Faculty Information |
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Article types | Original article |
Language | English |
Refereed paper | Refereed |
Title | Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naïve patients with advanced gastric cancer. |
Journal | Formal name:Annals of oncology : official journal of the European Society for Medical Oncology / ESMO Abbreviation:Ann Oncol ISSN code:1569-8041(Electronic)0923-7534(Linking) |
Volume, Number, Page | 26(1),pp.141-8 |
Papers・Author | Yamada Y, Higuchi K, Nishikawa K, Gotoh M, Fuse N, Sugimoto N, Nishina T, Amagai K, Chin K, Niwa Y, Tsuji A, Imamura H, Tsuda M, Yasui H, Fujii H, Yamaguchi K, Yasui H, Hironaka S, Shimada K, Miwa H, Hamada C, Hyodo I |
Publication date | 2014/10 |
Papers・Description | 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 withPATIENTS AND METHODS:60 mg/m(2) cisplatin on day 8, every 5 weeks). The primary endpoints were non-inferiority in progression-free survival (PFS) and relative efficacy in overall survival (OS) for SOX using adjusted hazard ratios (HR) 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 non-inferior to CS (n=324) in PFS (median, 5.5 versus 5.4 months; HR 1.004, 95% confidence interval [CIRESULTS:]RESULTS:0.840-1.199; predefined non-inferiority 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. |
DOI | 10.1093/annonc/mdu472 |
PMID | 25316259 |