Table 1.

Trial factors associated with sex disparities

Trial factor	No.	Mean DPF, % (95% CI)	P *
All included trials	147	−6.8 (−8.8 to −4.9)	<.001
Cooperative group trial
Yes	26	−1.1 (−4.6 to +2.4)	.001
No	121	−8.0 (−10.2 to −5.9)	—
Industry funding of trial
Yes	131	−7.1 (−9.2 to −5.0)	.18
No	16	−4.4 (−8.5 to −0.3)	—
Molecular profile restriction criterion†
Yes	16	+2.6 (−3.4 to +8.6)	.006
No	131	−8.0 (−9.9 to −6.0)	—
Disease site
Colorectal	39	−4.1 (−5.8 to −2.4)	.005
Lung	108	−7.8 (−10.3 to −5.3)	—
Modality
Systemic therapy	132	−7.2 (−9.2 to −5.2)	.75
Radiotherapy	4	−5.6 (−14.5 to +3.4)	—
Surgery	1	−4.8 (NA)	—
Supportive care	10	−3.2 (−13.3 to +6.9)	—
Systemic therapy subgroup‡
Cytotoxic chemotherapy	32	−8.0 (−11.8 to −4.2)	.69
Targeted therapy	100	−6.9 (−9.2 to −4.6)	—
Trial success (primary endpoint met)
Yes	60	−5.2 (−8.6 to −1.9)	.15
No	61	−8.5 (−11.2 to −5.9)	—

^*For all included trials (n = 147), the P value provided represents the results of a one-sample Wilcoxon signed rank test comparing the median DPF for all trials against a hypothetical population median DPF of 0%. All other P values provided reflect Mann-Whitney U tests or Kruskal-Wallis tests for each trial factor listed. CI = confidence interval; DPF = difference in proportion of female patients (trial minus population).

^†Molecular profile restriction trials were those that included an enrollment criterion that selected for female patients based on the molecular profile of patients’ tumors; this included trials specifically for patients with ALK-rearranged or EGFR-mutant nonsmall-cell lung cancer (both associated with higher proportions of female patients).

^‡Systemic therapy trials were divided into cytotoxic chemotherapy and targeted therapy; the latter included monoclonal antibodies, small molecule inhibitors, and similar.