Walter Alexander

A study of testicular cancer mortality finds worse outcomes among Hispanic men, but better outcomes among Black men.

The findings were reported at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

Incidence rates for testicular cancer in the United States have increased slowly in recent decades, said Anushka Ghosh, a clinical research coordinatory with Massachusetts General Hospital, Boston. Her analysis found mortality increases from 1999 to 2019 to be significantly greater among Hispanic men. The increase was 0.0019 per 100,000, compared with a 0.0003 per 100,000 decrease among non-Hispanic men (comparison P = .010).

Among Black men, testicular cancer–specific mortality rates declined by 0.0007 per 100,000, compared with a marginally significant increase of 0.0006 per 100,000 among White men (P =.049).

“Given that testicular cancer generally has a favorable prognosis, it is concerning that the mortality rate for this disease is increasing,” said Sophia C. Kamran, MD, the study’s lead author and a radiation oncologist at Massachusetts General Hospital.

Dr. Kamran urged new efforts to understand these trends and to make testicular cancer care more accessible for all patients.

Ms. Ghosh said that other researchers have identified the same disparity among Hispanic men with prostate cancer. “Even though testicular cancer is a rare, our finding warrants further investigation to find the basis of these disparities to better serve the Hispanic community.”

Other studies have shown higher likelihood of later stage diagnosis and worse survival outcomes among Black patients.

No funding sources were reported for this study.

A study of testicular cancer mortality finds worse outcomes among Hispanic men, but better outcomes among Black men.

The findings were reported at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

Incidence rates for testicular cancer in the United States have increased slowly in recent decades, said Anushka Ghosh, a clinical research coordinatory with Massachusetts General Hospital, Boston. Her analysis found mortality increases from 1999 to 2019 to be significantly greater among Hispanic men. The increase was 0.0019 per 100,000, compared with a 0.0003 per 100,000 decrease among non-Hispanic men (comparison P = .010).

Among Black men, testicular cancer–specific mortality rates declined by 0.0007 per 100,000, compared with a marginally significant increase of 0.0006 per 100,000 among White men (P =.049).

“Given that testicular cancer generally has a favorable prognosis, it is concerning that the mortality rate for this disease is increasing,” said Sophia C. Kamran, MD, the study’s lead author and a radiation oncologist at Massachusetts General Hospital.

Dr. Kamran urged new efforts to understand these trends and to make testicular cancer care more accessible for all patients.

Ms. Ghosh said that other researchers have identified the same disparity among Hispanic men with prostate cancer. “Even though testicular cancer is a rare, our finding warrants further investigation to find the basis of these disparities to better serve the Hispanic community.”

Other studies have shown higher likelihood of later stage diagnosis and worse survival outcomes among Black patients.

No funding sources were reported for this study.

A study of testicular cancer mortality finds worse outcomes among Hispanic men, but better outcomes among Black men.

The findings were reported at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

Incidence rates for testicular cancer in the United States have increased slowly in recent decades, said Anushka Ghosh, a clinical research coordinatory with Massachusetts General Hospital, Boston. Her analysis found mortality increases from 1999 to 2019 to be significantly greater among Hispanic men. The increase was 0.0019 per 100,000, compared with a 0.0003 per 100,000 decrease among non-Hispanic men (comparison P = .010).

Among Black men, testicular cancer–specific mortality rates declined by 0.0007 per 100,000, compared with a marginally significant increase of 0.0006 per 100,000 among White men (P =.049).

“Given that testicular cancer generally has a favorable prognosis, it is concerning that the mortality rate for this disease is increasing,” said Sophia C. Kamran, MD, the study’s lead author and a radiation oncologist at Massachusetts General Hospital.

Dr. Kamran urged new efforts to understand these trends and to make testicular cancer care more accessible for all patients.

Ms. Ghosh said that other researchers have identified the same disparity among Hispanic men with prostate cancer. “Even though testicular cancer is a rare, our finding warrants further investigation to find the basis of these disparities to better serve the Hispanic community.”

Other studies have shown higher likelihood of later stage diagnosis and worse survival outcomes among Black patients.

No funding sources were reported for this study.

Sotorasib, an approved treatment for lung cancer, has demonstrated clinically meaningful anticancer activity and tolerability in patients with heavily pretreated KRASG12C-mutated advanced pancreatic cancer.

The findings were reported at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

“This is clinically meaningful for patients because there is not an established standard therapy for these patients once they get to a third line of treatment,” said the study’s author John H Strickler, MD, of Duke University Medical Center, Durham, N.C.

The study, called CodeBreaK100, is an open-label global phase 1 and 2 trial. It consists of the largest dataset evaluating efficacy and safety of a KRASG12C inhibitor in patients with stage 4 pancreatic cancer.

Survival with Food and Drug Administration–approved second-line therapy in pancreatic ductal adenocarcinoma is 6 months with a 16% response rate. No therapies have demonstrated survival benefit after progression on first- and second-line chemotherapy. Among the 90% of pancreatic ductal adenocarcinoma tumors which harbor a KRAS mutation, 1%-2% are p.G12ac mutations. There are currently no approved treatments for KRASG12C-mutated PDAC.

The study included 38 patients (median age, 65.5 years; 76.3% male) with locally advanced or metastatic pancreatic malignancies who received oral sotorasib (960 mg once daily).

The patients in the trial received one or more prior systemic therapies (79% received two; range, one to eight) or were intolerant or ineligible for available therapies. The primary endpoint was complete plus partial response by blinded independent central review (RECIST 1.1).

Confirmed objective response were reported in 8 patients (21.1%; 95% confidence interval, 9.55%-37.22%) with disease control in 32 (84.2%; 95% CI, 68.75%-93.98%). The median duration of response was 5.7 months. After a median follow-up of 16.8 months, median progression-free survival was 4.0 months (95% CI, 2.8-5.6), and median overall survival was 6.9 months (95% CI, 5.0-9.1).

Once-daily sotorasib was well tolerated. The only treatment-related adverse events above grade 2 were six (15.8%) grade 3 events, with diarrhea in two and fatigue in two (each 5.3%), and single occurrences (2.6%) of abdominal pain, ALT/AST increase, pleural effusion and pulmonary embolism. Three adverse events were serious (7.9%), and no adverse events led to sotorasib discontinuation or were fatal.

Dr. Strickler described the case of a 64-year-old female with stage IV pancreatic cancer at diagnosis, who had baseline metastatic lesions in the liver, lymph nodes, lung and peritoneum. She received prior FOLFIRINOX first line until disease progression. With once-daily sotorasib, time to treatment response was 1.3 month, duration of response was 5.8 months, progression-free survival and overall were 7.1 months each.

Pointing to the centrally confirmed objective response rate of 21.1% and the disease control rate of 84.2%, Dr. Strickler observed in an interview that the CodeBreaK100 data support further exploration of sotorasib in this population with high unmet medical need and that based on these data, the CodeBreaK 100 clinical trial will be expanded to enroll more patients with pancreatic cancer and other tumor types.

The study was funded by Amgen.

Sotorasib, an approved treatment for lung cancer, has demonstrated clinically meaningful anticancer activity and tolerability in patients with heavily pretreated KRASG12C-mutated advanced pancreatic cancer.

The findings were reported at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

“This is clinically meaningful for patients because there is not an established standard therapy for these patients once they get to a third line of treatment,” said the study’s author John H Strickler, MD, of Duke University Medical Center, Durham, N.C.

The study, called CodeBreaK100, is an open-label global phase 1 and 2 trial. It consists of the largest dataset evaluating efficacy and safety of a KRASG12C inhibitor in patients with stage 4 pancreatic cancer.

Survival with Food and Drug Administration–approved second-line therapy in pancreatic ductal adenocarcinoma is 6 months with a 16% response rate. No therapies have demonstrated survival benefit after progression on first- and second-line chemotherapy. Among the 90% of pancreatic ductal adenocarcinoma tumors which harbor a KRAS mutation, 1%-2% are p.G12ac mutations. There are currently no approved treatments for KRASG12C-mutated PDAC.

The study included 38 patients (median age, 65.5 years; 76.3% male) with locally advanced or metastatic pancreatic malignancies who received oral sotorasib (960 mg once daily).

The patients in the trial received one or more prior systemic therapies (79% received two; range, one to eight) or were intolerant or ineligible for available therapies. The primary endpoint was complete plus partial response by blinded independent central review (RECIST 1.1).

Confirmed objective response were reported in 8 patients (21.1%; 95% confidence interval, 9.55%-37.22%) with disease control in 32 (84.2%; 95% CI, 68.75%-93.98%). The median duration of response was 5.7 months. After a median follow-up of 16.8 months, median progression-free survival was 4.0 months (95% CI, 2.8-5.6), and median overall survival was 6.9 months (95% CI, 5.0-9.1).

Once-daily sotorasib was well tolerated. The only treatment-related adverse events above grade 2 were six (15.8%) grade 3 events, with diarrhea in two and fatigue in two (each 5.3%), and single occurrences (2.6%) of abdominal pain, ALT/AST increase, pleural effusion and pulmonary embolism. Three adverse events were serious (7.9%), and no adverse events led to sotorasib discontinuation or were fatal.

Dr. Strickler described the case of a 64-year-old female with stage IV pancreatic cancer at diagnosis, who had baseline metastatic lesions in the liver, lymph nodes, lung and peritoneum. She received prior FOLFIRINOX first line until disease progression. With once-daily sotorasib, time to treatment response was 1.3 month, duration of response was 5.8 months, progression-free survival and overall were 7.1 months each.

Pointing to the centrally confirmed objective response rate of 21.1% and the disease control rate of 84.2%, Dr. Strickler observed in an interview that the CodeBreaK100 data support further exploration of sotorasib in this population with high unmet medical need and that based on these data, the CodeBreaK 100 clinical trial will be expanded to enroll more patients with pancreatic cancer and other tumor types.

The study was funded by Amgen.

Sotorasib, an approved treatment for lung cancer, has demonstrated clinically meaningful anticancer activity and tolerability in patients with heavily pretreated KRASG12C-mutated advanced pancreatic cancer.

The findings were reported at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

“This is clinically meaningful for patients because there is not an established standard therapy for these patients once they get to a third line of treatment,” said the study’s author John H Strickler, MD, of Duke University Medical Center, Durham, N.C.

The study, called CodeBreaK100, is an open-label global phase 1 and 2 trial. It consists of the largest dataset evaluating efficacy and safety of a KRASG12C inhibitor in patients with stage 4 pancreatic cancer.

Survival with Food and Drug Administration–approved second-line therapy in pancreatic ductal adenocarcinoma is 6 months with a 16% response rate. No therapies have demonstrated survival benefit after progression on first- and second-line chemotherapy. Among the 90% of pancreatic ductal adenocarcinoma tumors which harbor a KRAS mutation, 1%-2% are p.G12ac mutations. There are currently no approved treatments for KRASG12C-mutated PDAC.

The study included 38 patients (median age, 65.5 years; 76.3% male) with locally advanced or metastatic pancreatic malignancies who received oral sotorasib (960 mg once daily).

The patients in the trial received one or more prior systemic therapies (79% received two; range, one to eight) or were intolerant or ineligible for available therapies. The primary endpoint was complete plus partial response by blinded independent central review (RECIST 1.1).

Confirmed objective response were reported in 8 patients (21.1%; 95% confidence interval, 9.55%-37.22%) with disease control in 32 (84.2%; 95% CI, 68.75%-93.98%). The median duration of response was 5.7 months. After a median follow-up of 16.8 months, median progression-free survival was 4.0 months (95% CI, 2.8-5.6), and median overall survival was 6.9 months (95% CI, 5.0-9.1).

Once-daily sotorasib was well tolerated. The only treatment-related adverse events above grade 2 were six (15.8%) grade 3 events, with diarrhea in two and fatigue in two (each 5.3%), and single occurrences (2.6%) of abdominal pain, ALT/AST increase, pleural effusion and pulmonary embolism. Three adverse events were serious (7.9%), and no adverse events led to sotorasib discontinuation or were fatal.

Dr. Strickler described the case of a 64-year-old female with stage IV pancreatic cancer at diagnosis, who had baseline metastatic lesions in the liver, lymph nodes, lung and peritoneum. She received prior FOLFIRINOX first line until disease progression. With once-daily sotorasib, time to treatment response was 1.3 month, duration of response was 5.8 months, progression-free survival and overall were 7.1 months each.

Pointing to the centrally confirmed objective response rate of 21.1% and the disease control rate of 84.2%, Dr. Strickler observed in an interview that the CodeBreaK100 data support further exploration of sotorasib in this population with high unmet medical need and that based on these data, the CodeBreaK 100 clinical trial will be expanded to enroll more patients with pancreatic cancer and other tumor types.

The study was funded by Amgen.

Compared with control treatment among critically ill adults, low-molecular-weight heparin (LMWH) reduces the incidence of deep vein thrombosis (DVT), according to a systematic review and network meta-analysis of randomized clinical trials (RCTs) published in CHEST. The analysis showed also that risk of DVT may be reduced by unfractionated heparin (UFH) and by mechanical compressive devices, although LMWH should be considered the primary pharmacologic agent for thromboprophylaxis.

Risk of venous thromboembolism (VTE), including DVT and pulmonary embolism (PE), is heightened in critically ill patients. VTE incidence is highest in major surgery and trauma patients, and mortality estimates from PE among intensive care unit patients are as high as 12%. Clinical practice guidelines recommend prophylaxis with pharmacologic agents over no prophylaxis in critically ill adults. Shannon M. Fernando, MD, of the University of Ottawa and colleagues examined the comparative efficacy and safety of various agents for VTE prophylaxis in critically ill patients through a review of 13 RCTs (9,619 patients) in six databases (Medline, PubMed, EMBASE, Scopus, Webof Science, and the Cochrane Database of Systematic Reviews). The ICU patients received a variety of therapies including pharmacologic, mechanical, or their combination for thromboprophylaxis. The control population consisted of a composite of no prophylaxis, placebo, or compression stockings only.
 

Indicative results

Analysis showed LMWH to reduce the incidence of DVT (odds ratio, 0.59; high certainty), while UFH may reduce the incidence of DVT (OR, 0.82; low certainty). Compared with UFH, LMWH probably reduces DVT (OR, 0.72; moderate certainty). Compressive devices, based on low-certainty evidence, may reduce risk of DVT, compared with control treatments (OR, 0.85).

The effect of combination therapy on DVT, compared with either therapy alone was unclear (very low certainty). The large-scale (2,000 patients) PREVENT trial in 2019, Dr. Fernando noted in an interview, found that adding compression therapy to pharmacologic therapy produced no reduction in proximal lower limb DVT.

“Ultimately, I think that, even if multiple RCTs and subsequent meta-analyses were performed, at best we would find that the incremental benefit of combination therapy is very minimal,” Dr. Fernando stated.

The findings provide evidence supporting LMWH and UFH use as compared with no pharmacologic prophylaxis for prevention of DVT, according to the researchers. While a similar certainty of effect in reducing PE was not found, evidence with moderate certainty suggested that LMWH and UFH probably reduce the incidence of any VTE, compared with no pharmacologic prophylaxis. Cost-effectiveness modeling that takes into account VTE incidence supports the practice. “If you’re reducing the incidence of DVT, it’s likely you’re similarly reducing incidence of PE, though I will agree that currently the data do not support this,” he said in an interview.

Noting that, while support in existing literature for any specific agent is controversial, the authors cite that American Society of Hematology guidelines suggest considering LMWH over UFH in critically ill patients, and that their findings lend support to that position. Regarding safety, pair-wise meta-analysis did not reveal clear major bleeding incidence differences between UFH and LMWH.
 

In and out of the ICU

Concordant with studies outside the ICU finding that heparin-induced thrombocytopenia (HIT) incidence is lower among patients receiving LMWH rather than UFH for VTE prophylaxis, the meta-analysis revealed a lower incidence of HIT among the critically ill receiving LMWH, but with evidence that was of low certainty.

Uncertainty around the optimal approach to VTE prophylaxis in the ICU along with wide variations in clinical practice persist despite recognition of the issue’s importance, note Major Michael J. McMahon, MD, of Honolulu and Colonel Aaron B. Holley, MD, of Bethesda, Md., authors of an accompanying editorial, “To generalize or not to generalize? The approach to VTE prophylaxis”. They acknowledge also that the Fernando et al. analysis yields important insights into VTE prevention in the ICU. Rhetorically raising the question, “Can we now say without doubt that LMWH is the preferred agent for all patients in the ICU?” – they responded, “probably.” Not entirely eliminated, they observe, is the possibility that a specific patient subgroup may benefit from one agent compared with another. They add, “We came away more confident that LMWH should be the default choice for VTE prevention in the ICU.”

Dr. Fernando and coauthors listed multiple disclosures, but declared that they received no financial support. Dr. McMahon and Dr. Holley declared that they have no disclosures.

Compared with control treatment among critically ill adults, low-molecular-weight heparin (LMWH) reduces the incidence of deep vein thrombosis (DVT), according to a systematic review and network meta-analysis of randomized clinical trials (RCTs) published in CHEST. The analysis showed also that risk of DVT may be reduced by unfractionated heparin (UFH) and by mechanical compressive devices, although LMWH should be considered the primary pharmacologic agent for thromboprophylaxis.

Risk of venous thromboembolism (VTE), including DVT and pulmonary embolism (PE), is heightened in critically ill patients. VTE incidence is highest in major surgery and trauma patients, and mortality estimates from PE among intensive care unit patients are as high as 12%. Clinical practice guidelines recommend prophylaxis with pharmacologic agents over no prophylaxis in critically ill adults. Shannon M. Fernando, MD, of the University of Ottawa and colleagues examined the comparative efficacy and safety of various agents for VTE prophylaxis in critically ill patients through a review of 13 RCTs (9,619 patients) in six databases (Medline, PubMed, EMBASE, Scopus, Webof Science, and the Cochrane Database of Systematic Reviews). The ICU patients received a variety of therapies including pharmacologic, mechanical, or their combination for thromboprophylaxis. The control population consisted of a composite of no prophylaxis, placebo, or compression stockings only.
 

Indicative results

Analysis showed LMWH to reduce the incidence of DVT (odds ratio, 0.59; high certainty), while UFH may reduce the incidence of DVT (OR, 0.82; low certainty). Compared with UFH, LMWH probably reduces DVT (OR, 0.72; moderate certainty). Compressive devices, based on low-certainty evidence, may reduce risk of DVT, compared with control treatments (OR, 0.85).

The effect of combination therapy on DVT, compared with either therapy alone was unclear (very low certainty). The large-scale (2,000 patients) PREVENT trial in 2019, Dr. Fernando noted in an interview, found that adding compression therapy to pharmacologic therapy produced no reduction in proximal lower limb DVT.

“Ultimately, I think that, even if multiple RCTs and subsequent meta-analyses were performed, at best we would find that the incremental benefit of combination therapy is very minimal,” Dr. Fernando stated.

The findings provide evidence supporting LMWH and UFH use as compared with no pharmacologic prophylaxis for prevention of DVT, according to the researchers. While a similar certainty of effect in reducing PE was not found, evidence with moderate certainty suggested that LMWH and UFH probably reduce the incidence of any VTE, compared with no pharmacologic prophylaxis. Cost-effectiveness modeling that takes into account VTE incidence supports the practice. “If you’re reducing the incidence of DVT, it’s likely you’re similarly reducing incidence of PE, though I will agree that currently the data do not support this,” he said in an interview.

Noting that, while support in existing literature for any specific agent is controversial, the authors cite that American Society of Hematology guidelines suggest considering LMWH over UFH in critically ill patients, and that their findings lend support to that position. Regarding safety, pair-wise meta-analysis did not reveal clear major bleeding incidence differences between UFH and LMWH.
 

In and out of the ICU

Concordant with studies outside the ICU finding that heparin-induced thrombocytopenia (HIT) incidence is lower among patients receiving LMWH rather than UFH for VTE prophylaxis, the meta-analysis revealed a lower incidence of HIT among the critically ill receiving LMWH, but with evidence that was of low certainty.

Uncertainty around the optimal approach to VTE prophylaxis in the ICU along with wide variations in clinical practice persist despite recognition of the issue’s importance, note Major Michael J. McMahon, MD, of Honolulu and Colonel Aaron B. Holley, MD, of Bethesda, Md., authors of an accompanying editorial, “To generalize or not to generalize? The approach to VTE prophylaxis”. They acknowledge also that the Fernando et al. analysis yields important insights into VTE prevention in the ICU. Rhetorically raising the question, “Can we now say without doubt that LMWH is the preferred agent for all patients in the ICU?” – they responded, “probably.” Not entirely eliminated, they observe, is the possibility that a specific patient subgroup may benefit from one agent compared with another. They add, “We came away more confident that LMWH should be the default choice for VTE prevention in the ICU.”

Dr. Fernando and coauthors listed multiple disclosures, but declared that they received no financial support. Dr. McMahon and Dr. Holley declared that they have no disclosures.

Compared with control treatment among critically ill adults, low-molecular-weight heparin (LMWH) reduces the incidence of deep vein thrombosis (DVT), according to a systematic review and network meta-analysis of randomized clinical trials (RCTs) published in CHEST. The analysis showed also that risk of DVT may be reduced by unfractionated heparin (UFH) and by mechanical compressive devices, although LMWH should be considered the primary pharmacologic agent for thromboprophylaxis.

Risk of venous thromboembolism (VTE), including DVT and pulmonary embolism (PE), is heightened in critically ill patients. VTE incidence is highest in major surgery and trauma patients, and mortality estimates from PE among intensive care unit patients are as high as 12%. Clinical practice guidelines recommend prophylaxis with pharmacologic agents over no prophylaxis in critically ill adults. Shannon M. Fernando, MD, of the University of Ottawa and colleagues examined the comparative efficacy and safety of various agents for VTE prophylaxis in critically ill patients through a review of 13 RCTs (9,619 patients) in six databases (Medline, PubMed, EMBASE, Scopus, Webof Science, and the Cochrane Database of Systematic Reviews). The ICU patients received a variety of therapies including pharmacologic, mechanical, or their combination for thromboprophylaxis. The control population consisted of a composite of no prophylaxis, placebo, or compression stockings only.
 

Indicative results

Analysis showed LMWH to reduce the incidence of DVT (odds ratio, 0.59; high certainty), while UFH may reduce the incidence of DVT (OR, 0.82; low certainty). Compared with UFH, LMWH probably reduces DVT (OR, 0.72; moderate certainty). Compressive devices, based on low-certainty evidence, may reduce risk of DVT, compared with control treatments (OR, 0.85).

The effect of combination therapy on DVT, compared with either therapy alone was unclear (very low certainty). The large-scale (2,000 patients) PREVENT trial in 2019, Dr. Fernando noted in an interview, found that adding compression therapy to pharmacologic therapy produced no reduction in proximal lower limb DVT.

“Ultimately, I think that, even if multiple RCTs and subsequent meta-analyses were performed, at best we would find that the incremental benefit of combination therapy is very minimal,” Dr. Fernando stated.

The findings provide evidence supporting LMWH and UFH use as compared with no pharmacologic prophylaxis for prevention of DVT, according to the researchers. While a similar certainty of effect in reducing PE was not found, evidence with moderate certainty suggested that LMWH and UFH probably reduce the incidence of any VTE, compared with no pharmacologic prophylaxis. Cost-effectiveness modeling that takes into account VTE incidence supports the practice. “If you’re reducing the incidence of DVT, it’s likely you’re similarly reducing incidence of PE, though I will agree that currently the data do not support this,” he said in an interview.

Noting that, while support in existing literature for any specific agent is controversial, the authors cite that American Society of Hematology guidelines suggest considering LMWH over UFH in critically ill patients, and that their findings lend support to that position. Regarding safety, pair-wise meta-analysis did not reveal clear major bleeding incidence differences between UFH and LMWH.
 

In and out of the ICU

Concordant with studies outside the ICU finding that heparin-induced thrombocytopenia (HIT) incidence is lower among patients receiving LMWH rather than UFH for VTE prophylaxis, the meta-analysis revealed a lower incidence of HIT among the critically ill receiving LMWH, but with evidence that was of low certainty.

Uncertainty around the optimal approach to VTE prophylaxis in the ICU along with wide variations in clinical practice persist despite recognition of the issue’s importance, note Major Michael J. McMahon, MD, of Honolulu and Colonel Aaron B. Holley, MD, of Bethesda, Md., authors of an accompanying editorial, “To generalize or not to generalize? The approach to VTE prophylaxis”. They acknowledge also that the Fernando et al. analysis yields important insights into VTE prevention in the ICU. Rhetorically raising the question, “Can we now say without doubt that LMWH is the preferred agent for all patients in the ICU?” – they responded, “probably.” Not entirely eliminated, they observe, is the possibility that a specific patient subgroup may benefit from one agent compared with another. They add, “We came away more confident that LMWH should be the default choice for VTE prevention in the ICU.”

Dr. Fernando and coauthors listed multiple disclosures, but declared that they received no financial support. Dr. McMahon and Dr. Holley declared that they have no disclosures.

Unless air pollution and smoking patterns are reversed, lung cancer cases and deaths will grow unabated in some countries, according to estimates of lung cancer incident cases, deaths, and their age-standardized rates.

The findings, based on recently released data from GLOBOCAN 2020 projected to the year 2050, suggest that the lung cancer epidemic will continue to unfold, according to Rajesh Sharma, PhD, et al., in a study published in the International Journal of Clinical Oncology. GLOBOCAN 2020 is an online database produced by the International Agency for Research on Cancer. It provides global cancer statistics from 185 countries for 36 cancer types.

The increase in lung cancer, the leading cancer worldwide in terms of deaths, is generally attributed to increases in cigarette smoking, Sharma et al. wrote. They point out that, while cigarette smoking is expected to have peaked in industrialized countries in the latter half of the twentieth century, the tobacco smoking epidemic is unfolding in regions of Asia and Africa with concomitant increases in lung cancer burden in several countries. Smoking is the most significant lung cancer risk factor, followed by air pollution (especially particulate matter, passive smoking, and occupational exposure to radon and asbestos).

The authors investigated bivariate associations between smoking prevalence and age-standardized rates of lung cancer, and projected lung cancer incident cases and deaths to 2050. They also looked at mortality-to-incidence, considered to be a proxy indicator of 5-year survival, and at human development index, a measure including life expectancy at birth, years of schooling, and standard of living. The results, they state, are expected to aid in policy formulation to combat the lung cancer burden at global, regional, and national levels.

Tobacco smoking prevalence was 21.9% worldwide in 2016, with tobacco smoking prevalence exceeding 25% in 57/149 countries. It was high in European countries with 5 of the top-10 countries among the 149 countries within Europe. Prevalence was greater than 10% in all European countries. Notably, 11/33 countries in Africa had a smoking prevalence less than 10%.

Analysis showed 2.21 million new lung cancer cases and 1.8 million deaths attributed to lung cancer worldwide in 2020, with males accounting for about two-thirds of the burden. The analysis projection for 2050 was for 3.8 million incident cases of lung cancer and 3.2 million lung cancer deaths globally. In 2050, lung cancer cases and deaths are projected to be more than 100,000 in 10/21 regions, led by Eastern Asia, projected to record 1.7 million incident cases and 1.5 million deaths.

The burden of lung cancer in regions of Asia and Africa is expected to increase at least twofold from 2020 to 2050, surpassing European regions that are expected to have the smallest increases. Also, while incident cases will remain much higher in Northern America than in Southeastern Asia and South-Central Asia, the number of lives lost is projected to be similar. The age-specific incidence and death rates rose with age such that the oldest age groups had the highest age-specific rates. With the human development index, mortality-to-incidence showed a negative correlation.

The authors wrote that worsening smoking and pollution levels in developing countries may push the future lung cancer burden much higher than these projections. Unless reversed, cases and death will grow unabated.

“Countering the burden of lung cancer also requires curtailment of other risk factors such as air pollution and exposure to carcinogens,” the authors wrote.

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The authors stated that they have no conflicts of interest.

Unless air pollution and smoking patterns are reversed, lung cancer cases and deaths will grow unabated in some countries, according to estimates of lung cancer incident cases, deaths, and their age-standardized rates.

The findings, based on recently released data from GLOBOCAN 2020 projected to the year 2050, suggest that the lung cancer epidemic will continue to unfold, according to Rajesh Sharma, PhD, et al., in a study published in the International Journal of Clinical Oncology. GLOBOCAN 2020 is an online database produced by the International Agency for Research on Cancer. It provides global cancer statistics from 185 countries for 36 cancer types.

The increase in lung cancer, the leading cancer worldwide in terms of deaths, is generally attributed to increases in cigarette smoking, Sharma et al. wrote. They point out that, while cigarette smoking is expected to have peaked in industrialized countries in the latter half of the twentieth century, the tobacco smoking epidemic is unfolding in regions of Asia and Africa with concomitant increases in lung cancer burden in several countries. Smoking is the most significant lung cancer risk factor, followed by air pollution (especially particulate matter, passive smoking, and occupational exposure to radon and asbestos).

The authors investigated bivariate associations between smoking prevalence and age-standardized rates of lung cancer, and projected lung cancer incident cases and deaths to 2050. They also looked at mortality-to-incidence, considered to be a proxy indicator of 5-year survival, and at human development index, a measure including life expectancy at birth, years of schooling, and standard of living. The results, they state, are expected to aid in policy formulation to combat the lung cancer burden at global, regional, and national levels.

Tobacco smoking prevalence was 21.9% worldwide in 2016, with tobacco smoking prevalence exceeding 25% in 57/149 countries. It was high in European countries with 5 of the top-10 countries among the 149 countries within Europe. Prevalence was greater than 10% in all European countries. Notably, 11/33 countries in Africa had a smoking prevalence less than 10%.

Analysis showed 2.21 million new lung cancer cases and 1.8 million deaths attributed to lung cancer worldwide in 2020, with males accounting for about two-thirds of the burden. The analysis projection for 2050 was for 3.8 million incident cases of lung cancer and 3.2 million lung cancer deaths globally. In 2050, lung cancer cases and deaths are projected to be more than 100,000 in 10/21 regions, led by Eastern Asia, projected to record 1.7 million incident cases and 1.5 million deaths.

The burden of lung cancer in regions of Asia and Africa is expected to increase at least twofold from 2020 to 2050, surpassing European regions that are expected to have the smallest increases. Also, while incident cases will remain much higher in Northern America than in Southeastern Asia and South-Central Asia, the number of lives lost is projected to be similar. The age-specific incidence and death rates rose with age such that the oldest age groups had the highest age-specific rates. With the human development index, mortality-to-incidence showed a negative correlation.

The authors wrote that worsening smoking and pollution levels in developing countries may push the future lung cancer burden much higher than these projections. Unless reversed, cases and death will grow unabated.

“Countering the burden of lung cancer also requires curtailment of other risk factors such as air pollution and exposure to carcinogens,” the authors wrote.

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The authors stated that they have no conflicts of interest.

Unless air pollution and smoking patterns are reversed, lung cancer cases and deaths will grow unabated in some countries, according to estimates of lung cancer incident cases, deaths, and their age-standardized rates.

The findings, based on recently released data from GLOBOCAN 2020 projected to the year 2050, suggest that the lung cancer epidemic will continue to unfold, according to Rajesh Sharma, PhD, et al., in a study published in the International Journal of Clinical Oncology. GLOBOCAN 2020 is an online database produced by the International Agency for Research on Cancer. It provides global cancer statistics from 185 countries for 36 cancer types.

The increase in lung cancer, the leading cancer worldwide in terms of deaths, is generally attributed to increases in cigarette smoking, Sharma et al. wrote. They point out that, while cigarette smoking is expected to have peaked in industrialized countries in the latter half of the twentieth century, the tobacco smoking epidemic is unfolding in regions of Asia and Africa with concomitant increases in lung cancer burden in several countries. Smoking is the most significant lung cancer risk factor, followed by air pollution (especially particulate matter, passive smoking, and occupational exposure to radon and asbestos).

The authors investigated bivariate associations between smoking prevalence and age-standardized rates of lung cancer, and projected lung cancer incident cases and deaths to 2050. They also looked at mortality-to-incidence, considered to be a proxy indicator of 5-year survival, and at human development index, a measure including life expectancy at birth, years of schooling, and standard of living. The results, they state, are expected to aid in policy formulation to combat the lung cancer burden at global, regional, and national levels.

Tobacco smoking prevalence was 21.9% worldwide in 2016, with tobacco smoking prevalence exceeding 25% in 57/149 countries. It was high in European countries with 5 of the top-10 countries among the 149 countries within Europe. Prevalence was greater than 10% in all European countries. Notably, 11/33 countries in Africa had a smoking prevalence less than 10%.

Analysis showed 2.21 million new lung cancer cases and 1.8 million deaths attributed to lung cancer worldwide in 2020, with males accounting for about two-thirds of the burden. The analysis projection for 2050 was for 3.8 million incident cases of lung cancer and 3.2 million lung cancer deaths globally. In 2050, lung cancer cases and deaths are projected to be more than 100,000 in 10/21 regions, led by Eastern Asia, projected to record 1.7 million incident cases and 1.5 million deaths.

The burden of lung cancer in regions of Asia and Africa is expected to increase at least twofold from 2020 to 2050, surpassing European regions that are expected to have the smallest increases. Also, while incident cases will remain much higher in Northern America than in Southeastern Asia and South-Central Asia, the number of lives lost is projected to be similar. The age-specific incidence and death rates rose with age such that the oldest age groups had the highest age-specific rates. With the human development index, mortality-to-incidence showed a negative correlation.

The authors wrote that worsening smoking and pollution levels in developing countries may push the future lung cancer burden much higher than these projections. Unless reversed, cases and death will grow unabated.

“Countering the burden of lung cancer also requires curtailment of other risk factors such as air pollution and exposure to carcinogens,” the authors wrote.

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The authors stated that they have no conflicts of interest.

Patients with stage II to IVB nasopharyngeal carcinoma who were treated with nedaplatin-based concurrent chemoradiotherapy, achieved 5-year survival rates comparable to those of patients treated with cisplatin chemoradiotherapy, but with fewer toxic effects, shows a study in JAMA Network Open.

The findings confirm that nedaplatin-based chemoradiotherapy could be considered as an alternative to cisplatin for stage II to IVB nasopharyngeal carcinoma, wrote authors who were led by Lin-Quan Tang, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, China.

While the National Comprehensive Cancer Network recommends radiotherapy administered concurrently with 100 mg/m² of cisplatin every 3 weeks for patients with stage II to IVB nasopharyngeal carcinoma, the addition of cisplatin-based chemotherapy to radiotherapy increases the frequency of treatment-related toxic effects. They include severe gastrointestinal responses, hearing deficits, renal toxic effects, and neurotoxic effects, decreasing treatment adherence and patient quality of life. An antitumor drug with similar therapeutic efficacy to cisplatin but with reduced adverse effects is needed urgently, authors wrote.

The cisplatin analogue nedaplatin, designed to decrease the nephrotoxic and gastrointestinal toxic effects seen with cisplatin, has antitumor mechanisms and efficacy similar to cisplatin. It has demonstrated effectiveness and tolerability in various malignant tumors, and has, in vitro, shown potential as a radiosensitizing agent with nasopharyngeal carcinoma and cervical squamous cell carcinoma cells.

In the initial 2-year results of the phase 3 randomized trial in this population of patients with stage II to IVB nasopharyngeal carcinoma, nedaplatin-based concurrent chemoradiotherapy was noninferior to cisplatin-based concurrent chemoradiotherapy with differences of 1.9% and 1.0% (P = .005 and P = .002), in the intention-to-treat and per-protocol analyses of progression-free survival, respectively. Patients (n = 402) were randomly assigned (1:1) to receive nedaplatin (100 mg/m²)– or cisplatin (100 mg/m²)–based chemotherapy every 3 weeks for three cycles concurrently with intensity-modulated radiotherapy. Information on long-term follow-up and late toxic effects was limited.

In the current analysis of 402 patients (about 25% female, median age 44.5 years), the intention-to-treat 5-year progression-free survival rate was 81.4% (95% CI, 75.9%-86.9%) for the cisplatin group and 79.8% (95% CI, 74.1%-85.5%) for the nedaplatin group, with a difference of 1.6% (95% CI, −6.3% to 9.5%; P = .002 for noninferiority). No significant survival differences were observed between the cisplatin and nedaplatin groups for 5-year overall survival (89.4% vs. 88.8%; P = .63), distant metastasis–free survival (85.9% vs. 90.4%, P = .17), and locoregional relapse–free survival (92.6% vs. 89.6%; P = .17) rates.

The incidence of grade 3 and 4 auditory toxic effects was higher in the cisplatin group than in the nedaplatin group (35 [17.7%] vs. 21 [10.5%], P = .04). Also, the cumulative incidence of grade 3-4 auditory toxic effects was higher in the cisplatin group versus patients in the nedaplatin group (19.9% vs. 12.0%; P = .42). The odds ratio, in a post hoc regression analysis, for auditory toxic effects was 0.51 (0.51; 95% CI, 0.28-0.93; P = .03) for patients in the nedaplatin group.

The findings, the authors concluded, confirm that nedaplatin-based concurrent chemoradiotherapy could be an alternative to cisplatin-based concurrent chemoradiotherapy as doublet therapy for II to IVB nasopharyngeal carcinoma. The potential of nedaplatin in combination drug chemotherapy for nasopharyngeal carcinoma in the induction or adjuvant phase needs to be explored in further investigations, the authors added.

The study was funded by multiple grants; the study investigator reported no conflicts of interest.

Patients with stage II to IVB nasopharyngeal carcinoma who were treated with nedaplatin-based concurrent chemoradiotherapy, achieved 5-year survival rates comparable to those of patients treated with cisplatin chemoradiotherapy, but with fewer toxic effects, shows a study in JAMA Network Open.

The findings confirm that nedaplatin-based chemoradiotherapy could be considered as an alternative to cisplatin for stage II to IVB nasopharyngeal carcinoma, wrote authors who were led by Lin-Quan Tang, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, China.

While the National Comprehensive Cancer Network recommends radiotherapy administered concurrently with 100 mg/m² of cisplatin every 3 weeks for patients with stage II to IVB nasopharyngeal carcinoma, the addition of cisplatin-based chemotherapy to radiotherapy increases the frequency of treatment-related toxic effects. They include severe gastrointestinal responses, hearing deficits, renal toxic effects, and neurotoxic effects, decreasing treatment adherence and patient quality of life. An antitumor drug with similar therapeutic efficacy to cisplatin but with reduced adverse effects is needed urgently, authors wrote.

The cisplatin analogue nedaplatin, designed to decrease the nephrotoxic and gastrointestinal toxic effects seen with cisplatin, has antitumor mechanisms and efficacy similar to cisplatin. It has demonstrated effectiveness and tolerability in various malignant tumors, and has, in vitro, shown potential as a radiosensitizing agent with nasopharyngeal carcinoma and cervical squamous cell carcinoma cells.

In the initial 2-year results of the phase 3 randomized trial in this population of patients with stage II to IVB nasopharyngeal carcinoma, nedaplatin-based concurrent chemoradiotherapy was noninferior to cisplatin-based concurrent chemoradiotherapy with differences of 1.9% and 1.0% (P = .005 and P = .002), in the intention-to-treat and per-protocol analyses of progression-free survival, respectively. Patients (n = 402) were randomly assigned (1:1) to receive nedaplatin (100 mg/m²)– or cisplatin (100 mg/m²)–based chemotherapy every 3 weeks for three cycles concurrently with intensity-modulated radiotherapy. Information on long-term follow-up and late toxic effects was limited.

In the current analysis of 402 patients (about 25% female, median age 44.5 years), the intention-to-treat 5-year progression-free survival rate was 81.4% (95% CI, 75.9%-86.9%) for the cisplatin group and 79.8% (95% CI, 74.1%-85.5%) for the nedaplatin group, with a difference of 1.6% (95% CI, −6.3% to 9.5%; P = .002 for noninferiority). No significant survival differences were observed between the cisplatin and nedaplatin groups for 5-year overall survival (89.4% vs. 88.8%; P = .63), distant metastasis–free survival (85.9% vs. 90.4%, P = .17), and locoregional relapse–free survival (92.6% vs. 89.6%; P = .17) rates.

The incidence of grade 3 and 4 auditory toxic effects was higher in the cisplatin group than in the nedaplatin group (35 [17.7%] vs. 21 [10.5%], P = .04). Also, the cumulative incidence of grade 3-4 auditory toxic effects was higher in the cisplatin group versus patients in the nedaplatin group (19.9% vs. 12.0%; P = .42). The odds ratio, in a post hoc regression analysis, for auditory toxic effects was 0.51 (0.51; 95% CI, 0.28-0.93; P = .03) for patients in the nedaplatin group.

The findings, the authors concluded, confirm that nedaplatin-based concurrent chemoradiotherapy could be an alternative to cisplatin-based concurrent chemoradiotherapy as doublet therapy for II to IVB nasopharyngeal carcinoma. The potential of nedaplatin in combination drug chemotherapy for nasopharyngeal carcinoma in the induction or adjuvant phase needs to be explored in further investigations, the authors added.

The study was funded by multiple grants; the study investigator reported no conflicts of interest.

Patients with stage II to IVB nasopharyngeal carcinoma who were treated with nedaplatin-based concurrent chemoradiotherapy, achieved 5-year survival rates comparable to those of patients treated with cisplatin chemoradiotherapy, but with fewer toxic effects, shows a study in JAMA Network Open.

The findings confirm that nedaplatin-based chemoradiotherapy could be considered as an alternative to cisplatin for stage II to IVB nasopharyngeal carcinoma, wrote authors who were led by Lin-Quan Tang, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, China.

While the National Comprehensive Cancer Network recommends radiotherapy administered concurrently with 100 mg/m² of cisplatin every 3 weeks for patients with stage II to IVB nasopharyngeal carcinoma, the addition of cisplatin-based chemotherapy to radiotherapy increases the frequency of treatment-related toxic effects. They include severe gastrointestinal responses, hearing deficits, renal toxic effects, and neurotoxic effects, decreasing treatment adherence and patient quality of life. An antitumor drug with similar therapeutic efficacy to cisplatin but with reduced adverse effects is needed urgently, authors wrote.

The cisplatin analogue nedaplatin, designed to decrease the nephrotoxic and gastrointestinal toxic effects seen with cisplatin, has antitumor mechanisms and efficacy similar to cisplatin. It has demonstrated effectiveness and tolerability in various malignant tumors, and has, in vitro, shown potential as a radiosensitizing agent with nasopharyngeal carcinoma and cervical squamous cell carcinoma cells.

In the initial 2-year results of the phase 3 randomized trial in this population of patients with stage II to IVB nasopharyngeal carcinoma, nedaplatin-based concurrent chemoradiotherapy was noninferior to cisplatin-based concurrent chemoradiotherapy with differences of 1.9% and 1.0% (P = .005 and P = .002), in the intention-to-treat and per-protocol analyses of progression-free survival, respectively. Patients (n = 402) were randomly assigned (1:1) to receive nedaplatin (100 mg/m²)– or cisplatin (100 mg/m²)–based chemotherapy every 3 weeks for three cycles concurrently with intensity-modulated radiotherapy. Information on long-term follow-up and late toxic effects was limited.

In the current analysis of 402 patients (about 25% female, median age 44.5 years), the intention-to-treat 5-year progression-free survival rate was 81.4% (95% CI, 75.9%-86.9%) for the cisplatin group and 79.8% (95% CI, 74.1%-85.5%) for the nedaplatin group, with a difference of 1.6% (95% CI, −6.3% to 9.5%; P = .002 for noninferiority). No significant survival differences were observed between the cisplatin and nedaplatin groups for 5-year overall survival (89.4% vs. 88.8%; P = .63), distant metastasis–free survival (85.9% vs. 90.4%, P = .17), and locoregional relapse–free survival (92.6% vs. 89.6%; P = .17) rates.

The incidence of grade 3 and 4 auditory toxic effects was higher in the cisplatin group than in the nedaplatin group (35 [17.7%] vs. 21 [10.5%], P = .04). Also, the cumulative incidence of grade 3-4 auditory toxic effects was higher in the cisplatin group versus patients in the nedaplatin group (19.9% vs. 12.0%; P = .42). The odds ratio, in a post hoc regression analysis, for auditory toxic effects was 0.51 (0.51; 95% CI, 0.28-0.93; P = .03) for patients in the nedaplatin group.

The findings, the authors concluded, confirm that nedaplatin-based concurrent chemoradiotherapy could be an alternative to cisplatin-based concurrent chemoradiotherapy as doublet therapy for II to IVB nasopharyngeal carcinoma. The potential of nedaplatin in combination drug chemotherapy for nasopharyngeal carcinoma in the induction or adjuvant phase needs to be explored in further investigations, the authors added.

The study was funded by multiple grants; the study investigator reported no conflicts of interest.

While the representation of women in radiation oncology and medical oncology academic faculties has increased over time, racial and ethnic minorities are still vastly underrepresented in these fields, according to a cross-sectional study of data from the Association of American Medical Colleges.

“Creating and maintaining a diverse health care workforce is a priority to help combat societal inequities and health disparities, particularly in light of the evolving demographic characteristics of the general U.S. population,” wrote authors who were led by Sophia C. Kamran, MD, a radiation oncologist with Massachusetts General Hospital, Boston.

The study, which was published Dec. 9 in JAMA Oncology, surveyed full-time U.S.-based faculty in radiation and medical oncology departments from 1970 through 2019.

Improved patient satisfaction, compliance, and outcomes have been documented when a health care workforce better reflects the demographic traits of those whom it serves, Dr. Kamran and associates wrote.

They point to recent increases in the number and urgency of calls for improved diversity in the health care workforce, citing also higher incidence and mortality of new cancer cases among Black, indigenous, and Hispanic populations, compared with their non-Hispanic White counterparts. Prior calls for health care work force diversity have led to some creation of opportunities and pathways for increased representation of women and racial and ethnic minority groups in medicine, and the overall diversity of medical school faculty has been increasing by race and ethnicity and sex.

The change, however, is of lesser magnitude than what has been seen among medical school applicants, students, and graduates, and the gains in medical school faculty diversity have not kept pace with increasing diversity of the U.S. population. It has remained unclear whether corresponding progress has occurred in the composition of radiation oncology and medical oncology departments during the last 5 decades.
 

Despite lack of diversity, total faculty numbers have increased

Dr. Kamran and associates’ analysis revealed that total faculty numbers increased over time in both radiation oncology and medical oncology, with faculty representation of underrepresented-in-medicine (URM) women proportionally increased by 0.1% per decade in both radiation oncology (95% confidence interval, 0.005%-0.110%; P < . 001 for trend) and medical oncology (95% CI, −0.03% to 0.16%; P = .06 for trend), compared with non–URM women faculty, which increased by 0.4% (95% CI, 0.25%-0.80%) per decade in radiation oncology and 0.7% (95% CI, 0.47%-0.87%) per decade in medical oncology (P < .001 for trend for both). Faculty representation of URM men did not significantly change for radiation oncology (0.03% per decade [95% CI, −0.008% to 0.065%]; P = .09 for trend) or for medical oncology (0.003% per decade [95% CI, −0.13% to 0.14%]; P = .94 for trend).

In both 2009 and 2019, representation of both women and URM individuals for both specialties was less than their representation in the U.S. population. Radiation oncology faculty had the lowest URM representation in 2019 at 5.1%. The number of total URM faculty represented among both medical oncology and radiation oncology remained low for every rank in 2019 (Medical oncology: instructor, 2 of 44 [5%]; assistant professor, 18 of 274 [7%]; associate professor, 13 of 177 [7%]; full professor, 13 of 276 [5%]. Radiation oncology: instructor, 9 of 147 [6%]; assistant professor, 57 of 927 [6%]; associate professor, 20 of 510 [4%]; full professor, 18 of 452 [4%]).

“Our results highlight significant diversity differences along the career ladder in both specialties, with women having lower academic rank than men throughout the study period, and underrepresented [racial and ethnic groups] at every rank,” the authors wrote.

And, although Black, Hispanic, and indigenous people make up about 31% of the U.S. population, their inclusion in the health care workforce trails at all stages in the pipeline, the investigators found.

Diversity among radiation and medical oncologists lags behind that of medical school diversity in general, which has grown through efforts by the Association of American Medical Colleges.

Despite some improvements, the authors suggest the need for more initiatives to retain racial and ethnic minorities in an effort to reflect the diversity of the U.S. cancer population.

“This is a multifactorial issue, with focus not only on increasing diversity of the upstream pipeline but maintaining diversity throughout the entire pipeline, requiring difficult but necessary conversations about racial and ethnic systemic bias, lack of exposure and opportunities, and financial toxicities and pressures, to name a few. Until these factors are further delineated and better addressed, focused and targeted mentorship is key,” the authors wrote.
 

Small steps can have a collective impact

In a commentary published with the study, Frederick Lansigan, MD, and Charles R. Thomas Jr, MD, both of the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., called for a systemic change in hiring practices.

“Any small steps of change that contribute to supporting the issues highlighted by the Kamran et al. study can have a collective positive impact. A holistic evaluation of [underrepresented] applicants at all stages of education and training is paramount, and joining selection committees is necessary to ensure fair processes. Mentoring programs, leadership courses, and addressing microaggressions and mistreatment may improve retention of [underrepresented] medical school matriculants and trainees in oncology. Cancer centers can build and lead visible and tangible diversity, equity, inclusion, justice, and belonging efforts as we are doing at our institution,” the physicians wrote.

But above all, Dr. Lansigan and Dr. Thomas said that the oncology community needs to agree that intentionally increasing the number of underrepresented physicians in the U.S. workforce is necessary to better address health care inequities.

“We need all hands on deck to reduce structural barriers in early education. We need STEM programs that start in elementary school and offer support through college. Oncologists can mentor these early learners to highlight the positive aspects of a career in oncology, the importance of [underrepresented] physicians in oncology, and the resilience required in caring for those with serious illness, many of whom will come from underserved populations. “Physicians and public health experts themselves who are interested in tackling the discrepancy between [underrepresented] and [non-underrepresented] medical school [students] and oncology trainees need to seek and be elected into positions that can start to balance this equation. If more are willing to acknowledge the structural inequities that exist in the oncology workforce pipeline, we can start to solve the complex equation of structural inequities.”

Dr Lansigan reported being the Interim Associate Dean of Diversity, Equity, and Inclusion at the Geisel School of Medicine and the Principal of Diversity, Equity, and Inclusion for the department of medicine at Dartmouth-Hitchcock Medical Center. No other disclosures were reported.

While the representation of women in radiation oncology and medical oncology academic faculties has increased over time, racial and ethnic minorities are still vastly underrepresented in these fields, according to a cross-sectional study of data from the Association of American Medical Colleges.

“Creating and maintaining a diverse health care workforce is a priority to help combat societal inequities and health disparities, particularly in light of the evolving demographic characteristics of the general U.S. population,” wrote authors who were led by Sophia C. Kamran, MD, a radiation oncologist with Massachusetts General Hospital, Boston.

The study, which was published Dec. 9 in JAMA Oncology, surveyed full-time U.S.-based faculty in radiation and medical oncology departments from 1970 through 2019.

Improved patient satisfaction, compliance, and outcomes have been documented when a health care workforce better reflects the demographic traits of those whom it serves, Dr. Kamran and associates wrote.

They point to recent increases in the number and urgency of calls for improved diversity in the health care workforce, citing also higher incidence and mortality of new cancer cases among Black, indigenous, and Hispanic populations, compared with their non-Hispanic White counterparts. Prior calls for health care work force diversity have led to some creation of opportunities and pathways for increased representation of women and racial and ethnic minority groups in medicine, and the overall diversity of medical school faculty has been increasing by race and ethnicity and sex.

The change, however, is of lesser magnitude than what has been seen among medical school applicants, students, and graduates, and the gains in medical school faculty diversity have not kept pace with increasing diversity of the U.S. population. It has remained unclear whether corresponding progress has occurred in the composition of radiation oncology and medical oncology departments during the last 5 decades.
 

Despite lack of diversity, total faculty numbers have increased

Dr. Kamran and associates’ analysis revealed that total faculty numbers increased over time in both radiation oncology and medical oncology, with faculty representation of underrepresented-in-medicine (URM) women proportionally increased by 0.1% per decade in both radiation oncology (95% confidence interval, 0.005%-0.110%; P < . 001 for trend) and medical oncology (95% CI, −0.03% to 0.16%; P = .06 for trend), compared with non–URM women faculty, which increased by 0.4% (95% CI, 0.25%-0.80%) per decade in radiation oncology and 0.7% (95% CI, 0.47%-0.87%) per decade in medical oncology (P < .001 for trend for both). Faculty representation of URM men did not significantly change for radiation oncology (0.03% per decade [95% CI, −0.008% to 0.065%]; P = .09 for trend) or for medical oncology (0.003% per decade [95% CI, −0.13% to 0.14%]; P = .94 for trend).

In both 2009 and 2019, representation of both women and URM individuals for both specialties was less than their representation in the U.S. population. Radiation oncology faculty had the lowest URM representation in 2019 at 5.1%. The number of total URM faculty represented among both medical oncology and radiation oncology remained low for every rank in 2019 (Medical oncology: instructor, 2 of 44 [5%]; assistant professor, 18 of 274 [7%]; associate professor, 13 of 177 [7%]; full professor, 13 of 276 [5%]. Radiation oncology: instructor, 9 of 147 [6%]; assistant professor, 57 of 927 [6%]; associate professor, 20 of 510 [4%]; full professor, 18 of 452 [4%]).

“Our results highlight significant diversity differences along the career ladder in both specialties, with women having lower academic rank than men throughout the study period, and underrepresented [racial and ethnic groups] at every rank,” the authors wrote.

And, although Black, Hispanic, and indigenous people make up about 31% of the U.S. population, their inclusion in the health care workforce trails at all stages in the pipeline, the investigators found.

Diversity among radiation and medical oncologists lags behind that of medical school diversity in general, which has grown through efforts by the Association of American Medical Colleges.

Despite some improvements, the authors suggest the need for more initiatives to retain racial and ethnic minorities in an effort to reflect the diversity of the U.S. cancer population.

“This is a multifactorial issue, with focus not only on increasing diversity of the upstream pipeline but maintaining diversity throughout the entire pipeline, requiring difficult but necessary conversations about racial and ethnic systemic bias, lack of exposure and opportunities, and financial toxicities and pressures, to name a few. Until these factors are further delineated and better addressed, focused and targeted mentorship is key,” the authors wrote.
 

Small steps can have a collective impact

In a commentary published with the study, Frederick Lansigan, MD, and Charles R. Thomas Jr, MD, both of the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., called for a systemic change in hiring practices.

“Any small steps of change that contribute to supporting the issues highlighted by the Kamran et al. study can have a collective positive impact. A holistic evaluation of [underrepresented] applicants at all stages of education and training is paramount, and joining selection committees is necessary to ensure fair processes. Mentoring programs, leadership courses, and addressing microaggressions and mistreatment may improve retention of [underrepresented] medical school matriculants and trainees in oncology. Cancer centers can build and lead visible and tangible diversity, equity, inclusion, justice, and belonging efforts as we are doing at our institution,” the physicians wrote.

But above all, Dr. Lansigan and Dr. Thomas said that the oncology community needs to agree that intentionally increasing the number of underrepresented physicians in the U.S. workforce is necessary to better address health care inequities.

“We need all hands on deck to reduce structural barriers in early education. We need STEM programs that start in elementary school and offer support through college. Oncologists can mentor these early learners to highlight the positive aspects of a career in oncology, the importance of [underrepresented] physicians in oncology, and the resilience required in caring for those with serious illness, many of whom will come from underserved populations. “Physicians and public health experts themselves who are interested in tackling the discrepancy between [underrepresented] and [non-underrepresented] medical school [students] and oncology trainees need to seek and be elected into positions that can start to balance this equation. If more are willing to acknowledge the structural inequities that exist in the oncology workforce pipeline, we can start to solve the complex equation of structural inequities.”

Dr Lansigan reported being the Interim Associate Dean of Diversity, Equity, and Inclusion at the Geisel School of Medicine and the Principal of Diversity, Equity, and Inclusion for the department of medicine at Dartmouth-Hitchcock Medical Center. No other disclosures were reported.

While the representation of women in radiation oncology and medical oncology academic faculties has increased over time, racial and ethnic minorities are still vastly underrepresented in these fields, according to a cross-sectional study of data from the Association of American Medical Colleges.

“Creating and maintaining a diverse health care workforce is a priority to help combat societal inequities and health disparities, particularly in light of the evolving demographic characteristics of the general U.S. population,” wrote authors who were led by Sophia C. Kamran, MD, a radiation oncologist with Massachusetts General Hospital, Boston.

The study, which was published Dec. 9 in JAMA Oncology, surveyed full-time U.S.-based faculty in radiation and medical oncology departments from 1970 through 2019.

Improved patient satisfaction, compliance, and outcomes have been documented when a health care workforce better reflects the demographic traits of those whom it serves, Dr. Kamran and associates wrote.

They point to recent increases in the number and urgency of calls for improved diversity in the health care workforce, citing also higher incidence and mortality of new cancer cases among Black, indigenous, and Hispanic populations, compared with their non-Hispanic White counterparts. Prior calls for health care work force diversity have led to some creation of opportunities and pathways for increased representation of women and racial and ethnic minority groups in medicine, and the overall diversity of medical school faculty has been increasing by race and ethnicity and sex.

The change, however, is of lesser magnitude than what has been seen among medical school applicants, students, and graduates, and the gains in medical school faculty diversity have not kept pace with increasing diversity of the U.S. population. It has remained unclear whether corresponding progress has occurred in the composition of radiation oncology and medical oncology departments during the last 5 decades.
 

Despite lack of diversity, total faculty numbers have increased

Dr. Kamran and associates’ analysis revealed that total faculty numbers increased over time in both radiation oncology and medical oncology, with faculty representation of underrepresented-in-medicine (URM) women proportionally increased by 0.1% per decade in both radiation oncology (95% confidence interval, 0.005%-0.110%; P < . 001 for trend) and medical oncology (95% CI, −0.03% to 0.16%; P = .06 for trend), compared with non–URM women faculty, which increased by 0.4% (95% CI, 0.25%-0.80%) per decade in radiation oncology and 0.7% (95% CI, 0.47%-0.87%) per decade in medical oncology (P < .001 for trend for both). Faculty representation of URM men did not significantly change for radiation oncology (0.03% per decade [95% CI, −0.008% to 0.065%]; P = .09 for trend) or for medical oncology (0.003% per decade [95% CI, −0.13% to 0.14%]; P = .94 for trend).

In both 2009 and 2019, representation of both women and URM individuals for both specialties was less than their representation in the U.S. population. Radiation oncology faculty had the lowest URM representation in 2019 at 5.1%. The number of total URM faculty represented among both medical oncology and radiation oncology remained low for every rank in 2019 (Medical oncology: instructor, 2 of 44 [5%]; assistant professor, 18 of 274 [7%]; associate professor, 13 of 177 [7%]; full professor, 13 of 276 [5%]. Radiation oncology: instructor, 9 of 147 [6%]; assistant professor, 57 of 927 [6%]; associate professor, 20 of 510 [4%]; full professor, 18 of 452 [4%]).

“Our results highlight significant diversity differences along the career ladder in both specialties, with women having lower academic rank than men throughout the study period, and underrepresented [racial and ethnic groups] at every rank,” the authors wrote.

And, although Black, Hispanic, and indigenous people make up about 31% of the U.S. population, their inclusion in the health care workforce trails at all stages in the pipeline, the investigators found.

Diversity among radiation and medical oncologists lags behind that of medical school diversity in general, which has grown through efforts by the Association of American Medical Colleges.

Despite some improvements, the authors suggest the need for more initiatives to retain racial and ethnic minorities in an effort to reflect the diversity of the U.S. cancer population.

“This is a multifactorial issue, with focus not only on increasing diversity of the upstream pipeline but maintaining diversity throughout the entire pipeline, requiring difficult but necessary conversations about racial and ethnic systemic bias, lack of exposure and opportunities, and financial toxicities and pressures, to name a few. Until these factors are further delineated and better addressed, focused and targeted mentorship is key,” the authors wrote.
 

Small steps can have a collective impact

In a commentary published with the study, Frederick Lansigan, MD, and Charles R. Thomas Jr, MD, both of the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., called for a systemic change in hiring practices.

“Any small steps of change that contribute to supporting the issues highlighted by the Kamran et al. study can have a collective positive impact. A holistic evaluation of [underrepresented] applicants at all stages of education and training is paramount, and joining selection committees is necessary to ensure fair processes. Mentoring programs, leadership courses, and addressing microaggressions and mistreatment may improve retention of [underrepresented] medical school matriculants and trainees in oncology. Cancer centers can build and lead visible and tangible diversity, equity, inclusion, justice, and belonging efforts as we are doing at our institution,” the physicians wrote.

But above all, Dr. Lansigan and Dr. Thomas said that the oncology community needs to agree that intentionally increasing the number of underrepresented physicians in the U.S. workforce is necessary to better address health care inequities.

“We need all hands on deck to reduce structural barriers in early education. We need STEM programs that start in elementary school and offer support through college. Oncologists can mentor these early learners to highlight the positive aspects of a career in oncology, the importance of [underrepresented] physicians in oncology, and the resilience required in caring for those with serious illness, many of whom will come from underserved populations. “Physicians and public health experts themselves who are interested in tackling the discrepancy between [underrepresented] and [non-underrepresented] medical school [students] and oncology trainees need to seek and be elected into positions that can start to balance this equation. If more are willing to acknowledge the structural inequities that exist in the oncology workforce pipeline, we can start to solve the complex equation of structural inequities.”

Dr Lansigan reported being the Interim Associate Dean of Diversity, Equity, and Inclusion at the Geisel School of Medicine and the Principal of Diversity, Equity, and Inclusion for the department of medicine at Dartmouth-Hitchcock Medical Center. No other disclosures were reported.

A study comparing the cost of hypofractionated radiotherapy for early-stage breast cancer with the more expensive multidose conventional form, finds that physicians are increasingly opting for hypofractionated radiotherapy despite lower reimbursements rates for the procedure.

Hypofractionated radiotherapy is administered in fewer fractions requiring fewer hospital visits, which, in turn, should lead to less expensive procedures. According to previously reported randomized controlled trials of patients with early breast cancer, both procedures are equally efficacious. In 2011, the American Society of Radiation Oncology published guidelines recommending hypofractionated whole-breast irradiation for patients who have not undergone chemotherapy and who are at least 50 years old with a small primary tumor (T1-2).

In the new study, Loren Saulsberry, PhD, of the department of public health at the University of Chicago, and colleagues Chuanhong Liao and Dezheng Huo, hypothesized that a fee-for-service incentive structure in which doctors are paid by volume and quantity of services, would drive up use of conventional therapy among patients with commercial insurance. And, they hypothesized that, when presented with a smaller cost difference between the two procedures, physicians would recommend hypofractionated radiotherapy over the conventional form, but neither theory was proven true.

This was a retrospective study of private employer–sponsored health insurance claims processed between 2008 and 2017 for women with early-stage breast cancer who were treated with lumpectomy and whole-breast irradiation.

The study included 15,869 women who received hypofractionated radiotherapy and 59,328 who received the conventional form. Women who underwent hypofractionated radiotherapy received 15-24 fractions over 21-31 days. Those who received conventional radiotherapy received 25-40 fractions over 39-120 days. The primary outcomes and measures were the use of hypofractionated or conventional radiotherapy, costs incurred by insurers and out-of-pocket patient expenses.

Dr. Saulsberry and colleagues found the use of hypofractionated radiotherapy increased during this period. They found no association between the likelihood of receiving hypofractionated radiotherapy and insurance plan characteristics. At $23,286, conventional radiotherapy was $6,253 more expensive than hypofractionated radiotherapy which averaged $17,763.

After out-of-pocket expenses were paid (average of $502 for conventional and $363 for hypofractionated radiotherapy), insurers paid an average of $6,375 more for conventional therapy after adjustments.

“Hypofractionated radiotherapy represents significant savings to both the health care system and to individual patients. It may soon become the dominant form of radiation treatment in the U.S. if current trends continue,” Dr. Saulsberry said in an interview after she presented the study (Abstract P3-19-07) at the San Antonio Breast Cancer Symposium.

According to the National Cancer Institute, the cost of cancer care grew from $190.2 billion in 2015 to $208.9 billion in 2020.

Dr. Saulsberry declared no conflicts of interest.

A study comparing the cost of hypofractionated radiotherapy for early-stage breast cancer with the more expensive multidose conventional form, finds that physicians are increasingly opting for hypofractionated radiotherapy despite lower reimbursements rates for the procedure.

Hypofractionated radiotherapy is administered in fewer fractions requiring fewer hospital visits, which, in turn, should lead to less expensive procedures. According to previously reported randomized controlled trials of patients with early breast cancer, both procedures are equally efficacious. In 2011, the American Society of Radiation Oncology published guidelines recommending hypofractionated whole-breast irradiation for patients who have not undergone chemotherapy and who are at least 50 years old with a small primary tumor (T1-2).

In the new study, Loren Saulsberry, PhD, of the department of public health at the University of Chicago, and colleagues Chuanhong Liao and Dezheng Huo, hypothesized that a fee-for-service incentive structure in which doctors are paid by volume and quantity of services, would drive up use of conventional therapy among patients with commercial insurance. And, they hypothesized that, when presented with a smaller cost difference between the two procedures, physicians would recommend hypofractionated radiotherapy over the conventional form, but neither theory was proven true.

This was a retrospective study of private employer–sponsored health insurance claims processed between 2008 and 2017 for women with early-stage breast cancer who were treated with lumpectomy and whole-breast irradiation.

The study included 15,869 women who received hypofractionated radiotherapy and 59,328 who received the conventional form. Women who underwent hypofractionated radiotherapy received 15-24 fractions over 21-31 days. Those who received conventional radiotherapy received 25-40 fractions over 39-120 days. The primary outcomes and measures were the use of hypofractionated or conventional radiotherapy, costs incurred by insurers and out-of-pocket patient expenses.

Dr. Saulsberry and colleagues found the use of hypofractionated radiotherapy increased during this period. They found no association between the likelihood of receiving hypofractionated radiotherapy and insurance plan characteristics. At $23,286, conventional radiotherapy was $6,253 more expensive than hypofractionated radiotherapy which averaged $17,763.

After out-of-pocket expenses were paid (average of $502 for conventional and $363 for hypofractionated radiotherapy), insurers paid an average of $6,375 more for conventional therapy after adjustments.

“Hypofractionated radiotherapy represents significant savings to both the health care system and to individual patients. It may soon become the dominant form of radiation treatment in the U.S. if current trends continue,” Dr. Saulsberry said in an interview after she presented the study (Abstract P3-19-07) at the San Antonio Breast Cancer Symposium.

According to the National Cancer Institute, the cost of cancer care grew from $190.2 billion in 2015 to $208.9 billion in 2020.

Dr. Saulsberry declared no conflicts of interest.

A study comparing the cost of hypofractionated radiotherapy for early-stage breast cancer with the more expensive multidose conventional form, finds that physicians are increasingly opting for hypofractionated radiotherapy despite lower reimbursements rates for the procedure.

Hypofractionated radiotherapy is administered in fewer fractions requiring fewer hospital visits, which, in turn, should lead to less expensive procedures. According to previously reported randomized controlled trials of patients with early breast cancer, both procedures are equally efficacious. In 2011, the American Society of Radiation Oncology published guidelines recommending hypofractionated whole-breast irradiation for patients who have not undergone chemotherapy and who are at least 50 years old with a small primary tumor (T1-2).

In the new study, Loren Saulsberry, PhD, of the department of public health at the University of Chicago, and colleagues Chuanhong Liao and Dezheng Huo, hypothesized that a fee-for-service incentive structure in which doctors are paid by volume and quantity of services, would drive up use of conventional therapy among patients with commercial insurance. And, they hypothesized that, when presented with a smaller cost difference between the two procedures, physicians would recommend hypofractionated radiotherapy over the conventional form, but neither theory was proven true.

This was a retrospective study of private employer–sponsored health insurance claims processed between 2008 and 2017 for women with early-stage breast cancer who were treated with lumpectomy and whole-breast irradiation.

The study included 15,869 women who received hypofractionated radiotherapy and 59,328 who received the conventional form. Women who underwent hypofractionated radiotherapy received 15-24 fractions over 21-31 days. Those who received conventional radiotherapy received 25-40 fractions over 39-120 days. The primary outcomes and measures were the use of hypofractionated or conventional radiotherapy, costs incurred by insurers and out-of-pocket patient expenses.

Dr. Saulsberry and colleagues found the use of hypofractionated radiotherapy increased during this period. They found no association between the likelihood of receiving hypofractionated radiotherapy and insurance plan characteristics. At $23,286, conventional radiotherapy was $6,253 more expensive than hypofractionated radiotherapy which averaged $17,763.

After out-of-pocket expenses were paid (average of $502 for conventional and $363 for hypofractionated radiotherapy), insurers paid an average of $6,375 more for conventional therapy after adjustments.

“Hypofractionated radiotherapy represents significant savings to both the health care system and to individual patients. It may soon become the dominant form of radiation treatment in the U.S. if current trends continue,” Dr. Saulsberry said in an interview after she presented the study (Abstract P3-19-07) at the San Antonio Breast Cancer Symposium.

According to the National Cancer Institute, the cost of cancer care grew from $190.2 billion in 2015 to $208.9 billion in 2020.

Dr. Saulsberry declared no conflicts of interest.

Greater access to next-generation sequencing (NGS) testing enabled by the national coverage determination (NCD) issued by Medicare in 2018 has not narrowed racial and ethnic disparities in uptake, according to an analysis of data from patients with advanced non–small cell lung cancer (aNSCLC), metastatic colorectal cancer, metastatic breast cancer, or advanced melanoma. The finding was reported in JAMA Network Open.

Biomarker testing has become an essential tool in cancer care over the last decade. In 2011, for example, less than 1% of patients with aNSCLC, metastatic colorectal cancer, metastatic breast cancer, and advanced melanoma underwent NGS testing, but by 2019, 40% of patients with these cancers received the testing.

“Next-generation sequencing testing has become increasingly important because it enables identification of multiple biomarkers simultaneously and efficiently while minimizing the number of biopsies required,” wrote the authors, led by William B. Wong, PharmD, of Genentech.

It has been unknown whether for Medicare beneficiaries and the overall population, if the NCD affected health equity issues, the authors wrote. While increased use of appropriate targeted therapies facilitated by NGS testing is associated with improved survival rates in patients with advanced or metastatic cancer, variability in health care coverage policies has posed a significant barrier to obtaining NGS testing for cancer patients, specifically through policy coverage limitations. It has remained unclear if the NCD has influenced NGS testing coverage in insurance types (for example, Medicaid) encompassing a larger population of minority racial and ethnic groups often experiencing poorer care and outcomes.

The retrospective cohort analysis compared EHR data from 280 U.S. cancer clinics in the (800 sites of care) pre- versus post-NCD period for patients with aNSCLC, metastatic colorectal cancer, metastatic breast cancer, or advanced melanoma (January 2011–March 2020). Nearly 70% of all patients in the study were Medicare recipients who needed NCD approval to cover the cost of testing.

Among 92,687 patients (mean age, 66.6 years; 55.7% women), compared with Medicare beneficiaries, changes in pre- to post-NCD NGS testing trends were similar in commercially insured patients (odds ratio, 1.03; 95% CI, 0.98-1.08; P = .25). Pre- to post-NCD NGS testing trends increased at a slower rate among patients in assistance programs (OR, 0.93; 95% CI, 0.87-0.99; P = .03), compared with Medicare beneficiaries. The rate of increase for patients receiving Medicaid was not significantly different statistically compared with those receiving Medicare (OR, 0.92; 95% CI, 0.84-1.01; P = .07). Also, the NCD was not associated with racial and ethnic groups within Medicare beneficiaries alone or across all insurance types.

Compared with non-Hispanic White individuals, increases in average NGS use from the pre-NCD to post-NCD period were 14% lower (OR, 0.86; 95% CI, 0.74-0.99; P = .04) among African American and 23% lower (OR, 0.77; 95% CI, 0.62-0.96; P = .02) among Hispanic/Latino individuals; increases were similar, however, among Asian individuals and other races and ethnicities.

The authors observed that the post-NCD trend of increasing NGS testing seen in Medicare beneficiaries was similarly observed in those with commercial insurance. Testing rate differences, however, widened or were maintained after versus before the NCD in PAP (personal assistance program) and Medicaid beneficiaries relative to Medicare beneficiaries, suggesting that access to NGS testing did not improve equally across insurance types. Since Medicare coverage is determined at the state level, the authors urged research examining individual state coverage policies to further elucidate factors slowing uptake among Medicaid beneficiaries. “Additional efforts beyond coverage policies,” the authors concluded, “are needed to ensure equitable access to the benefits of precision medicine.”

The study was supported by Genentech.

Greater access to next-generation sequencing (NGS) testing enabled by the national coverage determination (NCD) issued by Medicare in 2018 has not narrowed racial and ethnic disparities in uptake, according to an analysis of data from patients with advanced non–small cell lung cancer (aNSCLC), metastatic colorectal cancer, metastatic breast cancer, or advanced melanoma. The finding was reported in JAMA Network Open.

Biomarker testing has become an essential tool in cancer care over the last decade. In 2011, for example, less than 1% of patients with aNSCLC, metastatic colorectal cancer, metastatic breast cancer, and advanced melanoma underwent NGS testing, but by 2019, 40% of patients with these cancers received the testing.

“Next-generation sequencing testing has become increasingly important because it enables identification of multiple biomarkers simultaneously and efficiently while minimizing the number of biopsies required,” wrote the authors, led by William B. Wong, PharmD, of Genentech.

It has been unknown whether for Medicare beneficiaries and the overall population, if the NCD affected health equity issues, the authors wrote. While increased use of appropriate targeted therapies facilitated by NGS testing is associated with improved survival rates in patients with advanced or metastatic cancer, variability in health care coverage policies has posed a significant barrier to obtaining NGS testing for cancer patients, specifically through policy coverage limitations. It has remained unclear if the NCD has influenced NGS testing coverage in insurance types (for example, Medicaid) encompassing a larger population of minority racial and ethnic groups often experiencing poorer care and outcomes.

The retrospective cohort analysis compared EHR data from 280 U.S. cancer clinics in the (800 sites of care) pre- versus post-NCD period for patients with aNSCLC, metastatic colorectal cancer, metastatic breast cancer, or advanced melanoma (January 2011–March 2020). Nearly 70% of all patients in the study were Medicare recipients who needed NCD approval to cover the cost of testing.

Among 92,687 patients (mean age, 66.6 years; 55.7% women), compared with Medicare beneficiaries, changes in pre- to post-NCD NGS testing trends were similar in commercially insured patients (odds ratio, 1.03; 95% CI, 0.98-1.08; P = .25). Pre- to post-NCD NGS testing trends increased at a slower rate among patients in assistance programs (OR, 0.93; 95% CI, 0.87-0.99; P = .03), compared with Medicare beneficiaries. The rate of increase for patients receiving Medicaid was not significantly different statistically compared with those receiving Medicare (OR, 0.92; 95% CI, 0.84-1.01; P = .07). Also, the NCD was not associated with racial and ethnic groups within Medicare beneficiaries alone or across all insurance types.

Compared with non-Hispanic White individuals, increases in average NGS use from the pre-NCD to post-NCD period were 14% lower (OR, 0.86; 95% CI, 0.74-0.99; P = .04) among African American and 23% lower (OR, 0.77; 95% CI, 0.62-0.96; P = .02) among Hispanic/Latino individuals; increases were similar, however, among Asian individuals and other races and ethnicities.

The authors observed that the post-NCD trend of increasing NGS testing seen in Medicare beneficiaries was similarly observed in those with commercial insurance. Testing rate differences, however, widened or were maintained after versus before the NCD in PAP (personal assistance program) and Medicaid beneficiaries relative to Medicare beneficiaries, suggesting that access to NGS testing did not improve equally across insurance types. Since Medicare coverage is determined at the state level, the authors urged research examining individual state coverage policies to further elucidate factors slowing uptake among Medicaid beneficiaries. “Additional efforts beyond coverage policies,” the authors concluded, “are needed to ensure equitable access to the benefits of precision medicine.”

The study was supported by Genentech.

Greater access to next-generation sequencing (NGS) testing enabled by the national coverage determination (NCD) issued by Medicare in 2018 has not narrowed racial and ethnic disparities in uptake, according to an analysis of data from patients with advanced non–small cell lung cancer (aNSCLC), metastatic colorectal cancer, metastatic breast cancer, or advanced melanoma. The finding was reported in JAMA Network Open.

Biomarker testing has become an essential tool in cancer care over the last decade. In 2011, for example, less than 1% of patients with aNSCLC, metastatic colorectal cancer, metastatic breast cancer, and advanced melanoma underwent NGS testing, but by 2019, 40% of patients with these cancers received the testing.

“Next-generation sequencing testing has become increasingly important because it enables identification of multiple biomarkers simultaneously and efficiently while minimizing the number of biopsies required,” wrote the authors, led by William B. Wong, PharmD, of Genentech.

It has been unknown whether for Medicare beneficiaries and the overall population, if the NCD affected health equity issues, the authors wrote. While increased use of appropriate targeted therapies facilitated by NGS testing is associated with improved survival rates in patients with advanced or metastatic cancer, variability in health care coverage policies has posed a significant barrier to obtaining NGS testing for cancer patients, specifically through policy coverage limitations. It has remained unclear if the NCD has influenced NGS testing coverage in insurance types (for example, Medicaid) encompassing a larger population of minority racial and ethnic groups often experiencing poorer care and outcomes.

The retrospective cohort analysis compared EHR data from 280 U.S. cancer clinics in the (800 sites of care) pre- versus post-NCD period for patients with aNSCLC, metastatic colorectal cancer, metastatic breast cancer, or advanced melanoma (January 2011–March 2020). Nearly 70% of all patients in the study were Medicare recipients who needed NCD approval to cover the cost of testing.

Among 92,687 patients (mean age, 66.6 years; 55.7% women), compared with Medicare beneficiaries, changes in pre- to post-NCD NGS testing trends were similar in commercially insured patients (odds ratio, 1.03; 95% CI, 0.98-1.08; P = .25). Pre- to post-NCD NGS testing trends increased at a slower rate among patients in assistance programs (OR, 0.93; 95% CI, 0.87-0.99; P = .03), compared with Medicare beneficiaries. The rate of increase for patients receiving Medicaid was not significantly different statistically compared with those receiving Medicare (OR, 0.92; 95% CI, 0.84-1.01; P = .07). Also, the NCD was not associated with racial and ethnic groups within Medicare beneficiaries alone or across all insurance types.

Compared with non-Hispanic White individuals, increases in average NGS use from the pre-NCD to post-NCD period were 14% lower (OR, 0.86; 95% CI, 0.74-0.99; P = .04) among African American and 23% lower (OR, 0.77; 95% CI, 0.62-0.96; P = .02) among Hispanic/Latino individuals; increases were similar, however, among Asian individuals and other races and ethnicities.

The authors observed that the post-NCD trend of increasing NGS testing seen in Medicare beneficiaries was similarly observed in those with commercial insurance. Testing rate differences, however, widened or were maintained after versus before the NCD in PAP (personal assistance program) and Medicaid beneficiaries relative to Medicare beneficiaries, suggesting that access to NGS testing did not improve equally across insurance types. Since Medicare coverage is determined at the state level, the authors urged research examining individual state coverage policies to further elucidate factors slowing uptake among Medicaid beneficiaries. “Additional efforts beyond coverage policies,” the authors concluded, “are needed to ensure equitable access to the benefits of precision medicine.”

The study was supported by Genentech.

Two expert analyses appearing in the same issue of the Journal of Thoracic Oncology arrive at opposite conclusions regarding the value for metastatic non–small cell lung cancer (mNSCLC) of combining first-generation endothelial growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) with either chemotherapy or vascular EGF (VEGF) monoclonal antibodies. One affirms single-agent EGFR TKI treatment, such as with osimertinib, as the current standard of care for first-line advanced metastatic EGFR-positive mNSCLC, and the other affirms clear benefits for first-generation EGFR TKIs combined with either chemotherapy or VEGF monoclonal antibodies.

In the analysis supporting combination therapy for mNSCLC, Sara Moore, MD, and Paul Wheatley-Price MD, wrote that while targeted therapy with EGFR TKIs is highly effective initially, resistance inevitably develops.

Recent data, they stated, have demonstrated that combination strategies can delay development of resistance and improve outcomes for mNSCLC populations. Combining first-generation EGFR TKIs with either chemotherapy or VEGF monoclonal antibodies has led to consistent improvement in progression-free survival (PFS) and overall survival (OS) in some cases. In the NEJ009 trial, the combination of chemotherapy (carboplatin and pemetrexed, with pemetrexed maintenance) plus gefitinib versus gefitinib alone improved response rate (84% vs. 67%, P < 0.001), PFS (median, 20.9 months vs. 11.2 months; P < .001), and OS (median, 50.9 months vs. 38.8 months; P = .021). An increase in adverse events in the chemotherapy arm led to a decrease in quality of life.

Another clinical trial (by Noronha and colleagues) conducted in India of the same combination found benefit for combination therapy in response rate (75% vs. 63%), PFS (median, 16 months vs. 8 months), and OS (not reached vs. 17 months). Grade 3 or higher adverse event rates were higher with the combination (51% vs. 25%) with quality of life was not yet reported.

While both trials have been criticized owing to a lack of standard T790M resistance testing and low use of osimertinib in subsequent lines of therapy, Dr. Moore and Dr. Wheatley-Price pointed out: “Even with the use of first-line osimertinib monotherapy, patients may still be exposed to chemotherapy with later lines of treatment. Therefore, combination therapy does not expose patients to new toxicity, it simply changes when they will be exposed to that toxicity during their treatment course.”

The importance of using combination therapy in the first-line setting, they stated, is underscored by the consistent drop-off in patients who receive second-line combination therapy. In the phase 3 FLAURA trial of first-line osimertinib monotherapy, of the patients who discontinued osimertinib, the most common reason for not receiving subsequent therapy was death (60% went on to receive further systemic therapy). This highlights the need to use the most effective treatments up front, Dr. Moore and Dr. Wheatley-Price wrote.

The four large trials of VEGF-targeted therapy with either monoclonal antibodies or TKIs added to first-generation EGFR TKIs have consistently shown improved PFS. Increased toxicities led to discontinuation of VEGF-targeted therapy in 20%-30%.

In the RELAY trial, however, despite more toxicities, quality of life was not diminished. In general, the authors concluded that long-term detriments to quality of life have not been demonstrated. Ongoing studies of osimertinib in combination with VEGF inhibition include a phase 1/2 trial with bevacizumab in previously untreated patients showing an 80% response rate (median PFS, 18.4 months) with no unexpected toxicity.

Chemotherapy-based treatment for mNSCLC with third-generation EGFR TKIs, in appropriately selected patients, the authors concluded, “can offer an additional standard-of-care option as first-line treatment of EGFR-mutant lung cancer.”

Since the introduction of EGFR TKIs, Sophie Stock-Martineau, MD and Frances A. Shepherd, MD noted in their analysis, researchers have aimed to improve their efficacy through combining them with other agents. The authors review research on the addition of chemo- or immunotherapy and agents targeting major resistance mechanisms such as MET. Their review of the same NEJ009 trial focuses, however, on the 65.3% (EGFR TKI plus chemotherapy) versus 31.0% (gefitinib alone) grade 3 adverse event rate, and the 51% versus 25% grade 3 adverse event rate in a similar trial by Noronha and colleagues. The review by Dr. Stock-Martineau and Dr. Shepherd further found that, while adding antiangiogenic agents to an EGFR TKI “mildly” prolongs PFS, survival benefits have not been demonstrated. The added costs, not just in toxicity, were a “far from negligible” $120,000 above the cost of bevacizumab alone for 16 treatments. Data from trials of immune checkpoint inhibitors added to EGFR TKIs reveal heightened toxicities and limited efficacy. Trials of EGFR monoclonal antibodies with an EGFR TKI showed no PFS or OS benefit and were terminated early. Similarly, evidence to date shows no benefit beyond that shown for EGFR TKI monotherapy with the addition of a MET inhibitor.

“Adding virtually all agents to EGFR TKIs has been associated with more toxicity to patients and a significant financial burden to the health care system,” Dr. Stock-Martineau and Dr. Shepherd concluded, further observing that combinations, given their heightened toxicity profiles, could potentially also worsen quality of life.

No conflicts of interest were reported by the authors of either study.

Two expert analyses appearing in the same issue of the Journal of Thoracic Oncology arrive at opposite conclusions regarding the value for metastatic non–small cell lung cancer (mNSCLC) of combining first-generation endothelial growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) with either chemotherapy or vascular EGF (VEGF) monoclonal antibodies. One affirms single-agent EGFR TKI treatment, such as with osimertinib, as the current standard of care for first-line advanced metastatic EGFR-positive mNSCLC, and the other affirms clear benefits for first-generation EGFR TKIs combined with either chemotherapy or VEGF monoclonal antibodies.

In the analysis supporting combination therapy for mNSCLC, Sara Moore, MD, and Paul Wheatley-Price MD, wrote that while targeted therapy with EGFR TKIs is highly effective initially, resistance inevitably develops.

Recent data, they stated, have demonstrated that combination strategies can delay development of resistance and improve outcomes for mNSCLC populations. Combining first-generation EGFR TKIs with either chemotherapy or VEGF monoclonal antibodies has led to consistent improvement in progression-free survival (PFS) and overall survival (OS) in some cases. In the NEJ009 trial, the combination of chemotherapy (carboplatin and pemetrexed, with pemetrexed maintenance) plus gefitinib versus gefitinib alone improved response rate (84% vs. 67%, P < 0.001), PFS (median, 20.9 months vs. 11.2 months; P < .001), and OS (median, 50.9 months vs. 38.8 months; P = .021). An increase in adverse events in the chemotherapy arm led to a decrease in quality of life.

Another clinical trial (by Noronha and colleagues) conducted in India of the same combination found benefit for combination therapy in response rate (75% vs. 63%), PFS (median, 16 months vs. 8 months), and OS (not reached vs. 17 months). Grade 3 or higher adverse event rates were higher with the combination (51% vs. 25%) with quality of life was not yet reported.

While both trials have been criticized owing to a lack of standard T790M resistance testing and low use of osimertinib in subsequent lines of therapy, Dr. Moore and Dr. Wheatley-Price pointed out: “Even with the use of first-line osimertinib monotherapy, patients may still be exposed to chemotherapy with later lines of treatment. Therefore, combination therapy does not expose patients to new toxicity, it simply changes when they will be exposed to that toxicity during their treatment course.”

The importance of using combination therapy in the first-line setting, they stated, is underscored by the consistent drop-off in patients who receive second-line combination therapy. In the phase 3 FLAURA trial of first-line osimertinib monotherapy, of the patients who discontinued osimertinib, the most common reason for not receiving subsequent therapy was death (60% went on to receive further systemic therapy). This highlights the need to use the most effective treatments up front, Dr. Moore and Dr. Wheatley-Price wrote.

The four large trials of VEGF-targeted therapy with either monoclonal antibodies or TKIs added to first-generation EGFR TKIs have consistently shown improved PFS. Increased toxicities led to discontinuation of VEGF-targeted therapy in 20%-30%.

In the RELAY trial, however, despite more toxicities, quality of life was not diminished. In general, the authors concluded that long-term detriments to quality of life have not been demonstrated. Ongoing studies of osimertinib in combination with VEGF inhibition include a phase 1/2 trial with bevacizumab in previously untreated patients showing an 80% response rate (median PFS, 18.4 months) with no unexpected toxicity.

Chemotherapy-based treatment for mNSCLC with third-generation EGFR TKIs, in appropriately selected patients, the authors concluded, “can offer an additional standard-of-care option as first-line treatment of EGFR-mutant lung cancer.”

Since the introduction of EGFR TKIs, Sophie Stock-Martineau, MD and Frances A. Shepherd, MD noted in their analysis, researchers have aimed to improve their efficacy through combining them with other agents. The authors review research on the addition of chemo- or immunotherapy and agents targeting major resistance mechanisms such as MET. Their review of the same NEJ009 trial focuses, however, on the 65.3% (EGFR TKI plus chemotherapy) versus 31.0% (gefitinib alone) grade 3 adverse event rate, and the 51% versus 25% grade 3 adverse event rate in a similar trial by Noronha and colleagues. The review by Dr. Stock-Martineau and Dr. Shepherd further found that, while adding antiangiogenic agents to an EGFR TKI “mildly” prolongs PFS, survival benefits have not been demonstrated. The added costs, not just in toxicity, were a “far from negligible” $120,000 above the cost of bevacizumab alone for 16 treatments. Data from trials of immune checkpoint inhibitors added to EGFR TKIs reveal heightened toxicities and limited efficacy. Trials of EGFR monoclonal antibodies with an EGFR TKI showed no PFS or OS benefit and were terminated early. Similarly, evidence to date shows no benefit beyond that shown for EGFR TKI monotherapy with the addition of a MET inhibitor.

“Adding virtually all agents to EGFR TKIs has been associated with more toxicity to patients and a significant financial burden to the health care system,” Dr. Stock-Martineau and Dr. Shepherd concluded, further observing that combinations, given their heightened toxicity profiles, could potentially also worsen quality of life.

No conflicts of interest were reported by the authors of either study.

Two expert analyses appearing in the same issue of the Journal of Thoracic Oncology arrive at opposite conclusions regarding the value for metastatic non–small cell lung cancer (mNSCLC) of combining first-generation endothelial growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) with either chemotherapy or vascular EGF (VEGF) monoclonal antibodies. One affirms single-agent EGFR TKI treatment, such as with osimertinib, as the current standard of care for first-line advanced metastatic EGFR-positive mNSCLC, and the other affirms clear benefits for first-generation EGFR TKIs combined with either chemotherapy or VEGF monoclonal antibodies.

In the analysis supporting combination therapy for mNSCLC, Sara Moore, MD, and Paul Wheatley-Price MD, wrote that while targeted therapy with EGFR TKIs is highly effective initially, resistance inevitably develops.

Recent data, they stated, have demonstrated that combination strategies can delay development of resistance and improve outcomes for mNSCLC populations. Combining first-generation EGFR TKIs with either chemotherapy or VEGF monoclonal antibodies has led to consistent improvement in progression-free survival (PFS) and overall survival (OS) in some cases. In the NEJ009 trial, the combination of chemotherapy (carboplatin and pemetrexed, with pemetrexed maintenance) plus gefitinib versus gefitinib alone improved response rate (84% vs. 67%, P < 0.001), PFS (median, 20.9 months vs. 11.2 months; P < .001), and OS (median, 50.9 months vs. 38.8 months; P = .021). An increase in adverse events in the chemotherapy arm led to a decrease in quality of life.

Another clinical trial (by Noronha and colleagues) conducted in India of the same combination found benefit for combination therapy in response rate (75% vs. 63%), PFS (median, 16 months vs. 8 months), and OS (not reached vs. 17 months). Grade 3 or higher adverse event rates were higher with the combination (51% vs. 25%) with quality of life was not yet reported.

While both trials have been criticized owing to a lack of standard T790M resistance testing and low use of osimertinib in subsequent lines of therapy, Dr. Moore and Dr. Wheatley-Price pointed out: “Even with the use of first-line osimertinib monotherapy, patients may still be exposed to chemotherapy with later lines of treatment. Therefore, combination therapy does not expose patients to new toxicity, it simply changes when they will be exposed to that toxicity during their treatment course.”

The importance of using combination therapy in the first-line setting, they stated, is underscored by the consistent drop-off in patients who receive second-line combination therapy. In the phase 3 FLAURA trial of first-line osimertinib monotherapy, of the patients who discontinued osimertinib, the most common reason for not receiving subsequent therapy was death (60% went on to receive further systemic therapy). This highlights the need to use the most effective treatments up front, Dr. Moore and Dr. Wheatley-Price wrote.

The four large trials of VEGF-targeted therapy with either monoclonal antibodies or TKIs added to first-generation EGFR TKIs have consistently shown improved PFS. Increased toxicities led to discontinuation of VEGF-targeted therapy in 20%-30%.

In the RELAY trial, however, despite more toxicities, quality of life was not diminished. In general, the authors concluded that long-term detriments to quality of life have not been demonstrated. Ongoing studies of osimertinib in combination with VEGF inhibition include a phase 1/2 trial with bevacizumab in previously untreated patients showing an 80% response rate (median PFS, 18.4 months) with no unexpected toxicity.

Chemotherapy-based treatment for mNSCLC with third-generation EGFR TKIs, in appropriately selected patients, the authors concluded, “can offer an additional standard-of-care option as first-line treatment of EGFR-mutant lung cancer.”

Since the introduction of EGFR TKIs, Sophie Stock-Martineau, MD and Frances A. Shepherd, MD noted in their analysis, researchers have aimed to improve their efficacy through combining them with other agents. The authors review research on the addition of chemo- or immunotherapy and agents targeting major resistance mechanisms such as MET. Their review of the same NEJ009 trial focuses, however, on the 65.3% (EGFR TKI plus chemotherapy) versus 31.0% (gefitinib alone) grade 3 adverse event rate, and the 51% versus 25% grade 3 adverse event rate in a similar trial by Noronha and colleagues. The review by Dr. Stock-Martineau and Dr. Shepherd further found that, while adding antiangiogenic agents to an EGFR TKI “mildly” prolongs PFS, survival benefits have not been demonstrated. The added costs, not just in toxicity, were a “far from negligible” $120,000 above the cost of bevacizumab alone for 16 treatments. Data from trials of immune checkpoint inhibitors added to EGFR TKIs reveal heightened toxicities and limited efficacy. Trials of EGFR monoclonal antibodies with an EGFR TKI showed no PFS or OS benefit and were terminated early. Similarly, evidence to date shows no benefit beyond that shown for EGFR TKI monotherapy with the addition of a MET inhibitor.

“Adding virtually all agents to EGFR TKIs has been associated with more toxicity to patients and a significant financial burden to the health care system,” Dr. Stock-Martineau and Dr. Shepherd concluded, further observing that combinations, given their heightened toxicity profiles, could potentially also worsen quality of life.

No conflicts of interest were reported by the authors of either study.

In a large-scale study among Danish children, no statistically significant association was found between maternal hormonal contraception use and increased risk for central nervous system (CNS) tumors in their offspring.

The study was based on population-based registry data and included 1.1 million children age 19 or younger born in Denmark between 1996 and 2014.

The study, by Marie Hargreave, PhD, Danish Cancer Society Research Center, and colleagues, was published online Jan. 4 in the Journal of the American Medical Association.

Exposure to sex hormones in utero is a recognized cause of cancer in affected offspring, note the authors. Also, the incidence of CNS tumors, among the most common and lethal childhood cancer types, appears to be increasing. Hence, they sought to investigate if there may be a relationship between the two.

During a mean follow-up of 12.9 years, the team found that 725 children were diagnosed with a CNS tumor (47.2% female). Mean age at diagnosis was 7 years. The team noted that 11.5%, 65.7%, and 22.8% of diagnosed children were born to mothers with recent, previous, or no use of hormonal contraception, respectively.

The adjusted incidence rate of CNS tumors was 5.0 per 100,000 person-years for children born to mothers with recent hormonal contraception use (hazard ratio, 0.95), 4.5 per 100,000 person-years for children born to mothers with previous use (HR, 0.86), and 5.3 per 100,000 person-years for children born to mothers with no use.

While recent use of implants (HR, 0.9) and intrauterine devices (HR, 1.5) showed no statistically significant associations for the subgroups of nonoral progestin-only hormonal contraception assessed, the team found that progestin-only injections were significantly associated with an increased risk compared with no use (HR, 6.7). Also, in all post hoc sensitivity analyses, recent use of the main group of nonoral progestin-only products was significantly associated with CNS tumors.

The authors observe that an association between maternal use of injectable contraceptives and increased risk of chromosomal anomalies and major malformations in children has previously been reported. Those results for injections, however, were based on a small number of cases, the result of the likelihood test was null, and adjustments for multiple comparisons were not made. Even if the results for this subgroup are confirmed, the authors point out, because CNS tumors in children are uncommon, the high relative risk estimates would translate to low absolute risk increases.

Although the large number of person-years and cancers increases the statistical precision, and the population-based nationwide design increases the generalizability of the results, the authors caution that uncommonness of CNS tumors in children and the small number of cases in the studied cohort limit subgroup analyses and the statistical precision of certain estimates.

In an accompanying editorial, Logan G. Spector, PhD, and Christopher L. Moertel, MD, from the University of Minnesota Medical School, and H. Irene Su, MD, from the University of California, San Diego, echo the authors’ conclusions, and state: “Thus, women should be reassured about the use of hormonal contraception, including progestin-only injections, and the lack of any increased risk of CNS tumors in their offspring.”

The study was supported by the Danish Cancer Research Foundation, the Arvid Nilssons Foundation, the Gangsted Foundation, the Harboe Foundation, and the Johannes Clemmesens Foundation. Co-author Lina S. Mørch, PhD, reported receiving personal fees from Novo Nordisk as an employee from 2017 to 2019 and grants from Novo Nordisk for a collaborative research project outside the submitted work. Editorialist Christopher Moertel, MD, reported receiving personal fees from OX2 Therapeutics, a spin-off of the University of Minnesota that is involved in the development of brain tumor therapeutics.

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

In a large-scale study among Danish children, no statistically significant association was found between maternal hormonal contraception use and increased risk for central nervous system (CNS) tumors in their offspring.

The study was based on population-based registry data and included 1.1 million children age 19 or younger born in Denmark between 1996 and 2014.

The study, by Marie Hargreave, PhD, Danish Cancer Society Research Center, and colleagues, was published online Jan. 4 in the Journal of the American Medical Association.

Exposure to sex hormones in utero is a recognized cause of cancer in affected offspring, note the authors. Also, the incidence of CNS tumors, among the most common and lethal childhood cancer types, appears to be increasing. Hence, they sought to investigate if there may be a relationship between the two.

During a mean follow-up of 12.9 years, the team found that 725 children were diagnosed with a CNS tumor (47.2% female). Mean age at diagnosis was 7 years. The team noted that 11.5%, 65.7%, and 22.8% of diagnosed children were born to mothers with recent, previous, or no use of hormonal contraception, respectively.

The adjusted incidence rate of CNS tumors was 5.0 per 100,000 person-years for children born to mothers with recent hormonal contraception use (hazard ratio, 0.95), 4.5 per 100,000 person-years for children born to mothers with previous use (HR, 0.86), and 5.3 per 100,000 person-years for children born to mothers with no use.

While recent use of implants (HR, 0.9) and intrauterine devices (HR, 1.5) showed no statistically significant associations for the subgroups of nonoral progestin-only hormonal contraception assessed, the team found that progestin-only injections were significantly associated with an increased risk compared with no use (HR, 6.7). Also, in all post hoc sensitivity analyses, recent use of the main group of nonoral progestin-only products was significantly associated with CNS tumors.

The authors observe that an association between maternal use of injectable contraceptives and increased risk of chromosomal anomalies and major malformations in children has previously been reported. Those results for injections, however, were based on a small number of cases, the result of the likelihood test was null, and adjustments for multiple comparisons were not made. Even if the results for this subgroup are confirmed, the authors point out, because CNS tumors in children are uncommon, the high relative risk estimates would translate to low absolute risk increases.

Although the large number of person-years and cancers increases the statistical precision, and the population-based nationwide design increases the generalizability of the results, the authors caution that uncommonness of CNS tumors in children and the small number of cases in the studied cohort limit subgroup analyses and the statistical precision of certain estimates.

In an accompanying editorial, Logan G. Spector, PhD, and Christopher L. Moertel, MD, from the University of Minnesota Medical School, and H. Irene Su, MD, from the University of California, San Diego, echo the authors’ conclusions, and state: “Thus, women should be reassured about the use of hormonal contraception, including progestin-only injections, and the lack of any increased risk of CNS tumors in their offspring.”

The study was supported by the Danish Cancer Research Foundation, the Arvid Nilssons Foundation, the Gangsted Foundation, the Harboe Foundation, and the Johannes Clemmesens Foundation. Co-author Lina S. Mørch, PhD, reported receiving personal fees from Novo Nordisk as an employee from 2017 to 2019 and grants from Novo Nordisk for a collaborative research project outside the submitted work. Editorialist Christopher Moertel, MD, reported receiving personal fees from OX2 Therapeutics, a spin-off of the University of Minnesota that is involved in the development of brain tumor therapeutics.

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

In a large-scale study among Danish children, no statistically significant association was found between maternal hormonal contraception use and increased risk for central nervous system (CNS) tumors in their offspring.

The study was based on population-based registry data and included 1.1 million children age 19 or younger born in Denmark between 1996 and 2014.

The study, by Marie Hargreave, PhD, Danish Cancer Society Research Center, and colleagues, was published online Jan. 4 in the Journal of the American Medical Association.

Exposure to sex hormones in utero is a recognized cause of cancer in affected offspring, note the authors. Also, the incidence of CNS tumors, among the most common and lethal childhood cancer types, appears to be increasing. Hence, they sought to investigate if there may be a relationship between the two.

During a mean follow-up of 12.9 years, the team found that 725 children were diagnosed with a CNS tumor (47.2% female). Mean age at diagnosis was 7 years. The team noted that 11.5%, 65.7%, and 22.8% of diagnosed children were born to mothers with recent, previous, or no use of hormonal contraception, respectively.

The adjusted incidence rate of CNS tumors was 5.0 per 100,000 person-years for children born to mothers with recent hormonal contraception use (hazard ratio, 0.95), 4.5 per 100,000 person-years for children born to mothers with previous use (HR, 0.86), and 5.3 per 100,000 person-years for children born to mothers with no use.

While recent use of implants (HR, 0.9) and intrauterine devices (HR, 1.5) showed no statistically significant associations for the subgroups of nonoral progestin-only hormonal contraception assessed, the team found that progestin-only injections were significantly associated with an increased risk compared with no use (HR, 6.7). Also, in all post hoc sensitivity analyses, recent use of the main group of nonoral progestin-only products was significantly associated with CNS tumors.

The authors observe that an association between maternal use of injectable contraceptives and increased risk of chromosomal anomalies and major malformations in children has previously been reported. Those results for injections, however, were based on a small number of cases, the result of the likelihood test was null, and adjustments for multiple comparisons were not made. Even if the results for this subgroup are confirmed, the authors point out, because CNS tumors in children are uncommon, the high relative risk estimates would translate to low absolute risk increases.

Although the large number of person-years and cancers increases the statistical precision, and the population-based nationwide design increases the generalizability of the results, the authors caution that uncommonness of CNS tumors in children and the small number of cases in the studied cohort limit subgroup analyses and the statistical precision of certain estimates.

In an accompanying editorial, Logan G. Spector, PhD, and Christopher L. Moertel, MD, from the University of Minnesota Medical School, and H. Irene Su, MD, from the University of California, San Diego, echo the authors’ conclusions, and state: “Thus, women should be reassured about the use of hormonal contraception, including progestin-only injections, and the lack of any increased risk of CNS tumors in their offspring.”

The study was supported by the Danish Cancer Research Foundation, the Arvid Nilssons Foundation, the Gangsted Foundation, the Harboe Foundation, and the Johannes Clemmesens Foundation. Co-author Lina S. Mørch, PhD, reported receiving personal fees from Novo Nordisk as an employee from 2017 to 2019 and grants from Novo Nordisk for a collaborative research project outside the submitted work. Editorialist Christopher Moertel, MD, reported receiving personal fees from OX2 Therapeutics, a spin-off of the University of Minnesota that is involved in the development of brain tumor therapeutics.

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