目前对于使用抗PD-1治疗患有黑色素瘤的患者在5年之后的长期疗效了解甚少，尤其是那些不在临床试验中接受治疗的患者。本回顾性队列研究选取了2014年至2017年期间在Memorial Sloan Kettering癌症中心接受抗PD-1治疗的无法切除的III/IV期非视网膜型黑色素瘤患者，并至少在首个抗PD-1剂使用5年后存活了5年以上的患者（N=139）。我们对包括总体生存率（OS）、黑色素瘤特异性生存率（MSS）估计、治疗期间无需治疗幸存率和随后的治疗方案进行了表征。在5年以上幸存者（N=125）中，中位随访时间为78.4个月（范围为60.0-96.3个月）。第7年（5年里程碑后2年）的OS为90.1%（95% CI：83.0%-94.3%）。共发生14例死亡事件，其中7例由于黑色素瘤。第7年（5年里程碑后2年）的MSS为95.0%（95% CI：33.5%-95.2%）。在5年里无需随后治疗而完成抗PD-1基础治疗的患者中（N=80），不需要额外治疗的概率为95.7%（95% CI：91.0%-100%）。对于那些接受非临床试验抗PD-1治疗并且能够在初始抗PD-1治疗后至少存活5年的患者（尤其是在前5年中无需进行额外黑色素瘤治疗的患者），可以放心其长期治疗效果良好。© 2023 John Wiley＆Sons A / S。 由John Wiley＆Sons Ltd发表。

Little is known about the long-term outcomes of anti-PD-1 treated patients with melanoma beyond 5 years, especially for patients treated off clinical trials. This retrospective cohort study includes patients with unresectable stage III/IV nonuveal melanoma treated with anti-PD-1 off-trial at Memorial Sloan Kettering Cancer Center between 2014 and 2017 who survived at least 5 years following their first anti-PD-1 dose (N = 139). We characterized overall survival (OS), melanoma-specific survival (MSS) estimates, treatment-free survival rates, and subsequent treatment courses. Median follow-up among 5-plus year survivors (N = 125) was 78.4 months (range 60.0-96.3). OS at year 7 (2 years post 5-year landmark) was 90.1% (95% CI: 83.0%-94.3%). Fourteen deaths occurred, seven due to melanoma. MSS at year 7 (2 years post 5-year landmark) was 95.0% (95% CI: 33.5%-95.2%). In patients who completed anti-PD-1 based therapy and did not require subsequent treatment by 5 years (N = 80), the probability of not requiring additional treatment for an additional 2 years was 95.7% (95% CI: 91.0%-100%). Patients treated with anti-PD-1 regimens off clinical trials who survive at least 5 years from initial anti-PD-1 treatment can be reassured of their excellent long-term prognosis, particularly if they did not require additional melanoma treatment during the first 5 years.© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.