A randomized phase 3 study of maintenance therapy with S-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus S-1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L).

Autor: Tanaka K; Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan., Morita S; Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan., Ando M; Data Coordinating Center, Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan., Yokoyama T; Department of Respiratory Medicine, Kyorin University School of Medicine, Tokyo, Japan., Nakamura A; Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan., Yoshioka H; Department of Thoracic Oncology, Kansai Medical University, Hirakata, Japan., Ishiguro T; Division of Respiratory Medicine and Oncology, Gifu Municipal Hospital, Gifu, Japan., Miura S; Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan., Toyozawa R; Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan., Oguri T; Department of Education and Research Center for Community Medicine, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan., Daga H; Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan., Ko R; Department of Respiratory Medicine, Juntendo University School of Medicine, Tokyo, Japan., Bessho A; Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan., Tachihara M; Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan., Iwamoto Y; Department of Respiratory Medicine, Hiroshima City Hospital, Hiroshima, Japan., Hirano K; Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan., Nakanishi Y; Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan., Nakagawa K; Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan., Yamamoto N; Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan., Okamoto I; Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Jazyk: angličtina
Zdroj: Cancer [Cancer] 2020 Aug 15; Vol. 126 (16), pp. 3648-3656. Date of Electronic Publication: 2020 Jun 02.
DOI: 10.1002/cncr.32987
Abstrakt: Background: A randomized phase 3 study was performed to investigate the efficacy and safety of maintenance therapy with S-1 after induction therapy with carboplatin plus S-1 in patients with advanced squamous non-small cell lung cancer (NSCLC).
Methods: Chemotherapy-naive patients with advanced or relapsed squamous NSCLC were treated with carboplatin (area under the curve of 5 on day 1 every 3 weeks) plus S-1 (40 mg/m 2 twice per day on days 1-14 every 3 weeks) as induction therapy. Patients who did not progress after 4 cycles of induction therapy were randomized to receive either S-1 plus best supportive care (BSC) or BSC alone. The primary objective of the study was to confirm the superiority of S-1 plus BSC in comparison with BSC alone with respect to progression-free survival.
Results: Of the 365 patients enrolled in the study, 347 participated in the induction phase, and 131 of these individuals were randomized to receive S-1 plus BSC (n = 67) or BSC alone (n = 64). The risk of disease progression was significantly lower for patients in the S-1 plus BSC arm than those in the BSC-alone arm (hazard ratio, 0.548; 95% confidence interval, 0.374-0.802; P = .0019). The most common toxicities during maintenance therapy with S-1 included anorexia, anemia, and fatigue, but most cases were not severe.
Conclusions: Continued maintenance with S-1 plus BSC is an effective and well-tolerated treatment option for patients with advanced squamous NSCLC previously treated with carboplatin plus S-1.
(© 2020 American Cancer Society.)
Databáze: MEDLINE
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