Background/Objective: Dabrafenib and trametinib (D + T) have been approved for the treatment of stage III melanoma with BRAF V600E V600K mutations in an adjuvant setting, based on the results from the COMBI-AD trial. To provide early access to this combination therapy prior to its commercial availability in Italy, a Managed Access Program (MAP) was run in Italy from June 2018 to December 2019.Methods: The MADAM (Maximing ADjuvAnt MAP) study is an Italian retrospective–prospective observational study that included patients who received at least one dose of D + T through the MAP. The primary endpoints were relapse-free survival (RFS) and overall survival (OS).Results: This interim analysis presents findings after the first 24 months of follow-up. A total of 310 patients were included in the study; 240 completed the 12-month treatment with D + T, while 70 discontinued the combination. RFS rates were 93.2% at 12 months and 80.2% at 24 months. The median RFS was not reached for the overall population or any subgroups. Similarly, the median OS was not reached, with OS rates of 96.4% at 12 months and 92.5% at 24 months.Conclusions: D + T achieved an RFS benefit, with effects sustained beyond the treatment period, indicating positive outcomes in this patient population.
背景/目的：基于COMBI-AD试验结果，达拉非尼联合曲美替尼（D+T）方案已获批用于携带BRAF V600E/V600K突变的III期黑色素瘤辅助治疗。在意大利该联合疗法上市前，为提供早期用药途径，意大利于2018年6月至2019年12月期间实施了药物可及性计划（MAP）。 方法：MADAM研究是一项意大利回顾性-前瞻性观察研究，纳入通过MAP接受至少一剂D+T治疗的患者。主要终点为无复发生存期（RFS）和总生存期（OS）。 结果：本次中期分析呈现24个月随访结果。研究共纳入310例患者，其中240例完成12个月D+T治疗，70例中止联合治疗。12个月和24个月RFS率分别为93.2%和80.2%。总体人群及各亚组的中位RFS均未达到。中位OS同样未达到，12个月和24个月OS率分别为96.4%和92.5%。 结论：D+T方案在治疗期结束后仍能持续产生RFS获益，表明该方案在此患者群体中具有积极疗效。
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