A randomized phase III trial of oral S-1 plus cisplatin versus docetaxel plus cisplatin in Japanese patients with advanced non-small-cell lung cancer: TCOG0701 CATS trial |
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| Institution: | 1. Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo;2. Department of Thoracic Oncology, Saitama Cancer Center, Kita-adachi-gun;3. Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe;4. Department of Thoracic Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo;5. Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai;6. Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen''s HospitalHodogaya-ku;7. Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo;8. Department of Medical Oncology, Japanese Red Cross Medical Center, Tokyo;9. Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba;10. Department of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama;11. Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki;12. Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa;13. Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai;14. Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota;15. Department of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center, Omura;16. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata;17. Department of Clinical Medicine (Biostatistics and Pharmaceutical Medicine), Kitasato University School of Pharmacy, Tokyo;18. Double-Barred Cross Hospital Japan Anti-Tuberculosis Association, Tokyo, Japan |
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| Abstract: | BackgroundPlatinum-based two-drug combination chemotherapy has been standard of care for patients with advanced nonsmall-cell lung cancer (NSCLC). The primary aim was to compare overall survival (OS) of patients with advanced NSCLC between the two chemotherapy regimens. Secondary end points included progression-free survival (PFS), response, safety, and quality of life (QoL).Patients and methodsPatients with previously untreated stage IIIB or IV NSCLC, an Eastern Cooperative Oncology Group performance status of 0–1 and adequate organ function were randomized to receive either oral S-1 80 mg/m2/day on days 1–21 plus cisplatin 60 mg/m2 on day 8 every 4–5 weeks, or docetaxel 60 mg/m2 on day 1 plus cisplatin 80 mg/m2 on day 1 every 3–4 weeks, both up to six cycles.ResultsA total of 608 patients from 66 sites in Japan were randomized to S-1 plus cisplatin (n = 303) or docetaxel plus cisplatin (n = 305). OS for oral S-1 plus cisplatin was noninferior to docetaxel plus cisplatin median survival, 16.1 versus 17.1 months, respectively; hazard ratio = 1.013; 96.4% confidence interval (CI) 0.837–1.227]. Significantly higher febrile neutropenia (7.4% versus 1.0%), grade 3/4 neutropenia (73.4% versus 22.9%), grade 3/4 infection (14.5% versus 5.3%), and grade 1/2 alopecia (59.3% versus 12.3%) were observed in the docetaxel plus cisplatin than in the S-1 plus cisplatin. There were no differences found in PFS or response between the two arms. QoL data investigated by EORTC QLQ-C30 and LC-13 favored the S-1 plus cisplatin.ConclusionOral S-1 plus cisplatin is not inferior to docetaxel plus cisplatin and is better tolerated in Japanese patients with advanced NSCLC.Clinical trial numberUMIN000000608. |
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