Women with cancer are at substantially greater risk of severe adverse events with immunotherapy compared to men, a new study shows.
A review of adverse event data from 23,296 patients enrolled in 202 cancer clinical trials has shown that women have a 34% higher rate of adverse events than men for all systemic therapies and a 66% higher risk of severe symptomatic adverse events with immunotherapy.
The findings, published in the Journal of Clinical Oncology, showed that sex disparities in immunotherapy-related adverse events were greatest for haematological toxicity, gastrointestinal adverse events and symptomatic adverse effects such as sleep disruption.
Researchers at the Fred Hutchinson Cancer Research Center, Seattle, analysed adverse event data from 8,838 female and 14,458 male patients involved in clinical trials in which they received immunotherapy, targeted therapy and/or chemotherapy.
Overall, 65% of patients experienced one or more severe (grade 3 and above) adverse event, and women had a significantly higher risk than men of having a severe adverse events with any therapy ( 68.6% v 62.2%).
For immunotherapy, women had an almost 50% higher increased risk of a severe adverse event compared with men (odds ratio 1.49; P > .001). The discrepancy was greatest for severe symptomatic adverse events (33.7% vs 25.4%, OR 0.66), and was also significant for haematologic adverse events (22.1% vs 18.4%, OR 0.32). No statistically significant sex differences in risk of non-haematologic adverse events were found with immunotherapy.
For targeted therapy there was a significant 34% higher rate of severe adverse events for women than men (30.1% vs 24.6%).