ESMO open · 2026
Sex-based differences in tolerability of developmental antibody-drug conjugates (ADCs) in non-small-cell lung cancer (NSCLC).
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Parisi C, Banini M, Mantuano F, Aldea M, Abdayem P, Derosa L, Frelaut M, Lavaud P, Robert A, Simon S, Gazzah A, Hollebecque A, Massard C, Besse B, Remon J, Wagner A, Pistilli B, Vaz-Luis I, Planchard D, Barlesi F
Аннотация
BACKGROUND: Sex-based differences in treatment-related adverse events (TRAEs) have been described across several anticancer therapies. However, sex-disaggregated safety data for antibody-drug conjugates (ADCs) in non-small-cell lung cancer (NSCLC) is lacking.
PATIENTS AND METHODS: We conducted a monocentric cohort study including patients with advanced NSCLC treated with developmental ADCs within phase I-II clinical trials at Gustave Roussy (2018-2023). Clinically significant TRAEs (grade ≥2, Common Terminology Criteria for Adverse Events version 5.0), dose modifications, hospitalisations, and survival outcomes were analysed according to sex using univariate and multivariate analysis.
RESULTS: Our population included 132 patients [women, 64 (48.5%); men, 68 (51.5%)] receiving ADCs targeting TROP2 (32.6%), ITGB6 (31.8%), HER2 (13.6%), CEACAM5 (13.6%), HER3 (5.4%), c-MET (2.3%), and Nectin-4 (0.7%). Overall, 100 (76%) and 39 (29%) patients experienced grade ≥2 and grade ≥3 TRAEs, respectively. Women had a higher incidence of grade ≥2 TRAEs than men [82.8% versus 69.1%; adjusted odds ratio (OR) 2.8, 95% confidence interval (CI) 1.03-7.84, P = 0.04)] and a higher median number of TRAEs (2 versus 1, P = 0.04). Metabolic TRAEs (anorexia, weight loss, ion and lipid imbalances) were significantly more frequent in women (29.7% versus 10.3%; OR 3.68, 95% CI 1.42-9.49, P = 0.009), as were dose reductions (37.5% versus 19.1%; OR 3.35, 95% CI 1.24-9.01, P = 0.02).
CONCLUSIONS: Women treated with developmental ADCs for advanced NSCLC experience a higher burden of clinically relevant TRAEs. Our data suggest that sex may represent a key variable to integrate into safety reporting and monitoring strategies for developmental ADCs in NSCLC.
PATIENTS AND METHODS: We conducted a monocentric cohort study including patients with advanced NSCLC treated with developmental ADCs within phase I-II clinical trials at Gustave Roussy (2018-2023). Clinically significant TRAEs (grade ≥2, Common Terminology Criteria for Adverse Events version 5.0), dose modifications, hospitalisations, and survival outcomes were analysed according to sex using univariate and multivariate analysis.
RESULTS: Our population included 132 patients [women, 64 (48.5%); men, 68 (51.5%)] receiving ADCs targeting TROP2 (32.6%), ITGB6 (31.8%), HER2 (13.6%), CEACAM5 (13.6%), HER3 (5.4%), c-MET (2.3%), and Nectin-4 (0.7%). Overall, 100 (76%) and 39 (29%) patients experienced grade ≥2 and grade ≥3 TRAEs, respectively. Women had a higher incidence of grade ≥2 TRAEs than men [82.8% versus 69.1%; adjusted odds ratio (OR) 2.8, 95% confidence interval (CI) 1.03-7.84, P = 0.04)] and a higher median number of TRAEs (2 versus 1, P = 0.04). Metabolic TRAEs (anorexia, weight loss, ion and lipid imbalances) were significantly more frequent in women (29.7% versus 10.3%; OR 3.68, 95% CI 1.42-9.49, P = 0.009), as were dose reductions (37.5% versus 19.1%; OR 3.35, 95% CI 1.24-9.01, P = 0.02).
CONCLUSIONS: Women treated with developmental ADCs for advanced NSCLC experience a higher burden of clinically relevant TRAEs. Our data suggest that sex may represent a key variable to integrate into safety reporting and monitoring strategies for developmental ADCs in NSCLC.