancer and why.

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

In states that adopted Medicaid expansion following the implementation of the Affordable Care Act (ACA), patients with cancer have improved 2-year overall survival rates, compared with patients in states that did not adopt the expansion.

The finding comes from an American Cancer Society study of more than 2 million patients with newly diagnosed cancer, published online in the Journal of the National Cancer Institute.

The analysis also showed that the evidence was strongest for malignancies with poor prognosis such as lung, pancreatic, and liver cancer, and also for colorectal cancer.

Importantly, improvements in survival were larger in non-Hispanic Black patients and individuals residing in rural areas, suggesting there was a narrowing of disparities in cancer survival by race and rurality.

“Our findings provide further evidence of the importance of expanding Medicaid eligibility in all states, particularly considering the economic crisis and health care disruptions caused by the COVID-19 pandemic,” said lead author Xuesong Han, PhD, scientific director of health services research at the American Cancer Society, in a statement. “What’s encouraging is the American Rescue Plan Act of 2021 provides new incentives for Medicaid expansion in states that have yet to increase eligibility.”

The ACA provided states with incentives to expand Medicaid eligibility to all low-income adults under 138% federal poverty level, regardless of parental status.

As of last month, just 12 states have not yet opted for Medicaid expansion, even though the American Rescue Plan Act of 2021 provides new incentives for those remaining jurisdictions. But to date, none of the remaining states have taken advantage of these new incentives.

An interactive map showing the status of Medicare expansion by state is available here. The 12 states that have not adopted Medicare expansion (as of April) are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.  

The benefit of Medicaid expansion on cancer outcomes has already been observed in other studies. The first study to show a survival benefit was presented at the 2020 American Society of Clinical Oncology annual meeting. That analysis showed that cancer mortality declined by 29% in states that expanded Medicaid and by 25% in those that did not. The authors also noted that the greatest mortality benefit was observed in Hispanic patients.
 

Improved survival with expansion

In the current paper, Dr. Han and colleagues used population-based cancer registries from 42 states and compared data on patients aged 18-62 years who were diagnosed with cancer in a period of 2 years before (2010-2012) and after (2014-2016) ACA Medicaid expansion. They were followed through Sept. 30, 2013, and Dec. 31, 2017, respectively.

The analysis involved a total of 2.5 million patients, of whom 1.52 million lived in states that adopted Medicaid expansion and compared with 1 million patients were in states that did not.

Patients with grouped by sex, race and ethnicity, census tract-level poverty, and rurality. The authors note that non-Hispanic Black patients and those from high poverty areas and nonmetropolitan areas were disproportionately represented in nonexpansion states. 

During the 2-year follow-up period, a total of 453,487 deaths occurred (257,950 in expansion states and 195,537 in nonexpansion states).

Overall, patients in expansion states generally had better survival versus those in nonexpansion states, the authors comment. However, for most cancer types, overall survival improved after the ACA for both groups of states.

The 2-year overall survival increased from 80.6% before the ACA to 82.2% post ACA in expansion states and from 78.7% to 80% in nonexpansion states.

This extrapolated to net increase of 0.44 percentage points in expansion states after adjusting for sociodemographic factors. By cancer site, the net increase was greater for colorectal cancer, lung cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and liver cancer.

For Hispanic patients, 2-year survival also increased but was similar in expansion and nonexpansion states, and little net change was associated with Medicaid expansion.

“Our study shows that the increase was largely driven by improvements in survival for cancer types with poor prognosis, suggesting improved access to timely and effective treatments,” said Dr. Han. “It adds to accumulating evidence of the multiple benefits of Medicaid expansion.”

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

In states that adopted Medicaid expansion following the implementation of the Affordable Care Act (ACA), patients with cancer have improved 2-year overall survival rates, compared with patients in states that did not adopt the expansion.

The finding comes from an American Cancer Society study of more than 2 million patients with newly diagnosed cancer, published online in the Journal of the National Cancer Institute.

The analysis also showed that the evidence was strongest for malignancies with poor prognosis such as lung, pancreatic, and liver cancer, and also for colorectal cancer.

Importantly, improvements in survival were larger in non-Hispanic Black patients and individuals residing in rural areas, suggesting there was a narrowing of disparities in cancer survival by race and rurality.

“Our findings provide further evidence of the importance of expanding Medicaid eligibility in all states, particularly considering the economic crisis and health care disruptions caused by the COVID-19 pandemic,” said lead author Xuesong Han, PhD, scientific director of health services research at the American Cancer Society, in a statement. “What’s encouraging is the American Rescue Plan Act of 2021 provides new incentives for Medicaid expansion in states that have yet to increase eligibility.”

The ACA provided states with incentives to expand Medicaid eligibility to all low-income adults under 138% federal poverty level, regardless of parental status.

As of last month, just 12 states have not yet opted for Medicaid expansion, even though the American Rescue Plan Act of 2021 provides new incentives for those remaining jurisdictions. But to date, none of the remaining states have taken advantage of these new incentives.

An interactive map showing the status of Medicare expansion by state is available here. The 12 states that have not adopted Medicare expansion (as of April) are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.  

The benefit of Medicaid expansion on cancer outcomes has already been observed in other studies. The first study to show a survival benefit was presented at the 2020 American Society of Clinical Oncology annual meeting. That analysis showed that cancer mortality declined by 29% in states that expanded Medicaid and by 25% in those that did not. The authors also noted that the greatest mortality benefit was observed in Hispanic patients.
 

Improved survival with expansion

In the current paper, Dr. Han and colleagues used population-based cancer registries from 42 states and compared data on patients aged 18-62 years who were diagnosed with cancer in a period of 2 years before (2010-2012) and after (2014-2016) ACA Medicaid expansion. They were followed through Sept. 30, 2013, and Dec. 31, 2017, respectively.

The analysis involved a total of 2.5 million patients, of whom 1.52 million lived in states that adopted Medicaid expansion and compared with 1 million patients were in states that did not.

Patients with grouped by sex, race and ethnicity, census tract-level poverty, and rurality. The authors note that non-Hispanic Black patients and those from high poverty areas and nonmetropolitan areas were disproportionately represented in nonexpansion states. 

During the 2-year follow-up period, a total of 453,487 deaths occurred (257,950 in expansion states and 195,537 in nonexpansion states).

Overall, patients in expansion states generally had better survival versus those in nonexpansion states, the authors comment. However, for most cancer types, overall survival improved after the ACA for both groups of states.

The 2-year overall survival increased from 80.6% before the ACA to 82.2% post ACA in expansion states and from 78.7% to 80% in nonexpansion states.

This extrapolated to net increase of 0.44 percentage points in expansion states after adjusting for sociodemographic factors. By cancer site, the net increase was greater for colorectal cancer, lung cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and liver cancer.

For Hispanic patients, 2-year survival also increased but was similar in expansion and nonexpansion states, and little net change was associated with Medicaid expansion.

“Our study shows that the increase was largely driven by improvements in survival for cancer types with poor prognosis, suggesting improved access to timely and effective treatments,” said Dr. Han. “It adds to accumulating evidence of the multiple benefits of Medicaid expansion.”

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

In states that adopted Medicaid expansion following the implementation of the Affordable Care Act (ACA), patients with cancer have improved 2-year overall survival rates, compared with patients in states that did not adopt the expansion.

The finding comes from an American Cancer Society study of more than 2 million patients with newly diagnosed cancer, published online in the Journal of the National Cancer Institute.

The analysis also showed that the evidence was strongest for malignancies with poor prognosis such as lung, pancreatic, and liver cancer, and also for colorectal cancer.

Importantly, improvements in survival were larger in non-Hispanic Black patients and individuals residing in rural areas, suggesting there was a narrowing of disparities in cancer survival by race and rurality.

“Our findings provide further evidence of the importance of expanding Medicaid eligibility in all states, particularly considering the economic crisis and health care disruptions caused by the COVID-19 pandemic,” said lead author Xuesong Han, PhD, scientific director of health services research at the American Cancer Society, in a statement. “What’s encouraging is the American Rescue Plan Act of 2021 provides new incentives for Medicaid expansion in states that have yet to increase eligibility.”

The ACA provided states with incentives to expand Medicaid eligibility to all low-income adults under 138% federal poverty level, regardless of parental status.

As of last month, just 12 states have not yet opted for Medicaid expansion, even though the American Rescue Plan Act of 2021 provides new incentives for those remaining jurisdictions. But to date, none of the remaining states have taken advantage of these new incentives.

An interactive map showing the status of Medicare expansion by state is available here. The 12 states that have not adopted Medicare expansion (as of April) are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.  

The benefit of Medicaid expansion on cancer outcomes has already been observed in other studies. The first study to show a survival benefit was presented at the 2020 American Society of Clinical Oncology annual meeting. That analysis showed that cancer mortality declined by 29% in states that expanded Medicaid and by 25% in those that did not. The authors also noted that the greatest mortality benefit was observed in Hispanic patients.
 

Improved survival with expansion

In the current paper, Dr. Han and colleagues used population-based cancer registries from 42 states and compared data on patients aged 18-62 years who were diagnosed with cancer in a period of 2 years before (2010-2012) and after (2014-2016) ACA Medicaid expansion. They were followed through Sept. 30, 2013, and Dec. 31, 2017, respectively.

The analysis involved a total of 2.5 million patients, of whom 1.52 million lived in states that adopted Medicaid expansion and compared with 1 million patients were in states that did not.

Patients with grouped by sex, race and ethnicity, census tract-level poverty, and rurality. The authors note that non-Hispanic Black patients and those from high poverty areas and nonmetropolitan areas were disproportionately represented in nonexpansion states. 

During the 2-year follow-up period, a total of 453,487 deaths occurred (257,950 in expansion states and 195,537 in nonexpansion states).

Overall, patients in expansion states generally had better survival versus those in nonexpansion states, the authors comment. However, for most cancer types, overall survival improved after the ACA for both groups of states.

The 2-year overall survival increased from 80.6% before the ACA to 82.2% post ACA in expansion states and from 78.7% to 80% in nonexpansion states.

This extrapolated to net increase of 0.44 percentage points in expansion states after adjusting for sociodemographic factors. By cancer site, the net increase was greater for colorectal cancer, lung cancer, non-Hodgkin’s lymphoma, pancreatic cancer, and liver cancer.

For Hispanic patients, 2-year survival also increased but was similar in expansion and nonexpansion states, and little net change was associated with Medicaid expansion.

“Our study shows that the increase was largely driven by improvements in survival for cancer types with poor prognosis, suggesting improved access to timely and effective treatments,” said Dr. Han. “It adds to accumulating evidence of the multiple benefits of Medicaid expansion.”

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

The number of men with prostate cancer who opted for active surveillance (AS) doubled nationally between 2014 and 2021, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.

Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.

Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.

Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.

In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.

Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.

Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”

In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.

Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.

“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”

The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.

In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.

In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
 

Aiming higher

William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”

Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.

However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.

Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”

Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.

“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”

Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”

Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.

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

The number of men with prostate cancer who opted for active surveillance (AS) doubled nationally between 2014 and 2021, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.

Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.

Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.

Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.

In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.

Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.

Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”

In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.

Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.

“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”

The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.

In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.

In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
 

Aiming higher

William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”

Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.

However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.

Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”

Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.

“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”

Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”

Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.

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

The number of men with prostate cancer who opted for active surveillance (AS) doubled nationally between 2014 and 2021, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.

Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.

Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.

Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.

In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.

Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.

Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”

In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.

Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.

“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”

The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.

In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.

In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
 

Aiming higher

William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”

Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.

However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.

Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”

Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.

“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”

Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”

Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.

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

New results from a phase 3 clinical trial may shut the door on the addition of progressive death–1 or PD–ligand 1 inhibitors to the combination of BRAF and MEK inhibitors for the treatment of BRAF V600–mutated melanoma.

The approach seemed promising, given the efficacy of PD-1 and PD-L1 inhibitors in metastatic melanoma, and the relatively short response times to BRAF and MEK inhibitors could potentially be supplemented by longer response times associated with PD-1 and PD-L1 inhibitors. The two categories also have different mechanisms of action and nonoverlapping toxicities, which led to an expectation that the combination would be well tolerated.

But the new study joins two previous randomized, controlled trials that also failed to show much clinical benefit. IMspire150 assigned BRAF V600–mutated melanoma patients to vemurafenib and cobimetinib plus the anti–PD-L1 antibody atezolizumab or placebo. The treatment arm had a small benefit in progression-free survival (hazard ratio, 0.78), which led to Food and Drug Administration approval of the combination, though there was no significant difference when the two cohorts were assessed by an independent review committee. The KEYNOTE-022 trial examined dabrafenib plus trametinib with or without the anti–PD-1 antibody pembrolizumab, and found no difference in investigator-assessed progression free survival.

The new study was published in the Journal of Clinical Oncology. In an accompanying editorial, Margaret K. Callahan, MD, PhD, of Memorial Sloan Kettering Cancer Center, and Paul B. Chapman, MD, of Weill Cornell Medicine, both in New York, speculated that the toxicity of the triplet combination might explain the latest failure, since patients in the triplet arm had more treatment interruptions and dose reductions than the doublet arm (32% received full-dose dabrafenib vs. 54% in the doublet arm), which may have undermined efficacy.

Citing the fact that there are now three randomized, controlled trials with discouraging results, “we believe that there are sufficient data now to be confident that the addition of anti–PD-1 or anti–PD-L1 antibodies to combination RAFi [RAF inhibitors] plus MEKi [MEK inhibitors] is not associated with a significant clinical benefit and should not be studied further in melanoma.

Moreover, “there is some evidence of harm,” the editorial authors wrote. “As the additional toxicity of triplet combination limited the delivery of combination RAFi plus MEKi therapy in COMBI-I. Focus should turn instead to optimizing doses and schedules of combination RAFi plus MEKi and checkpoint inhibitors, developing treatment strategies to overcome resistance to these therapies, and determining how best to sequence combination RAFi plus MEKi therapy and checkpoint inhibitors. Regarding the latter point, there are several sequential therapy trials currently underway in previously untreated patients with BRAF V600–mutated melanoma.”

In the study, patients were randomized to receive dabrafenib and trametinib plus the anti–PD receptor–1 antibody spartalizumab or placebo. After a median follow-up of 27.2 months, mean progression-free survival was 16.2 months in the spartalizumab arm and 12.0 months in the placebo arm (HR, 0.82; P = .042). The spartalizumab group had a 69% objective response rate versus 64% in the placebo group. 55% of the spartalizumab group experienced grade 3 or higher treatment-related adverse events, compared with 33% in the placebo group.

“These results do not support broad use of first-line immunotherapy plus targeted therapy combination, but they provide additional data toward understanding the optimal application of these therapeutic classes in patients with BRAF V600–mutant metastatic melanoma,” the authors of the study wrote.

The study was funded by F Hoffmann–La Roche and Genentech. Dr. Callahan has been employed at Bristol-Myers Squibb, Celgene, and Kleo Pharmaceuticals. Dr. Callahan has consulted for or advised AstraZeneca, Moderna Therapeutics, Merck, and Immunocore. Dr. Chapman has stock or ownership interest in Rgenix; has consulted for or advised Merck, Pfizer, and Black Diamond Therapeutics; and has received research funding from Genentech.

New results from a phase 3 clinical trial may shut the door on the addition of progressive death–1 or PD–ligand 1 inhibitors to the combination of BRAF and MEK inhibitors for the treatment of BRAF V600–mutated melanoma.

The approach seemed promising, given the efficacy of PD-1 and PD-L1 inhibitors in metastatic melanoma, and the relatively short response times to BRAF and MEK inhibitors could potentially be supplemented by longer response times associated with PD-1 and PD-L1 inhibitors. The two categories also have different mechanisms of action and nonoverlapping toxicities, which led to an expectation that the combination would be well tolerated.

But the new study joins two previous randomized, controlled trials that also failed to show much clinical benefit. IMspire150 assigned BRAF V600–mutated melanoma patients to vemurafenib and cobimetinib plus the anti–PD-L1 antibody atezolizumab or placebo. The treatment arm had a small benefit in progression-free survival (hazard ratio, 0.78), which led to Food and Drug Administration approval of the combination, though there was no significant difference when the two cohorts were assessed by an independent review committee. The KEYNOTE-022 trial examined dabrafenib plus trametinib with or without the anti–PD-1 antibody pembrolizumab, and found no difference in investigator-assessed progression free survival.

The new study was published in the Journal of Clinical Oncology. In an accompanying editorial, Margaret K. Callahan, MD, PhD, of Memorial Sloan Kettering Cancer Center, and Paul B. Chapman, MD, of Weill Cornell Medicine, both in New York, speculated that the toxicity of the triplet combination might explain the latest failure, since patients in the triplet arm had more treatment interruptions and dose reductions than the doublet arm (32% received full-dose dabrafenib vs. 54% in the doublet arm), which may have undermined efficacy.

Citing the fact that there are now three randomized, controlled trials with discouraging results, “we believe that there are sufficient data now to be confident that the addition of anti–PD-1 or anti–PD-L1 antibodies to combination RAFi [RAF inhibitors] plus MEKi [MEK inhibitors] is not associated with a significant clinical benefit and should not be studied further in melanoma.

Moreover, “there is some evidence of harm,” the editorial authors wrote. “As the additional toxicity of triplet combination limited the delivery of combination RAFi plus MEKi therapy in COMBI-I. Focus should turn instead to optimizing doses and schedules of combination RAFi plus MEKi and checkpoint inhibitors, developing treatment strategies to overcome resistance to these therapies, and determining how best to sequence combination RAFi plus MEKi therapy and checkpoint inhibitors. Regarding the latter point, there are several sequential therapy trials currently underway in previously untreated patients with BRAF V600–mutated melanoma.”

In the study, patients were randomized to receive dabrafenib and trametinib plus the anti–PD receptor–1 antibody spartalizumab or placebo. After a median follow-up of 27.2 months, mean progression-free survival was 16.2 months in the spartalizumab arm and 12.0 months in the placebo arm (HR, 0.82; P = .042). The spartalizumab group had a 69% objective response rate versus 64% in the placebo group. 55% of the spartalizumab group experienced grade 3 or higher treatment-related adverse events, compared with 33% in the placebo group.

“These results do not support broad use of first-line immunotherapy plus targeted therapy combination, but they provide additional data toward understanding the optimal application of these therapeutic classes in patients with BRAF V600–mutant metastatic melanoma,” the authors of the study wrote.

The study was funded by F Hoffmann–La Roche and Genentech. Dr. Callahan has been employed at Bristol-Myers Squibb, Celgene, and Kleo Pharmaceuticals. Dr. Callahan has consulted for or advised AstraZeneca, Moderna Therapeutics, Merck, and Immunocore. Dr. Chapman has stock or ownership interest in Rgenix; has consulted for or advised Merck, Pfizer, and Black Diamond Therapeutics; and has received research funding from Genentech.

New results from a phase 3 clinical trial may shut the door on the addition of progressive death–1 or PD–ligand 1 inhibitors to the combination of BRAF and MEK inhibitors for the treatment of BRAF V600–mutated melanoma.

The approach seemed promising, given the efficacy of PD-1 and PD-L1 inhibitors in metastatic melanoma, and the relatively short response times to BRAF and MEK inhibitors could potentially be supplemented by longer response times associated with PD-1 and PD-L1 inhibitors. The two categories also have different mechanisms of action and nonoverlapping toxicities, which led to an expectation that the combination would be well tolerated.

But the new study joins two previous randomized, controlled trials that also failed to show much clinical benefit. IMspire150 assigned BRAF V600–mutated melanoma patients to vemurafenib and cobimetinib plus the anti–PD-L1 antibody atezolizumab or placebo. The treatment arm had a small benefit in progression-free survival (hazard ratio, 0.78), which led to Food and Drug Administration approval of the combination, though there was no significant difference when the two cohorts were assessed by an independent review committee. The KEYNOTE-022 trial examined dabrafenib plus trametinib with or without the anti–PD-1 antibody pembrolizumab, and found no difference in investigator-assessed progression free survival.

The new study was published in the Journal of Clinical Oncology. In an accompanying editorial, Margaret K. Callahan, MD, PhD, of Memorial Sloan Kettering Cancer Center, and Paul B. Chapman, MD, of Weill Cornell Medicine, both in New York, speculated that the toxicity of the triplet combination might explain the latest failure, since patients in the triplet arm had more treatment interruptions and dose reductions than the doublet arm (32% received full-dose dabrafenib vs. 54% in the doublet arm), which may have undermined efficacy.

Citing the fact that there are now three randomized, controlled trials with discouraging results, “we believe that there are sufficient data now to be confident that the addition of anti–PD-1 or anti–PD-L1 antibodies to combination RAFi [RAF inhibitors] plus MEKi [MEK inhibitors] is not associated with a significant clinical benefit and should not be studied further in melanoma.

Moreover, “there is some evidence of harm,” the editorial authors wrote. “As the additional toxicity of triplet combination limited the delivery of combination RAFi plus MEKi therapy in COMBI-I. Focus should turn instead to optimizing doses and schedules of combination RAFi plus MEKi and checkpoint inhibitors, developing treatment strategies to overcome resistance to these therapies, and determining how best to sequence combination RAFi plus MEKi therapy and checkpoint inhibitors. Regarding the latter point, there are several sequential therapy trials currently underway in previously untreated patients with BRAF V600–mutated melanoma.”

In the study, patients were randomized to receive dabrafenib and trametinib plus the anti–PD receptor–1 antibody spartalizumab or placebo. After a median follow-up of 27.2 months, mean progression-free survival was 16.2 months in the spartalizumab arm and 12.0 months in the placebo arm (HR, 0.82; P = .042). The spartalizumab group had a 69% objective response rate versus 64% in the placebo group. 55% of the spartalizumab group experienced grade 3 or higher treatment-related adverse events, compared with 33% in the placebo group.

“These results do not support broad use of first-line immunotherapy plus targeted therapy combination, but they provide additional data toward understanding the optimal application of these therapeutic classes in patients with BRAF V600–mutant metastatic melanoma,” the authors of the study wrote.

The study was funded by F Hoffmann–La Roche and Genentech. Dr. Callahan has been employed at Bristol-Myers Squibb, Celgene, and Kleo Pharmaceuticals. Dr. Callahan has consulted for or advised AstraZeneca, Moderna Therapeutics, Merck, and Immunocore. Dr. Chapman has stock or ownership interest in Rgenix; has consulted for or advised Merck, Pfizer, and Black Diamond Therapeutics; and has received research funding from Genentech.

Women with ductal carcinoma in situ (DCIS) breast cancer are generally uninformed about their diagnosis and are making uninformed treatment decisions, according to results of a study presented this month at ESMO Breast Cancer 2022, an annual meeting of the European Society for Medical Oncology.

The standard of care for women diagnosed with DCIS includes surgery with or without radiotherapy – even low-risk patients who are increasingly being steered toward active surveillance with annual mammograms. But few patients understand their diagnosis well enough to make informed decisions about treatment, according to a study led by Ellen Engelhardt, PhD, a postdoctoral fellow at The Netherlands Cancer Institute, Amsterdam.

“You’re not able to really have an informed preference until you understand the choices,” she said.

Dr. Engelhardt and colleagues surveyed 200 patients (mean age 59 years) from the LORD study, which is currently underway at The Netherlands Cancer Institute. The women were asked to complete a survey before treatment decisions were made. Their objective was to determine how knowledgeable patients were about DCIS. They found that only 34% of women answered four out of seven questions correctly: 19% of patients believed that DCIS could metastasize to organs other than the breast; 31% did not realize DCIS could progress to invasive breast cancer if left untreated; 79% thought DCIS could always be seen on mammograms; and, 93% said that progression could always be detected before it becomes “too extensive.” Knowledge of DCIS was found not to be associated with patient education level.

Susie X. Sun, MD, FACS, a breast surgeon at the University of Texas MD Anderson Cancer Center, Houston, said the findings clearly highlight a disconnect in communication between doctor and patient.

“I was surprised, because this clearly demonstrates there is a disconnect between what patients are being told by their providers and what is being perceived. It really shows us that we need to do a better job of making sure that our patients understand the information they’re given,” she said.

Dr. Sun, who was not involved in the study, said that DCIS needs to be explained well to patients. When they receive a diagnosis, often all they hear is, “I have breast cancer. It is really important for us to stress to patients how DCIS is different from invasive breast cancer,” she said.

The “Management of Low-risk (grade I and II) DCIS (LORD)” study is one of three studies comparing active surveillance to surgery (with or without radiotherapy).

A limitation of the study presented at ESMO Breast Cancer is that it remains unclear why patients answered questions incorrectly. Was information never communicated to them? Or, did they mishear or misunderstand the doctor? In future studies, Dr. Engelhardt and her colleagues plan to record and analyze audio tapes of consultations to determine where the communication disconnect lies.

Dr. Engelhardt did not disclose any conflicts associated with this work.

Women with ductal carcinoma in situ (DCIS) breast cancer are generally uninformed about their diagnosis and are making uninformed treatment decisions, according to results of a study presented this month at ESMO Breast Cancer 2022, an annual meeting of the European Society for Medical Oncology.

The standard of care for women diagnosed with DCIS includes surgery with or without radiotherapy – even low-risk patients who are increasingly being steered toward active surveillance with annual mammograms. But few patients understand their diagnosis well enough to make informed decisions about treatment, according to a study led by Ellen Engelhardt, PhD, a postdoctoral fellow at The Netherlands Cancer Institute, Amsterdam.

“You’re not able to really have an informed preference until you understand the choices,” she said.

Dr. Engelhardt and colleagues surveyed 200 patients (mean age 59 years) from the LORD study, which is currently underway at The Netherlands Cancer Institute. The women were asked to complete a survey before treatment decisions were made. Their objective was to determine how knowledgeable patients were about DCIS. They found that only 34% of women answered four out of seven questions correctly: 19% of patients believed that DCIS could metastasize to organs other than the breast; 31% did not realize DCIS could progress to invasive breast cancer if left untreated; 79% thought DCIS could always be seen on mammograms; and, 93% said that progression could always be detected before it becomes “too extensive.” Knowledge of DCIS was found not to be associated with patient education level.

Susie X. Sun, MD, FACS, a breast surgeon at the University of Texas MD Anderson Cancer Center, Houston, said the findings clearly highlight a disconnect in communication between doctor and patient.

“I was surprised, because this clearly demonstrates there is a disconnect between what patients are being told by their providers and what is being perceived. It really shows us that we need to do a better job of making sure that our patients understand the information they’re given,” she said.

Dr. Sun, who was not involved in the study, said that DCIS needs to be explained well to patients. When they receive a diagnosis, often all they hear is, “I have breast cancer. It is really important for us to stress to patients how DCIS is different from invasive breast cancer,” she said.

The “Management of Low-risk (grade I and II) DCIS (LORD)” study is one of three studies comparing active surveillance to surgery (with or without radiotherapy).

A limitation of the study presented at ESMO Breast Cancer is that it remains unclear why patients answered questions incorrectly. Was information never communicated to them? Or, did they mishear or misunderstand the doctor? In future studies, Dr. Engelhardt and her colleagues plan to record and analyze audio tapes of consultations to determine where the communication disconnect lies.

Dr. Engelhardt did not disclose any conflicts associated with this work.

Women with ductal carcinoma in situ (DCIS) breast cancer are generally uninformed about their diagnosis and are making uninformed treatment decisions, according to results of a study presented this month at ESMO Breast Cancer 2022, an annual meeting of the European Society for Medical Oncology.

The standard of care for women diagnosed with DCIS includes surgery with or without radiotherapy – even low-risk patients who are increasingly being steered toward active surveillance with annual mammograms. But few patients understand their diagnosis well enough to make informed decisions about treatment, according to a study led by Ellen Engelhardt, PhD, a postdoctoral fellow at The Netherlands Cancer Institute, Amsterdam.

“You’re not able to really have an informed preference until you understand the choices,” she said.

Dr. Engelhardt and colleagues surveyed 200 patients (mean age 59 years) from the LORD study, which is currently underway at The Netherlands Cancer Institute. The women were asked to complete a survey before treatment decisions were made. Their objective was to determine how knowledgeable patients were about DCIS. They found that only 34% of women answered four out of seven questions correctly: 19% of patients believed that DCIS could metastasize to organs other than the breast; 31% did not realize DCIS could progress to invasive breast cancer if left untreated; 79% thought DCIS could always be seen on mammograms; and, 93% said that progression could always be detected before it becomes “too extensive.” Knowledge of DCIS was found not to be associated with patient education level.

Susie X. Sun, MD, FACS, a breast surgeon at the University of Texas MD Anderson Cancer Center, Houston, said the findings clearly highlight a disconnect in communication between doctor and patient.

“I was surprised, because this clearly demonstrates there is a disconnect between what patients are being told by their providers and what is being perceived. It really shows us that we need to do a better job of making sure that our patients understand the information they’re given,” she said.

Dr. Sun, who was not involved in the study, said that DCIS needs to be explained well to patients. When they receive a diagnosis, often all they hear is, “I have breast cancer. It is really important for us to stress to patients how DCIS is different from invasive breast cancer,” she said.

The “Management of Low-risk (grade I and II) DCIS (LORD)” study is one of three studies comparing active surveillance to surgery (with or without radiotherapy).

A limitation of the study presented at ESMO Breast Cancer is that it remains unclear why patients answered questions incorrectly. Was information never communicated to them? Or, did they mishear or misunderstand the doctor? In future studies, Dr. Engelhardt and her colleagues plan to record and analyze audio tapes of consultations to determine where the communication disconnect lies.

Dr. Engelhardt did not disclose any conflicts associated with this work.

Early-onset colorectal cancer (CRC) affecting patients younger than 50 years has risen sharply since 1988 from 7.9 to 12.9 cases in 2015 per 100,000 people. The reason for the increase isn’t well understood.

The findings were highlighted in a recent review article published online in the New England Journal of Medicine. “It’s a national phenomenon and it’s also occurring in other parts of the developed world. We’re used to seeing mostly older people who have this diagnosis. Now we’re seeing a lot of younger people with this disease. It’s rather alarming,” said author Frank Sinicrope, MD, a medical oncologist with Mayo Clinic, Rochester, Minn.

The trend contrasts with a decline in later-onset CRC likely attributable to increases in screening. As a result of the two trends, but especially the increased number of early-onset cases, the median age of diagnosis dropped from 72 in the early 2000s to 66 today.

“Although patients with early-onset colorectal cancer are more likely to have a hereditary syndrome than those who have later-onset disease, most cases are sporadic, with no identifiable cause. Furthermore, somatic mutational profiling of early-onset colorectal cancers has not revealed previously unidentified or actionable alterations to inform our understanding of the pathogenesis of these cancers or to guide treatment,” he wrote in the review.

“Early-onset colorectal cancers are most commonly detected in the rectum, followed by the distal colon; more than 70% of early-onset colorectal cancers are in the left colon at presentation,” he wrote in the review. Younger patients tend to be unfamiliar with CRC symptoms, which are often mistaken for benign conditions.

“We’ve moved the screening age down to 45, but that still is not going to capture a lot of these patients,” Dr. Sinicrope said. He estimates that 25% of rectal cancers and 10%-12% of colon cancers diagnosed in the next 10 years will be early onset.

Although the direct cause of the increased incidence isn’t clear, Dr. Sinicrope suggested it may reflect changing dietary habits and rising obesity among adolescents. “The sugar-containing beverages, the processed sugar and a lot of red meat in the diet and refined grains … reflect changes in the diet over the last 50 years. We may now be seeing the end result of many of these dietary changes that have occurred,” he said, calling for a greater emphasis on plant-based diets, which promote a healthier gut microbiome that may reduce CRC risk. Western-style diets can change the gut microbiome leading to inflammation which increases the risk of CRC.

Most patients with early CRC present with advanced disease in the left colon. And, pathogenic germline variants are present in one in six patients – half of which are associated with Lynch syndrome which increases the risk for CRC.

Dr. Sinicrope highlighted the need for more risk-based intervention, which in turn requires a better knowledge of family history.

“We need to do better job to risk stratify, and that will help us figure out who’s best to target our screening efforts toward,” Dr. Sinicrope said. He pointed out guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer and the American Cancer Society that can help physicians identify patients who might benefit from earlier screening. The American Cancer Society recommends that CRC screening be conducted at 45 years for average-risk individuals.

“The best screening test is the one that the patient will do,” Dr. Sinicrope said.

Early-onset colorectal cancer (CRC) affecting patients younger than 50 years has risen sharply since 1988 from 7.9 to 12.9 cases in 2015 per 100,000 people. The reason for the increase isn’t well understood.

The findings were highlighted in a recent review article published online in the New England Journal of Medicine. “It’s a national phenomenon and it’s also occurring in other parts of the developed world. We’re used to seeing mostly older people who have this diagnosis. Now we’re seeing a lot of younger people with this disease. It’s rather alarming,” said author Frank Sinicrope, MD, a medical oncologist with Mayo Clinic, Rochester, Minn.

The trend contrasts with a decline in later-onset CRC likely attributable to increases in screening. As a result of the two trends, but especially the increased number of early-onset cases, the median age of diagnosis dropped from 72 in the early 2000s to 66 today.

“Although patients with early-onset colorectal cancer are more likely to have a hereditary syndrome than those who have later-onset disease, most cases are sporadic, with no identifiable cause. Furthermore, somatic mutational profiling of early-onset colorectal cancers has not revealed previously unidentified or actionable alterations to inform our understanding of the pathogenesis of these cancers or to guide treatment,” he wrote in the review.

“Early-onset colorectal cancers are most commonly detected in the rectum, followed by the distal colon; more than 70% of early-onset colorectal cancers are in the left colon at presentation,” he wrote in the review. Younger patients tend to be unfamiliar with CRC symptoms, which are often mistaken for benign conditions.

“We’ve moved the screening age down to 45, but that still is not going to capture a lot of these patients,” Dr. Sinicrope said. He estimates that 25% of rectal cancers and 10%-12% of colon cancers diagnosed in the next 10 years will be early onset.

Although the direct cause of the increased incidence isn’t clear, Dr. Sinicrope suggested it may reflect changing dietary habits and rising obesity among adolescents. “The sugar-containing beverages, the processed sugar and a lot of red meat in the diet and refined grains … reflect changes in the diet over the last 50 years. We may now be seeing the end result of many of these dietary changes that have occurred,” he said, calling for a greater emphasis on plant-based diets, which promote a healthier gut microbiome that may reduce CRC risk. Western-style diets can change the gut microbiome leading to inflammation which increases the risk of CRC.

Most patients with early CRC present with advanced disease in the left colon. And, pathogenic germline variants are present in one in six patients – half of which are associated with Lynch syndrome which increases the risk for CRC.

Dr. Sinicrope highlighted the need for more risk-based intervention, which in turn requires a better knowledge of family history.

“We need to do better job to risk stratify, and that will help us figure out who’s best to target our screening efforts toward,” Dr. Sinicrope said. He pointed out guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer and the American Cancer Society that can help physicians identify patients who might benefit from earlier screening. The American Cancer Society recommends that CRC screening be conducted at 45 years for average-risk individuals.

“The best screening test is the one that the patient will do,” Dr. Sinicrope said.

Early-onset colorectal cancer (CRC) affecting patients younger than 50 years has risen sharply since 1988 from 7.9 to 12.9 cases in 2015 per 100,000 people. The reason for the increase isn’t well understood.

The findings were highlighted in a recent review article published online in the New England Journal of Medicine. “It’s a national phenomenon and it’s also occurring in other parts of the developed world. We’re used to seeing mostly older people who have this diagnosis. Now we’re seeing a lot of younger people with this disease. It’s rather alarming,” said author Frank Sinicrope, MD, a medical oncologist with Mayo Clinic, Rochester, Minn.

The trend contrasts with a decline in later-onset CRC likely attributable to increases in screening. As a result of the two trends, but especially the increased number of early-onset cases, the median age of diagnosis dropped from 72 in the early 2000s to 66 today.

“Although patients with early-onset colorectal cancer are more likely to have a hereditary syndrome than those who have later-onset disease, most cases are sporadic, with no identifiable cause. Furthermore, somatic mutational profiling of early-onset colorectal cancers has not revealed previously unidentified or actionable alterations to inform our understanding of the pathogenesis of these cancers or to guide treatment,” he wrote in the review.

“Early-onset colorectal cancers are most commonly detected in the rectum, followed by the distal colon; more than 70% of early-onset colorectal cancers are in the left colon at presentation,” he wrote in the review. Younger patients tend to be unfamiliar with CRC symptoms, which are often mistaken for benign conditions.

“We’ve moved the screening age down to 45, but that still is not going to capture a lot of these patients,” Dr. Sinicrope said. He estimates that 25% of rectal cancers and 10%-12% of colon cancers diagnosed in the next 10 years will be early onset.

Although the direct cause of the increased incidence isn’t clear, Dr. Sinicrope suggested it may reflect changing dietary habits and rising obesity among adolescents. “The sugar-containing beverages, the processed sugar and a lot of red meat in the diet and refined grains … reflect changes in the diet over the last 50 years. We may now be seeing the end result of many of these dietary changes that have occurred,” he said, calling for a greater emphasis on plant-based diets, which promote a healthier gut microbiome that may reduce CRC risk. Western-style diets can change the gut microbiome leading to inflammation which increases the risk of CRC.

Most patients with early CRC present with advanced disease in the left colon. And, pathogenic germline variants are present in one in six patients – half of which are associated with Lynch syndrome which increases the risk for CRC.

Dr. Sinicrope highlighted the need for more risk-based intervention, which in turn requires a better knowledge of family history.

“We need to do better job to risk stratify, and that will help us figure out who’s best to target our screening efforts toward,” Dr. Sinicrope said. He pointed out guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer and the American Cancer Society that can help physicians identify patients who might benefit from earlier screening. The American Cancer Society recommends that CRC screening be conducted at 45 years for average-risk individuals.

“The best screening test is the one that the patient will do,” Dr. Sinicrope said.

A qualitative analysis of 20 people with head and neck cancer (HNC) has led to recommendations for improvements in care.

HNC has a high burden of treatment-related adverse events, along with frequent trouble with speech, swallowing, facial disfigurement, and psychological distress.

Among cancer patients, “they have the highest rates of emergency department use and hospitalization during treatment. They also have the highest rates of psychological distress. We have some Ontario data that shows they’ve got the highest rates of suicide and self-harm. So I think this is a really special population that we need to support,” Christopher Noel, MD, PhD, said in an interview. Dr. Noel was the lead author of the study, which was published in JAMA Otolaryngology – Head & Neck Surgery.

These issues can strongly affect quality of life, and even patient outcomes. “Even a 1-day interruption in treatment has been shown to impact oncologic outcomes. This is a very big issue whether you’re a surgeon, a medical oncologist, or a radiation oncologist,” said Dr. Noel, who is a resident physician at the University of Toronto.

He advocates that physicians interview patients and review the results in a structured way and then act on it. “If we just rely on patient [provided] communication, we’re going to miss about 50% of patient symptoms,” he said.

The researchers aimed for the patient’s perspective on treatment. “What is the patient’s perception of going through head neck cancer and their treatment, and managing their symptoms at home? And where do they think that we could do better?” Dr. Noel asked.

The most pressing issue was that patients felt their emotional and informational needs often were not met. That challenge is even harder for patients who have trouble communicating, which in turn makes them more prone to isolation and loneliness. Many felt that they had to get the information on their own. “They wanted it to be a more effortless process,” said Dr. Noel.

He described one patient with oropharynx cancer who was able to talk to people about her grief over her diagnosis, but treatment led to her throat becoming swollen and she lost the ability to communicate. “She felt very isolated and lonely. She really highlighted the emotional and psychosocial barriers in cancer care. Her treatment inherently leaves her feeling very isolated and lonely, and she had such a hard time connecting with a psychotherapist,” Dr. Noel said.

Another common issue revolved around efforts to communicate about symptoms and adverse effects of treatment. Resources often aren’t available on evenings or weekends, and it can take time for a nurse to call them back. Patients wanted to see more modern approaches, such as use of email or apps.

The patients in the study recommended 11 health care improvements.

• 1. Nurse navigator teams should have hours extended to evenings and weekends.
• 2. Patient communication methods should be expanded, using methods like email or apps.
• 3. HNC resources should be more broadly disseminated.
• 4. Education and information approaches should be individualized to the patient.
• 5. All HNC patients should be offered psychological resources.
• 6. Mental health needs should be assessed repeatedly throughout treatment and extended care.
• 7. Physicians should recognize the added symptom burden often faced by patients who travel extensively for treatment.
• 8. Partners and caregivers should be included as part of the treatment team.
• 9. Share symptom data with patients, which can improve engagement.
• 10. Review symptom scores and act on them regularly.
• 11. A member of the care team should be identified to oversee symptom management.

Dr. Noel had no relevant financial disclosures.

A qualitative analysis of 20 people with head and neck cancer (HNC) has led to recommendations for improvements in care.

HNC has a high burden of treatment-related adverse events, along with frequent trouble with speech, swallowing, facial disfigurement, and psychological distress.

Among cancer patients, “they have the highest rates of emergency department use and hospitalization during treatment. They also have the highest rates of psychological distress. We have some Ontario data that shows they’ve got the highest rates of suicide and self-harm. So I think this is a really special population that we need to support,” Christopher Noel, MD, PhD, said in an interview. Dr. Noel was the lead author of the study, which was published in JAMA Otolaryngology – Head & Neck Surgery.

These issues can strongly affect quality of life, and even patient outcomes. “Even a 1-day interruption in treatment has been shown to impact oncologic outcomes. This is a very big issue whether you’re a surgeon, a medical oncologist, or a radiation oncologist,” said Dr. Noel, who is a resident physician at the University of Toronto.

He advocates that physicians interview patients and review the results in a structured way and then act on it. “If we just rely on patient [provided] communication, we’re going to miss about 50% of patient symptoms,” he said.

The researchers aimed for the patient’s perspective on treatment. “What is the patient’s perception of going through head neck cancer and their treatment, and managing their symptoms at home? And where do they think that we could do better?” Dr. Noel asked.

The most pressing issue was that patients felt their emotional and informational needs often were not met. That challenge is even harder for patients who have trouble communicating, which in turn makes them more prone to isolation and loneliness. Many felt that they had to get the information on their own. “They wanted it to be a more effortless process,” said Dr. Noel.

He described one patient with oropharynx cancer who was able to talk to people about her grief over her diagnosis, but treatment led to her throat becoming swollen and she lost the ability to communicate. “She felt very isolated and lonely. She really highlighted the emotional and psychosocial barriers in cancer care. Her treatment inherently leaves her feeling very isolated and lonely, and she had such a hard time connecting with a psychotherapist,” Dr. Noel said.

Another common issue revolved around efforts to communicate about symptoms and adverse effects of treatment. Resources often aren’t available on evenings or weekends, and it can take time for a nurse to call them back. Patients wanted to see more modern approaches, such as use of email or apps.

The patients in the study recommended 11 health care improvements.

• 1. Nurse navigator teams should have hours extended to evenings and weekends.
• 2. Patient communication methods should be expanded, using methods like email or apps.
• 3. HNC resources should be more broadly disseminated.
• 4. Education and information approaches should be individualized to the patient.
• 5. All HNC patients should be offered psychological resources.
• 6. Mental health needs should be assessed repeatedly throughout treatment and extended care.
• 7. Physicians should recognize the added symptom burden often faced by patients who travel extensively for treatment.
• 8. Partners and caregivers should be included as part of the treatment team.
• 9. Share symptom data with patients, which can improve engagement.
• 10. Review symptom scores and act on them regularly.
• 11. A member of the care team should be identified to oversee symptom management.

Dr. Noel had no relevant financial disclosures.

A qualitative analysis of 20 people with head and neck cancer (HNC) has led to recommendations for improvements in care.

HNC has a high burden of treatment-related adverse events, along with frequent trouble with speech, swallowing, facial disfigurement, and psychological distress.

Among cancer patients, “they have the highest rates of emergency department use and hospitalization during treatment. They also have the highest rates of psychological distress. We have some Ontario data that shows they’ve got the highest rates of suicide and self-harm. So I think this is a really special population that we need to support,” Christopher Noel, MD, PhD, said in an interview. Dr. Noel was the lead author of the study, which was published in JAMA Otolaryngology – Head & Neck Surgery.

These issues can strongly affect quality of life, and even patient outcomes. “Even a 1-day interruption in treatment has been shown to impact oncologic outcomes. This is a very big issue whether you’re a surgeon, a medical oncologist, or a radiation oncologist,” said Dr. Noel, who is a resident physician at the University of Toronto.

He advocates that physicians interview patients and review the results in a structured way and then act on it. “If we just rely on patient [provided] communication, we’re going to miss about 50% of patient symptoms,” he said.

The researchers aimed for the patient’s perspective on treatment. “What is the patient’s perception of going through head neck cancer and their treatment, and managing their symptoms at home? And where do they think that we could do better?” Dr. Noel asked.

The most pressing issue was that patients felt their emotional and informational needs often were not met. That challenge is even harder for patients who have trouble communicating, which in turn makes them more prone to isolation and loneliness. Many felt that they had to get the information on their own. “They wanted it to be a more effortless process,” said Dr. Noel.

He described one patient with oropharynx cancer who was able to talk to people about her grief over her diagnosis, but treatment led to her throat becoming swollen and she lost the ability to communicate. “She felt very isolated and lonely. She really highlighted the emotional and psychosocial barriers in cancer care. Her treatment inherently leaves her feeling very isolated and lonely, and she had such a hard time connecting with a psychotherapist,” Dr. Noel said.

Another common issue revolved around efforts to communicate about symptoms and adverse effects of treatment. Resources often aren’t available on evenings or weekends, and it can take time for a nurse to call them back. Patients wanted to see more modern approaches, such as use of email or apps.

The patients in the study recommended 11 health care improvements.

• 1. Nurse navigator teams should have hours extended to evenings and weekends.
• 2. Patient communication methods should be expanded, using methods like email or apps.
• 3. HNC resources should be more broadly disseminated.
• 4. Education and information approaches should be individualized to the patient.
• 5. All HNC patients should be offered psychological resources.
• 6. Mental health needs should be assessed repeatedly throughout treatment and extended care.
• 7. Physicians should recognize the added symptom burden often faced by patients who travel extensively for treatment.
• 8. Partners and caregivers should be included as part of the treatment team.
• 9. Share symptom data with patients, which can improve engagement.
• 10. Review symptom scores and act on them regularly.
• 11. A member of the care team should be identified to oversee symptom management.

Dr. Noel had no relevant financial disclosures.