Survival outcomes of adjuvant therapy in resected stage III melanoma: results from a real-life cohort study (TAMARIS)
Menée en France à partir de données de vie réelle portant sur 1 016 patients atteints d'un mélanome de stade III ayant été réséqué (âge médian : 60 ans ; durée médiane de suivi : 29,6 mois), cette étude de cohorte rétrospective évalue l'efficacité, du point de vue de la survie globale, de traitements adjuvants (anti-PD-1 ou inhibiteurs de BRAF/MEK)
Background: The approval of adjuvant treatment with anti-PD-1 antibodies (anti-PD-1) and BRAF and MEK inhibitors (BRAFi/MEKi) for resected stage III/IV melanoma was based on randomized controlled trials demonstrating a benefit in recurrence-free survival (RFS). However, none showed a significant impact on overall survival (OS). We aimed to evaluate the OS impact of adjuvant therapies in real-world settings.
Methods: TAMARIS is a national multicenter retrospective study evaluating the efficacy of anti-PD-1 and BRAFi/MEKi for resected stage III melanoma in a French real-life prospective database (RIC-Mel). Patients with resectable stage III melanoma (AJCC 8th edition), who underwent complete surgical resection between 2018 and 2023 were included. OS in patients who received an adjuvant treatment (adjuvant group) was compared to those who did not receive systemic therapies (control group). Associations between the adjuvant strategy (adjuvant treatment versus observation) and OS were evaluated using a Cox regression model and inverse of probability of treatment weighting (IPTW) methodology in order to limit potential biases. Subgroup analyses by baseline characteristics and treatment regimens were also conducted.
Results: Among the 1016 patients (median age: 60 years) included, 701 (69%) received adjuvant therapies with either anti-PD-1 (n=588) or BRAFi/MEKi (n=113). The median treatment duration was 10.9 months, and the median follow-up was 29.6 months. OS was significantly higher in the adjuvant group compared to the control group (HR: 0.62, [IC95%, 0.47-0.80], P = 0.003) confirmed in multivariate analysis and after IPTW-adjustment (HR: 0.68, [IC95%, 0.49-0.94], P = 0.020). In subgroup analyses, adjuvant treatment had a significant positive impact on OS across most subgroups, but not for stage IIIA.
Conclusion: These real-world data indicate a significant OS benefit of adjuvant therapy in AJCC 8th stage III melanoma, but not in stage IIIA.
European Journal of Cancer , résumé, 2026