临床试验的长期生存数据显示，接受免疫检查点抑制剂（ICIs）治疗的晚期黑色素瘤患者的生存曲线逐渐达到平台期，表明患者有机会实现长期生存。临床试验外接受 ICI 治疗的晚期黑色素瘤患者。队列研究使用从全国荷兰黑色素瘤治疗登记处前瞻性收集的数据，包括 2012 年至 2019 年荷兰接受一线 ICI 治疗的晚期黑色素瘤患者。数据分析时间为 1 月至2023 年 9 月。患者接受一线 ipilimumab-nivolumab、靶向程序性细胞死亡的抗体（抗 PD-1）或 ipilimumab 治疗。分析无进展生存期 (PFS) 和黑色素瘤特异性生存期，并使用 Cox 比例使用风险模型来调查达到部分缓解 (PR) 或完全缓解 (CR) 后与 PFS 相关的因素。总共纳入了 2490 名接受一线 ICI 治疗的患者（中位 [IQR] 年龄，65.0 [55.3-73.0]年; 1561 名男性患者 [62.7%]）。大多数患者的东部肿瘤合作组表现状态为 1 或更低（2202 名患者 [88.5%]），乳酸脱氢酶水平正常（1715 名患者 [68.9%]）。所有患者 3 年后的 PFS 为 23.4%（95% CI，21.7%-25.2%），5 年后为 19.7%（95% CI，18.0%-21.4%）。所有患者 3 年后总生存率为 44.0%（95% CI，42.1%-46.1%），5 年后总生存率为 35.9%（95% CI，33.9%-38.0%）。 3 个或更多器官部位发生转移的患者在达到 PR 或 CR 后进展风险显着更高（调整后风险比，1.37；95% CI，1.11-1.69）。这项队列研究针对临床上接受 ICI 治疗的晚期黑色素瘤患者实践表明，他们的生存达到了稳定水平，与参与临床试验的患者相当。这些发现可用于日常临床实践，以指导长期监测策略，并告知医生和患者有关长期治疗结果的信息。

Long-term survival data from clinical trials show that survival curves of patients with advanced melanoma treated with immune checkpoint inhibitors (ICIs) gradually reach a plateau, suggesting that patients have a chance of achieving long-term survival.To investigate long-term survival in patients with advanced melanoma treated with ICIs outside clinical trials.Cohort study using prospectively collected data from the nationwide Dutch Melanoma Treatment Registry, including patients in the Netherlands with advanced melanoma treated with first-line ICIs from 2012 to 2019. Data were analyzed from January to September 2023.Patients were treated with first-line ipilimumab-nivolumab, antibodies that target programmed cell death (anti-PD-1), or ipilimumab.Progression-free survival (PFS) and melanoma-specific survival were analyzed, and a Cox proportional hazards model was used to investigate factors associated with PFS after reaching partial response (PR) or complete response (CR).A total of 2490 patients treated with first-line ICIs were included (median [IQR] age, 65.0 [55.3-73.0] years; 1561 male patients [62.7%]). Most patients had an Eastern Cooperative Oncology Group Performance Status of 1 or lower (2202 patients [88.5%]) and normal lactate dehydrogenase levels (1715 patients [68.9%]). PFS for all patients was 23.4% (95% CI, 21.7%-25.2%) after 3 years and 19.7% (95% CI, 18.0%-21.4%) after 5 years. Overall survival for all patients was 44.0% (95% CI, 42.1%-46.1%) after 3 years and 35.9% (95% CI, 33.9%-38.0%) after 5 years. Patients with metastases in 3 or more organ sites had a significantly higher hazard of progression after reaching PR or CR (adjusted hazard ratio, 1.37; 95% CI, 1.11-1.69).This cohort study of patients with advanced melanoma treated with ICIs in clinical practice showed that their survival reached a plateau, comparable with patients participating in clinical trials. These findings can be used in daily clinical practice to guide long-term surveillance strategies and inform both physicians and patients regarding long-term treatment outcomes.