Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409). Efficacy was assessed in all randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233). Safety was assessed in treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231). Results At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs ( P = .97). Median overall survival had not been reached in either group ( P = .23). The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. The vast majority of grade 3 or 4 AEs occurred during the induction phase, with most resolving after appropriate management. Conclusion Efficacy outcomes seemed similar between patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction phase and those who did not discontinue because of AEs. Therefore, even after discontinuation, many patients may continue to derive benefit from combination therapy.

中文翻译：

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因不良事件而停止纳武单抗和易普利姆玛治疗的晚期黑色素瘤患者的疗效和安全性结果：随机 II 期和 III 期试验的汇总分析


目的 在临床试验中接受纳武单抗联合伊匹单抗治疗的晚期黑色素瘤患者中，约 40% 因不良事件 (AE) 停止治疗。我们进行了一项回顾性分析，以评估纳武单抗加伊匹单抗对因 AE 停止治疗的患者的疗效和安全性。方法 汇总 II 期和 III 期试验的数据，这些患者每 3 周接受 1 mg/kg 纳武单抗加 3 mg/kg 伊匹单抗治疗，共 4 剂，随后每 2 周接受 3 mg/kg 纳武单抗单药治疗 (N = 409)。对所有随机分配的诱导期因 AE 停药的患者 (n = 96) 和因 AE 未停药的患者 (n = 233) 进行了疗效评估。对因 AE 随时停药的患者 (n = 176) 和因 AE 未停药的患者 (n = 231) 进行安全性评估。结果 在最短 18 个月的随访中，在诱导阶段因 AE 停止治疗的患者的中位无进展生存期为 8.4 个月，而因 AE 未停止治疗的患者的中位无进展生存期为 10.8 个月 ( P = .97)。两组均未达到中位总生存期 (P = .23)。在诱导阶段因 AE 停药的患者的客观缓解率为 58.3%，未停药的患者的客观缓解率为 50.2%。绝大多数 3 级或 4 级 AE 发生在诱导阶段，大多数在适当的管理后得到解决。结论 在诱导期因 AE 停止纳武单抗加伊匹单抗治疗的患者与因 AE 未停止治疗的患者的疗效结果似乎相似。 因此，即使停药后，许多患者仍可能继续从联合治疗中获益。