免疫检查点抑制剂与免疫介导的不良反应风险:比较延长间隔与标准间隔给药的队列研究。
Immune checkpoint inhibitors and risk of immune-mediated adverse events: a cohort study comparing extended versus standard interval administration.
机构信息
Faculté de Pharmacie, Université Laval, Québec, QC, Canada.
Département de Pharmacie, Hôpital Sainte-Croix, Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-Centre-du-Québec, Drummondville, Canada.
出版信息
Clin Exp Med. 2024 Feb 22;24(1):40. doi: 10.1007/s10238-024-01301-7.
The COVID-19 pandemic precipitated the implementation of extended interval immune checkpoint inhibitors (ICIs) in an effort to limit hospital visits, but few studies have examined their safety. This study aimed to compare in oncology outpatients, immune-mediated adverse events (IMAEs) in terms of total number, incidence, severity, and time to occurrence, based on exposure to standard or extended interval ICIs. A retrospective cohort study was conducted in patients who received at least one dose of an ICI between 2015 and 2021. Data were collected from patient records and pharmacy software. Adjusted logistic, Poisson, and Cox regression models were estimated. A total of 310 patients with a mean age of 67.1 years were included, 130 of whom had the extended interval. No statistically significant differences were observed between the groups. With the standard and extended intervals, the mean total number of IMAE per participant was 1.02 and 1.18, respectively; the incidence of an IMAE was 62% and 64%. Of the 147 IMAE episodes in the standard interval group, 14 (9.5%) were grade 3 or higher, while there were 15 (12.4%) among the 121 IMAE episodes in the extended interval group. Compared with standard interval, the use of extended interval did not increase the risk of having a first IMAE (adjusted hazard ratio 0.92 (95% CI 0.67-1.26)). This study suggests that the administration of an ICI according to extended interval is as safe as the administration according to standard interval in oncology outpatients.
COVID-19 大流行促使人们实施延长间隔免疫检查点抑制剂(ICI),以限制医院就诊次数,但很少有研究检查其安全性。本研究旨在比较标准间隔和延长间隔 ICI 下,肿瘤门诊患者的免疫介导不良事件(IMAEs)总数、发生率、严重程度和发生时间。这是一项回顾性队列研究,纳入了 2015 年至 2021 年间至少接受一剂 ICI 的患者。数据来自患者记录和药房软件。采用调整后的逻辑回归、泊松回归和 Cox 回归模型进行估计。共纳入 310 名平均年龄为 67.1 岁的患者,其中 130 名患者采用延长间隔。两组间无统计学差异。标准间隔和延长间隔组参与者的 IMAE 总数平均值分别为 1.02 和 1.18,发生率分别为 62%和 64%。标准间隔组 147 次 IMAE 中有 14 次(9.5%)为 3 级或更高级别,而延长间隔组 121 次 IMAE 中有 15 次(12.4%)。与标准间隔相比,使用延长间隔并不会增加首次发生 IMAE 的风险(调整后的危害比为 0.92(95%CI 0.67-1.26))。本研究表明,在肿瘤门诊患者中,延长间隔给药与标准间隔给药一样安全。