Oxaliplatin plus S-1 or capecitabine as neoadjuvant or adjuvant chemotherapy for locally advanced gastric cancer with D2lymphadenectomy: 5-year follow-up results of a phase II-III randomized trial

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英文篇名：Oxaliplatin plus S-1 or capecitabine as neoadjuvant or adjuvant chemotherapy for locally advanced gastric cancer with D2lymphadenectomy: 5-year follow-up results of a phase II-III randomized trial 作者：Kan ; Xue ; Xiangji ; Ying ; Zhaode ; Bu ; Aiwen ; Wu ; Zhongwu ; Li ; Lei ; Tang ; Lianhai ; Zhang ; Yan ; Zhang ; Ziyu ; Li ; Jiafu ; Ji 英文作者：Kan Xue;Xiangji Ying;Zhaode Bu;Aiwen Wu;Zhongwu Li;Lei Tang;Lianhai Zhang;Yan Zhang;Ziyu Li;Jiafu Ji;Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute;Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Department of Pathology, Peking University Cancer Hospital & Institute;Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Department of Radiology, Peking University Cancer Hospital & Institute; 英文关键词：SOX;;CapeOX;;neoadjuvant chemotherapy;;adjuvant chemotherapy;;gastric cancer 中文刊名：ZHAY 英文刊名：中国癌症研究(英文版) 机构：Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute;Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Department of Pathology, Peking University Cancer Hospital & Institute;Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Department of Radiology, Peking University Cancer Hospital & Institute; 出版日期：2018-10-15 出版单位：Chinese Journal of Cancer Research 年：2018 期：v.30 基金：supported in part by the grants from Beijing Municipal Science&Technology Commission(No D171100006517002) 语种：英文; 页：ZHAY201805005 页数：10 CN：05 ISSN：11-2591/R 分类号：44-53

摘要

Objective: To compare the effect of neoadjuvant chemotherapy(NACT) with adjuvant chemotherapy(ACT)using oxaliplatin plus S-1(SOX) or capecitabine(CapeOX) on gastric cancer patients with D2 lymphadenectomy.Methods: This was a two-by-two factorial randomized phase II-III trial, and registered on ISRCTN registry(No. ISRCTN12206108). Locally advanced gastric cancer patients were randomized to neoadjuvant SOX,neoadjuvant CapeOX, adjuvant SOX, or adjuvant CapeOX arms. Primary analysis was performed on an intentionto-treat(ITT) basis using overall survival(OS) as primary endpoint.Results: This trial started in September 2011 and closed in December 2012 with 100 patients enrolled.Treatment completion rate was 56%, 52%, 38% and 30% in the four arms, respectively. NACT group had fewer dropouts due to unacceptable toxicity(P=0.042). Surgical complication rate did not differ by the four groups(P=0.986). No survival significant difference was found comparing NACT with ACT(P=0.664; 5-year-OS: 70% vs.74% respectively), nor between the SOX and CapeOX groups(P=0.252; 5-year-OS: 78% vs. 66% respectively).Subgroup analysis showed SOX significantly improved survival in patients with diffuse type(P=0.048).Conclusions: No significant survival difference was found between NACT and ACT. SOX and CapeOX had good safety and efficacy as neoadjuvant regimens. Diffuse type patients may survive longer due to SOX.
        Objective: To compare the effect of neoadjuvant chemotherapy(NACT) with adjuvant chemotherapy(ACT)using oxaliplatin plus S-1(SOX) or capecitabine(CapeOX) on gastric cancer patients with D2 lymphadenectomy.Methods: This was a two-by-two factorial randomized phase II-III trial, and registered on ISRCTN registry(No. ISRCTN12206108). Locally advanced gastric cancer patients were randomized to neoadjuvant SOX,neoadjuvant CapeOX, adjuvant SOX, or adjuvant CapeOX arms. Primary analysis was performed on an intentionto-treat(ITT) basis using overall survival(OS) as primary endpoint.Results: This trial started in September 2011 and closed in December 2012 with 100 patients enrolled.Treatment completion rate was 56%, 52%, 38% and 30% in the four arms, respectively. NACT group had fewer dropouts due to unacceptable toxicity(P=0.042). Surgical complication rate did not differ by the four groups(P=0.986). No survival significant difference was found comparing NACT with ACT(P=0.664; 5-year-OS: 70% vs.74% respectively), nor between the SOX and CapeOX groups(P=0.252; 5-year-OS: 78% vs. 66% respectively).Subgroup analysis showed SOX significantly improved survival in patients with diffuse type(P=0.048).Conclusions: No significant survival difference was found between NACT and ACT. SOX and CapeOX had good safety and efficacy as neoadjuvant regimens. Diffuse type patients may survive longer due to SOX.

引文

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