Background: Anti-PD-1-based immunotherapy has improved outcomes in stage IIB to IV resected melanoma patients in clinical trials. However, little is known about real-world outcomes, prognostic factors and patterns of relapse. Methods: This is a retrospective multicenter observational study including patients with resected melanoma treated with subsequent anti-PD-1-based adjuvant immunotherapy. Data on clinical and demographic characteristics, delivered treatment, prognostic factors, time and pattern of relapse were collected. Results: We included 245 patients from eight centers; 4% of patients were at stage IIB-C, 80% at stage IIIA-D and 16% at stage IV. Recurrence-free survival (RFS) rates at 18 and 36 months were 60% and 48%, respectively, with a median RFS of 33.7 months. Prognostic factors associated with recurrence were melanoma primary site (HR 2.64, 95% CI 1.15–6.01) and starting adjuvant therapy more than 12 weeks after the last resection (HR 1.68, 95% CI 1.13–2.5); presence of serious immune-related adverse events was associated with better RFS (HR 0.4, 95% CI 0.19–0.87). Early relapses accounted for 63% of the total recurrences, with a higher number of metastatic sites (18%); in contrast, late relapses presented more frequently with brain metastases (20%). Conclusions: In our patients with resected melanoma who underwent anti-PD-1-based adjuvant immunotherapy, survival outcomes were worse than those reported in clinical trials. Primary melanoma site and time interval between the last resection and the start of adjuvant therapy were associated with survival.
背景：在临床试验中，基于抗PD-1的免疫疗法改善了IIB至IV期已切除黑色素瘤患者的预后。然而，关于真实世界中的治疗效果、预后因素及复发模式的信息尚不充分。方法：本研究是一项回顾性多中心观察性研究，纳入了接受基于抗PD-1辅助免疫治疗的已切除黑色素瘤患者。收集了患者的临床与人口学特征、治疗方案、预后因素、复发时间及复发模式等数据。结果：研究共纳入来自八个中心的245例患者；其中4%为IIB-C期，80%为IIIA-D期，16%为IV期。18个月和36个月的无复发生存率分别为60%和48%，中位无复发生存期为33.7个月。与复发相关的预后因素包括黑色素瘤原发部位（HR 2.64，95% CI 1.15–6.01）以及末次切除后超过12周才开始辅助治疗（HR 1.68，95% CI 1.13–2.5）；而出现严重免疫相关不良事件与更好的无复发生存相关（HR 0.4，95% CI 0.19–0.87）。早期复发占总复发数的63%，且转移部位数量较多（18%）；相比之下，晚期复发更常表现为脑转移（20%）。结论：在接受基于抗PD-1辅助免疫治疗的已切除黑色素瘤患者中，生存结局较临床试验报告的结果更差。黑色素瘤原发部位以及末次切除至开始辅助治疗的时间间隔与生存相关。
肿瘤(癌症)患者之家