Tasaka Yuri, Honda Takayuki, Nishiyama Naoki, Tsutsui Toshiharu, Saito Hiroaki, Watabe Haruna, Shimaya Kazuhiro, Mochizuki Akifumi, Tsuyuki Shun, Kawahara Tatsuo, Sakakibara Rie, Mitsumura Takahiro, Okamoto Tsukasa, Kobayashi Masayoshi, Chiaki Tomoshige, Yamashita Takaaki, Tsukada Yoshikazu, Taki Reiko, Jin Yasuto, Sakashita Hiroyuki, Natsume Ichirou, Saitou Kazuhito, Miyashita Yoshihiro, Miyazaki Yasunari
Department of Respiratory Medicine, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.
Department of Respiratory Medicine, Tokyo Metropolitan Bokutoh Hospital, 4-23-15 Koutoubashi, Sumida-ku, Tokyo 130-8575, Japan.
Lung Cancer. 2021 May;155:120-126. doi: 10.1016/j.lungcan.2021.03.014. Epub 2021 Mar 22.
The efficacy of immune checkpoint inhibitors (ICIs) in non-small-cell lung cancer (NSCLC) patients with pre-existing interstitial lung disease (ILD) is unclear.
Retrospective medical data from advanced or recurrent NSCLC patients who were treated with nivolumab or pembrolizumab at ten institutions in Japan between January 2016 and September 2018 were analyzed. Eligible patients were divided into two groups according to the presence of pre-existing ILD.
A total of 461 NSCLC patients were enrolled, 412 without ILD (Non-ILD group) and 49 with ILD (ILD group). The response rate (RR) and disease control rate (DCR) of the ILD group were not inferior to those of the Non-ILD group [RR: 49.0 % (24/49) vs. 30.1 % (124/412), P < 0.01 and DCR: 69.4 % (34/49) vs. 51.2 % (211/412), P = 0.016, respectively]. Non-inferior outcomes were also observed with respect to progression-free survival (PFS) and overall survival (OS) (median PFS: 5.9 months vs. 3.5 months, P = 0.14 and median OS: 27.8 months vs. 25.2 months, P = 0.74 in the ILD and Non-ILD groups, respectively). Among immune-related adverse effects (irAEs), checkpoint inhibitor pneumonitis (CIP) was more frequently observed among NSCLC patients in the ILD group [30.6 % (15/49) vs. 9.5 % (39/412), P < 0.01]. The frequency of irAEs other than CIP and infusion reactions was not significantly different between the ILD group and the Non-ILD group.
These results suggest that the clinical outcomes of ICIs are not significantly affected by pre-existing ILD despite the increased frequency of CIP. NSCLC patients with ILD are therefore probable candidates for ICIs.
免疫检查点抑制剂（ICI）在已患有间质性肺疾病（ILD）的非小细胞肺癌（NSCLC）患者中的疗效尚不清楚。
分析了2016年1月至2018年9月期间在日本10家机构接受纳武单抗或派姆单抗治疗的晚期或复发性NSCLC患者的回顾性医疗数据。符合条件的患者根据是否存在既往ILD分为两组。
共纳入461例NSCLC患者，412例无ILD（非ILD组），49例有ILD（ILD组）。ILD组的缓解率（RR）和疾病控制率（DCR）不低于非ILD组[RR：49.0%（24/49）对30.1%（124/412），P<0.01；DCR：69.4%（34/49）对51.2%（211/412），P=0.016]。在无进展生存期（PFS）和总生存期（OS）方面也观察到非劣效结果（ILD组和非ILD组的中位PFS分别为5.9个月对3.5个月，P=0.14；中位OS分别为27.8个月对25.2个月，P=0.74）。在免疫相关不良反应（irAE）中，ILD组的NSCLC患者中更频繁地观察到检查点抑制剂肺炎（CIP）[30.6%（15/49）对9.5%（39/412），P<0.01]。ILD组和非ILD组之间除CIP和输液反应外的irAE频率无显著差异。
这些结果表明，尽管CIP频率增加，但既往ILD对ICI的临床结果没有显著影响。因此，患有ILD的NSCLC患者可能是ICI的候选者。
