Oncology

Women remain underrepresented in lung cancer RCTs and underrepresentation correlates with AE reporting differences.

Meta-analysis of 636 lung cancer RCTs (265,989 participants) found pooled enrolment incidence disparity of -3.17%, indicating female underrepresentation. Underrepresentation was greatest in very high HDI settings and across younger and predominantly Caucasian subgroups. Trial-level differences in female enrolment were associated with differences in reported adverse event incidence. These findings underscore the need for inclusive recruitment and routine sex-disaggregated safety reporting in lung cancer trials. 1

Breast cancer patients balance faster approvals against evidentiary certainty, prioritizing survival and quality of life.

Qualitative interviews with 30 women with breast cancer explored acceptability of faster FDA approvals versus evidentiary certainty. Faster approval was most acceptable when no alternatives existed or benefits were perceived as transformative. When benefits were uncertain, participants prioritized survival and quality of life and worried about toxicity and treatment burden. Many favored broader trial access over accelerated approval to both meet needs and generate stronger evidence. 2

Antibiotics associated with worse OS and PFS in NSCLC patients on ICIs, but RCT evidence is non-significant.

Meta-analysis of 41 studies (54,250 patients; 27.8% antibiotic-exposed) found worse OS (HR 1.47) and PFS (HR 1.32) with antibiotic exposure. No clear association was seen for objective response rate (OR 0.95). Post-hoc RCT estimates were non-significant and observational estimates were larger and less adjusted. Authors conclude the observational signal likely reflects confounding and exposure heterogeneity rather than a uniform pharmacological interaction. 3