J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan
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, multic...
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2025-03-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Eisaku Miyauchi, MD, PhD |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-5f1aefda4e28419ab609c2b76d9968ca |
| institution | Kabale University |
| issn | 2666-3643 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JTO Clinical and Research Reports |
| spelling | doaj-art-5f1aefda4e28419ab609c2b76d9968ca2025-02-03T04:16:57ZengElsevierJTO Clinical and Research Reports2666-36432025-03-0163100783J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in JapanEisaku Miyauchi, MD, PhD0Makoto Nishio, MD, PhD1Kadoaki Ohashi, MD, PhD2Atsushi Osoegawa, MD, PhD3Eiki Kikuchi, MD, PhD4Hideharu Kimura, MD, PhD5Yasushi Goto, MD, PhD6Junichi Shimizu, MD, PhD7Hiroshige Yoshioka, MD, PhD8Ichiro Yoshino, MD, PhD9Toshihiro Misumi, PhD10Nobuyuki Katakami, MD, PhD11Masahide Oki, MD, PhD12Takashi Kijima, MD, PhD13Kenichi Chikamori, MD, PhD14Kazumi Nishino, MD, PhD15Yuki Kobayashi, MS16Asako Miwa, BA17Misa Tanaka, MS18Akihiko Gemma, PhD19Department of Respiratory Medicine, Tohoku University Hospital, Sendai, JapanDepartment of Thoracic Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Respiratory Medicine Okayama University Hospital, Okayama, JapanDepartment of Thoracic and Breast Surgery, Oita University Faculty of Medicine, Yufu, JapanDepartment of Respiratory Medicine, Faculty of Medicine, Hokkaido University, Sapporo, JapanDepartment of Respiratory Medicine, Kanazawa University Hospital, Kanazawa, JapanDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo, JapanDepartment of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, JapanDepartment of Thoracic Oncology, Kansai Medical University, Hirakata, JapanInternational University of Health and Welfare, Narita Hospital, Narita, Japan and Department of General Thoracic Surgery, Chiba University Hospital, Chiba, JapanDepartment of Data Science, National Cancer Center Hospital East, Kashiwa, JapanDepartment of Pulmonary Medicine and Medical Oncology, Takarazuka City Hospital, Takarazuka, JapanDepartment of Respiratory Medicine, NHO Nagoya Medical Center, Nagoya, JapanDepartment of Respiratory Medicine and Hematology, Hyogo Medical University, School of Medicine, Nishinomiya, JapanDepartment of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, JapanDepartment of Thoracic Oncology, Osaka International Cancer Institute, Osaka, JapanChugai Pharmaceutical Co., Ltd., Tokyo, JapanChugai Pharmaceutical Co., Ltd., Tokyo, JapanChugai Pharmaceutical Co., Ltd., Tokyo, JapanNippon 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.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.http://www.sciencedirect.com/science/article/pii/S266636432400153XExtensive-stage small cell lung cancerAtezolizumabImmune checkpoint inhibitorObservational study |
| spellingShingle | 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 J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan JTO Clinical and Research Reports Extensive-stage small cell lung cancer Atezolizumab Immune checkpoint inhibitor Observational study |
| title | J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan |
| title_full | J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan |
| title_fullStr | J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan |
| title_full_unstemmed | J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan |
| title_short | J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan |
| title_sort | j tail 2 a prospective observational study of atezolizumab combined with carboplatin and etoposide in patients with extensive stage sclc in japan |
| topic | Extensive-stage small cell lung cancer Atezolizumab Immune checkpoint inhibitor Observational study |
| url | http://www.sciencedirect.com/science/article/pii/S266636432400153X |
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