Effectiveness and Safety of Atezolizumab Monotherapy in Previously Treated Japanese Patients With Unresectable Advanced or Recurrent NSCLC: A Multicenter, Prospective, Observational Study (J-TAIL)

Satoru Miura; Makoto Nishio; Hiroaki Akamatsu; Yasushi Goto; Hidetoshi Hayashi; Akihiko Gemma; Ichiro Yoshino; Toshihiro Misumi; Akito Hata; Osamu Hataji; Kohei Fujita; Masahiro Seike; Noriko Yanagitani; Kazumi Nishino; Satoshi Hara; Ryota Saito; Masahide Mori; Takeshi Tsuda; Shunichiro Iwasawa; Shintaro Nakagawa; Tetsuya Mitsudomi

doi:10.1016/j.jtocrr.2023.100484

Effectiveness and Safety of Atezolizumab Monotherapy in Previously Treated Japanese Patients With Unresectable Advanced or Recurrent NSCLC: A Multicenter, Prospective, Observational Study (J-TAIL)

JTO Clin Res Rep. 2023 Feb 24;4(3):100484. doi: 10.1016/j.jtocrr.2023.100484. eCollection 2023 Mar.

Authors

Satoru Miura¹, Makoto Nishio², Hiroaki Akamatsu³, Yasushi Goto⁴, Hidetoshi Hayashi⁵, Akihiko Gemma⁶, Ichiro Yoshino⁷, Toshihiro Misumi⁸, Akito Hata⁹, Osamu Hataji¹⁰, Kohei Fujita¹¹, Masahiro Seike⁶, Noriko Yanagitani², Kazumi Nishino¹², Satoshi Hara¹³, Ryota Saito¹⁴, Masahide Mori¹⁵, Takeshi Tsuda¹⁶, Shunichiro Iwasawa¹⁷, Shintaro Nakagawa¹⁷, Tetsuya Mitsudomi¹⁸

Affiliations

¹ Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
² Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
³ Internal Medicine III, Wakayama Medical University, Wakayama, Japan.
⁴ Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
⁵ Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.
⁶ Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan.
⁷ Department of General Thoracic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.
⁸ Department of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan.
⁹ Department of Medical Oncology, Kobe Minimally Invasive Cancer Center, Hyogo, Japan.
¹⁰ Respiratory Center, Matsusaka Municipal Hospital, Mie, Japan.
¹¹ Division of Respiratory Medicine, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
¹² Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan.
¹³ Department of Respiratory Medicine, Itami City Hospital, Hyogo, Japan.
¹⁴ Department of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan.
¹⁵ Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, Osaka, Japan.
¹⁶ Department of Respiratory Medicine, Toyama Prefectural Central Hospital, Toyama, Japan.
¹⁷ Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
¹⁸ Kindai Hospital Global Research Alliance Center and Thoracic Surgery, Kindai University, Osaka, Japan.

Abstract

Introduction: The efficacy and safety of atezolizumab in previously treated patients with NSCLC have been established in the registrational phase 3 OAK trial. In this study, we evaluated the effectiveness and safety of atezolizumab monotherapy in a large real-world cohort to confirm the reproducibility of the results of the registrational trial.

Methods: This was a multicenter, prospective, single-arm observational study. Consecutive patients with previously treated NSCLC scheduled to receive atezolizumab monotherapy were enrolled. The primary end point was the 18-month overall survival (OS) rate. The incidence of adverse events (AEs) and immune-related AEs was evaluated.

Results: Overall, 1002 patients were included in the safety analysis set and 1000 in the full analysis set. Median follow-up was 11.5 months. Of the full analysis set, 62% were ineligible for the OAK trial (OAK-unlike subpopulation). The 18-month OS rate was 41.1%, with a median OS of 13.0 months (95% confidence interval: 12.2-15.1). The 18-month OS rate was 49.4% and 36.1% in OAK-like and OAK-unlike subpopulations, respectively; that in patients with Eastern Cooperative Oncology Group performance status greater than or equal to 2 was 14.3%. The incidence of AEs overall, in the OAK-like, and OAK-unlike subpopulations was 43.9%, 46.2%, and 42.5%; that of immune-related AEs was 19.0%, 20.1%, and 18.3%, respectively.

Conclusions: The findings suggest that atezolizumab may be effective and safe for previously treated patients with NSCLC in real-world settings; however, atezolizumab administration should be considered carefully regarding the benefit-risk balance for the OAK-unlike subpopulation, especially in patients with Eastern Cooperative Oncology Group performance status greater than or equal to 2.

Keywords: Atezolizumab; Immune checkpoint inhibitors; Non–small cell lung cancer; Observational study.