Yoneda Taro, Sone Takashi, Koba Hayato, Shibata Kazuhiko, Suzuki Junya, Tani Mayuko, Nishitsuji Masaru, Nishi Koichi, Kobayashi Takafumi, Shirasaki Hiroki, Araya Tomoyuki, Kita Toshiyuki, Kase Kazumasa, Yamamura Kenta, Terada Nanao, Nishikawa Shingo, Tambo Yuichi, Kimura Hideharu, Kasahara Kazuo
Department of Respiratory Medicine, Komatsu Municipal Hospital, Komatsu, Japan.
Department of Respiratory Medicine, Kanazawa University, Kanazawa, Japan.
Clin Lung Cancer. 2022 Sep;23(6):467-476. doi: 10.1016/j.cllc.2022.03.008. Epub 2022 May 1.
Immune checkpoint inhibitor (ICI) monotherapy is more effective than cytotoxic chemotherapy in improving overall survival (OS) among patients with advanced-stage non-small cell lung cancer (NSCLC). Recently, chemotherapy combined with ICI has been found to yield good outcomes. However, ICI monotherapy is still considered an important treatment option. Data on long-term progression-free survival (PFS) and OS in real-world settings are limited.
This was a multicenter retrospective observational study. A total of 435 consecutive patients histologically diagnosed with advanced, metastatic, or recurrent NSCLC treated with ICI monotherapy were enrolled in this study from December 2015 to December 2018. Clinical data were collected from electronic medical records and pharmacy databases.
The PFS and OS of the patients were 3.4 and 13.0 months, respectively. The objective response and disease control rates were 22.8% and 54.9%, respectively, and the 4-year survival rate was 17.9%. Multivariate analyses revealed that elder patients (>70 years), good Eastern Cooperative Oncology Group Performance Status (ECOG PS) score, programmed death-ligand 1 tumor proportion score (PD-L1 TPS) of ≥ 50%, absence of bone metastasis, and presence of immune-related skin toxicity, which is an immune-related adverse event, were correlated with good PFS. Moreover, good ECOG PS score, PD-L1 TPS of ≥ 50%, absence of bone metastasis, and presence of skin toxicity were correlated with good OS.
The 4-year survival rate was 17.9%. Good ECOG PS score, PD-L1 TPS of ≥ 50%, absence of bone metastasis, and presence of skin toxicity were correlated with good PFS and OS.
在晚期非小细胞肺癌（NSCLC）患者中，免疫检查点抑制剂（ICI）单药治疗在改善总生存期（OS）方面比细胞毒性化疗更有效。最近，已发现化疗联合ICI可产生良好疗效。然而，ICI单药治疗仍被视为一种重要的治疗选择。关于真实世界环境中长期无进展生存期（PFS）和OS的数据有限。
这是一项多中心回顾性观察研究。2015年12月至2018年12月期间，共有435例经组织学诊断为晚期、转移性或复发性NSCLC并接受ICI单药治疗的连续患者纳入本研究。临床数据从电子病历和药房数据库中收集。
患者的PFS和OS分别为3.4个月和13.0个月。客观缓解率和疾病控制率分别为22.8%和54.9%，4年生存率为17.9%。多因素分析显示，老年患者（>70岁）、东部肿瘤协作组体能状态（ECOG PS）评分良好、程序性死亡配体1肿瘤比例评分（PD-L1 TPS）≥50%、无骨转移以及存在免疫相关皮肤毒性（一种免疫相关不良事件）与良好的PFS相关。此外，良好的ECOG PS评分、PD-L1 TPS≥50%、无骨转移以及存在皮肤毒性与良好的OS相关。
4年生存率为17.9%。良好的ECOG PS评分、PD-L1 TPS≥50%、无骨转移以及存在皮肤毒性与良好的PFS和OS相关。
