Université Paris Saclay, AP-HP, Hôpital de Bicêtre, Department of Internal Medicine, UMR 1184, CEA INSERM, FHU CARE, Le Kremlin Bicêtre, France.
Drug Development Department (DITEP), Gustave Roussy, 94805 Villejuif, France.
Eur J Cancer. 2024 Jun;204:114065. doi: 10.1016/j.ejca.2024.114065. Epub 2024 Apr 14.
Immune checkpoint blockers (ICBs) can induce immune-related adverse events (irAEs) whose management is based on expert opinion and may require the prescription of steroids and/or immunosuppressants (ISs). Recent data suggest that these treatments can reduce the effectiveness of ICBs.
To investigate the relationship between the use of steroids and/or ISs and overall survival (OS) and progression-free survival (PFS) among ICB-treated patients with an irAE.
We prospectively collected data from the medical records of patients with solid tumors or lymphoma in the French REISAMIC cohort and who had been treated with ICBs between June 2014 and June 2020.
184 ICB-treated patients experienced at least one Common Terminology Criteria for Adverse Events grade ≥ 2 irAE. 107 (58.2%) were treated with steroids alone, 20 (10.9%) with steroids plus IS, 57 (31.0%) not received steroids or IS. The median OS was significantly shorter for patients treated with steroids alone (25.2 months [95% confidence interval (CI): 22.3-32.4] than for patients treated without steroids or IS (63 months [95%CI: 40.4-NA]) and those receiving an IS with steroids (53.4 months [95%CI: 47.3-NA]) (p < 0.001). The median PFS was significantly shorter for patients treated with steroids alone (17.0 months [95%CI: 11.7-22.9]) than for patients treated without steroids or IS (33.9 months [95%CI: 18.0-NA]) and those receiving an IS with steroids (41.1 months [95%CI: 26.2-NA]) (p = 0.006). There were no significant intergroup differences in the hospital admission and infection rates.
In a prospective cohort of ICB-treated patients, the use of IS was not associated with worse OS or PFS, contrasting with the use of steroids for the management of irAEs.
免疫检查点抑制剂(ICB)可引起免疫相关不良事件(irAE),其管理基于专家意见,可能需要开具类固醇和/或免疫抑制剂(IS)。最近的数据表明,这些治疗方法会降低 ICB 的疗效。
研究 irAE 接受 ICB 治疗的患者中使用类固醇和/或 IS 与总生存期(OS)和无进展生存期(PFS)之间的关系。
我们前瞻性地从法国 REISAMIC 队列中接受 ICB 治疗的实体瘤或淋巴瘤患者的病历中收集数据,这些患者在 2014 年 6 月至 2020 年 6 月期间接受了 ICB 治疗。
184 名接受 ICB 治疗的患者至少经历了一次常见不良事件术语标准≥2 级 irAE。107 名(58.2%)患者单独接受类固醇治疗,20 名(10.9%)患者接受类固醇联合 IS 治疗,57 名(31.0%)未接受类固醇或 IS 治疗。单独接受类固醇治疗的患者中位 OS 明显短于未接受类固醇或 IS 治疗的患者(25.2 个月[95%置信区间(CI):22.3-32.4]和接受 IS 联合类固醇治疗的患者(53.4 个月[95%CI:47.3-NA])(p<0.001)。单独接受类固醇治疗的患者中位 PFS 明显短于未接受类固醇或 IS 治疗的患者(33.9 个月[95%CI:18.0-NA])和接受 IS 联合类固醇治疗的患者(41.1 个月[95%CI:26.2-NA])(p=0.006)。三组间住院和感染率无显著差异。
在接受 ICB 治疗的患者前瞻性队列中,与 irAE 管理中使用类固醇相比,使用 IS 与较差的 OS 或 PFS 无关。