BACKGROUND The treatment response to new immunotherapy in advanced melanoma patients remains varied between individuals. Immune-related cutaneous side effects might have prognostic value. OBJECTIVE To determine whether development of ≥1 of the 3 immune-mediated cutaneous events (eczema, lichenoid reaction, or vitiligo-like depigmentation) is associated with improved progression-free survival. METHODS A cohort study of adults with stage IIIC-IV melanoma treated with pembrolizumab or nivolumab during May 1, 2012-February 1, 2018, at Westmead Hospital, Sydney, Australia. Treatment response was based on iRECIST version 1.1. RESULTS In total, 82 patients of an average age of 59.9 years were included. Median follow-up was 40.7 months; 33 patients had ≥1 target skin reaction. Skin reactions developed in one-third of individuals by 6 months. At any given time, the instantaneous risk of disease progression and death was lower for individuals who had ≥1 cutaneous adverse event (CAE) develop. Compared with individuals with no CAE, the hazard ratio for disease progression and death for individuals who had ≥1 CAE develop was 0.46 (95% confidence interval 0.23-0.91; P = .025) by the time-dependent Cox proportional hazards model. LIMITATIONS Single-center study. CONCLUSION This study demonstrates an association between the development of ≥1 of 3 CAEs and improved progression-free survival in this cohort of patients.

中文翻译：

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接受程序性细胞死亡1抑制剂（有或没有免疫性皮肤不良事件）的个体的生存和预后。

背景技术晚期黑素瘤患者对新免疫疗法的治疗反应在个体之间仍然不同。免疫相关的皮肤副作用可能具有预后价值。目的要确定3种免疫介导的皮肤事件（湿疹，苔藓样反应或白癜风样色素沉着）中≥1的发展是否与无进展生存期改善有关。方法于2012年5月1日至2018年2月1日期间，在澳大利亚悉尼的韦斯特米德医院进行了一项用pembrolizumab或nivolumab治疗的IIIC-IV期黑色素瘤成人的队列研究。治疗反应基于iRECIST 1.1版。结果总共纳入了82例平均年龄为59.9岁的患者。中位随访时间为40.7个月；33例目标皮肤反应≥1。到6个月时，三分之一的人出现了皮肤反应。在任何给定时间，发生≥1皮肤不良事件（CAE）的个体发生疾病进展和死亡的瞬时风险较低。与没有CAE的个体相比，根据时间相关的Cox比例风险模型，CAE≥1的个体发生疾病进展和死亡的风险比为0.46（95％置信区间0.23-0.91； P = .025）。局限性单中心研究。结论这项研究证明了该组患者中3例CAE≥1的发展与无进展生存期的改善之间的相关性。时间相关的Cox比例风险模型得出46（95％置信区间0.23-0.91; P = .025）。局限性单中心研究。结论这项研究表明，在这组患者中，≥1的3种CAE的发生与改善的无进展生存率之间存在关联。时间相关的Cox比例风险模型得出46（95％置信区间0.23-0.91; P = .025）。局限性单中心研究。结论这项研究证明了该组患者中3例CAE≥1的发展与无进展生存期的改善之间的相关性。