• Ann. Oncol. · Jan 2015

    Randomized Controlled Trial Multicenter Study Comparative Study

    Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naïve patients with advanced gastric cancer.

    • Y Yamada, K Higuchi, K Nishikawa, M Gotoh, N Fuse, N Sugimoto, T Nishina, K Amagai, K Chin, Y Niwa, A Tsuji, H Imamura, M Tsuda, H Yasui, H Fujii, K Yamaguchi, S Hironaka, K Shimada, H Miwa, C Hamada, and I Hyodo.
    • Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo. Electronic address: yayamada@ncc.go.jp.
    • Ann. Oncol. 2015 Jan 1; 26 (1): 141-148.

    BackgroundWe 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 MethodsIn 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.ResultsOverall, 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%).ConclusionSOX is as effective as CS for AGC with favorable safety profile, therefore SOX can replace CS.Clinical Trial NumberJapicCTI-101021.© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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