Kaoru Tanaka1, Satoshi Morita2, Masahiko Ando3, Takuma Yokoyama4, Atsushi Nakamura5, Hiroshige Yoshioka6, Takashi Ishiguro7, Satoru Miura8, Ryo Toyozawa9, Tetsuya Oguri10, Haruko Daga11, Ryo Ko12, Akihiro Bessho13, Motoko Tachihara14, Yasuo Iwamoto15, Katsuya Hirano16, Yoichi Nakanishi17, Kazuhiko Nakagawa1, Nobuyuki Yamamoto18, Isamu Okamoto17. 1. Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan. 2. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 3. Data Coordinating Center, Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan. 4. Department of Respiratory Medicine, Kyorin University School of Medicine, Tokyo, Japan. 5. Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan. 6. Department of Thoracic Oncology, Kansai Medical University, Hirakata, Japan. 7. Division of Respiratory Medicine and Oncology, Gifu Municipal Hospital, Gifu, Japan. 8. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan. 9. Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan. 10. Department of Education and Research Center for Community Medicine, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan. 11. Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan. 12. Department of Respiratory Medicine, Juntendo University School of Medicine, Tokyo, Japan. 13. Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan. 14. Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. 15. Department of Respiratory Medicine, Hiroshima City Hospital, Hiroshima, Japan. 16. Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan. 17. Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 18. Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Abstract
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/m2 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 withcarboplatin plus S-1.
RCT Entities:
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/m2 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.