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

JTO Clinical and Research Reports (Mar 2023)

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

Affiliations

Satoru Miura, MD, PhD: Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan
Makoto Nishio, MD, PhD: Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
Hiroaki Akamatsu, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama, Japan
Yasushi Goto, MD, PhD: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
Hidetoshi Hayashi, MD, PhD: Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan
Akihiko Gemma, MD, PhD: Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan
Ichiro Yoshino, MD, PhD: Department of General Thoracic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan
Toshihiro Misumi, PhD: Department of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan
Akito Hata, MD: Department of Medical Oncology, Kobe Minimally Invasive Cancer Center, Hyogo, Japan
Osamu Hataji, MD, PhD: Respiratory Center, Matsusaka Municipal Hospital, Mie, Japan
Kohei Fujita, MD, PhD: Division of Respiratory Medicine, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
Masahiro Seike, MD, PhD: Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan
Noriko Yanagitani, MD, PhD: Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
Kazumi Nishino, MD, PhD: Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan
Satoshi Hara, MD: Department of Respiratory Medicine, Itami City Hospital, Hyogo, Japan
Ryota Saito, MD, PhD: Department of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan
Masahide Mori, MD, PhD: Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, Osaka, Japan
Takeshi Tsuda, MD: Department of Respiratory Medicine, Toyama Prefectural Central Hospital, Toyama, Japan
Shunichiro Iwasawa, MD, PhD: Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
Shintaro Nakagawa, MSc: Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
Tetsuya Mitsudomi, MD, PhD: Kindai Hospital Global Research Alliance Center and Thoracic Surgery, Kindai University, Osaka, Japan; Corresponding author. Address for correspondence: Tetsuya Mitsudomi, MD, PhD, Kindai Hospital Global Research Alliance Center and Thoracic Surgery, Kindai University, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.

Journal volume & issue: Vol. 4, no. 3
p. 100484

Abstract

Read online

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.

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

About the journal

Abstract

Keywords