Oxaliplatin plus S-1 or capecitabine as neoadjuvant or adjuvant chemotherapy for locally advanced gastric cancer with D2 lymphadenectomy: 5-year follow-up results of a phase II-III randomized trial
Oxaliplatin plus S-1 or capecitabine as neoadjuvant or adjuvant chemotherapy for locally advanced gastric cancer with D2 lymphadenectomy: 5-year follow-up results of a phase II-III randomized trial
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DOI：
10.21147/j.issn.1000-9604.2018.05.05
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发表时间：
2018-10-01
影响因子：
5.1
通讯作者：
Ji, Jiafu
中科院分区：
文献类型：
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作者：
Xue, Kan;Ying, Xiangji;Ji, Jiafu
目的：比较新辅助化疗（NACT）与奥沙利铂联合S-1 （SOX）或卡培他滨（CapeOX）辅助化疗（ACT）对胃癌D2淋巴结切除术患者的疗效。方法：这是一项2乘2因子随机II-III期试验，并在ISRCTN注册中心注册（No. 5）。ISRCTN12206108)。局部晚期胃癌患者随机分到新辅助SOX组、新辅助CapeOX组、辅助SOX组或辅助CapeOX组。主要分析以意向治疗（ITT）为基础，以总生存期（OS）为主要终点。结果：该试验于2011年9月开始，2012年12月结束，入组100例患者。四组治疗完成率分别为56%、52%、38%和30%。NACT组因不可接受毒性而退出的患者较少（P=0.042）。四组手术并发症发生率差异无统计学意义（P=0.986）。NACT组和ACT组的生存率无显著差异（P=0.664； 5年生存率分别为70%和74%），SOX组和CapeOX组的生存率也无显著差异（P=0.252； 5年生存率分别为78%和66%）。亚组分析显示，SOX可显著提高弥漫型患者的生存率（P=0.048）。结论：NACT与ACT的生存率无显著差异。SOX和CapeOX作为新辅助方案具有良好的安全性和有效性。弥漫性患者可因SOX存活更长时间。
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.