文章：

III/IV期切除性黑色素瘤辅助靶向治疗与抗PD1药物的真实世界疗效分析

Real-Life Outcomes of Adjuvant Targeted Therapy and Anti-PD1 Agents in Stage III/IV Resected Melanoma

原文发布日期：6 September 2024

DOI: 10.3390/cancers16173095

类型: Article

开放获取: 是

英文摘要：

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%,p= 0.532), DMFS (58.2–59.8%,p= 0.761), and OS (62.4–69.5%,p= 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.

摘要翻译： 

本研究在意大利都灵大学皮肤科诊所开展，旨在评估接受靶向治疗（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）辅助治疗长达12个月患者的疗效与安全性。共纳入163例患者，其中147例为III期，19例为IV期无疾病证据者。主要研究终点包括无复发生存期（RFS）、无远处转移生存期（DMFS）和总生存期（OS）。在48个月随访时，TT与IT两种方案在RFS（55.6% vs 55.4%，p=0.532）、DMFS（58.2% vs 59.8%，p=0.761）及OS（62.4% vs 69.5%，p=0.889）方面均呈现相当疗效。虽然TT组患者治疗暂停率高于IT组，但两组因不良事件导致的治疗终止率相近。复发预测因素包括核分裂象、淋巴血管侵犯、溃疡形成及前哨淋巴结阳性。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。

原文链接：

Real-Life Outcomes of Adjuvant Targeted Therapy and Anti-PD1 Agents in Stage III/IV Resected Melanoma