Scientific Department, Dutch Institute for Clinical Auditing, Leiden, The Netherlands.
Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Int J Cancer. 2022 Jan 15;150(2):317-326. doi: 10.1002/ijc.33800. Epub 2021 Oct 2.
There is no consensus on the optimal treatment duration of anti-PD-1 for advanced melanoma. The aim of our study was to gain insight into the outcomes of anti-PD-1 discontinuation, the association of treatment duration with progression and anti-PD-1 re-treatment in relapsing patients. Analyses were performed on advanced melanoma patients in the Netherlands who discontinued first-line anti-PD-1 monotherapy in the absence of progressive disease (n = 324). Survival was estimated after anti-PD-1 discontinuation and with a Cox model the association of treatment duration with progression was assessed. At the time of anti-PD-1 discontinuation, 90 (28%) patients had a complete response (CR), 190 (59%) a partial response (PR) and 44 (14%) stable disease (SD). Median treatment duration for patients with CR, PR and SD was 11.2, 11.5 and 7.2 months, respectively. The 24-month progression-free survival and overall survival probabilities for patients with a CR, PR and SD were, respectively, 64% and 88%, 53% and 82%, 31% and 64%. Survival outcomes of patients with a PR and CR were similar when anti-PD-1 discontinuation was not due to adverse events. Having a PR at anti-PD-1 discontinuation and longer time to first response were associated with progression [hazard ratio (HR) = 1.81 (95% confidence interval, CI = 1.11-2.97) and HR = 1.10 (95% CI = 1.02-1.19; per month increase)]. In 17 of the 27 anti-PD-1 re-treated patients (63%), a response was observed. Advanced melanoma patients can have durable remissions after (elective) anti-PD-1 discontinuation.
抗 PD-1 治疗晚期黑色素瘤的最佳疗程尚未达成共识。本研究旨在深入了解抗 PD-1 停药后的结果、治疗持续时间与复发患者进展的关系，以及抗 PD-1 再治疗。对荷兰无进展性疾病（n=324）停止一线抗 PD-1 单药治疗的晚期黑色素瘤患者进行了分析。在抗 PD-1 停药后估计生存情况，并使用 Cox 模型评估治疗持续时间与进展的关系。在抗 PD-1 停药时，90 例（28%）患者达到完全缓解（CR），190 例（59%）达到部分缓解（PR），44 例（14%）为稳定疾病（SD）。CR、PR 和 SD 患者的中位治疗持续时间分别为 11.2、11.5 和 7.2 个月。CR、PR 和 SD 患者的 24 个月无进展生存率和总生存率分别为 64%和 88%、53%和 82%、31%和 64%。抗 PD-1 停药不是由于不良反应的情况下，PR 和 CR 患者的生存结果相似。抗 PD-1 停药时达到 PR 和更长的首次反应时间与进展相关[风险比（HR）=1.81（95%置信区间，CI=1.11-2.97）和 HR=1.10（95%CI=1.02-1.19；每月增加）]。在 27 例抗 PD-1 再治疗患者中的 17 例（63%）观察到了反应。晚期黑色素瘤患者在（选择性）抗 PD-1 停药后可以有持久的缓解。
