Changes in the dosing schedules for immune checkpoint inhibitors, specifically nivolumab and pembrolizumab, in the treatment of metastatic melanoma, were introduced based on pharmacokinetic data and analysis of pre-existing clinical trial data in the absence of new clinical trials. Therefore, we sought to provide real-world data examining whether fixed-dose therapy (FDT) or weight-adapted therapy (WAT) influenced progression-free (PFS) and overall survival (OS), and the incidence of immune-related adverse events (irAEs). The electronic case notes of all patients (n = 77) treated with immune checkpoint inhibitor immunotherapy (ICI) in the first-line setting for melanoma in the Department of Dermatology, University of Luebeck, between the 1 January 2017 and the 31 December 2020, were retrospectively analysed. Although a higher proportion of patients in the WAT cohort were treated in the palliative setting, there were no correlations between dosing schedule, renal function, or BMI and PFS. Moreover, there were no differences between the cohorts in terms of PFS, OS, or the number and nature of irAEs. An elevated serum S100 concentration was associated with a decreased mean PFS in the FDT cohort (p< 0.001). This study, although inherently limited by its retrospective and monocentric nature, provides reassuring evidence that dosing schedule and pre-existing comorbidities do not influence efficacy or the irAE profile of ICI therapy in the management of melanoma.
在缺乏新临床试验的情况下，基于药代动力学数据及现有临床试验数据的分析，针对转移性黑色素瘤治疗中免疫检查点抑制剂（特别是纳武利尤单抗和帕博利珠单抗）的给药方案进行了调整。因此，本研究旨在通过真实世界数据，探讨固定剂量疗法（FDT）或体重调整疗法（WAT）是否影响无进展生存期（PFS）和总生存期（OS），以及免疫相关不良事件（irAEs）的发生率。本研究回顾性分析了2017年1月1日至2020年12月31日期间，在吕贝克大学皮肤科接受一线免疫检查点抑制剂（ICI）治疗的所有黑色素瘤患者（n = 77）的电子病历。尽管WAT组中接受姑息治疗的患者比例较高，但给药方案、肾功能或体重指数（BMI）与PFS之间均无相关性。此外，两组在PFS、OS以及irAEs的数量和性质方面均无差异。在FDT组中，血清S100浓度升高与平均PFS降低相关（p < 0.001）。尽管本研究因回顾性和单中心性质存在固有局限性，但仍提供了令人安心的证据，表明在黑色素瘤治疗中，给药方案和既有合并症不影响ICI治疗的疗效或irAE特征。
肿瘤(癌症)患者之家