Patients with resected stage IIIB, IIIC and IIID melanomas have a high risk of recurrence. Therefore, an appropriate protocol for stage III melanoma is needed. Since adjuvant dabrafenib plus trametinib (D+T) combined therapy and anti-PD1 antibody (Ab) therapy reduce the risk of recurrence in patients with resected stage III BRAF-mutated melanoma, selecting the adjuvant therapy for BRAF-mutated melanoma is controversial. The efficacy and safety profiles of D+T combined therapy in the adjuvant setting were retrospectively analyzed in 36 Japanese. BRAF-mutated advanced melanoma patients. The relapse-free rate (RFR) at 12 months was 82.1% (95% confidential interval (CI), 63.9-92.6%). In the 21 patients who completed the protocol, the RFR at 12 months was 85.7% (95% CI, 64.5-95.9%). In the seven patients whose protocol was interrupted by adverse events, the RFR was 71.4% (95% CI, 35.2-92.4%). The incidence rate of any AEs for all patients was 69.7% (95% CI, 52.5-82.8%), including 13 cases of pyrexia, five cases of skin rash and four cases of liver dysfunction. The present study suggested that D+T therapy in the adjuvant setting is a useful and very tolerable protocol for BRAF-mutated melanoma in the Japanese population.

中文翻译：

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达拉非尼联合曲美替尼辅助治疗日本晚期黑色素瘤患者的回顾性分析：36例分析。

切除 IIIB、IIIC 和 IIID 期黑色素瘤的患者复发风险很高。因此，需要针对 III 期黑色素瘤制定适当的方案。由于辅助达拉非尼联合曲美替尼（D+T）联合治疗和抗PD1抗体（Ab）治疗可降低III期BRAF突变黑色素瘤切除患者的复发风险，因此选择BRAF突变黑色素瘤的辅助治疗存在争议。在 36 名日本人中回顾性分析了辅助治疗中 D+T 联合治疗的疗效和安全性。BRAF 突变的晚期黑色素瘤患者。12 个月时的无复发率 (RFR) 为 82.1%（95% 可信区间 (CI)，63.9-92.6%）。在完成方案的 21 名患者中，12 个月时的 RFR 为 85.7%（95% CI，64.5-95.9%）。在七名因不良事件而中断方案的患者中，RFR 为 71.4%（95% CI，35.2-92.4%）。所有患者的任何AE发生率为69.7%（95% CI，52.5-82.8%），其中发热13例，皮疹5例，肝功能障碍4例。目前的研究表明，辅助治疗中的 D+T 治疗对于日本人群中的 BRAF 突变黑色素瘤是一种有用且耐受性良好的方案。