J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan

Eisaku Miyauchi, MD, PhD; Makoto Nishio, MD, PhD; Kadoaki Ohashi, MD, PhD; Atsushi Osoegawa, MD, PhD; Eiki Kikuchi, MD, PhD; Hideharu Kimura, MD, PhD; Yasushi Goto, MD, PhD; Junichi Shimizu, MD, PhD; Hiroshige Yoshioka, MD, PhD; Ichiro Yoshino, MD, PhD; Toshihiro Misumi, PhD; Nobuyuki Katakami, MD, PhD; Masahide Oki, MD, PhD; Takashi Kijima, MD, PhD; Kenichi Chikamori, MD, PhD; Kazumi Nishino, MD, PhD; Yuki Kobayashi, MS; Asako Miwa, BA; Misa Tanaka, MS; Akihiko Gemma, PhD

JTO Clinical and Research Reports (Mar 2025)

J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan

Eisaku Miyauchi, MD, PhD,
Makoto Nishio, MD, PhD,
Kadoaki Ohashi, MD, PhD,
Atsushi Osoegawa, MD, PhD,
Eiki Kikuchi, MD, PhD,
Hideharu Kimura, MD, PhD,
Yasushi Goto, MD, PhD,
Junichi Shimizu, MD, PhD,
Hiroshige Yoshioka, MD, PhD,
Ichiro Yoshino, MD, PhD,
Toshihiro Misumi, PhD,
Nobuyuki Katakami, MD, PhD,
Masahide Oki, MD, PhD,
Takashi Kijima, MD, PhD,
Kenichi Chikamori, MD, PhD,
Kazumi Nishino, MD, PhD,
Yuki Kobayashi, MS,
Asako Miwa, BA,
Misa Tanaka, MS,
Akihiko Gemma, PhD

Affiliations

Eisaku Miyauchi, MD, PhD: Department of Respiratory Medicine, Tohoku University Hospital, Sendai, Japan
Makoto Nishio, MD, PhD: Department of Thoracic Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
Kadoaki Ohashi, MD, PhD: Department of Respiratory Medicine Okayama University Hospital, Okayama, Japan
Atsushi Osoegawa, MD, PhD: Department of Thoracic and Breast Surgery, Oita University Faculty of Medicine, Yufu, Japan
Eiki Kikuchi, MD, PhD: Department of Respiratory Medicine, Faculty of Medicine, Hokkaido University, Sapporo, Japan
Hideharu Kimura, MD, PhD: Department of Respiratory Medicine, Kanazawa University Hospital, Kanazawa, Japan
Yasushi Goto, MD, PhD: Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
Junichi Shimizu, MD, PhD: Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
Hiroshige Yoshioka, MD, PhD: Department of Thoracic Oncology, Kansai Medical University, Hirakata, Japan
Ichiro Yoshino, MD, PhD: International University of Health and Welfare, Narita Hospital, Narita, Japan and Department of General Thoracic Surgery, Chiba University Hospital, Chiba, Japan
Toshihiro Misumi, PhD: Department of Data Science, National Cancer Center Hospital East, Kashiwa, Japan
Nobuyuki Katakami, MD, PhD: Department of Pulmonary Medicine and Medical Oncology, Takarazuka City Hospital, Takarazuka, Japan
Masahide Oki, MD, PhD: Department of Respiratory Medicine, NHO Nagoya Medical Center, Nagoya, Japan
Takashi Kijima, MD, PhD: Department of Respiratory Medicine and Hematology, Hyogo Medical University, School of Medicine, Nishinomiya, Japan
Kenichi Chikamori, MD, PhD: Department of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan
Kazumi Nishino, MD, PhD: Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan
Yuki Kobayashi, MS: Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
Asako Miwa, BA: Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
Misa Tanaka, MS: Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
Akihiko Gemma, PhD: Nippon Medical School, Tokyo, Japan; Corresponding author. Address for correspondence: Akihiko Gemma, MD, PhD, Nippon Medical School, 1 Chome-1-5 Sendagi, Bunkyo City, Tokyo 113-8602, Japan.

Journal volume & issue: Vol. 6, no. 3
p. 100783

Abstract

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Introduction: On the basis of the IMpower133 trial, atezolizumab plus carboplatin and etoposide (CE) is approved as first-line treatment for extensive-stage (ES)-SCLC. The J-TAIL-2 study evaluated atezolizumab plus CE in routine clinical practice settings. Methods: J-TAIL-2 was a prospective, multicenter observational study in Japan. Patients with ES-SCLC received atezolizumab plus CE in clinical practice. The primary end point was 12-month OS rate. Secondary end points included overall survival (OS), progression-free survival (PFS), and safety in select subgroups, including the IMpower133-unlike (i.e., Eastern Cooperative Oncology Group performance status 2 or more, interstitial lung disease, autoimmune disease) versus IMpower133-like groups. Results: Overall, 403 patients were included; the median age was 71 years, 16.6% (n = 67) had an Eastern Cooperative Oncology Group performance status 2 or more, 26.8% (n = 108) had brain metastasis, 6.9% (n = 28) had interstitial lung disease, 4.0% (n = 16) had autoimmune disease, and 72.7% (n = 293) were IMpower133-unlike. In the efficacy population (n = 399), the 12-month OS rate was 63.7%, median OS was 16.5 months, and median PFS was 5.1 months. In IMpower133-unlike versus IMpower133-like subgroups, the 12-month OS rate was 58.5% versus 77.5%, median OS was 15.5 versus 19.1 months (hazard ratio, 1.32; 95% confidence interval: 0.98–1.77), and median PFS was 4.8 versus 5.4 months (hazard ratio, 1.14; 95% confidence interval: 0.90–1.45). No new safety signals were observed (safety population, n = 400); safety outcomes in the IMpower133-unlike and IMpower133-like subgroups were similar. Conclusions: In J-TAIL-2, atezolizumab plus CE had efficacy in patients with ES-SCLC in clinical practice that was consistent with that in IMpower133. Taken together with the acceptable safety profile, these data support the use of atezolizumab plus CE in patients with ES-SCLC in Japan, including those who would have been ineligible for IMpower133.

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/

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