Y Yamada1, K Higuchi2, K Nishikawa3, M Gotoh4, N Fuse5, N Sugimoto6, T Nishina7, K Amagai8, K Chin9, Y Niwa10, A Tsuji11, H Imamura12, M Tsuda13, H Yasui17, H Fujii15, K Yamaguchi16, H Yasui17, S Hironaka18, K Shimada19, H Miwa20, C Hamada21, I Hyodo22. 1. Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo. Electronic address: yayamada@ncc.go.jp. 2. Department of Gastroenterology, Kitasato University East Hospital, Sagamihara. 3. Department of Surgery, Osaka General Medical Center, Osaka. 4. Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki. 5. Division of Gastrointestinal Oncology and Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa. 6. Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka. 7. Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama. 8. Department of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama. 9. Department of Gastroenterology, Cancer Institute Hospital of JFCR, Tokyo. 10. Department of Endoscopy, Aichi Cancer Center Hospital, Nagoya. 11. Department of Medical Oncology, Kochi Health Sciences Center, Kochi. 12. Department of Surgery, Sakai City Hospital, Sakai. 13. Department of Gastroenterological Oncology, Hyogo Cancer Center, Akashi. 14. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun. 15. Division of Clinical Oncology, Jichi Medical University, Shimotsuke. 16. Division of Gastroenterology, Saitama Cancer Center, Kita-adachi-gun. 17. Department of Medical Oncology, National Hospital Organization Kyoto Medical Center, Kyoto. 18. Clinical Trial Promotion Department, Chiba Cancer Center, Chiba. 19. Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama. 20. Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya. 21. Faculty of Engineering, Tokyo University of Science, Tokyo. 22. Division of Gastroenterology, University of Tsukuba, Tsukuba, Japan.
Abstract
BACKGROUND: We evaluated the efficacy and safety of S-1 plus oxaliplatin (SOX) as an alternative to cisplatin plus S-1 (CS) in first-line chemotherapy for advanced gastric cancer (AGC). PATIENTS AND METHODS: In this randomized, open-label, multicenter phase III study, patients were randomly assigned to receive SOX (80-120 mg/day S-1 for 2 weeks with 100 mg/m(2) oxaliplatin on day 1, every 3 weeks) or CS (S-1 for 3 weeks with 60 mg/m(2) cisplatin on day 8, every 5 weeks). The primary end points were noninferiority in progression-free survival (PFS) and relative efficacy in overall survival (OS) for SOX using adjusted hazard ratios (HRs) with stratification factors; performance status and unresectable or recurrent (+adjuvant chemotherapy) disease. RESULTS: Overall, 685 patients were randomized from January 2010 to October 2011. In per-protocol population, SOX (n = 318) was noninferior to CS (n = 324) in PFS [median, 5.5 versus 5.4 months; HR 1.004, 95% confidence interval (CI) 0.840-1.199; predefined noninferiority margin 1.30]. The median OS for SOX and CS were 14.1 and 13.1 months, respectively (HR 0.958 with 95% CI 0.803-1.142). In the intention-to-treat population (SOX, n = 339; CS, n = 337), the HRs in PFS and OS were 0.979 (95% CI 0.821-1.167) and 0.934 (95% CI 0.786-1.108), respectively. The most common ≥grade 3 adverse events (SOX versus CS) were neutropenia (19.5% versus 41.8%), anemia (15.1% versus 32.5%), hyponatremia (4.4% versus 13.4%), febrile neutropenia (0.9% versus 6.9%), and sensory neuropathy (4.7% versus 0%). CONCLUSION:SOX is as effective as CS for AGC with favorable safety profile, therefore SOX can replace CS. CLINICAL TRIAL NUMBER: JapicCTI-101021.
RCT Entities:
BACKGROUND: We evaluated the efficacy and safety of S-1 plus oxaliplatin (SOX) as an alternative to cisplatin plus S-1 (CS) in first-line chemotherapy for advanced gastric cancer (AGC). PATIENTS AND METHODS: In this randomized, open-label, multicenter phase III study, patients were randomly assigned to receive SOX (80-120 mg/day S-1 for 2 weeks with 100 mg/m(2) oxaliplatin on day 1, every 3 weeks) or CS (S-1 for 3 weeks with 60 mg/m(2) cisplatin on day 8, every 5 weeks). The primary end points were noninferiority in progression-free survival (PFS) and relative efficacy in overall survival (OS) for SOX using adjusted hazard ratios (HRs) with stratification factors; performance status and unresectable or recurrent (+adjuvant chemotherapy) disease. RESULTS: Overall, 685 patients were randomized from January 2010 to October 2011. In per-protocol population, SOX (n = 318) was noninferior to CS (n = 324) in PFS [median, 5.5 versus 5.4 months; HR 1.004, 95% confidence interval (CI) 0.840-1.199; predefined noninferiority margin 1.30]. The median OS for SOX and CS were 14.1 and 13.1 months, respectively (HR 0.958 with 95% CI 0.803-1.142). In the intention-to-treat population (SOX, n = 339; CS, n = 337), the HRs in PFS and OS were 0.979 (95% CI 0.821-1.167) and 0.934 (95% CI 0.786-1.108), respectively. The most common ≥grade 3 adverse events (SOX versus CS) were neutropenia (19.5% versus 41.8%), anemia (15.1% versus 32.5%), hyponatremia (4.4% versus 13.4%), febrile neutropenia (0.9% versus 6.9%), and sensory neuropathy (4.7% versus 0%). CONCLUSION: SOX is as effective as CS for AGC with favorable safety profile, therefore SOX can replace CS. CLINICAL TRIAL NUMBER: JapicCTI-101021.
Authors: Vincent T Janmaat; Ewout W Steyerberg; Ate van der Gaast; Ron Hj Mathijssen; Marco J Bruno; Maikel P Peppelenbosch; Ernst J Kuipers; Manon Cw Spaander Journal: Cochrane Database Syst Rev Date: 2017-11-28
Authors: Haeseong Park; Ramon U Jin; Andrea Wang-Gillam; Rama Suresh; Caron Rigden; Manik Amin; Benjamin R Tan; Katrina S Pedersen; Kian-Huat Lim; Nikolaos A Trikalinos; Abhilasha Acharya; Megan L Copsey; Katherine A Navo; Ashley E Morton; Feng Gao; A Craig Lockhart Journal: JAMA Oncol Date: 2020-08-01 Impact factor: 31.777