周剂量紫杉醇联合顺铂、卡培他滨治疗晚期胃癌的临床研究

Clinical Comparison of Weekly Paclitaxel Combined Cisplatin and Capecitabine in Treatment of Advanced Gastric Cancer

目的观察周剂量紫杉醇联合顺铂、卡培他滨方案治疗晚期胃癌的客观疗效、疾病进展时间和不良反应。方法77例晚期胃癌患者随机分为2组,治疗组39例晚期胃癌患者接受周剂量紫杉醇75 mg/m^2（d1、d8、d15）,顺铂25 mg/m2（d1、d8、d15）,卡培他滨每日1 250 mg/m^2,分2次口服,d1-d14,28 d为1周期,疗程2-6周期。对照组38例晚期胃癌患者接受奥沙利铂85 mg/m^2,d1,亚叶酸钙200 mg/m^2（2 h静脉输注）d1-d2,而后5-氟尿嘧啶（5-Fu）400 mg/m^2（10 min静脉推注）及5-Fu 600 mg/m^2（持续静脉泵入22 h）,d1-d2,每14天重复,2次为1周期。结果治疗组有效率显著高于对照组（59.0%vs 47.4%,P〈0.05）,TTP治疗组较对照组显著延长（6.8个月vs 5.8个月,P〈0.05）。治疗组手足综合征发生率显著高于对照组（P〈0.01）,其他不良反应按分级比较2组无显著性差异（P〉0.05）。Karnofsky评分治疗组改善率较对照组显著增高（P〈0.05）。结论周剂量紫杉醇联合顺铂、卡培他滨化疗方案治疗晚期胃癌近期疗效显著,耐受性较好。

Objective To evaluate the objective response rate, time to progression（TTP） and toxicity of weekly paclitaxel combined cisplatin and capecitabine in the treatment for the advanced gastric cancer. Methods 77 patients with advanced gastric cancer were divided randomly into two groups. The patients （n= 39） in treatment group were administrated with paclitaxel 75 mg/m^2 （d1 ,d8,d15） ,cisplatin 25 mg/m^2 （dl ,d8,d15） ,and capecitabine 1 250 mg/（m^2· d） divided in two daily doses given from day 1 to day 14. The cycles were repeated every 28 days. All patients received two to six cycles. The patients （n=38） in control group were administrated with oxaliplatin （85 mg/m^2 , ivgtt, dl ） combined with Leueovorin （200 mg/m^2 , ivgtt ; dl to d2）, fluorouracil （400 mg/m^2 ,iv,followed by 5-Fu 600 mg/m^2 continuous venous infusion 22 hours,dl to d2）,repeated every 14 days,twice for one recycle. The treatment was finished after 2 recycles. Results The response rate of treatment group was significantly higher than control group（59. 0% vs 47.4% ,P〈0.05）. The median TTP of treatment group was significantly more than that of control group（6.8 month vs 5.8 month,P〈0.05）. The incidence of hand-foot syndrome in treatment group was much higher than control groups（P〈0.01）. There was no significant difference of side effects like hematologic toxicity,peripheral neuropathy and gastrointestinal response between two groups（P〉0.05）. Karnofsky score of treatment group is significantely higher than that of control group（P〈0.05）. Conclusion The weekly paclitaxel combined cisplatin and capecitabine regimen offers a better therapeutic option in patients with advanced gastric cancer.