Internal Medicine Department, Lahey Hospital and Medical Center, Burlington, MA, USA.
Department of Oncology, Lahey Hospital and Medical Center, Burlington, MA, USA.
J Cancer Res Clin Oncol. 2023 Jun;149(6):2375-2382. doi: 10.1007/s00432-022-04137-4. Epub 2022 Jun 21.
The use of immune checkpoint inhibitors (ICI) has transformed cancer treatment. Subsequent ICI use has become increasingly common following disease progression. We aim to evaluate the safety and tolerability of the sequential ICI treatment modality.
Retrospective review of confirmed carcinoma from January 2014 to December 2018. Patients were categorized into "initial ICI arm" and "sequential ICI arm" defined as patients receiving single, dual or chemo-immunotherapy ICI following an initial ICI regimen. Primary outcome was the development of a new or recurrent immune related adverse event (irAE) during sequential therapy. Secondary outcomes were the number of cycles prior to the development of irAE and grade of irAE.
A total of 483 patients received ICI during the timeframe. Of those, 22 patients received sequential ICI. The diagnoses included ten lung cancer, seven melanoma, four renal cell carcinoma and one bladder cancer. 16 patients received single agent ICI following the initial ICI, three patients received dual ICI following the initial ICI, one patient received chemotherapy-immunotherapy following initial ICI, and two patients received chemo-immunotherapy after dual ICI. Four patients developed new irAE and one patient developed the same irAE on sequential treatment. A higher proportion of patients experienced grade 3 irAE in the sequential arm compared to the initial ICI arm (p = 0.03). No statistical difference was found between the development of irAE and the number of cycles prior to development of irAE in either treatment groups (p = 0.5).
Our data shows overall safety of sequencing ICI when close monitoring was employed.
免疫检查点抑制剂(ICI)的应用改变了癌症治疗方式。在疾病进展后,随后使用 ICI 变得越来越普遍。我们旨在评估连续使用 ICI 的治疗模式的安全性和耐受性。
回顾性分析 2014 年 1 月至 2018 年 12 月确诊的癌症患者。患者分为“初始 ICI 组”和“序贯 ICI 组”,定义为初始 ICI 方案后接受单药、双药或化疗免疫治疗的患者。主要结局是序贯治疗期间新发生或复发的免疫相关不良事件(irAE)。次要结局是发生 irAE 前的治疗周期数和 irAE 的严重程度。
在研究期间,共有 483 例患者接受了 ICI 治疗。其中 22 例患者接受了序贯 ICI。诊断包括 10 例肺癌、7 例黑色素瘤、4 例肾细胞癌和 1 例膀胱癌。16 例患者在初始 ICI 后接受单药 ICI,3 例患者在初始 ICI 后接受双药 ICI,1 例患者在初始 ICI 后接受化疗免疫治疗,2 例患者在双药 ICI 后接受化疗免疫治疗。4 例患者出现新的 irAE,1 例患者在序贯治疗中出现相同的 irAE。与初始 ICI 组相比,序贯组发生 3 级 irAE 的患者比例更高(p=0.03)。在两组中,irAE 的发生与发生 irAE 前的治疗周期数之间均无统计学差异(p=0.5)。
我们的数据表明,在密切监测的情况下,序贯使用 ICI 总体上是安全的。