Roccuzzo Gabriele, Fava Paolo, Astrua Chiara, Brizio Matteo Giovanni, Cavaliere Giovanni, Bongiovanni Eleonora, Santaniello Umberto, Carpentieri Giulia, Cangiolosi Luca, Brondino Camilla, Pala Valentina, Ribero Simone, Quaglino Pietro
Section of Dermatology, Department of Medical Sciences, University of Turin, 10126 Turin, Torino, Italy.
Cancers (Basel). 2024 Sep 6;16(17):3095. doi: 10.3390/cancers16173095.
This study was carried out at the Dermatologic Clinic of the University of Turin, Italy, to assess the effectiveness and safety of adjuvant therapy in patients who received either targeted therapy (TT: dabrafenib + trametinib) or immunotherapy (IT: nivolumab or pembrolizumab) for up to 12 months. A total of 163 patients participated, including 147 with stage III and 19 with stage IV with no evidence of disease. The primary outcomes were relapse-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS). At 48 months, both TT and IT approaches yielded comparable outcomes in terms of RFS (55.6-55.4%, = 0.532), DMFS (58.2-59.8%, = 0.761), and OS (62.4-69.5%, = 0.889). Whilst temporary therapy suspension was more common among TT-treated patients compared to IT-treated individuals, therapy discontinuation due to adverse events occurred at comparable rates in both groups. Predictors of relapse included mitoses, lymphovascular invasion, ulceration, and positive sentinel lymph nodes. Overall, the proportion of BRAF-mutated patients receiving IT stood at 7.4%, lower than what was observed in clinical trials.
本研究在意大利都灵大学皮肤科诊所开展,旨在评估辅助治疗对接受靶向治疗(TT:达拉非尼+曲美替尼)或免疫治疗(IT:纳武利尤单抗或帕博利珠单抗)长达12个月的患者的有效性和安全性。共有163例患者参与,其中147例为III期患者,19例为IV期且无疾病证据的患者。主要结局为无复发生存期(RFS)、无远处转移生存期(DMFS)和总生存期(OS)。在48个月时,TT和IT方法在RFS(55.6 - 55.4%,P = 0.532)、DMFS(58.2 - 59.8%,P = 0.761)和OS(62.4 - 69.5%,P = 0.889)方面产生了相当的结果。虽然与接受IT治疗的患者相比,接受TT治疗的患者中临时治疗中断更为常见,但两组因不良事件导致的治疗中断发生率相当。复发的预测因素包括有丝分裂、淋巴管浸润、溃疡和前哨淋巴结阳性。总体而言,接受IT治疗的BRAF突变患者比例为7.4%,低于临床试验中的观察值。