Lung Cancer

The Oncology Care Model (OCM), launched by the Centers for Medicare & Medicaid Services (CMS) with the goal of reducing spending for Medicare beneficiaries, was “associated with meaningful changes in the use of supportive care medications during chemotherapy treatment episodes,” according to new findings.

The OCM led to a statistically significant reduction in the use of denosumab – a pricier bone-modifying drug – by patients with bone metastases without changing the overall use of bone-modifying medications. The OCM also prompted more rapid adoption of a less expensive white blood cell growth factor agent – the biosimilar filgrastim – and more selective use of costly antiemetics as primary prophylaxis for chemotherapy-induced nausea.

Overall, the “OCM led to the reduced use of some high-cost supportive care medications, suggesting more value-conscious care,” study author Gabriel A. Brooks, MD, MPH, of the Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Lebanon, N.H., and colleagues write.

The study was published online Feb. 25 in the Journal of Clinical Oncology.

Since the OCM was launched in 2016, several studies have evaluated whether the alternative payment model reached its goal of reducing spending while improving or maintaining the quality of cancer care.

The results have been decidedly mixed.

As previously reported by this news organization, one study found that after 4 years, the OCM led to a $155 million net loss to Medicare. During that time, physician participation in the program also declined, with the number of practices dropping almost 30% between 2016 and 2020.

Other studies, however, have highlighted more positive results.

One large community practice reported saving Medicare $3 million over the course of 1 year. Another analysis found that among community practices that adopted the OCM, in the first year of the program, there was less physician-administered drug use by patients with prostate cancer, lower drug costs by patients with lung and prostate cancer, fewer visits by patients with breast or colon cancer, and lower office-based costs in all cancers analyzed. However, these savings were largely offset by the costs of these programs.

In the current study, DR. Brooks and colleagues compared the use of supportive care medications – bone-modifying drugs as well as prophylactic white blood cell (WBC) growth factors and antiemetics – in practices that adopted the OCM and those that didn’t.

More specifically, the authors zeroed in on the bone-modifying agent denosumab for patients with breast, lung, or prostate cancer and the WBC growth factor biosimilar filgrastim for those receiving chemotherapy for breast, lung, or colorectal cancer. Prophylactic use of higher-cost neurokinin-1 (NK1) antagonists and long-acting serotonin antagonists for patients receiving chemotherapy for any type of cancer was also evaluated.

The authors evaluated chemotherapy episodes assigned to OCM (n = 201) and comparison practices (n = 534) using Medicare claims from 2013-2019.

There was a total of 255,638 treatment episodes for bone metastases. The authors found that the OCM led to relative reductions in the use of denosumab but not in the overall use of bone-modifying medications, which included the less costly options zoledronic acid and pamidronate. The use of denosumab was similar for OCM and comparison practices during the baseline period, but during the intervention period, there were statistically significant relative reductions in the use of denosumab at OCM practices for breast (-5.0%), prostate (-4.0%), and lung cancer (-4.1%).

For WBC growth factors, 164,310 episodes were included in analyses. The OCM did not affect the use of prophylactic WBC growth factors during breast cancer chemotherapy for those at high risk of febrile neutropenia but did lead to a relative decrease during intermediate-risk chemotherapy (-7.6%). The authors observed no OCM impact on the use of prophylactic WBC growth factors among intermediate-risk lung or colorectal cancer patients. But, during the intervention period, OCM practices did demonstrate an increased use of originator or biosimilar filgrastim (57.3%) compared to other practices (47.6%), and the quarterly rate of increase in the use of the biosimilar grew 2.6 percentage points faster in OCM practices.

The authors report that there were 414,792 treatment episodes involving the use of prophylactic antiemetics. Overall, among patients receiving chemotherapy with high or moderate emetic risk, the OCM led to reductions in the prophylactic use of NK1 antagonists and long-acting serotonin antagonists. The authors report a 6.0 percentage point reduction in the use of NK1 antagonists during high-emetic-risk chemotherapy.

“We found that OCM was associated with meaningful changes in the use of supportive care medications during chemotherapy treatment episodes consistent with value-based care redesign,” the authors conclude. “These impacts on supportive care medication use align with previously reported spending reductions attributable to OCM and suggest that alternative payment models have potential to drive value-based changes in supportive care during cancer treatment.”

The study was supported by CMS. Several of the coauthors have reported relationships with industry, as noted in the article.

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

The Oncology Care Model (OCM), launched by the Centers for Medicare & Medicaid Services (CMS) with the goal of reducing spending for Medicare beneficiaries, was “associated with meaningful changes in the use of supportive care medications during chemotherapy treatment episodes,” according to new findings.

The OCM led to a statistically significant reduction in the use of denosumab – a pricier bone-modifying drug – by patients with bone metastases without changing the overall use of bone-modifying medications. The OCM also prompted more rapid adoption of a less expensive white blood cell growth factor agent – the biosimilar filgrastim – and more selective use of costly antiemetics as primary prophylaxis for chemotherapy-induced nausea.

Overall, the “OCM led to the reduced use of some high-cost supportive care medications, suggesting more value-conscious care,” study author Gabriel A. Brooks, MD, MPH, of the Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Lebanon, N.H., and colleagues write.

The study was published online Feb. 25 in the Journal of Clinical Oncology.

Since the OCM was launched in 2016, several studies have evaluated whether the alternative payment model reached its goal of reducing spending while improving or maintaining the quality of cancer care.

The results have been decidedly mixed.

As previously reported by this news organization, one study found that after 4 years, the OCM led to a $155 million net loss to Medicare. During that time, physician participation in the program also declined, with the number of practices dropping almost 30% between 2016 and 2020.

Other studies, however, have highlighted more positive results.

One large community practice reported saving Medicare $3 million over the course of 1 year. Another analysis found that among community practices that adopted the OCM, in the first year of the program, there was less physician-administered drug use by patients with prostate cancer, lower drug costs by patients with lung and prostate cancer, fewer visits by patients with breast or colon cancer, and lower office-based costs in all cancers analyzed. However, these savings were largely offset by the costs of these programs.

In the current study, DR. Brooks and colleagues compared the use of supportive care medications – bone-modifying drugs as well as prophylactic white blood cell (WBC) growth factors and antiemetics – in practices that adopted the OCM and those that didn’t.

More specifically, the authors zeroed in on the bone-modifying agent denosumab for patients with breast, lung, or prostate cancer and the WBC growth factor biosimilar filgrastim for those receiving chemotherapy for breast, lung, or colorectal cancer. Prophylactic use of higher-cost neurokinin-1 (NK1) antagonists and long-acting serotonin antagonists for patients receiving chemotherapy for any type of cancer was also evaluated.

The authors evaluated chemotherapy episodes assigned to OCM (n = 201) and comparison practices (n = 534) using Medicare claims from 2013-2019.

There was a total of 255,638 treatment episodes for bone metastases. The authors found that the OCM led to relative reductions in the use of denosumab but not in the overall use of bone-modifying medications, which included the less costly options zoledronic acid and pamidronate. The use of denosumab was similar for OCM and comparison practices during the baseline period, but during the intervention period, there were statistically significant relative reductions in the use of denosumab at OCM practices for breast (-5.0%), prostate (-4.0%), and lung cancer (-4.1%).

For WBC growth factors, 164,310 episodes were included in analyses. The OCM did not affect the use of prophylactic WBC growth factors during breast cancer chemotherapy for those at high risk of febrile neutropenia but did lead to a relative decrease during intermediate-risk chemotherapy (-7.6%). The authors observed no OCM impact on the use of prophylactic WBC growth factors among intermediate-risk lung or colorectal cancer patients. But, during the intervention period, OCM practices did demonstrate an increased use of originator or biosimilar filgrastim (57.3%) compared to other practices (47.6%), and the quarterly rate of increase in the use of the biosimilar grew 2.6 percentage points faster in OCM practices.

The authors report that there were 414,792 treatment episodes involving the use of prophylactic antiemetics. Overall, among patients receiving chemotherapy with high or moderate emetic risk, the OCM led to reductions in the prophylactic use of NK1 antagonists and long-acting serotonin antagonists. The authors report a 6.0 percentage point reduction in the use of NK1 antagonists during high-emetic-risk chemotherapy.

“We found that OCM was associated with meaningful changes in the use of supportive care medications during chemotherapy treatment episodes consistent with value-based care redesign,” the authors conclude. “These impacts on supportive care medication use align with previously reported spending reductions attributable to OCM and suggest that alternative payment models have potential to drive value-based changes in supportive care during cancer treatment.”

The study was supported by CMS. Several of the coauthors have reported relationships with industry, as noted in the article.

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

The Oncology Care Model (OCM), launched by the Centers for Medicare & Medicaid Services (CMS) with the goal of reducing spending for Medicare beneficiaries, was “associated with meaningful changes in the use of supportive care medications during chemotherapy treatment episodes,” according to new findings.

The OCM led to a statistically significant reduction in the use of denosumab – a pricier bone-modifying drug – by patients with bone metastases without changing the overall use of bone-modifying medications. The OCM also prompted more rapid adoption of a less expensive white blood cell growth factor agent – the biosimilar filgrastim – and more selective use of costly antiemetics as primary prophylaxis for chemotherapy-induced nausea.

Overall, the “OCM led to the reduced use of some high-cost supportive care medications, suggesting more value-conscious care,” study author Gabriel A. Brooks, MD, MPH, of the Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Lebanon, N.H., and colleagues write.

The study was published online Feb. 25 in the Journal of Clinical Oncology.

Since the OCM was launched in 2016, several studies have evaluated whether the alternative payment model reached its goal of reducing spending while improving or maintaining the quality of cancer care.

The results have been decidedly mixed.

As previously reported by this news organization, one study found that after 4 years, the OCM led to a $155 million net loss to Medicare. During that time, physician participation in the program also declined, with the number of practices dropping almost 30% between 2016 and 2020.

Other studies, however, have highlighted more positive results.

One large community practice reported saving Medicare $3 million over the course of 1 year. Another analysis found that among community practices that adopted the OCM, in the first year of the program, there was less physician-administered drug use by patients with prostate cancer, lower drug costs by patients with lung and prostate cancer, fewer visits by patients with breast or colon cancer, and lower office-based costs in all cancers analyzed. However, these savings were largely offset by the costs of these programs.

In the current study, DR. Brooks and colleagues compared the use of supportive care medications – bone-modifying drugs as well as prophylactic white blood cell (WBC) growth factors and antiemetics – in practices that adopted the OCM and those that didn’t.

More specifically, the authors zeroed in on the bone-modifying agent denosumab for patients with breast, lung, or prostate cancer and the WBC growth factor biosimilar filgrastim for those receiving chemotherapy for breast, lung, or colorectal cancer. Prophylactic use of higher-cost neurokinin-1 (NK1) antagonists and long-acting serotonin antagonists for patients receiving chemotherapy for any type of cancer was also evaluated.

The authors evaluated chemotherapy episodes assigned to OCM (n = 201) and comparison practices (n = 534) using Medicare claims from 2013-2019.

There was a total of 255,638 treatment episodes for bone metastases. The authors found that the OCM led to relative reductions in the use of denosumab but not in the overall use of bone-modifying medications, which included the less costly options zoledronic acid and pamidronate. The use of denosumab was similar for OCM and comparison practices during the baseline period, but during the intervention period, there were statistically significant relative reductions in the use of denosumab at OCM practices for breast (-5.0%), prostate (-4.0%), and lung cancer (-4.1%).

For WBC growth factors, 164,310 episodes were included in analyses. The OCM did not affect the use of prophylactic WBC growth factors during breast cancer chemotherapy for those at high risk of febrile neutropenia but did lead to a relative decrease during intermediate-risk chemotherapy (-7.6%). The authors observed no OCM impact on the use of prophylactic WBC growth factors among intermediate-risk lung or colorectal cancer patients. But, during the intervention period, OCM practices did demonstrate an increased use of originator or biosimilar filgrastim (57.3%) compared to other practices (47.6%), and the quarterly rate of increase in the use of the biosimilar grew 2.6 percentage points faster in OCM practices.

The authors report that there were 414,792 treatment episodes involving the use of prophylactic antiemetics. Overall, among patients receiving chemotherapy with high or moderate emetic risk, the OCM led to reductions in the prophylactic use of NK1 antagonists and long-acting serotonin antagonists. The authors report a 6.0 percentage point reduction in the use of NK1 antagonists during high-emetic-risk chemotherapy.

“We found that OCM was associated with meaningful changes in the use of supportive care medications during chemotherapy treatment episodes consistent with value-based care redesign,” the authors conclude. “These impacts on supportive care medication use align with previously reported spending reductions attributable to OCM and suggest that alternative payment models have potential to drive value-based changes in supportive care during cancer treatment.”

The study was supported by CMS. Several of the coauthors have reported relationships with industry, as noted in the article.

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

The U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening should be expanded to include more women, especially those with a history of breast cancer, according to a new study published in BJS Open.

The 2021 screening guidelines include adults aged between 50 and 80 years who have a 20–pack-year smoking history and currently smoke or have quit within the past 15 years, but the guidelines do not include nonsmokers or patients with a history of previous malignancies, such as breast cancer.

Led by Daniela Molena, MD, a thoracic surgeon and director of esophageal surgery at Memorial Sloan Kettering Cancer Center, New York, researchers conducted an analysis of 2,192 women with first-time lung cancer who underwent lung resections at Memorial Sloan Kettering between January 2000 and December 2017. The study’s objective was to determine stage at diagnosis, survival, and eligibility for lung cancer screening among patients with lung cancer who had a previous breast cancer diagnosis and those who did not have a history of breast cancer.

Only 331 (15.1%) patients were previously diagnosed with breast cancer, which was not statistically significant. “Overall, there were no statistically significant differences in genomic or oncogenic pathway alterations between the two groups, which suggests that lung cancer in patients who previously had breast cancer may not be affected at the genomic level by the previous breast cancer,” the authors wrote.

However, at 58.4%, more than half of patients in the study (1,281 patients) were prior smokers and only 33.3% met the USPSTF criteria for lung cancer screening, which the authors said was concerning.

“The most important finding of the study was that a high percentage of women with lung cancer, regardless of breast cancer history, did not meet the current USPSTF criteria for lung cancer screening. This is very important given the observation that nearly half of the women included in the study did not have a history of smoking. As such, the role of imaging for other causes, such as cancer surveillance, becomes especially important for early cancer diagnosis,” Dr. Molena and colleagues wrote. “To reduce late-stage cancer diagnoses, further assessment of guidelines for lung cancer screening for all women may be needed.”

Instead, for almost half of women in the study group with a history of breast cancer, the lung cancer was detected on a routine follow-up imaging scan.

USPSTF guidelines for lung cancer screening do not include previous malignancy as a high-risk feature requiring evaluation, which may explain why so few women in this study were screened for lung cancer, even though lung cancer is more common in breast cancer survivors than the general population. Approximately 10% of women who have had breast cancer will develop a second malignancy within 10 years and in most cases, it will be lung cancer. Plus, according to the National Cancer Institute, breast, lung, and colorectal cancers are the three most common cancers in women and account for approximately 50% of all new cancer diagnoses in women in 2020.

A 2018 analysis published in Frontiers in Oncology found that, of more than 6,000 women with secondary primary lung cancer after having had breast cancer, 42% had distant-stage disease at the time of diagnosis which, Dr. Molena and colleagues said, suggests an ongoing need to update screening recommendations.

“Given that lung cancer has a 5-year overall survival rate of less than 20% (highlighting the benefits of early-stage diagnosis), a better understanding of lung cancer in women with a history of breast cancer could have important implications for screening and surveillance,” the authors wrote.

Estrogen is known to play a role in the development of lung cancer by activating the epidermal growth factor receptor (EGFR). Previous research has shown an increased risk of lung cancer in patients with estrogen receptor–negative, progesterone receptor–negative, HER2-negative, or triple-negative breast cancer.

“Antiestrogen treatment has been demonstrated to decrease the incidence of lung cancer and has been associated with improved long-term survival in patients with lung cancer after breast cancer. Future studies should seek to identify high-risk populations on the basis of hormone receptor status and antiestrogen therapy use,” the authors wrote.

The authors noted a number of limitations to the study, including the single hospital as the sole source of data, plus, the analysis did not account for the length of time since patients quit smoking and a lung cancer diagnosis. Nor did it consider other risk factors, such as radiation, chemotherapy, or antiestrogen therapies.

The authors did not disclose any study-related conflicts of interests.

This article was updated 3/2/22.

The U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening should be expanded to include more women, especially those with a history of breast cancer, according to a new study published in BJS Open.

The 2021 screening guidelines include adults aged between 50 and 80 years who have a 20–pack-year smoking history and currently smoke or have quit within the past 15 years, but the guidelines do not include nonsmokers or patients with a history of previous malignancies, such as breast cancer.

Led by Daniela Molena, MD, a thoracic surgeon and director of esophageal surgery at Memorial Sloan Kettering Cancer Center, New York, researchers conducted an analysis of 2,192 women with first-time lung cancer who underwent lung resections at Memorial Sloan Kettering between January 2000 and December 2017. The study’s objective was to determine stage at diagnosis, survival, and eligibility for lung cancer screening among patients with lung cancer who had a previous breast cancer diagnosis and those who did not have a history of breast cancer.

Only 331 (15.1%) patients were previously diagnosed with breast cancer, which was not statistically significant. “Overall, there were no statistically significant differences in genomic or oncogenic pathway alterations between the two groups, which suggests that lung cancer in patients who previously had breast cancer may not be affected at the genomic level by the previous breast cancer,” the authors wrote.

However, at 58.4%, more than half of patients in the study (1,281 patients) were prior smokers and only 33.3% met the USPSTF criteria for lung cancer screening, which the authors said was concerning.

“The most important finding of the study was that a high percentage of women with lung cancer, regardless of breast cancer history, did not meet the current USPSTF criteria for lung cancer screening. This is very important given the observation that nearly half of the women included in the study did not have a history of smoking. As such, the role of imaging for other causes, such as cancer surveillance, becomes especially important for early cancer diagnosis,” Dr. Molena and colleagues wrote. “To reduce late-stage cancer diagnoses, further assessment of guidelines for lung cancer screening for all women may be needed.”

Instead, for almost half of women in the study group with a history of breast cancer, the lung cancer was detected on a routine follow-up imaging scan.

USPSTF guidelines for lung cancer screening do not include previous malignancy as a high-risk feature requiring evaluation, which may explain why so few women in this study were screened for lung cancer, even though lung cancer is more common in breast cancer survivors than the general population. Approximately 10% of women who have had breast cancer will develop a second malignancy within 10 years and in most cases, it will be lung cancer. Plus, according to the National Cancer Institute, breast, lung, and colorectal cancers are the three most common cancers in women and account for approximately 50% of all new cancer diagnoses in women in 2020.

A 2018 analysis published in Frontiers in Oncology found that, of more than 6,000 women with secondary primary lung cancer after having had breast cancer, 42% had distant-stage disease at the time of diagnosis which, Dr. Molena and colleagues said, suggests an ongoing need to update screening recommendations.

“Given that lung cancer has a 5-year overall survival rate of less than 20% (highlighting the benefits of early-stage diagnosis), a better understanding of lung cancer in women with a history of breast cancer could have important implications for screening and surveillance,” the authors wrote.

Estrogen is known to play a role in the development of lung cancer by activating the epidermal growth factor receptor (EGFR). Previous research has shown an increased risk of lung cancer in patients with estrogen receptor–negative, progesterone receptor–negative, HER2-negative, or triple-negative breast cancer.

“Antiestrogen treatment has been demonstrated to decrease the incidence of lung cancer and has been associated with improved long-term survival in patients with lung cancer after breast cancer. Future studies should seek to identify high-risk populations on the basis of hormone receptor status and antiestrogen therapy use,” the authors wrote.

The authors noted a number of limitations to the study, including the single hospital as the sole source of data, plus, the analysis did not account for the length of time since patients quit smoking and a lung cancer diagnosis. Nor did it consider other risk factors, such as radiation, chemotherapy, or antiestrogen therapies.

The authors did not disclose any study-related conflicts of interests.

This article was updated 3/2/22.

The U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening should be expanded to include more women, especially those with a history of breast cancer, according to a new study published in BJS Open.

The 2021 screening guidelines include adults aged between 50 and 80 years who have a 20–pack-year smoking history and currently smoke or have quit within the past 15 years, but the guidelines do not include nonsmokers or patients with a history of previous malignancies, such as breast cancer.

Led by Daniela Molena, MD, a thoracic surgeon and director of esophageal surgery at Memorial Sloan Kettering Cancer Center, New York, researchers conducted an analysis of 2,192 women with first-time lung cancer who underwent lung resections at Memorial Sloan Kettering between January 2000 and December 2017. The study’s objective was to determine stage at diagnosis, survival, and eligibility for lung cancer screening among patients with lung cancer who had a previous breast cancer diagnosis and those who did not have a history of breast cancer.

Only 331 (15.1%) patients were previously diagnosed with breast cancer, which was not statistically significant. “Overall, there were no statistically significant differences in genomic or oncogenic pathway alterations between the two groups, which suggests that lung cancer in patients who previously had breast cancer may not be affected at the genomic level by the previous breast cancer,” the authors wrote.

However, at 58.4%, more than half of patients in the study (1,281 patients) were prior smokers and only 33.3% met the USPSTF criteria for lung cancer screening, which the authors said was concerning.

“The most important finding of the study was that a high percentage of women with lung cancer, regardless of breast cancer history, did not meet the current USPSTF criteria for lung cancer screening. This is very important given the observation that nearly half of the women included in the study did not have a history of smoking. As such, the role of imaging for other causes, such as cancer surveillance, becomes especially important for early cancer diagnosis,” Dr. Molena and colleagues wrote. “To reduce late-stage cancer diagnoses, further assessment of guidelines for lung cancer screening for all women may be needed.”

Instead, for almost half of women in the study group with a history of breast cancer, the lung cancer was detected on a routine follow-up imaging scan.

USPSTF guidelines for lung cancer screening do not include previous malignancy as a high-risk feature requiring evaluation, which may explain why so few women in this study were screened for lung cancer, even though lung cancer is more common in breast cancer survivors than the general population. Approximately 10% of women who have had breast cancer will develop a second malignancy within 10 years and in most cases, it will be lung cancer. Plus, according to the National Cancer Institute, breast, lung, and colorectal cancers are the three most common cancers in women and account for approximately 50% of all new cancer diagnoses in women in 2020.

A 2018 analysis published in Frontiers in Oncology found that, of more than 6,000 women with secondary primary lung cancer after having had breast cancer, 42% had distant-stage disease at the time of diagnosis which, Dr. Molena and colleagues said, suggests an ongoing need to update screening recommendations.

“Given that lung cancer has a 5-year overall survival rate of less than 20% (highlighting the benefits of early-stage diagnosis), a better understanding of lung cancer in women with a history of breast cancer could have important implications for screening and surveillance,” the authors wrote.

Estrogen is known to play a role in the development of lung cancer by activating the epidermal growth factor receptor (EGFR). Previous research has shown an increased risk of lung cancer in patients with estrogen receptor–negative, progesterone receptor–negative, HER2-negative, or triple-negative breast cancer.

“Antiestrogen treatment has been demonstrated to decrease the incidence of lung cancer and has been associated with improved long-term survival in patients with lung cancer after breast cancer. Future studies should seek to identify high-risk populations on the basis of hormone receptor status and antiestrogen therapy use,” the authors wrote.

The authors noted a number of limitations to the study, including the single hospital as the sole source of data, plus, the analysis did not account for the length of time since patients quit smoking and a lung cancer diagnosis. Nor did it consider other risk factors, such as radiation, chemotherapy, or antiestrogen therapies.

The authors did not disclose any study-related conflicts of interests.

This article was updated 3/2/22.

U.S. prices for brand-name lung cancer drugs generally increased between 2015 and 2020 without evidence of price competition, a cross-sectional analysis revealed.

The findings underscore the need for price reform, according to the investigators, who analyzed prices for 17 brand-name medications used for treating metastatic non–small cell lung cancer (NSCLC).

Prices increased during the study period and correlated within each drug class, Aakash Desai, MBBS, and colleagues from the Mayo Clinic, Rochester, Minn., found.

“Because numerous new drugs have been approved for the treatment of NSCLC in recent years, we sought to specifically study the price competition among drugs used to treat this cancer subtype,” they explained, noting that for most drug classes price increases outpaced changes in the consumer price index for prescription medications and the inflation rate.

The findings were published Jan. 25, 2022, in JAMA Network Open.

Multiple brand-name medications across several drug classes, including four immune checkpoint inhibitors (pembrolizumab, nivolumab, atezolizumab, and durvalumab), five epidermal growth factor receptor inhibitors (gefitinib, afatinib, erlotinib, osimertinib, and dacomitinib), five anaplastic lymphoma kinase inhibitors (crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib), two BRAF inhibitors (dabrafenib, vemurafenib), and one MEK inhibitor (trametinib) were included in the analysis.

Median Pearson correlation coefficients approached 1.0 for all drug classes, indicating that prices increased despite within-class drug competition. Median values ranged from 0.898 for epidermal growth factor inhibitors to 0.999 for anaplastic lymphoma kinase inhibitors and BRAF and MEK inhibitors, the investigators found.

Median compounded annual growth rates (CAGRs) were 1.81% for immune checkpoint inhibitors, 2.56% for epidermal growth factor receptor inhibitors, 2.46% for anaplastic lymphoma kinase and ROS1 inhibitors, and 3.06% for BRAF and MEK inhibitors.

“With the exception of the immunotherapy class, the median cost CAGR outpaced the annual growth rate of the consumer price index for prescription drugs at 2.10% and, for all classes, the average yearly inflation rate of 1.75% during the same period,” they wrote.

Also of note, only one price decrease occurred among all therapeutic classes studied.

“This was observed for erlotinib between 2019 and 2020, and it corresponded with the introduction of a generic competitor to the market,” the authors said.

The findings are reminiscent of an earlier study that showed a 25% increase in the price of 24 patented injectable anticancer agents in the United States over a period of 8 years after launch.

“These increases in cost were not offset by supplemental U.S. Food and Drug Administration approvals, new competitors, or new off-label indications. Thus, price increases over time were not substantially reduced by market competition and increased at similar rates among drugs within the same class,” they wrote, adding that “although one might expect oncology drug prices to decrease over time after market entry, the list price of most anticancer agents increases paradoxically.”

The “lock-step price increases” observed without evidence of price competition in this analysis raise concerns about the affordability of promising oncology drugs, they said, concluding that “academic, industry, and government partnerships should be developed to address the high costs of prescription oncology drugs, which may soon be unaffordable for most patients if the trends discovered in the present study continue.”

Dr. Desai reported having no disclosures.

U.S. prices for brand-name lung cancer drugs generally increased between 2015 and 2020 without evidence of price competition, a cross-sectional analysis revealed.

The findings underscore the need for price reform, according to the investigators, who analyzed prices for 17 brand-name medications used for treating metastatic non–small cell lung cancer (NSCLC).

Prices increased during the study period and correlated within each drug class, Aakash Desai, MBBS, and colleagues from the Mayo Clinic, Rochester, Minn., found.

“Because numerous new drugs have been approved for the treatment of NSCLC in recent years, we sought to specifically study the price competition among drugs used to treat this cancer subtype,” they explained, noting that for most drug classes price increases outpaced changes in the consumer price index for prescription medications and the inflation rate.

The findings were published Jan. 25, 2022, in JAMA Network Open.

Multiple brand-name medications across several drug classes, including four immune checkpoint inhibitors (pembrolizumab, nivolumab, atezolizumab, and durvalumab), five epidermal growth factor receptor inhibitors (gefitinib, afatinib, erlotinib, osimertinib, and dacomitinib), five anaplastic lymphoma kinase inhibitors (crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib), two BRAF inhibitors (dabrafenib, vemurafenib), and one MEK inhibitor (trametinib) were included in the analysis.

Median Pearson correlation coefficients approached 1.0 for all drug classes, indicating that prices increased despite within-class drug competition. Median values ranged from 0.898 for epidermal growth factor inhibitors to 0.999 for anaplastic lymphoma kinase inhibitors and BRAF and MEK inhibitors, the investigators found.

Median compounded annual growth rates (CAGRs) were 1.81% for immune checkpoint inhibitors, 2.56% for epidermal growth factor receptor inhibitors, 2.46% for anaplastic lymphoma kinase and ROS1 inhibitors, and 3.06% for BRAF and MEK inhibitors.

“With the exception of the immunotherapy class, the median cost CAGR outpaced the annual growth rate of the consumer price index for prescription drugs at 2.10% and, for all classes, the average yearly inflation rate of 1.75% during the same period,” they wrote.

Also of note, only one price decrease occurred among all therapeutic classes studied.

“This was observed for erlotinib between 2019 and 2020, and it corresponded with the introduction of a generic competitor to the market,” the authors said.

The findings are reminiscent of an earlier study that showed a 25% increase in the price of 24 patented injectable anticancer agents in the United States over a period of 8 years after launch.

“These increases in cost were not offset by supplemental U.S. Food and Drug Administration approvals, new competitors, or new off-label indications. Thus, price increases over time were not substantially reduced by market competition and increased at similar rates among drugs within the same class,” they wrote, adding that “although one might expect oncology drug prices to decrease over time after market entry, the list price of most anticancer agents increases paradoxically.”

The “lock-step price increases” observed without evidence of price competition in this analysis raise concerns about the affordability of promising oncology drugs, they said, concluding that “academic, industry, and government partnerships should be developed to address the high costs of prescription oncology drugs, which may soon be unaffordable for most patients if the trends discovered in the present study continue.”

Dr. Desai reported having no disclosures.

U.S. prices for brand-name lung cancer drugs generally increased between 2015 and 2020 without evidence of price competition, a cross-sectional analysis revealed.

The findings underscore the need for price reform, according to the investigators, who analyzed prices for 17 brand-name medications used for treating metastatic non–small cell lung cancer (NSCLC).

Prices increased during the study period and correlated within each drug class, Aakash Desai, MBBS, and colleagues from the Mayo Clinic, Rochester, Minn., found.

“Because numerous new drugs have been approved for the treatment of NSCLC in recent years, we sought to specifically study the price competition among drugs used to treat this cancer subtype,” they explained, noting that for most drug classes price increases outpaced changes in the consumer price index for prescription medications and the inflation rate.

The findings were published Jan. 25, 2022, in JAMA Network Open.

Multiple brand-name medications across several drug classes, including four immune checkpoint inhibitors (pembrolizumab, nivolumab, atezolizumab, and durvalumab), five epidermal growth factor receptor inhibitors (gefitinib, afatinib, erlotinib, osimertinib, and dacomitinib), five anaplastic lymphoma kinase inhibitors (crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib), two BRAF inhibitors (dabrafenib, vemurafenib), and one MEK inhibitor (trametinib) were included in the analysis.

Median Pearson correlation coefficients approached 1.0 for all drug classes, indicating that prices increased despite within-class drug competition. Median values ranged from 0.898 for epidermal growth factor inhibitors to 0.999 for anaplastic lymphoma kinase inhibitors and BRAF and MEK inhibitors, the investigators found.

Median compounded annual growth rates (CAGRs) were 1.81% for immune checkpoint inhibitors, 2.56% for epidermal growth factor receptor inhibitors, 2.46% for anaplastic lymphoma kinase and ROS1 inhibitors, and 3.06% for BRAF and MEK inhibitors.

“With the exception of the immunotherapy class, the median cost CAGR outpaced the annual growth rate of the consumer price index for prescription drugs at 2.10% and, for all classes, the average yearly inflation rate of 1.75% during the same period,” they wrote.

Also of note, only one price decrease occurred among all therapeutic classes studied.

“This was observed for erlotinib between 2019 and 2020, and it corresponded with the introduction of a generic competitor to the market,” the authors said.

The findings are reminiscent of an earlier study that showed a 25% increase in the price of 24 patented injectable anticancer agents in the United States over a period of 8 years after launch.

“These increases in cost were not offset by supplemental U.S. Food and Drug Administration approvals, new competitors, or new off-label indications. Thus, price increases over time were not substantially reduced by market competition and increased at similar rates among drugs within the same class,” they wrote, adding that “although one might expect oncology drug prices to decrease over time after market entry, the list price of most anticancer agents increases paradoxically.”

The “lock-step price increases” observed without evidence of price competition in this analysis raise concerns about the affordability of promising oncology drugs, they said, concluding that “academic, industry, and government partnerships should be developed to address the high costs of prescription oncology drugs, which may soon be unaffordable for most patients if the trends discovered in the present study continue.”

Dr. Desai reported having no disclosures.

About 5% of people who are eligible to receive lung cancer screening do not live close to a facility and have limited or no access to screening,a recent analysis shows.

That percentage, although quite small, still translates to more than 750,000 individuals who are eligible to receive lung cancer screening but live at least 40 miles from a facility.

Overall, a larger proportion of eligible individuals in rural areas had no access to a facility, but a greater number of people in urban areas had no access, especially at shorter distances.

Understanding access issues is important given that “lung cancer screening with low-dose computed tomography scanning (LDCT) reduces mortality among high-risk adults, ... [but] annual screening rates remain low,” write study authors Liora Sahar, PhD, of the American Cancer Society in Atlanta, and colleagues.

The study was published online Feb. 15 in the journal Cancer.

It expands on a previous report, which found that “less than 6% of those 55 to 79 years of age do not have access to registry screening facilities”.

The new analysis incorporates the most recent guidelines from the U.S. Preventive Services Task Force, which lowered the screening age to 50 years and compares access across urban and rural areas.

Dr. Sahar and colleagues calculated the distances from population centers to screening facilities and estimated the number of individuals living within different distances of those facilities – 10, 20, 40, 50, and 100 miles. Geographical subdivisions, or census tracts, were also classified along a spectrum of rural to urban.

The authors found that, overall, about 14.8 million people aged 50-80 years are eligible for lung cancer screening, and 5.1% of that population – or 753,038 individuals – do not live within 40 miles of a facility and have no access to screening.

The proportion of people affected by access issues varies by geographic location. For eligible people living 40 miles or more from a facility, almost 25% (n = 287,803) in rural counties had no access, compared with 1.6% (n = 195,120) in metropolitan areas.

At greater distances to facilities (50 and 100 miles), these proportions diminish. In rural counties, for instance, 16% of eligible individuals (n = 186,401) living 50 or more miles away and 2.8% (n = 33,504) living 100 or more miles away had no access to a facility.

Not surprisingly, across all distances, “there is a significantly higher percentage of rural residents who do not have access to facilities in comparison with those in urban settings,” the authors write. “There are fewer facilities in rural areas, so residents need to travel longer distances to reach a facility.”

Notably, however, distance to a facility was not necessarily the greatest barrier to screening. The authors found a greater number of eligible individuals living in or close to urban areas were not getting screening when facilities were 10 miles away – more than 2.8 million in metropolitan areas versus just over 1 million in rural areas.

“The total number of individuals with no access in urban areas exceeds that of rural individuals, particularly at shorter distances ... [which] reveals an additional underserved population.”

Identifying geographic areas with greater access issues can help researchers address barriers to screening and improve uptake. 

“Areas and local pockets with persistently low or no access across short and long distances should be considered for tailored interventions, such as implementing mobile units, repurposing existing imaging or health facilities, and adding appropriate navigation, radiology, and screening program staff to better support the communities,” the authors conclude.

The study was supported in part by the National Lung Cancer Roundtable. Coauthor Debra S. Dyer, MD, serves on the clinical advisory board for computer software company Imidex and on the GO2 Foundation scientific advisory board; she also serves as a consultant for Lung Ambition Alliance. Coauthor Ella A. Kazerooni, MD, reports past participation on the Bristol Myers Squibb Foundation advisory board. The other authors have disclosed no relevant financial relationships.

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

About 5% of people who are eligible to receive lung cancer screening do not live close to a facility and have limited or no access to screening,a recent analysis shows.

That percentage, although quite small, still translates to more than 750,000 individuals who are eligible to receive lung cancer screening but live at least 40 miles from a facility.

Overall, a larger proportion of eligible individuals in rural areas had no access to a facility, but a greater number of people in urban areas had no access, especially at shorter distances.

Understanding access issues is important given that “lung cancer screening with low-dose computed tomography scanning (LDCT) reduces mortality among high-risk adults, ... [but] annual screening rates remain low,” write study authors Liora Sahar, PhD, of the American Cancer Society in Atlanta, and colleagues.

The study was published online Feb. 15 in the journal Cancer.

It expands on a previous report, which found that “less than 6% of those 55 to 79 years of age do not have access to registry screening facilities”.

The new analysis incorporates the most recent guidelines from the U.S. Preventive Services Task Force, which lowered the screening age to 50 years and compares access across urban and rural areas.

Dr. Sahar and colleagues calculated the distances from population centers to screening facilities and estimated the number of individuals living within different distances of those facilities – 10, 20, 40, 50, and 100 miles. Geographical subdivisions, or census tracts, were also classified along a spectrum of rural to urban.

The authors found that, overall, about 14.8 million people aged 50-80 years are eligible for lung cancer screening, and 5.1% of that population – or 753,038 individuals – do not live within 40 miles of a facility and have no access to screening.

The proportion of people affected by access issues varies by geographic location. For eligible people living 40 miles or more from a facility, almost 25% (n = 287,803) in rural counties had no access, compared with 1.6% (n = 195,120) in metropolitan areas.

At greater distances to facilities (50 and 100 miles), these proportions diminish. In rural counties, for instance, 16% of eligible individuals (n = 186,401) living 50 or more miles away and 2.8% (n = 33,504) living 100 or more miles away had no access to a facility.

Not surprisingly, across all distances, “there is a significantly higher percentage of rural residents who do not have access to facilities in comparison with those in urban settings,” the authors write. “There are fewer facilities in rural areas, so residents need to travel longer distances to reach a facility.”

Notably, however, distance to a facility was not necessarily the greatest barrier to screening. The authors found a greater number of eligible individuals living in or close to urban areas were not getting screening when facilities were 10 miles away – more than 2.8 million in metropolitan areas versus just over 1 million in rural areas.

“The total number of individuals with no access in urban areas exceeds that of rural individuals, particularly at shorter distances ... [which] reveals an additional underserved population.”

Identifying geographic areas with greater access issues can help researchers address barriers to screening and improve uptake. 

“Areas and local pockets with persistently low or no access across short and long distances should be considered for tailored interventions, such as implementing mobile units, repurposing existing imaging or health facilities, and adding appropriate navigation, radiology, and screening program staff to better support the communities,” the authors conclude.

The study was supported in part by the National Lung Cancer Roundtable. Coauthor Debra S. Dyer, MD, serves on the clinical advisory board for computer software company Imidex and on the GO2 Foundation scientific advisory board; she also serves as a consultant for Lung Ambition Alliance. Coauthor Ella A. Kazerooni, MD, reports past participation on the Bristol Myers Squibb Foundation advisory board. The other authors have disclosed no relevant financial relationships.

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

About 5% of people who are eligible to receive lung cancer screening do not live close to a facility and have limited or no access to screening,a recent analysis shows.

That percentage, although quite small, still translates to more than 750,000 individuals who are eligible to receive lung cancer screening but live at least 40 miles from a facility.

Overall, a larger proportion of eligible individuals in rural areas had no access to a facility, but a greater number of people in urban areas had no access, especially at shorter distances.

Understanding access issues is important given that “lung cancer screening with low-dose computed tomography scanning (LDCT) reduces mortality among high-risk adults, ... [but] annual screening rates remain low,” write study authors Liora Sahar, PhD, of the American Cancer Society in Atlanta, and colleagues.

The study was published online Feb. 15 in the journal Cancer.

It expands on a previous report, which found that “less than 6% of those 55 to 79 years of age do not have access to registry screening facilities”.

The new analysis incorporates the most recent guidelines from the U.S. Preventive Services Task Force, which lowered the screening age to 50 years and compares access across urban and rural areas.

Dr. Sahar and colleagues calculated the distances from population centers to screening facilities and estimated the number of individuals living within different distances of those facilities – 10, 20, 40, 50, and 100 miles. Geographical subdivisions, or census tracts, were also classified along a spectrum of rural to urban.

The authors found that, overall, about 14.8 million people aged 50-80 years are eligible for lung cancer screening, and 5.1% of that population – or 753,038 individuals – do not live within 40 miles of a facility and have no access to screening.

The proportion of people affected by access issues varies by geographic location. For eligible people living 40 miles or more from a facility, almost 25% (n = 287,803) in rural counties had no access, compared with 1.6% (n = 195,120) in metropolitan areas.

At greater distances to facilities (50 and 100 miles), these proportions diminish. In rural counties, for instance, 16% of eligible individuals (n = 186,401) living 50 or more miles away and 2.8% (n = 33,504) living 100 or more miles away had no access to a facility.

Not surprisingly, across all distances, “there is a significantly higher percentage of rural residents who do not have access to facilities in comparison with those in urban settings,” the authors write. “There are fewer facilities in rural areas, so residents need to travel longer distances to reach a facility.”

Notably, however, distance to a facility was not necessarily the greatest barrier to screening. The authors found a greater number of eligible individuals living in or close to urban areas were not getting screening when facilities were 10 miles away – more than 2.8 million in metropolitan areas versus just over 1 million in rural areas.

“The total number of individuals with no access in urban areas exceeds that of rural individuals, particularly at shorter distances ... [which] reveals an additional underserved population.”

Identifying geographic areas with greater access issues can help researchers address barriers to screening and improve uptake. 

“Areas and local pockets with persistently low or no access across short and long distances should be considered for tailored interventions, such as implementing mobile units, repurposing existing imaging or health facilities, and adding appropriate navigation, radiology, and screening program staff to better support the communities,” the authors conclude.

The study was supported in part by the National Lung Cancer Roundtable. Coauthor Debra S. Dyer, MD, serves on the clinical advisory board for computer software company Imidex and on the GO2 Foundation scientific advisory board; she also serves as a consultant for Lung Ambition Alliance. Coauthor Ella A. Kazerooni, MD, reports past participation on the Bristol Myers Squibb Foundation advisory board. The other authors have disclosed no relevant financial relationships.

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

Learn More

New therapies developed to treat non-small cell lung cancer are not reaching all patients with this disease. Human-created barriers bar the way for those experiencing real or perceived stigma and those who reside in remote places or live on little income. 

In this supplement, Abbie Begnaud, MD, FCCP, hones in on this human-created dichotomy and discusses the problems and possible solutions, along with diagnostic and treatment options.

Learn more

Learn More

New therapies developed to treat non-small cell lung cancer are not reaching all patients with this disease. Human-created barriers bar the way for those experiencing real or perceived stigma and those who reside in remote places or live on little income. 

In this supplement, Abbie Begnaud, MD, FCCP, hones in on this human-created dichotomy and discusses the problems and possible solutions, along with diagnostic and treatment options.

Learn more

Learn More

New therapies developed to treat non-small cell lung cancer are not reaching all patients with this disease. Human-created barriers bar the way for those experiencing real or perceived stigma and those who reside in remote places or live on little income. 

In this supplement, Abbie Begnaud, MD, FCCP, hones in on this human-created dichotomy and discusses the problems and possible solutions, along with diagnostic and treatment options.

Learn more

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

The Centers for Medicare & Medicaid Services (CMS) will expand eligibility guidelines for lung cancer screening with low-dose computed tomography for Medicare recipients.

According to the final decision, announced February 10, CMS will lower the age for screening from 55 to 50 years up to 77 years and reduce criteria for tobacco smoking history from at least 30 pack-years to 20 pack-years. The expanded Medicare recommendation will address racial disparities associated with lung cancer, given evidence that one third of Black patients are diagnosed with lung cancer before age 55.

The updated CMS guidelines align closely with recommendations made by the U.S. Preventive Services Task Force (USPSTF) in March 2021. The USPSTF expanded its guidelines for screening to include individuals ages 50 to 80 years, as well as those who have a 20–pack-year smoking history and who currently smoke or have quit within the past 15 years.

Overall, the expanded guidelines will nearly double the number of individuals who are eligible for screening and have the potential to save significantly more lives by identifying cancers at an earlier, more treatable stage.

“Expanding coverage broadens access for lung cancer screening to at-risk populations,” said Lee Felisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. “Today’s decision not only expands access to quality care but is also critical to improving health outcomes for people by helping to detect lung cancer earlier.”

CMS’s decision also simplifies requirements for counseling and shared decision-making visits and removes an initial requirement for the reading radiologist to document participation in continuing medical education, which will reduce administrative burden. CMS also added a requirement back to the National Coverage Determination criteria that requires radiology imaging facilities to use a standardized lung nodule identification, classification, and reporting system.

The American Lung Association applauds the decision to update eligibility.

“[The] announcement from CMS will give more people enrolled in Medicare access to lifesaving lung cancer screening. Screening for individuals at high risk is the only tool to catch this disease early when it is more curable,” Harold Wimmer, president and CEO of the American Lung Association, said in a statement. “Unfortunately, only 5.7% of people who are eligible have been screened, so it’s important that we talk with our friends and family who are at high risk about getting screened.”

While access to screening will significantly increase, the American Lung Association recommends CMS go a step further and expand eligibility to individuals up to 80 years of age, as the USPSTF recommendations do, as well as remove the recommendation that individuals cease screening once they have stopped smoking for 15 years.

Given the new guidelines, most private insurance plans will need to update screening coverage policies to reflect the updated guidelines for plan years beginning after March 31.

To read the final decision, visit the CMS website.

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

The Centers for Medicare & Medicaid Services (CMS) will expand eligibility guidelines for lung cancer screening with low-dose computed tomography for Medicare recipients.

According to the final decision, announced February 10, CMS will lower the age for screening from 55 to 50 years up to 77 years and reduce criteria for tobacco smoking history from at least 30 pack-years to 20 pack-years. The expanded Medicare recommendation will address racial disparities associated with lung cancer, given evidence that one third of Black patients are diagnosed with lung cancer before age 55.

The updated CMS guidelines align closely with recommendations made by the U.S. Preventive Services Task Force (USPSTF) in March 2021. The USPSTF expanded its guidelines for screening to include individuals ages 50 to 80 years, as well as those who have a 20–pack-year smoking history and who currently smoke or have quit within the past 15 years.

Overall, the expanded guidelines will nearly double the number of individuals who are eligible for screening and have the potential to save significantly more lives by identifying cancers at an earlier, more treatable stage.

“Expanding coverage broadens access for lung cancer screening to at-risk populations,” said Lee Felisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. “Today’s decision not only expands access to quality care but is also critical to improving health outcomes for people by helping to detect lung cancer earlier.”

CMS’s decision also simplifies requirements for counseling and shared decision-making visits and removes an initial requirement for the reading radiologist to document participation in continuing medical education, which will reduce administrative burden. CMS also added a requirement back to the National Coverage Determination criteria that requires radiology imaging facilities to use a standardized lung nodule identification, classification, and reporting system.

The American Lung Association applauds the decision to update eligibility.

“[The] announcement from CMS will give more people enrolled in Medicare access to lifesaving lung cancer screening. Screening for individuals at high risk is the only tool to catch this disease early when it is more curable,” Harold Wimmer, president and CEO of the American Lung Association, said in a statement. “Unfortunately, only 5.7% of people who are eligible have been screened, so it’s important that we talk with our friends and family who are at high risk about getting screened.”

While access to screening will significantly increase, the American Lung Association recommends CMS go a step further and expand eligibility to individuals up to 80 years of age, as the USPSTF recommendations do, as well as remove the recommendation that individuals cease screening once they have stopped smoking for 15 years.

Given the new guidelines, most private insurance plans will need to update screening coverage policies to reflect the updated guidelines for plan years beginning after March 31.

To read the final decision, visit the CMS website.

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

The Centers for Medicare & Medicaid Services (CMS) will expand eligibility guidelines for lung cancer screening with low-dose computed tomography for Medicare recipients.

According to the final decision, announced February 10, CMS will lower the age for screening from 55 to 50 years up to 77 years and reduce criteria for tobacco smoking history from at least 30 pack-years to 20 pack-years. The expanded Medicare recommendation will address racial disparities associated with lung cancer, given evidence that one third of Black patients are diagnosed with lung cancer before age 55.

The updated CMS guidelines align closely with recommendations made by the U.S. Preventive Services Task Force (USPSTF) in March 2021. The USPSTF expanded its guidelines for screening to include individuals ages 50 to 80 years, as well as those who have a 20–pack-year smoking history and who currently smoke or have quit within the past 15 years.

Overall, the expanded guidelines will nearly double the number of individuals who are eligible for screening and have the potential to save significantly more lives by identifying cancers at an earlier, more treatable stage.

“Expanding coverage broadens access for lung cancer screening to at-risk populations,” said Lee Felisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. “Today’s decision not only expands access to quality care but is also critical to improving health outcomes for people by helping to detect lung cancer earlier.”

CMS’s decision also simplifies requirements for counseling and shared decision-making visits and removes an initial requirement for the reading radiologist to document participation in continuing medical education, which will reduce administrative burden. CMS also added a requirement back to the National Coverage Determination criteria that requires radiology imaging facilities to use a standardized lung nodule identification, classification, and reporting system.

The American Lung Association applauds the decision to update eligibility.

“[The] announcement from CMS will give more people enrolled in Medicare access to lifesaving lung cancer screening. Screening for individuals at high risk is the only tool to catch this disease early when it is more curable,” Harold Wimmer, president and CEO of the American Lung Association, said in a statement. “Unfortunately, only 5.7% of people who are eligible have been screened, so it’s important that we talk with our friends and family who are at high risk about getting screened.”

While access to screening will significantly increase, the American Lung Association recommends CMS go a step further and expand eligibility to individuals up to 80 years of age, as the USPSTF recommendations do, as well as remove the recommendation that individuals cease screening once they have stopped smoking for 15 years.

Given the new guidelines, most private insurance plans will need to update screening coverage policies to reflect the updated guidelines for plan years beginning after March 31.

To read the final decision, visit the CMS website.

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

This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Hello. This is Mark Kris from Memorial Sloan Kettering, talking today about circulating tumor DNA (ctDNA), an emerging technology for use in perioperative patients. Recently, there have been a number of presentations about the use of ctDNA measurements in patients receiving pre- or postoperative therapies. These are critical therapies because they are given with the intention of improving the chance for cure.

All three of the presentations I’m going to mention have one thing in common: They used the so-called tumor-informed panel. The investigators took the patients’ tumor tissue, looked for cancer-related genes in that tumor tissue, and then looked for those same genes in the patient’s blood. That technology is going to become very important, as shown in these presentations.

I made one of these presentations at the European Society for Medical Oncology Immuno-Oncology virtual meeting in Geneva. In our study, we were able to find genes in the majority of patients who had tumor tissue available. These patients were preoperative surgical candidates. In 72% of these, we were able to find and track ctDNA. When we tracked the DNA in the blood, we saw that the falling levels of DNA were associated with shrinkages of the cancer radiographically – the degree of shrinkage seen in this case in the neoadjuvant examination at the time of surgery and examining the resection specimen after neoadjuvant therapy. Ultimately, the major pathologic responses were associated with clearing or falling DNA as well. Perhaps the most interesting observation is that when you put this DNA information together with the major pathologic response information, all of the patients who had clearance of ctDNA and had a major pathologic response were disease free. I believe that eventually we will use this ctDNA data in conjunction with other measures of benefit to reach a more precise assessment of therapy benefit, and eventually it may be helpful for prognosis as well.

Two other studies also used this technology. One was earlier this year, presented by Patrick Forde at the American Association for Cancer Research meeting. They associated changes in ctDNA using another tumor-informed assay. In that study, using the Archer assay, they were able to show that the ctDNA clearance was associated with a complete pathologic response. So again, combining this information provides a more precise measurement of the benefit of therapy.

Another presentation at ESMO Immuno-Oncology, by Caicun Zhou, looked at the Natera assay, another tumor-informed assay, in a trial of adjuvant atezolizumab. This group showed that patients who had clearance of their ctDNA after surgery had the greatest benefit from subsequent atezolizumab therapy. And even those patients who did not have clearance experienced some benefit of the atezolizumab therapy. In addition, they assessed the degree of benefit associated with whether or not PD-L1 was present. Those patients who had PD-L1 expression experienced the greatest benefit from the atezolizumab. For patients who didn’t have PD-L1 expression, where you wouldn’t expect atezolizumab to have this greater benefit, they didn’t see it.

I believe that ctDNA-informed testing will become more and more useful, both in clinical trials and ultimately in the care of patients with early-stage lung cancers. These tumor-informed assays are going to be standards of care and provide physicians and patients a better estimate of the effectiveness of therapy going forward.

Dr. Kris is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York. He reported serving as a consultant and/or adviser for AstraZeneca, Daiichi Sankyo, and Pfizer, and has received payments for various services from Genentech.

This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Hello. This is Mark Kris from Memorial Sloan Kettering, talking today about circulating tumor DNA (ctDNA), an emerging technology for use in perioperative patients. Recently, there have been a number of presentations about the use of ctDNA measurements in patients receiving pre- or postoperative therapies. These are critical therapies because they are given with the intention of improving the chance for cure.

All three of the presentations I’m going to mention have one thing in common: They used the so-called tumor-informed panel. The investigators took the patients’ tumor tissue, looked for cancer-related genes in that tumor tissue, and then looked for those same genes in the patient’s blood. That technology is going to become very important, as shown in these presentations.

I made one of these presentations at the European Society for Medical Oncology Immuno-Oncology virtual meeting in Geneva. In our study, we were able to find genes in the majority of patients who had tumor tissue available. These patients were preoperative surgical candidates. In 72% of these, we were able to find and track ctDNA. When we tracked the DNA in the blood, we saw that the falling levels of DNA were associated with shrinkages of the cancer radiographically – the degree of shrinkage seen in this case in the neoadjuvant examination at the time of surgery and examining the resection specimen after neoadjuvant therapy. Ultimately, the major pathologic responses were associated with clearing or falling DNA as well. Perhaps the most interesting observation is that when you put this DNA information together with the major pathologic response information, all of the patients who had clearance of ctDNA and had a major pathologic response were disease free. I believe that eventually we will use this ctDNA data in conjunction with other measures of benefit to reach a more precise assessment of therapy benefit, and eventually it may be helpful for prognosis as well.

Two other studies also used this technology. One was earlier this year, presented by Patrick Forde at the American Association for Cancer Research meeting. They associated changes in ctDNA using another tumor-informed assay. In that study, using the Archer assay, they were able to show that the ctDNA clearance was associated with a complete pathologic response. So again, combining this information provides a more precise measurement of the benefit of therapy.

Another presentation at ESMO Immuno-Oncology, by Caicun Zhou, looked at the Natera assay, another tumor-informed assay, in a trial of adjuvant atezolizumab. This group showed that patients who had clearance of their ctDNA after surgery had the greatest benefit from subsequent atezolizumab therapy. And even those patients who did not have clearance experienced some benefit of the atezolizumab therapy. In addition, they assessed the degree of benefit associated with whether or not PD-L1 was present. Those patients who had PD-L1 expression experienced the greatest benefit from the atezolizumab. For patients who didn’t have PD-L1 expression, where you wouldn’t expect atezolizumab to have this greater benefit, they didn’t see it.

I believe that ctDNA-informed testing will become more and more useful, both in clinical trials and ultimately in the care of patients with early-stage lung cancers. These tumor-informed assays are going to be standards of care and provide physicians and patients a better estimate of the effectiveness of therapy going forward.

Dr. Kris is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York. He reported serving as a consultant and/or adviser for AstraZeneca, Daiichi Sankyo, and Pfizer, and has received payments for various services from Genentech.

This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Hello. This is Mark Kris from Memorial Sloan Kettering, talking today about circulating tumor DNA (ctDNA), an emerging technology for use in perioperative patients. Recently, there have been a number of presentations about the use of ctDNA measurements in patients receiving pre- or postoperative therapies. These are critical therapies because they are given with the intention of improving the chance for cure.

All three of the presentations I’m going to mention have one thing in common: They used the so-called tumor-informed panel. The investigators took the patients’ tumor tissue, looked for cancer-related genes in that tumor tissue, and then looked for those same genes in the patient’s blood. That technology is going to become very important, as shown in these presentations.

I made one of these presentations at the European Society for Medical Oncology Immuno-Oncology virtual meeting in Geneva. In our study, we were able to find genes in the majority of patients who had tumor tissue available. These patients were preoperative surgical candidates. In 72% of these, we were able to find and track ctDNA. When we tracked the DNA in the blood, we saw that the falling levels of DNA were associated with shrinkages of the cancer radiographically – the degree of shrinkage seen in this case in the neoadjuvant examination at the time of surgery and examining the resection specimen after neoadjuvant therapy. Ultimately, the major pathologic responses were associated with clearing or falling DNA as well. Perhaps the most interesting observation is that when you put this DNA information together with the major pathologic response information, all of the patients who had clearance of ctDNA and had a major pathologic response were disease free. I believe that eventually we will use this ctDNA data in conjunction with other measures of benefit to reach a more precise assessment of therapy benefit, and eventually it may be helpful for prognosis as well.

Two other studies also used this technology. One was earlier this year, presented by Patrick Forde at the American Association for Cancer Research meeting. They associated changes in ctDNA using another tumor-informed assay. In that study, using the Archer assay, they were able to show that the ctDNA clearance was associated with a complete pathologic response. So again, combining this information provides a more precise measurement of the benefit of therapy.

Another presentation at ESMO Immuno-Oncology, by Caicun Zhou, looked at the Natera assay, another tumor-informed assay, in a trial of adjuvant atezolizumab. This group showed that patients who had clearance of their ctDNA after surgery had the greatest benefit from subsequent atezolizumab therapy. And even those patients who did not have clearance experienced some benefit of the atezolizumab therapy. In addition, they assessed the degree of benefit associated with whether or not PD-L1 was present. Those patients who had PD-L1 expression experienced the greatest benefit from the atezolizumab. For patients who didn’t have PD-L1 expression, where you wouldn’t expect atezolizumab to have this greater benefit, they didn’t see it.

I believe that ctDNA-informed testing will become more and more useful, both in clinical trials and ultimately in the care of patients with early-stage lung cancers. These tumor-informed assays are going to be standards of care and provide physicians and patients a better estimate of the effectiveness of therapy going forward.

Dr. Kris is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York. He reported serving as a consultant and/or adviser for AstraZeneca, Daiichi Sankyo, and Pfizer, and has received payments for various services from Genentech.

A 2021 update to the U.S. Preventive Services Task Force lung cancer screening guidelines eliminated racial disparities that were prevalent in the group’s 2013 guidance, according to a report in JAMA Oncology.

Fewer Black people qualified for screening in the earlier guideline of which the majority of its participants were White. In response, the group changed the screening eligibility age from 55 to 50 years and lowered the smoking pack by year requirement from 30 to 20 years.

The changes showed that Black smokers tend to develop lung cancer earlier and with fewer pack-years than White smokers.
 

The study details

To gauge the impact, investigators from Wayne State University, Detroit, reviewed 912 patients with lung cancer and 1,457 controls without lung cancer to see who would have qualified for screening under the 2013 and 2021 criteria.

They were participants in the Detroit-area INHALE (Inflammation, Health, Ancestry, and Lung Epidemiology) study from 2012 to 2018. Over 30% were Black.

“Lowering the age and smoking criteria successfully bridged the gap in racial disparity,” said investigators led by Chan Yeu Pu, MD, a lung cancer specialist at Wayne State University.

With the 2021 criteria, 65% of White patients and 63% of Black patients with lung cancer would have been eligible for screening. Under the 2013 guidance, 52% of White patients were eligible for screening, but only 42% of Black patients.

The update also eliminated racial disparities among controls. The new guidance excluded 48% of White controls without lung cancer from screening and 50% of Black controls. The 2013 criteria excluded fewer White controls (61%) than Black control subjects (70%).

“As expected, broader inclusion criteria increased sensitivity, but at the cost of decreased specificity,” the investigators wrote.
 

Why is screening important?

The hope of screening is to catch lung cancer early, when curative surgical resection is still possible, the team wrote, but although screening has increased over the years, uptake remains dismal, just 5% in 2018, for instance.

In an editorial, Philadelphia-area thoracic surgeons Jonathan Nitz, MD, and Cherie Erkmen, MD, wrote that “multiple and changing criteria” and “nebulous payment plans” have made “for a confusing message. ... We need standardized” guidelines to deliver “a clear message about lung cancer screening.”

The fact that nearly two-thirds of lung cancer patients wouldn’t have qualified for screening under current guidelines also needs to be addressed. “We need standardized practice guidelines based on evidence from diverse populations and policies to ensure equitable access for high-risk individuals. Although this study demonstrates improved, calculated sensitivity of the 2021 USPSTF guidelines to detect lung cancer, these refinements of criteria do not address the nearly two-thirds of patients with diagnosed lung cancer who are not eligible for screening. There is a pressing need to redefine screening criteria,” Dr. Nitz and Dr. Erkmen wrote.

Both the 2013 and 2021 guidelines were outperformed in the study by the 2012 modification of the model from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCOm2012 criteria), but only marginally so in the case of USPSTF’s 2021 guidance.

PLCOm2012 screening eligibility, however, are based on a complicated risk factor assessments that include race but also education level and other factors which might not be readily available in electronic records. USPSTF’s criteria “are much more straightforward to use in a clinical setting,” the investigators noted.

Study subjects were 21-89 years old and were in their early 60s, on average. Just over half were women. The analysis excluded lung cancer patients and controls who had never smoked.

The authors noted some limitations, including the retrospective nature of the study, plus, few lung cancers were diagnosed among the control group, which were not only small, but they did not include follow-ups with CT scans.

The work was funded by the National Institutes of Health and the Herrick Foundation. Dr. Pu didn’t have any commercial disclosures. One investigator disclosed personal fees from Takeda, AstraZeneca, Genentech/Roche, Pfizer, and other companies. Dr. Erkmen reported an American Cancer Society-Pfizer Award to address disparities.

A 2021 update to the U.S. Preventive Services Task Force lung cancer screening guidelines eliminated racial disparities that were prevalent in the group’s 2013 guidance, according to a report in JAMA Oncology.

Fewer Black people qualified for screening in the earlier guideline of which the majority of its participants were White. In response, the group changed the screening eligibility age from 55 to 50 years and lowered the smoking pack by year requirement from 30 to 20 years.

The changes showed that Black smokers tend to develop lung cancer earlier and with fewer pack-years than White smokers.
 

The study details

To gauge the impact, investigators from Wayne State University, Detroit, reviewed 912 patients with lung cancer and 1,457 controls without lung cancer to see who would have qualified for screening under the 2013 and 2021 criteria.

They were participants in the Detroit-area INHALE (Inflammation, Health, Ancestry, and Lung Epidemiology) study from 2012 to 2018. Over 30% were Black.

“Lowering the age and smoking criteria successfully bridged the gap in racial disparity,” said investigators led by Chan Yeu Pu, MD, a lung cancer specialist at Wayne State University.

With the 2021 criteria, 65% of White patients and 63% of Black patients with lung cancer would have been eligible for screening. Under the 2013 guidance, 52% of White patients were eligible for screening, but only 42% of Black patients.

The update also eliminated racial disparities among controls. The new guidance excluded 48% of White controls without lung cancer from screening and 50% of Black controls. The 2013 criteria excluded fewer White controls (61%) than Black control subjects (70%).

“As expected, broader inclusion criteria increased sensitivity, but at the cost of decreased specificity,” the investigators wrote.
 

Why is screening important?

The hope of screening is to catch lung cancer early, when curative surgical resection is still possible, the team wrote, but although screening has increased over the years, uptake remains dismal, just 5% in 2018, for instance.

In an editorial, Philadelphia-area thoracic surgeons Jonathan Nitz, MD, and Cherie Erkmen, MD, wrote that “multiple and changing criteria” and “nebulous payment plans” have made “for a confusing message. ... We need standardized” guidelines to deliver “a clear message about lung cancer screening.”

The fact that nearly two-thirds of lung cancer patients wouldn’t have qualified for screening under current guidelines also needs to be addressed. “We need standardized practice guidelines based on evidence from diverse populations and policies to ensure equitable access for high-risk individuals. Although this study demonstrates improved, calculated sensitivity of the 2021 USPSTF guidelines to detect lung cancer, these refinements of criteria do not address the nearly two-thirds of patients with diagnosed lung cancer who are not eligible for screening. There is a pressing need to redefine screening criteria,” Dr. Nitz and Dr. Erkmen wrote.

Both the 2013 and 2021 guidelines were outperformed in the study by the 2012 modification of the model from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCOm2012 criteria), but only marginally so in the case of USPSTF’s 2021 guidance.

PLCOm2012 screening eligibility, however, are based on a complicated risk factor assessments that include race but also education level and other factors which might not be readily available in electronic records. USPSTF’s criteria “are much more straightforward to use in a clinical setting,” the investigators noted.

Study subjects were 21-89 years old and were in their early 60s, on average. Just over half were women. The analysis excluded lung cancer patients and controls who had never smoked.

The authors noted some limitations, including the retrospective nature of the study, plus, few lung cancers were diagnosed among the control group, which were not only small, but they did not include follow-ups with CT scans.

The work was funded by the National Institutes of Health and the Herrick Foundation. Dr. Pu didn’t have any commercial disclosures. One investigator disclosed personal fees from Takeda, AstraZeneca, Genentech/Roche, Pfizer, and other companies. Dr. Erkmen reported an American Cancer Society-Pfizer Award to address disparities.

A 2021 update to the U.S. Preventive Services Task Force lung cancer screening guidelines eliminated racial disparities that were prevalent in the group’s 2013 guidance, according to a report in JAMA Oncology.

Fewer Black people qualified for screening in the earlier guideline of which the majority of its participants were White. In response, the group changed the screening eligibility age from 55 to 50 years and lowered the smoking pack by year requirement from 30 to 20 years.

The changes showed that Black smokers tend to develop lung cancer earlier and with fewer pack-years than White smokers.
 

The study details

To gauge the impact, investigators from Wayne State University, Detroit, reviewed 912 patients with lung cancer and 1,457 controls without lung cancer to see who would have qualified for screening under the 2013 and 2021 criteria.

They were participants in the Detroit-area INHALE (Inflammation, Health, Ancestry, and Lung Epidemiology) study from 2012 to 2018. Over 30% were Black.

“Lowering the age and smoking criteria successfully bridged the gap in racial disparity,” said investigators led by Chan Yeu Pu, MD, a lung cancer specialist at Wayne State University.

With the 2021 criteria, 65% of White patients and 63% of Black patients with lung cancer would have been eligible for screening. Under the 2013 guidance, 52% of White patients were eligible for screening, but only 42% of Black patients.

The update also eliminated racial disparities among controls. The new guidance excluded 48% of White controls without lung cancer from screening and 50% of Black controls. The 2013 criteria excluded fewer White controls (61%) than Black control subjects (70%).

“As expected, broader inclusion criteria increased sensitivity, but at the cost of decreased specificity,” the investigators wrote.
 

Why is screening important?

The hope of screening is to catch lung cancer early, when curative surgical resection is still possible, the team wrote, but although screening has increased over the years, uptake remains dismal, just 5% in 2018, for instance.

In an editorial, Philadelphia-area thoracic surgeons Jonathan Nitz, MD, and Cherie Erkmen, MD, wrote that “multiple and changing criteria” and “nebulous payment plans” have made “for a confusing message. ... We need standardized” guidelines to deliver “a clear message about lung cancer screening.”

The fact that nearly two-thirds of lung cancer patients wouldn’t have qualified for screening under current guidelines also needs to be addressed. “We need standardized practice guidelines based on evidence from diverse populations and policies to ensure equitable access for high-risk individuals. Although this study demonstrates improved, calculated sensitivity of the 2021 USPSTF guidelines to detect lung cancer, these refinements of criteria do not address the nearly two-thirds of patients with diagnosed lung cancer who are not eligible for screening. There is a pressing need to redefine screening criteria,” Dr. Nitz and Dr. Erkmen wrote.

Both the 2013 and 2021 guidelines were outperformed in the study by the 2012 modification of the model from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCOm2012 criteria), but only marginally so in the case of USPSTF’s 2021 guidance.

PLCOm2012 screening eligibility, however, are based on a complicated risk factor assessments that include race but also education level and other factors which might not be readily available in electronic records. USPSTF’s criteria “are much more straightforward to use in a clinical setting,” the investigators noted.

Study subjects were 21-89 years old and were in their early 60s, on average. Just over half were women. The analysis excluded lung cancer patients and controls who had never smoked.

The authors noted some limitations, including the retrospective nature of the study, plus, few lung cancers were diagnosed among the control group, which were not only small, but they did not include follow-ups with CT scans.

The work was funded by the National Institutes of Health and the Herrick Foundation. Dr. Pu didn’t have any commercial disclosures. One investigator disclosed personal fees from Takeda, AstraZeneca, Genentech/Roche, Pfizer, and other companies. Dr. Erkmen reported an American Cancer Society-Pfizer Award to address disparities.