Association of Sex, Age, and Eastern Cooperative Oncology Group Performance Status With Survival Benefit of Cancer Immunotherapy in Randomized Clinical Trials: A Systematic Review and Meta-analysis.

Importance Sex, age, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) may affect immune response. However, the association of these factors with the survival benefit of cancer immunotherapy with immune checkpoint inhibitors (ICIs) remains unclear. Objective To assess the potential sex, age, and ECOG PS differences of immunotherapy survival benefit in patients with advanced cancer. Data Sources PubMed, Web of Science, Embase, and Scopus were searched from inception to August 31, 2019. Study Selection Published randomized clinical trials comparing overall survival (OS) in patients with advanced cancer treated with ICI immunotherapy vs non-ICI control therapy were included. Data Extraction and Synthesis Pooled OS hazard ratio (HR) and 95% CI for patients of different sex, age ( Main Outcomes and Measures The difference in survival benefit of ICIs between sex, age ( Results Thirty-seven phase 2 or 3 randomized clinical trials involving 23 760 patients were included. An OS benefit of immunotherapy was found for both men (HR, 0.75; 95% CI, 0.71-0.81) and women (HR, 0.79; 95% CI, 0.72-0.88); for both younger ( Conclusions and Relevance This meta-analysis found no evidence of an association of sex, age (