Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.
Oncology and Sterile Compound Pharmacy, Pharmacy Division, Wattanosoth Cancer Hospital Bangkok, Thailand.
Int J Pharm Pract. 2022 Aug 9;30(4):377-382. doi: 10.1093/ijpp/riac048.
The challenge of using immune checkpoint inhibitors (ICI) is the immune-related adverse events (irAEs). Nonetheless, there is scarce evidence regarding the irAEs in Thailand. The primary aims of this study are to assess the incidence as well as risk factors of irAEs among cancer patients in Wattanosoth hospital.
This was a cross-sectional retrospective chart review for the 3-year period (2017-2019). Data were collected after initiating the approved ICIs and patients were then followed for 12 months. The outcomes included incidences of irAEs, adverse events management, and tumor objective response. Bivariate analysis was performed for factors that might be associated with irAEs occurrences.
Data from 91 patients was collected. There was a 49.5% overall irAEs incidence. The most frequent irAE to occur affected the endocrine system (29.85%). In addition, we identified that odds ratios of irAEs development increased in patients who had four or more ICI cycles or had a serum creatinine level higher than 1.2 mg/dl, (OR: 1.75; 95% CI 1.1611:2.6256, P = 0.0074) and (OR: 1.58; 95% CI: 1.0628:2.3574; P = 0.0238), respectively. The emergence of irAEs may be a sign of tumor objective responses (OR: 1.79; 95% CI 1.0035:3.1889; P = 0.0486).
This study demonstrates that irAEs are common in patients treated with ICIs. In addition, our study identifies that number of cycles and serum creatinine influence the development of irAEs. Hence, prompt recognition and an adequate monitoring plan should be cautiously taken into consideration.
使用免疫检查点抑制剂（ICI）的挑战是免疫相关不良反应（irAEs）。然而，泰国关于 irAEs 的证据很少。本研究的主要目的是评估 Wattanosoth 医院癌症患者的 irAEs 发生率和危险因素。
这是一项为期 3 年（2017-2019 年）的回顾性病例分析。在开始使用批准的 ICI 后收集数据，并对患者进行 12 个月的随访。结果包括 irAEs 的发生率、不良反应的管理以及肿瘤客观缓解。对可能与 irAEs 发生相关的因素进行了双变量分析。
共收集了 91 例患者的数据。总的 irAEs 发生率为 49.5%。最常见的 irAE 影响内分泌系统（29.85%）。此外，我们发现 irAEs 发展的几率比增加了接受 4 个或更多 ICI 周期或血清肌酐水平高于 1.2mg/dl 的患者（OR：1.75；95%CI 1.1611：2.6256，P = 0.0074）和（OR：1.58；95%CI：1.0628：2.3574；P = 0.0238），分别。irAEs 的出现可能是肿瘤客观反应的标志（OR：1.79；95%CI 1.0035：3.1889；P = 0.0486）。
本研究表明，ICI 治疗患者中 irAEs 很常见。此外，我们的研究表明，周期数和血清肌酐影响 irAEs 的发生。因此，应谨慎考虑及时识别和适当的监测计划。
