Are patient factors associated with real-world antibody-drug conjugate outcomes in gynecologic cancers?

OBJECTIVES

Disparities in clinical trial enrollment raise concerns about the generalizability of antibody-drug conjugate (ADC) efficacy in gynecologic cancers. We evaluated real-world survival outcomes across demographic subgroups and assessed concordance with pivotal trials, while contextualizing findings within ongoing challenges of underrepresentation.

METHODS

We conducted a cohort study of patients with advanced gynecologic cancers treated with ADCs at a tertiary academic center (June 2019-September 2025). Primary outcomes were overall survival (OS) and progression-free survival (PFS) by age, race, and ethnicity. Secondary objectives examined ECOG performance status, line of therapy, and Area Deprivation Index. Exploratory analyses assessed treatment discontinuation secondary to toxicity. Survival was estimated using Kaplan-Meier methods with univariable and multivariable models.

RESULTS

Among 142 patients,105 received mirvetuximab soravtansine (MIRV), 34 trastuzumab deruxtecan (T-DXd), and 16 tisotumab vedotin (TV). Median age was 64.8 years; 66.9% identified as White, 12.7% Asian, 6.3% Black/African American, and 14.1% Other. Most patients were non-Hispanic/Latina (88.7%), while 11.3% identified as Hispanic/Latina. In unadjusted analyses, PFS varied by treatment line in the MIRV cohort (p = 0.04), while OS differed by ethnicity and performance status (p < 0.01). Performance status was also associated with OS in the T-DXd cohort (p = 0.01). These associations were not significant in multivariable models. Treatment discontinuation due to toxicity occurred in 17.6% and did not differ by subgroup.

CONCLUSIONS

Real-world ADC outcomes were consistent with pivotal trials, with no independent survival differences by subgroup after adjustment. These findings support continued investigation of clinical and structural factors influencing outcomes.