Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：免疫检查点阻断剂（ICBs）可诱导免疫相关不良事件（irAEs），其管理基于专家意见，可能需要类固醇和/或免疫抑制剂（ISs）的处方。最近的数据表明，这些治疗可以降低ICB的有效性。
目的：研究在ICB治疗的irAE患者中，使用类固醇和/或ISs与总生存期（OS）和无进展生存期（PFS）之间的关系。
方法：我们前瞻性收集了法国REISAMIC队列中实体瘤或淋巴瘤患者的病历数据，这些患者在2014年6月至2020年6月期间接受了ICB治疗。
结果：184例接受ICB治疗的患者经历了至少一个不良事件等级≥2irAE的通用术语标准。107（58.2％）单独使用类固醇治疗，20（10.9％）与类固醇加IS，57（31.0％）未接受类固醇或IS。仅使用类固醇治疗的患者的中位OS（25.2个月[95％置信区间（CI）：22.3-32.4]明显短于未使用类固醇或IS治疗的患者（63个月[95CI：40.4-NA]）和接受类固醇治疗的患者（53.4个月[95CI：47.3-NA]）（p<0.001）。单独使用类固醇治疗的患者的中位PFS（17.0个月[95CI：11.7-22.9]）明显短于未使用类固醇或IS治疗的患者（33.9个月[95CI：18.0-NA]）和接受IS治疗的患者（41.1个月[95CI：26.2-NA]）（p=0.006）。入院率和感染率无明显组间差异。
结论：在ICB治疗患者的前瞻性队列中，IS的使用与较差的OS或PFS无关，与使用类固醇治疗irAE形成鲜明对比。
目的：研究在ICB治疗的irAE患者中，使用类固醇和/或ISs与总生存期（OS）和无进展生存期（PFS）之间的关系。
方法：我们前瞻性收集了法国REISAMIC队列中实体瘤或淋巴瘤患者的病历数据，这些患者在2014年6月至2020年6月期间接受了ICB治疗。
结果：184例接受ICB治疗的患者经历了至少一个不良事件等级≥2irAE的通用术语标准。107（58.2％）单独使用类固醇治疗，20（10.9％）与类固醇加IS，57（31.0％）未接受类固醇或IS。仅使用类固醇治疗的患者的中位OS（25.2个月[95％置信区间（CI）：22.3-32.4]明显短于未使用类固醇或IS治疗的患者（63个月[95CI：40.4-NA]）和接受类固醇治疗的患者（53.4个月[95CI：47.3-NA]）（p<0.001）。单独使用类固醇治疗的患者的中位PFS（17.0个月[95CI：11.7-22.9]）明显短于未使用类固醇或IS治疗的患者（33.9个月[95CI：18.0-NA]）和接受IS治疗的患者（41.1个月[95CI：26.2-NA]）（p=0.006）。入院率和感染率无明显组间差异。
结论：在ICB治疗患者的前瞻性队列中，IS的使用与较差的OS或PFS无关，与使用类固醇治疗irAE形成鲜明对比。
