摘要
Objective： To compare the effect of neoadjuvant chemotherapy （NACT） with adjuvant chemotherapy （ACT） using oxaliplatin plus S-1 （sex） 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 sex, neoadjuvant CapeOX, adjuvant sex, or adjuvant CapeOX arms. Primary analysis was performed on an intention- to-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 signifcant difference was found comparing NACT with ACT （P=0.664; 5-year-OS： 70% vs. 74% respectively）, nor between the sex and CapeOX groups （P=0.252; 5-year-OS： 78% vs. 66% respectively）. Subgroup analysis showed sex significantly improved survival in patents with diffuse type （P=0.048）. Conclusions： No significant survival difference was found between NACT and ACT. sex and CapeOX had good safety and efficacy as neoadjuvant regimens. Diffuse type patients may survive longer due to sex.
Objective： To compare the effect of neoadjuvant chemotherapy （NACT） with adjuvant chemotherapy （ACT） using oxaliplatin plus S-1 （sex） 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 sex, neoadjuvant CapeOX, adjuvant sex, or adjuvant CapeOX arms. Primary analysis was performed on an intention- to-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 signifcant difference was found comparing NACT with ACT （P=0.664; 5-year-OS： 70% vs. 74% respectively）, nor between the sex and CapeOX groups （P=0.252; 5-year-OS： 78% vs. 66% respectively）. Subgroup analysis showed sex significantly improved survival in patents with diffuse type （P=0.048）. Conclusions： No significant survival difference was found between NACT and ACT. sex and CapeOX had good safety and efficacy as neoadjuvant regimens. Diffuse type patients may survive longer due to sex.
基金
supported in part by the grants from Beijing Municipal Science&Technology Commission(No D171100006517002)
作者简介
Correspondence to： Ziyu Li. Key Laboratory of Carcinogenesis and Translational Research （Ministry of Education/Beijing）, Gastrointestinal Cancer Center, Peking University Cancer Hospital ＆ Institute, Beijing 100142, China. Email： ziyu_li@hsc.pku.edu.cn.;Correspondence to： Prof. Jiafu Ji. Key Laboratory of Carcinogenesis and Translational Research （Ministry of Education/Beijing）, Gastrointestinal Cancer Center, Peking University Cancer Hospital ＆ Institute, Beijing 100142, China. Email： jijiafu@hsc.pku.edu.cn
