接受免疫检查点阻断治疗的非小细胞肺癌和既存自身免疫性疾病患者的风险和生存：来自全国性多机构回顾性研究的逆概率加权生存分析（NEJ047）。
Risk and survival of patients with non-small cell lung cancer and pre-existing autoimmune disorders receiving immune checkpoint blockade therapy: Survival analysis with inverse probability weighting from a nationwide, multi-institutional, retrospective study (NEJ047).
发表日期：2024 Aug
作者：
Tetsuhiko Asao, Takehito Shukuya, Kohei Uemura, Rui Kitadai, Gaku Yamamoto, Atsuto Mouri, Meiyo Tamaoka, Ryosuke Imai, Yoko Tsukita, Kazutoshi Isobe, Satoshi Watanabe, Mitsuhiro Kamimura, Ryo Morita, Keita Kudo, Minehiko Inomata, Kazunari Tateishi, Kazutaka Kakinuma, Hiroshige Yoshioka, Yukiko Namba, Issei Sumiyoshi, Taku Nakagawa, Kana Watanabe, Kunihiko Kobayashi, Kazuhisa Takahashi
来源：
LUNG CANCER
摘要：
既往患有自身免疫性疾病 (AID) 的非小细胞肺癌 (NSCLC) 患者接受免疫检查点阻断 (ICB) 治疗的风险和生存率尚未明确。 这项多机构回顾性队列研究于与日本 20 个中心合作。总共纳入并分析了 2010 年 1 月至 2020 年 2 月期间接受或未接受 ICB 治疗的 229 名晚期或复发性 NSCLC 和既往患有 AID 的患者。在接受 ICB 的 69 名患者中，有 2 名患者接受了两线 ICB，总共 71 次 ICB 治疗；分别有 57 名 (80.3%) 和 14 名 (19.7%) 患者接受 ICB 单一疗法和联合疗法。在 18 名接受 ICB 的患者中观察到 AID 症状（25.4%，95% 置信区间 [CI]，15.8-37.1%）。当 NSCLC 在 AID 诊断后不到 1 年内被诊断出时，AID 恶化的可能性更大（比值比 5.26 [95% CI，1.40-21.61]；P = 0.016）。 32 名患者观察到免疫相关不良事件（45.1%，95% CI，33.2-57.3%）； 17 人获得 3 级或以上成绩。联合免疫疗法的安全性与单一疗法没有显着差异。经过逆概率加权后，使用 ICB 延长了生存期（风险比 0.43 [95% CI，0.26-0.70]；P = 0.0006）。这些发现揭示了 ICB 治疗后 AID 发作的新危险因素，即 NSCLC 的诊断在 AID 诊断后 1 年内，结果表明 ICB 可以提高该人群的生存率。这些结果支持在 NSCLC 和既往患有 AID 的患者中使用 ICB。版权所有 © 2024。由 Elsevier B.V. 出版。
The risk and survival of patients with non-small cell lung cancer (NSCLC) with pre-existing autoimmune disorders (AIDs) receiving immune checkpoint blockade (ICB) therapy have not been clearly established.This multi-institutional, retrospective cohort study was conducted in collaboration with 20 centers in Japan.In total, 229 patients with advanced or recurrent NSCLC and pre-existing AID, with or without ICB treatment from January 2010-February 2020, were included and analyzed. Among 69 patients who received ICB, 2 received two lines of ICBs with a total of 71 ICB treatments; 57 (80.3 %) and 14 (19.7 %) patients received ICB monotherapy and combination therapy, respectively. AID flares were observed in 18 patients (25.4 %, 95 % confidence interval [CI], 15.8-37.1 %) receiving ICB. AID exacerbations were more likely when NSCLC was diagnosed less than 1 year after the AID diagnosis (odds ratio 5.26 [95 % CI, 1.40-21.61]; P = 0.016). Immune-related adverse events were observed in 32 patients (45.1 %, 95 % CI, 33.2-57.3 %); 17 had grade 3 or higher. The safety profile of combination immunotherapy was not significantly different from that of the monotherapy. After inverse probability weighting, the use of ICB prolonged survival (hazard ratio 0.43 [95 % CI, 0.26-0.70]; P = 0.0006).These findings revealed a novel risk factor for AID flares following ICB treatment, that is the diagnosis of NSCLC within 1 year of AID diagnosis, and showed that ICBs may improve survival in this population. These results support the utilization of ICB in patients with NSCLC and pre-existing AID.Copyright © 2024. Published by Elsevier B.V.