Research Article|Articles in Press, 100484

Effectiveness and safety of atezolizumab monotherapy in previously treated Japanese patients with unresectable advanced or recurrent non-small cell lung cancer: A multicenter, prospective, observational study (J-TAIL)

Open AccessPublished:February 24, 2023DOI:
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      The efficacy and safety of atezolizumab in previously treated patients with non-small cell lung cancer (NSCLC) have been established in the registrational phase III 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.


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


      Overall, 1002 patients were included in the safety analysis set and 1000 in the full analysis set (FAS). Median follow-up was 11.5 months. Of the FAS, 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 [CI], 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 (ECOG PS) ≥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 irAEs was 19.0%, 20.1%, and 18.3%, respectively.


      The findings suggest 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 ECOG PS ≥2.


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