多西他赛联合奥沙利铂及卡培他滨治疗进展期胃癌的疗效及安全性评估——单中心非对照Ⅱ期临床研究

Efficacy and safety evaluation of docetaxel plus oxaliplatin and capecitabine in the treatment of advanced gastric adenocarcinoma： a single center non-controlled phase Ⅱ clinical trial

目的评价多西他赛联合奥沙利铂及卡培他滨方案（DOX方案）治疗进展期胃癌的临床疗效和不良反应。方法采用单中心非对照Ⅱ期临床研究，进展期胃癌患者30例人组。DOX方案为：多西他赛75mg／m2，第1天，静脉滴注2h：奥沙利铂130mg／m2，第1天，静脉滴注2h：卡培他滨1000mg／mz．2次／d．口服。1～14d；每21d为1周期。至少2周期后评价疗效及不良反应。结果入组30例患者均根据RECIST标准评估疗效．完全缓解1例，部分缓解2例，稳定25例，进展2例；有效率为10．0％（3／30），疾病控制率为93．3％（28／30）。中位随访时间261d，全组患者中位无进展生存期197d，中位总生存期466d。不良反应：18例（60．0％）发生Ⅲ～Ⅳ度白细胞减少，13例（43．3％）发生Ⅲ～Ⅳ度中性粒细胞减少，9例（30．0％）出现粒细胞减少性发热，8例（26．7％）发生Ⅲ～Ⅳ度乏力。结论DOX方案治疗进展期胃癌疗效较好．有一定的耐受性．值得进一步扩大样本量开展后续研究．

Objective To assess the efficacy and safety of docetaxel plus oxaliplatin and capecitabine （DOX） in the treatment of advanced gastric adenocarcinoma. Methods A total of 30 patients were recruited to receive DOX regimen （docetaxel 75 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, and capecitabine 1000 mg/m2 bid dl-14, repeated every 3 weeks）. Only those who completed at least 2 cycles were assessed. Results The number of patients with complete response, partial response, stable disease and progressive disease were 1, 2, 25 and 2, respectively. The objective response rate was 10.0% （3/30） and the disease control rate was 93.3% （28/30）. After a median follow-up of 261 days, the median progression free survival and overall survival time were 197 days and 466 days, respectively. The most common grade m to iv toxicity was hematologic toxicity. The percentage of patients with grade m to Ⅳ leucopenia, neutropenia and febrile neutropenia were 60.0%, 43.3% and 30.0%, respectively. The most common grade Ⅱ to Ⅳ non-hematologic toxicity was fatigue, nausea, vomiting, anorexia, diarrhea, and hand-foot syndrome. Conclusions DOX regimen demonstrates promising efficacy in the treatment of advanced gastric adenocarcinoma. The associated toxicity can be well tolerated and controlled. Large scale clinical trial is necessary to obtain further evidence.