Eliminating Gender-Based Barriers to Immunotherapy

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Healthcare providers should not base cancer care with immune checkpoint inhibitors on gender, according to recent study findings.

A patient's gender should not influence whether they are appropriate candidates for immunotherapy, according to study findings published in JAMA Oncology.

“When otherwise indicated, immunotherapy is likely to benefit men and women equally,” Christopher J. D. Wallis, MD, PhD, division of urology, University of Toronto, said in an interview with Oncology Nursing News®.

An earlier meta-analysis of randomized clinical trials showed that men derived greater value from immune checkpoint inhibitors compared with women, the researchers explained. To examine whether women have less advantage of this type of therapy, researchers investigated data from 23 different clinical trials that included 13,721 patients—9,322 (67.9%) men and 4,399 (32.1%) women—and most were in their 70s who had previously failed therapy.

The included studies compared immunotherapy for metastatic cancers with other systemic treatment regimens, such as chemotherapy-based and targeted therapy, as well as immunotherapy-chemotherapy combinations compared with chemotherapy alone. The following cancer types were analyzed: non-small cell lung cancer (48%); melanoma (17%); clear cell renal cell carcinoma or small cell lung cancer (9%) each; and urothelial carcinoma, head and neck squamous carcinoma, mesothelioma, and gastric or gastroesophageal carcinoma (4%) each.

Overall survival in the first-line setting was evaluated in 11 of the trials. Most of the trials included therapy with a PD-1 or PD-L1 inhibitor and 6 trials (26%) used a CTLA-4 inhibitor, such as ipilimumab (Yervoy). The majority of the study designs included immunotherapy versus standard of care (SOC) and 6 trials included immunotherapy and SOC versus SOC alone.

No significant difference in treatment efficacy or overall survival between men and women were found, the researchers explained. “The study supports the use of immunotherapy for both men and women equally, when other was indicated,” Wallis said. “In contrast to prior hypothesis, it rejects the notion that women are less likely to benefit from immunotherapy.”

However, Wallis added that further exploration is needed based on the known differential autoimmune disease prevalence in women and men and in understanding how the immune system of men and women may respond to cancer and cancer therapies differently.

“There are many barriers to delivery of appropriate and efficacious health care,” Wallis said. “There was initially a suggestion that women may not benefit as much from immunotherapy as compared to men. Countering this message with data that women are likely to derive just as large a benefit should prevent any additional, gender-based barriers to immunotherapies which have proven, in many conditions, to be more effective than standard systemic therapies.”

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