Immuno-Oncology Resource Center
Immuno-Oncology Resource Center
February 20, 2019
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Patient sex does not influence immunotherapy efficacy

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Patient sex had no statistically significant impact on the efficacy of immunotherapy for treatment of advanced cancers, according to a study published in JAMA Oncology.

Results revealed no OS difference between men and women.

“Women and men differ in their immunologic response to both foreign and self-antigens, with women typically having stronger innate and adaptive immune responses,” Christopher J.D. Wallis, MD, urology resident in the division of urology at University of Toronto, and colleagues wrote. “Compared with men, women not only experience a higher prevalence of systemic autoimmune disease, but also have a greater response to vaccination and a lower severity and prevalence of many infectious conditions. In oncology, differences in immune response have been postulated to underlie observed differences in prevalence and mortality from many cancers.”

In a systematic review and meta-analysis, Wallis and colleagues searched the PubMed, Embase and Scopus databases for randomized clinical trials that compared immunotherapy with standard of care for treatment of advanced, solid-organ malignant neoplasms. Trials selected for inclusion had OS as an outcome and data stratified by patient sex.

OS, including a test for heterogeneity between men and women to evaluate the null hypothesis that patient sex does not confer any survival advantage in the use of immunotherapy, served as the primary outcome.

The 23 randomized clinical trials included in the study evaluated 9,322 men (67.9%) and 4,399 women (32.1%). The majority of patients were in their 70s. Most of the studies had a relatively short follow-up, although the median follow-up for three trials was 24 months or longer.

Results showed an OS benefit with immunotherapy compared with standard-of-care treatment among both men (HR =0.75; 95% CI, 0.69-0.81) and women (HR = 0.77; 95% CI, 0.67-0.88).

A random-effects meta-analysis of study-level disparities in immunotherapy response showed no statistically significant difference between the sexes (I² = 38%). Subgroup analyses based on disease site, line of therapy, class of immunotherapy, study methodology, and prevalence of women in the studies reinforced these findings.

“In this contemporary meta-analysis of all available immunotherapy clinical trials across all disease sites, we found no difference in immunotherapy efficacy or OS between women and men,” the researchers wrote. “Contrary to findings of a previous analysis, we found no evidence that sex should be considered when deciding whether to offer immunotherapy to patients with advanced cancers.” – by Jennifer Byrne

Disclosures: Wallis reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.