课件：胃癌新辅助化疗方案.ppt

* REAL-2 is a randomized, controlled, multicenter, phase III study evaluating the role of Xeloda and oxaliplatin in previously untreated 1st-line patients with esophagogastric cancer, using a 2x2 factorial design [1]. Patients (n=1002) were randomized to receive eight cycles of treatment with one of four regimens epirubicin 50mg/m2 and cisplatin 60mg/m2, day 1 every 3 weeks plus 5-FU 200mg/m2 daily continuous infusion (ECF) epirubicin 50mg/m2 and oxaliplatin 130mg/m2, day 1 every 3 weeks plus 5-FU 200mg/m2 daily continuous infusion (EOF) epirubicin 50mg/m2 and cisplatin 60mg/m2, day 1 every 3 weeks plus Xeloda 500–625mg/m2, twice daily continuously (ECX) epirubicin 50mg/m2 and oxaliplatin 130mg/m2, day 1 every 3 weeks plus Xeloda 500–625mg/m2, twice daily continuously (EOX). Stratified by center, performance status, extent of disease and esophagus/esophagogastric junction vs. stomach cancer. Chemona?ve pts, any prior radiotherapy must have been in adjuvant setting. Primary endpoint overall survival. Secondary endpoints included disease-free survival, response rates, response duration, TTP, toxicity, QoL and determination of optimal Xeloda and oxaliplatin doses. Initial dose escalation of Xeloda based on interim safety analysis of fluoropyrimidine toxicities. 1. Sumpter K et al. Br J Cancer 2005;92:1976–83. * 2005年ASCO年会上，Dank*报告CPT-11联合5-FU治疗晚胃癌的III期临床试验. 研究设计： CPT-11 80mg/m2， CF 500mg/m2， 5-FU 2000mg/m2civ， qw×6w 333例晚期胃癌 CPT-11方 案组 170 例 PF方案组 163例 PDD 100mg/m2d1， 5-FU1000mg/m2/d d1～5 q4w * Dank M et al Proc Am Soc Clin,2005 CPT-11联合5-FU III期临床试验 CPT-11方案III期试验结果 CPT-11+LF CPT-11+DDP RR (%) 32 26 TTP(月) 5.0 4.2 （P=0.018 ) TTF (月) 4.0 3.4 (P=0.002) OS 9.0 8.7 (P＝0.53) CPT-11方案III期研究结论 研究结论：CPT-11联合LF组在疾病进展期方面比CPT-11+DDP组有优势，但在总生存期上并没有显出优势，有待进一步验证。 4.含新型口服嘧啶类方案 新型口服氟嘧啶类主要有:卡培他滨 (Xeloda),替吉奥(S-1)等， 单药一线治疗晚期胃癌的RR:24% 联合用药方案,多是由Xe