A phase 2 trial of durvalumab treatment following radiation monotherapy in patients with non-small cell lung cancer ineligible for stage III chemoradiotherapy: The SPIRAL-RT study.

Autor: Yamada T; Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan., Goto Y; Department of Respiratory Medicine, Fujita Health University School of Medicine, Toyoake, Japan., Tanaka H; Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan., Kimura H; Respiratory Medicine, Kanazawa University Hospital, Ishikawa, Japan., Minato K; Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Japan., Gyotoku H; Department of Respiratory Medicine, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan., Honda T; Department of Internal Medicine Division of Medical Oncology, Teikyo University School of Medicine, Tokyo, Japan., Watanabe S; Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medicine and Dental Sciences, Niigata, Japan., Morimoto K; Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan., Kiyomi F; Statistics and Data Center, Clinical Research Support Center Kyushu, Fukuoka, Japan., Uchino J; Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan. Electronic address: uchino@koto.kpu-m.ac.jp., Takayama K; Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Jazyk: angličtina
Zdroj: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2023 Dec; Vol. 195, pp. 113373. Date of Electronic Publication: 2023 Oct 22.
DOI: 10.1016/j.ejca.2023.113373
Abstrakt: Background: Although concurrent chemoradiotherapy (CCRT) followed by durvalumab is the standard treatment for patients with stage III non-small cell lung cancer (NSCLC), only half of the patients are allowed to receive CCRT in real-world settings. We evaluated the efficacy and safety of durvalumab after radiation monotherapy for NSCLC patients who are ineligible for chemoradiotherapy.
Methods: A single-arm, prospective, open-label, multicenter phase II trial was conducted in Japan. The patients received radiation (54-66 Gy) followed by durvalumab (10 mg/kg every 2 weeks for up to 12 months). The primary endpoint was the 1-year progression-free survival (PFS) rate. The secondary endpoints were the objective response rate (ORR), PFS, overall survival (OS), and safety.
Results: Between September 2019 and April 2021, 33 patients were enroled from eight institutions. The median patient age was 79 years, and the majority of patients were male (78.8%). The 1-year PFS rate was 39.1% (90% confidence interval [CI]: 24.7-54.6%). Three patients (9.1%) had a performance status of 2. The ORR was 42.4% (95% CI: 27.2-59.2%). The median PFS and OS were 8.9 (95% CI: 7.4-19.4) and 20.8 (95% CI: 15.8-not estimable) months, respectively. The most common adverse event was radiation pneumonitis (51.5%). The median treatment duration was 6.4 (range: 0.50-12.0) months for durvalumab. At the endpoint, 30.3% (10/33) of the patients had completed 1 year of durvalumab therapy.
Conclusions: Durvalumab is an effective treatment with tolerable toxicity following radiation monotherapy in stage III NSCLC patients who are ineligible for chemoradiotherapy.
Trial Registration: JMA-IIA00434 (jRCT).
Competing Interests: Declaration of Competing Interest Tadaaki Yamada received grants from Pfizer, Ono Pharmaceutical, Janssen Pharmaceutical, AstraZeneca, and Takeda Pharmaceutical, and Honoraria for lecture from Eli Lilly. Yasuhiro Goto received Honoraria for lecture from AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceuticals, Eli Lilly, GlaxoSmithKline, KYOWA HAKKO, Merck, Nippon Boehringer Ingelheim, Novartis, Pfizer, Taiho pharmaceutical, and Takeda Pharmaceutical. Hiroshi Tanaka received Honoraria for lecture from Astra Zeneca, Chugai Pharmaceuticals, MSD, Ono Pharmaceutical, Bristol-Myers Squibb, Daiichi-Sankyo pharmaceutical, Eli Lilly, Takeda pharmaceutical, Taiho pharmaceutical, Merck, Boehringer Ingelheim, Sun pharmaceutical, and Eisai, Novartis and grants for trial from My institution, AstraZeneca, Chugai Pharmaceutical, MSD, Ono Pharmaceutical, Bristol-Myers Squibb, Daiichi-Sankyo pharmaceutical, Eli Lilly, Takeda pharmaceutical, Taiho pharmaceutical, Merck, Boehringer Ingelheim, Amgen, and Abbvie. Satoshi Watanabe received grants from Boehringer Ingelheim and Honoraria for lecture from Eli Lilly, Novartis, Chugai Pharmaceutical, Ono Pharmaceutical, Taiho Pharmaceutical, Pfizer, AstraZeneca, Bristol-Myers, Daiichi-Sankyo, and Nippon Kayaku. Junji Uchino received grants from AstraZeneca. Koichi Takayama received grants from Chugai-Roche, Taiho Pharmaceutical, Boehringer Ingelheim, and Ono Pharmaceutical, consulting fees from Ono Pharmaceutical and AstraZeneca, and lecture fees from AstraZeneca, Ono Pharmaceutical, Chugai-Roche, Eli Lilly, and Boehringer Ingelheim. The other authors have no conflicts of interest to declare.
(Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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