Consoli Francesca, Tucci Marco, Pigozzo Jacopo, Simeone Ester, Spagnolo Francesco, Troiani Teresa, Morgese Francesca, Del Vecchio Michele, Melotti Barbara, Tronconi Maria Chiara, Morelli Maria Francesca, Grosso Federica, Merelli Barbara, Marcon Ilaria, Valsecchi Diletta, Quaglino Pietro
Medical Oncology, ASST Spedali Civili, 25123 Brescia, Italy.
Medical Oncology Unit, University of Bari Aldo Moro, Policlinico Hospital of Bari, 70124 Bari, Italy.
Cancers (Basel). 2024 Dec 5;16(23):4072. doi: 10.3390/cancers16234072.
: 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. : 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). : 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. : D + T achieved an RFS benefit, with effects sustained beyond the treatment period, indicating positive outcomes in this patient population.
基于COMBI-AD试验的结果，达拉非尼和曲美替尼（D+T）已被批准用于辅助治疗伴有BRAF V600E或V600K突变的III期黑色素瘤。为了在该联合疗法于意大利上市之前让患者能够尽早使用，2018年6月至2019年12月在意大利开展了一项管理式准入项目（MAP）。MADAM（最大化辅助MAP）研究是一项意大利的回顾性-前瞻性观察性研究，纳入了通过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）。这项中期分析展示了随访24个月后的结果。共有310例患者纳入研究；240例完成了12个月的D+T治疗，70例停止了联合治疗。12个月时RFS率为93.2%，24个月时为80.2%。总体人群或任何亚组均未达到中位RFS。同样，未达到中位OS，12个月时OS率为96.4%，24个月时为92.5%。D+T实现了RFS获益，其效果在治疗期后仍持续存在，表明该患者群体有积极的预后。
