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

التفاصيل البيبلوغرافية
العنوان: Effectiveness and Safety of Atezolizumab Monotherapy in Previously Treated Japanese Patients With Unresectable Advanced or Recurrent NSCLC: A Multicenter, Prospective, Observational Study (J-TAIL)
المؤلفون: 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
المصدر: JTO Clinical and Research Reports, Vol 4, Iss 3, Pp 100484- (2023)
بيانات النشر: Elsevier, 2023.
سنة النشر: 2023
المجموعة: LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
مصطلحات موضوعية: Non–small cell lung cancer, Immune checkpoint inhibitors, Atezolizumab, Observational study, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
الوصف: 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.
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 2666-3643
العلاقة: http://www.sciencedirect.com/science/article/pii/S2666364323000231Test; https://doaj.org/toc/2666-3643Test
DOI: 10.1016/j.jtocrr.2023.100484
الوصول الحر: https://doaj.org/article/cf2603aadeec484c8f8d98e2ec1d639bTest
رقم الانضمام: edsdoj.f2603aadeec484c8f8d98e2ec1d639b
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:26663643
DOI:10.1016/j.jtocrr.2023.100484