No link between sex and survival on checkpoint inhibitors in latest meta-analysis

Men and women with cancer may derive a similar survival benefit from immune checkpoint inhibitor therapy, results of a recent meta-analysis suggest.

Both men and women had an overall survival benefit from immunotherapy versus standard of care therapy, with no significant difference between the sexes, according to authors of this meta-analysis, which included 23 randomized clinical trials comprising nearly 14,000 patients.

The findings, reported in JAMA Oncology, contrast with those of another recent analysis, which suggested that men had a greater advantage of receiving immunotherapy versus standard of care than women did.

“We found no evidence that sex should be considered when deciding whether to offer immunotherapy to patients with advanced cancers,” said Christopher J.D. Wallis, MD, PhD, of the University of Toronto, and his coauthors said in their report.

The present meta-analysis was based on a “more contemporary and comprehensive” literature search strategy than the earlier one, according to Dr. Wallis and his coinvestigators.

Specifically, they considered immunotherapy agents not included in the previous analysis, added seven new studies published since the previous analysis, and excluded three trials that compared immunotherapy agents, rather than comparing immunotherapy with standard of care, they explained in their report.

Their resulting meta-analysis included a total of 9,322 men and 4,399 women, most of whom were in their 70s. Overall, they found that immune checkpoint inhibitor therapy offered a statistically significant overall survival advantage versus standard systemic therapy, with a hazard ratio of 0.75 (95% confidence interval, 0.70-0.81; P less than .001).

That overall survival advantage was found for both men, with a hazard ratio of 0.75 (95% CI, 0.69-0.81; P less than .001) and women, at 0.77 (95% CI, 0.67-0.88; P = .002), investigators further reported. There was no statistically significant difference in overall survival advantage between men and women, both overall (P = 0.60) and in subgroup analyses that accounted for tumor type, line of treatment, and prevalence of women in the study.

The previous meta-analysis, published in the Lancet, found an overall survival hazard ratio of 0.72 for men receiving checkpoint inhibitors and 0.86 for women receiving checkpoint inhibitors (P = .0019), prompting those investigators to conclude that the magnitude of benefit was sex-dependent and that different immunotherapeutic approaches may be needed for men versus women.

“The present meta-analysis provides a more specific assessment of the research question while including a greater number of immunotherapy agents and an updated search,” Dr. Wallis and his coauthors said in a discussion of their more recent findings.

Dr. Wallis reported no disclosures related to the study. Study coauthors provided disclosures related to Merck, AstraZeneca, Bristol-Myers Squibb, Illumina, Tempus, Novartis, Eli Lilly, Fate, Incyte, MedImmune, Pfizer, Roche/Genentech, Xcovery, Fate Therapeutics, Genocea, and Iovance.
 

SOURCE: Wallis CJD et al. JAMA Oncol. 2019 Jan 3. doi:10.1001/jamaoncol.2018.5904.

Men and women with cancer may derive a similar survival benefit from immune checkpoint inhibitor therapy, results of a recent meta-analysis suggest.

Both men and women had an overall survival benefit from immunotherapy versus standard of care therapy, with no significant difference between the sexes, according to authors of this meta-analysis, which included 23 randomized clinical trials comprising nearly 14,000 patients.

The findings, reported in JAMA Oncology, contrast with those of another recent analysis, which suggested that men had a greater advantage of receiving immunotherapy versus standard of care than women did.

“We found no evidence that sex should be considered when deciding whether to offer immunotherapy to patients with advanced cancers,” said Christopher J.D. Wallis, MD, PhD, of the University of Toronto, and his coauthors said in their report.

The present meta-analysis was based on a “more contemporary and comprehensive” literature search strategy than the earlier one, according to Dr. Wallis and his coinvestigators.

Specifically, they considered immunotherapy agents not included in the previous analysis, added seven new studies published since the previous analysis, and excluded three trials that compared immunotherapy agents, rather than comparing immunotherapy with standard of care, they explained in their report.

Their resulting meta-analysis included a total of 9,322 men and 4,399 women, most of whom were in their 70s. Overall, they found that immune checkpoint inhibitor therapy offered a statistically significant overall survival advantage versus standard systemic therapy, with a hazard ratio of 0.75 (95% confidence interval, 0.70-0.81; P less than .001).

That overall survival advantage was found for both men, with a hazard ratio of 0.75 (95% CI, 0.69-0.81; P less than .001) and women, at 0.77 (95% CI, 0.67-0.88; P = .002), investigators further reported. There was no statistically significant difference in overall survival advantage between men and women, both overall (P = 0.60) and in subgroup analyses that accounted for tumor type, line of treatment, and prevalence of women in the study.

The previous meta-analysis, published in the Lancet, found an overall survival hazard ratio of 0.72 for men receiving checkpoint inhibitors and 0.86 for women receiving checkpoint inhibitors (P = .0019), prompting those investigators to conclude that the magnitude of benefit was sex-dependent and that different immunotherapeutic approaches may be needed for men versus women.

“The present meta-analysis provides a more specific assessment of the research question while including a greater number of immunotherapy agents and an updated search,” Dr. Wallis and his coauthors said in a discussion of their more recent findings.

Dr. Wallis reported no disclosures related to the study. Study coauthors provided disclosures related to Merck, AstraZeneca, Bristol-Myers Squibb, Illumina, Tempus, Novartis, Eli Lilly, Fate, Incyte, MedImmune, Pfizer, Roche/Genentech, Xcovery, Fate Therapeutics, Genocea, and Iovance.
 

SOURCE: Wallis CJD et al. JAMA Oncol. 2019 Jan 3. doi:10.1001/jamaoncol.2018.5904.

Men and women with cancer may derive a similar survival benefit from immune checkpoint inhibitor therapy, results of a recent meta-analysis suggest.

Both men and women had an overall survival benefit from immunotherapy versus standard of care therapy, with no significant difference between the sexes, according to authors of this meta-analysis, which included 23 randomized clinical trials comprising nearly 14,000 patients.

The findings, reported in JAMA Oncology, contrast with those of another recent analysis, which suggested that men had a greater advantage of receiving immunotherapy versus standard of care than women did.

“We found no evidence that sex should be considered when deciding whether to offer immunotherapy to patients with advanced cancers,” said Christopher J.D. Wallis, MD, PhD, of the University of Toronto, and his coauthors said in their report.

The present meta-analysis was based on a “more contemporary and comprehensive” literature search strategy than the earlier one, according to Dr. Wallis and his coinvestigators.

Specifically, they considered immunotherapy agents not included in the previous analysis, added seven new studies published since the previous analysis, and excluded three trials that compared immunotherapy agents, rather than comparing immunotherapy with standard of care, they explained in their report.

Their resulting meta-analysis included a total of 9,322 men and 4,399 women, most of whom were in their 70s. Overall, they found that immune checkpoint inhibitor therapy offered a statistically significant overall survival advantage versus standard systemic therapy, with a hazard ratio of 0.75 (95% confidence interval, 0.70-0.81; P less than .001).

That overall survival advantage was found for both men, with a hazard ratio of 0.75 (95% CI, 0.69-0.81; P less than .001) and women, at 0.77 (95% CI, 0.67-0.88; P = .002), investigators further reported. There was no statistically significant difference in overall survival advantage between men and women, both overall (P = 0.60) and in subgroup analyses that accounted for tumor type, line of treatment, and prevalence of women in the study.

The previous meta-analysis, published in the Lancet, found an overall survival hazard ratio of 0.72 for men receiving checkpoint inhibitors and 0.86 for women receiving checkpoint inhibitors (P = .0019), prompting those investigators to conclude that the magnitude of benefit was sex-dependent and that different immunotherapeutic approaches may be needed for men versus women.

“The present meta-analysis provides a more specific assessment of the research question while including a greater number of immunotherapy agents and an updated search,” Dr. Wallis and his coauthors said in a discussion of their more recent findings.

Dr. Wallis reported no disclosures related to the study. Study coauthors provided disclosures related to Merck, AstraZeneca, Bristol-Myers Squibb, Illumina, Tempus, Novartis, Eli Lilly, Fate, Incyte, MedImmune, Pfizer, Roche/Genentech, Xcovery, Fate Therapeutics, Genocea, and Iovance.
 

SOURCE: Wallis CJD et al. JAMA Oncol. 2019 Jan 3. doi:10.1001/jamaoncol.2018.5904.