PMID- 37034464
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230411
IS  - 2666-3643 (Electronic)
IS  - 2666-3643 (Linking)
VI  - 4
IP  - 3
DP  - 2023 Mar
TI  - Effectiveness and Safety of Atezolizumab Monotherapy in Previously Treated 
      Japanese Patients With Unresectable Advanced or Recurrent NSCLC: A Multicenter, 
      Prospective, Observational Study (J-TAIL).
PG  - 100484
LID - 10.1016/j.jtocrr.2023.100484 [doi]
LID - 100484
AB  - 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.
CI  - (c) 2023 The Authors.
FAU - Miura, Satoru
AU  - Miura S
AD  - Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
FAU - Nishio, Makoto
AU  - Nishio M
AD  - Department of Thoracic Medical Oncology, The Cancer Institute Hospital of 
      Japanese Foundation for Cancer Research, Tokyo, Japan.
FAU - Akamatsu, Hiroaki
AU  - Akamatsu H
AD  - Internal Medicine III, Wakayama Medical University, Wakayama, Japan.
FAU - Goto, Yasushi
AU  - Goto Y
AD  - Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
FAU - Hayashi, Hidetoshi
AU  - Hayashi H
AD  - Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, 
      Japan.
FAU - Gemma, Akihiko
AU  - Gemma A
AD  - Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate 
      School of Medicine, Tokyo, Japan.
FAU - Yoshino, Ichiro
AU  - Yoshino I
AD  - Department of General Thoracic Surgery, Chiba University Graduate School of 
      Medicine, Chiba, Japan.
FAU - Misumi, Toshihiro
AU  - Misumi T
AD  - Department of Biostatistics, Yokohama City University School of Medicine, 
      Kanagawa, Japan.
FAU - Hata, Akito
AU  - Hata A
AD  - Department of Medical Oncology, Kobe Minimally Invasive Cancer Center, Hyogo, 
      Japan.
FAU - Hataji, Osamu
AU  - Hataji O
AD  - Respiratory Center, Matsusaka Municipal Hospital, Mie, Japan.
FAU - Fujita, Kohei
AU  - Fujita K
AD  - Division of Respiratory Medicine, National Hospital Organization Kyoto Medical 
      Center, Kyoto, Japan.
FAU - Seike, Masahiro
AU  - Seike M
AD  - Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate 
      School of Medicine, Tokyo, Japan.
FAU - Yanagitani, Noriko
AU  - Yanagitani N
AD  - Department of Thoracic Medical Oncology, The Cancer Institute Hospital of 
      Japanese Foundation for Cancer Research, Tokyo, Japan.
FAU - Nishino, Kazumi
AU  - Nishino K
AD  - Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, 
      Japan.
FAU - Hara, Satoshi
AU  - Hara S
AD  - Department of Respiratory Medicine, Itami City Hospital, Hyogo, Japan.
FAU - Saito, Ryota
AU  - Saito R
AD  - Department of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan.
FAU - Mori, Masahide
AU  - Mori M
AD  - Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama 
      Medical Center, Osaka, Japan.
FAU - Tsuda, Takeshi
AU  - Tsuda T
AD  - Department of Respiratory Medicine, Toyama Prefectural Central Hospital, Toyama, 
      Japan.
FAU - Iwasawa, Shunichiro
AU  - Iwasawa S
AD  - Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
FAU - Nakagawa, Shintaro
AU  - Nakagawa S
AD  - Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
FAU - Mitsudomi, Tetsuya
AU  - Mitsudomi T
AD  - Kindai Hospital Global Research Alliance Center and Thoracic Surgery, Kindai 
      University, Osaka, Japan.
LA  - eng
PT  - Journal Article
DEP - 20230224
PL  - United States
TA  - JTO Clin Res Rep
JT  - JTO clinical and research reports
JID - 101769967
PMC - PMC10074249
OTO - NOTNLM
OT  - Atezolizumab
OT  - Immune checkpoint inhibitors
OT  - Non-small cell lung cancer
OT  - Observational study
EDAT- 2023/04/11 06:00
MHDA- 2023/04/11 06:01
PMCR- 2023/02/24
CRDT- 2023/04/10 04:09
PHST- 2022/10/03 00:00 [received]
PHST- 2023/01/19 00:00 [revised]
PHST- 2023/02/16 00:00 [accepted]
PHST- 2023/04/11 06:01 [medline]
PHST- 2023/04/10 04:09 [entrez]
PHST- 2023/04/11 06:00 [pubmed]
PHST- 2023/02/24 00:00 [pmc-release]
AID - S2666-3643(23)00023-1 [pii]
AID - 100484 [pii]
AID - 10.1016/j.jtocrr.2023.100484 [doi]
PST - epublish
SO  - JTO Clin Res Rep. 2023 Feb 24;4(3):100484. doi: 10.1016/j.jtocrr.2023.100484. 
      eCollection 2023 Mar.