Abstract:

Background and purpose: Melanoma is the most lethal cutaneous malignant tumor. Patients with resected stage Ⅲ melanomas have a high risk of recurrence after surgery. This study retrospectively analyzed the efficacy and safety of dabrafenib combined with trametinib in the adjuvant setting for stage Ⅲ melanoma patients with BRAF mutation in China. Methods: A retrospective analysis was performed on 24 patients with stage Ⅲ cutaneous and acral malignant melanoma who received adjuvant treatment with trametinib and dabrafenib in Zhejiang Cancer Hospital from August 2019 to April 2022. Results: Of the 24 patients, 7 were stage Ⅲ B, 11 were stage Ⅲ C, 3 were stage Ⅲ D, and 3 were stage Ⅲ (the specific stage was unknown). As of October 1, 2022, 12 patients (50.0%) had completed the protocol for one year. Of the 24 patients, 5 (20.8%) patients relapsed. The The 1-year recurrence-free survival (RFS) rate was 76.2% (95% CI: 65.2%-87.2%). In the cutaneous melanoma subgroup, the 1-year RFS rate was 81.6% (95% CI: 71.6%-91.6%). Two patients relapsed during adjuvant therapy, and three patients relapsed after completing the protocol. Twenty patients (83.3%) reported at least one adverse event, of which 7 patients (29.2%) had grade 3 or grade 4 serious adverse reactions. The most common adverse reactions were fever, fatigue and nausea. Panniculitis occurred in 4 patients, mainly involving thighs and upper limbs. One patient (4.2%) permanently stopped taking the drug due to adverse events, the dose was adjusted in 2 patients (8.3%) due to adverse events, and drug treatment was interrupted in 7 patients (29.2%) due to adverse events. Conclusion: This study confirmed the short-term benefit and good tolerance of the adjuvant therapy with dabrafenib combined with trametinib in Chinese patients with stage Ⅲ melanoma with BRAF^V600 mutation.

Key words: Malignant melanoma, Adjuvant therapy, Targeted therapy, Effectiveness, Safety