文章：

抗PD1免疫检查点抑制剂或BRAF/MEK靶向疗法在黑色素瘤辅助治疗中的现代策略：多中心真实世界研究报告

Modern Approach to Melanoma Adjuvant Treatment with Anti-PD1 Immune Check Point Inhibitors orBRAF/MEKTargeted Therapy: Multicenter Real-World Report

原文发布日期：1 September 2023

DOI: 10.3390/cancers15174384

类型: Article

开放获取: 是

英文摘要：

Background: The landscape of melanoma management changed as randomized trials have launched adjuvant treatment. Materials and Methods: An analysis of data on 248 consecutive melanoma stage III and IV patients given adjuvant therapy in eight centers (February 2019 to January 2021) was conducted. Results: The analyzed cohort comprised 147 melanoma patients given anti-PD1 (33% nivolumab, 26% pembrolizumab), and 101 (41%) were given dabrafenib plus trametinib (DT). The 2-year overall survival (OS), relapse-free survival (RFS), and distant-metastases-free survival (DMFS) rates were 86.7%, 61.4%, and 70.2%, respectively. The disease stage affected only the RFS rate; for stage IV, it was 52.2% (95% CI: 33.4–81.5%) vs. 62.5% (95% CI: 52.3–74.8%) for IIIA-D,p= 0.0033. The type of lymph node surgery before adjuvant therapy did not influence the outcomes. Completion of lymph node dissection cessation after positive SLNB did not affect the results in terms of RFS or OS. Treatment-related adverse events (TRAE) were associated with longer 24-month RFS, with a rate of 68.7% (55.5–84.9%) for TRAE vs. 56.6% (45.8–70%) without TRAE,p= 0.0031. For TRAE of grade ≥ 3, a significant decline in OS to 60.6% (26.9–100%;p= 0.004) was observed. Conclusions: Melanoma adjuvant therapy with anti-PD1 or DT outside clinical trials appears to be effective and comparable with the results of registration studies. Our data support a de-escalating surgery approach in melanoma treatment.

摘要翻译： 

背景：随着随机试验启动辅助治疗，黑色素瘤的治疗格局已发生改变。材料与方法：本研究对八家中心在2019年2月至2021年1月期间连续接受辅助治疗的248例III期和IV期黑色素瘤患者数据进行分析。结果：分析队列包括147例接受抗PD-1治疗的患者（33%使用纳武利尤单抗，26%使用帕博利珠单抗），101例（41%）接受达拉非尼联合曲美替尼（DT）治疗。两年总生存率（OS）、无复发生存率（RFS）和无远处转移生存率（DMFS）分别为86.7%、61.4%和70.2%。疾病分期仅影响RFS：IV期患者为52.2%（95% CI：33.4–81.5%），而IIIA-D期患者为62.5%（95% CI：52.3–74.8%），p=0.0033。辅助治疗前的淋巴结手术类型不影响治疗结果。前哨淋巴结活检阳性后是否完成淋巴结清扫术，对RFS或OS结果均无影响。治疗相关不良事件（TRAE）与更长的24个月RFS相关：发生TRAE的患者RFS为68.7%（55.5–84.9%），未发生TRAE的患者为56.6%（45.8–70%），p=0.0031。对于≥3级的TRAE，观察到OS显著下降至60.6%（26.9–100%；p=0.004）。结论：临床试验外的抗PD-1或DT黑色素瘤辅助治疗似乎有效，且与注册研究结果相当。我们的数据支持在黑色素瘤治疗中采用降阶梯手术策略。

原文链接：

Modern Approach to Melanoma Adjuvant Treatment with Anti-PD1 Immune Check Point Inhibitors orBRAF/MEKTargeted Therapy: Multicenter Real-World Report