Clinical trials have demonstrated promising outcomes for adjuvant immunotherapy in patients with resected melanoma. Real-life data provide valuable insights to support patient guidance and treatment decisions. Observational population-based study examining a national cohort of patients with resected stage III-IV melanoma referred for adjuvant therapy. Data were extracted from the Danish Metastatic Melanoma Database (DAMMED). Between November 2018 and January 2022, 785 patients received adjuvant anti-PD-1. The majority had stage III resected melanoma (87%), normal LDH levels (80%), and performance score 0 (87%). Patients were followed for a median of 25.6 months (95%CI 24−28). The median recurrence-free survival (RFS) and melanoma-specific survival (MSS) were not reached. The RFS was 78% (95%CI 75−81), 66% (63−70), and 59% (55−63); MSS was 97% (95−98), 93% (91−95), and 87% (84−90) at 1-, 2-, and 3-year; respectively. Less than half (42%) of the patients finalized planned therapy, 32% discontinued due to toxicity, and 19% due to melanoma recurrence. Patients discontinuing adjuvant treatment prematurely, without recurrence, had similar outcomes as patients finalizing therapy. In a multivariable analysis, ipilimumab plus nivolumab did not improve outcomes compared to ipilimumab monotherapy as a first-line metastatic treatment after adjuvant anti-PD-1. Survival outcomes in real-world patients with melanoma treated with adjuvant anti-PD-1 align with results from the randomized controlled trials. Patients discontinuing therapy prematurely, for other reasons than recurrence, had similar outcomes as patients finalizing planned treatment. First-line metastatic treatment with ipilimumab and nivolumab post-adjuvant anti-PD-1 did not show improved outcomes compared to ipilimumab/anti-PD-1 monotherapy.

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现实世界全国黑色素瘤患者队列中辅助免疫治疗的结果

临床试验已证明辅助免疫治疗对黑色素瘤切除患者有良好的效果。现实生活中的数据提供了宝贵的见解，以支持患者指导和治疗决策。基于人群的观察性研究，检查了接受辅助治疗的已切除 III-IV 期黑色素瘤患者的全国队列。数据提取自丹麦转移性黑色素瘤数据库 (DAMMED)。 2018年11月至2022年1月期间，785名患者接受了抗PD-1辅助治疗。大多数人的黑色素瘤已切除 III 期（87%），LDH 水平正常（80%），表现评分为 0（87%）。患者的随访时间中位数为 25.6 个月 (95% CI 24−28)。中位无复发生存期（RFS）和黑色素瘤特异性生存期（MSS）尚未达到。 RFS 为 78% (95%CI 75−81)、66% (63−70) 和 59% (55−63)； 1 年、2 年和 3 年的 MSS 分别为 97% (95−98)、93% (91−95) 和 87% (84−90)；分别。不到一半 (42%) 的患者最终完成了计划治疗，32% 的患者因毒性而停止治疗，19% 的患者因黑色素瘤复发而停止治疗。过早停止辅助治疗而没有复发的患者与最终治疗的患者具有相似的结果。在多变量分析中，与伊匹单抗单药治疗相比，伊匹单抗加纳武单抗作为辅助抗 PD-1 后的一线转移治疗并没有改善结局。现实世界中接受抗 PD-1 辅助治疗的黑色素瘤患者的生存结果与随机对照试验的结果一致。由于复发以外的其他原因而提前停止治疗的患者与最终完成计划治疗的患者具有相似的结果。与伊匹单抗/抗 PD-1 单一疗法相比，伊匹单抗和纳武单抗辅助抗 PD-1 一线转移治疗并未显示出改善的结果。