Is one year enough? Extended adjuvant dabrafenib plus trametinib for Chinese patients with resected stage III melanoma.

Abstract

e21587 Background: Pathogenic BRAF mutations occur in approximately 60% of melanomas, prompting the use of dabrafenib plus trametinib (BRAF/MEK inhibitors) as an effective adjuvant regimen. However, the optimal duration of adjuvant therapy in stage III melanoma remains uncertain, with many centers traditionally adopting a 12-month course. Methods: This retrospective, registry-based study involved Chinese patients with resected stage III melanoma harboring BRAF V600E/K mutations across six institutions between August 2019 and September 2024. Patients received either 1-year or extended (> 1 year) adjuvant dabrafenib plus trametinib. The primary endpoint was relapse-free survival (RFS). Results: Among 122 enrolled patients (45 in the 1-year group and 77 in the > 1-year group), those receiving extended therapy demonstrated a significantly improved RFS (log-rank p = 0.04). In multivariate analysis, treatment beyond one year was independently associated with a lower risk of recurrence (hazard ratio, 2.42; p = 0.035). Notably, toxicity profiles were comparable between the two groups, with no increase in adverse events related to longer treatment duration. Conclusions: Prolonging adjuvant dabrafenib plus trametinib beyond one year in Chinese patients with resected stage III melanoma appears feasible, offering potentially enhanced RFS without additional toxicity. These findings warrant further prospective evaluation to refine clinical guidelines.