摘要
目的比较EOX(表阿霉素/奥沙利铂/卡培他滨)和m DCF(多西他赛/顺铂/5-氟尿嘧啶/甲酰四氢叶酸钙)方案一线姑息化疗未经治疗过的晚期人类表皮生长因子受体2(HER2)阴性胃癌的疗效和安全性。方法 158例患者随机分为EOX组(n=79)和m DCF组(n=79)。EOX化疗方案:静脉注射表阿霉素,剂量50 mg/m^2;其次是静脉滴注奥沙利铂2 h,剂量130 mg/m^2;口服卡培他滨21 d,剂量625 mg/m^2,每日两次。m DCF方案:第1天静脉滴注多西他赛60 min,剂量40 mg/m^2;其次静脉滴注甲酰四氢叶酸钙120 min,剂量400 mg/m^2;静脉滴注5-氟尿嘧啶,剂量400mg/m^2,持续2 d;静脉滴注顺铂60 min,剂量40 mg/m^2。连续3 d。每周对患者进行体检和血液检测,评价患者临床疗效和毒性反应,记录数据并统计分析。结果 EOX和m DCF方案组中位总生存期分别为8.9个月和11.2个月(P=0.21),中位无进展生存期分别为6.7个月和6.9个月(P=0.34),两年生存率分别为6.3%和22.8%(P<0.05)。EOX组患者比m DCF组患者化疗剂量降低发生率显著增高(34.2%vs.3.8%,P=0.01),而且出现了延迟治疗(86.1%vs.62.0%,P=0.25)。EOX和m DCF方案组患者3~4级毒性反应发生率间无显著性差异(P>0.05)。与m DCF方案相比,EOX方案组患者恶心、血栓、腹痛和3~4级中性粒细胞减少的发生率较高,但是贫血、黏膜炎和外周神经病变的发生率较低。结论 m DCF与EOX方案一线姑息化疗HER2阴性晚期胃癌的疗效和安全性无显著性差异。
Objective To compare efficacy and safety of first - line palliative chemotherapy with epimbicin/oxaliplatin/cap （EOX） and docetaxel/cisplatin/5FU/leucovorin （mDCF） regimens for untreated advanced HER2 - negative gastric or gastroesophageal junction denocarcinoma. Methods 158 patients were randomly assigned to EOX （n =79） and mDCF （n = 79） group. The EOX regimen consisted of in travenous bolus epirubicin 50 mg/m^2 , followed by intravenous infusion oxaliplatin 130 mg/m^2（2 h） , capecitabine was administered orally, twice daily at the dose of 625 mg/m^2 for 21 days. The mDCF regimen consisted of intravenous infusion docetaxel 40 mg/m^2 （60 min） on day 1 , followed by intravenous infusion leucovorin 400 mg/m^2 （120 min） on day 1 , followed by intravenous bolus 5 - fiuorouracil 400 mg/m^2 on day 1 , and then 5 - fiuorouracil 1 000 mg/m^2/day continuous intravenous infusion on day 1 and day 2, followed by intravenous infusion cisplatin 40 mg/m^2 （60 min） on day 3. The patients was performed physical examination and blood test weekly to evaluate the efficacy and toxicity, and the data were recorded and analyzed. Results The median overall survival was 8.9 months with EOX and 11.2 months with mDCF （ P = 0 .2 1 ） , while median progression - free survival was 6.7 and 6.9 months, respectively （ P = 0. 3 4 ） . Two - year survival rate was 6 .3 % with EOX compared to 22. 8 % with mDCF. Patients in the EOX had more frequent reductions in chemotherapy doses （34.2% vs. 3. 8% , P = 0 .0 1 ） and delays in subse-quent chemotherapy cycles （86.1% vs. 62.0% , P =0.25） . There was no statistically significant difference in the rates of grade 3 -4 toxic reac-tions （ P 〉0. 05）. As compared with the mDCF, the EOX regimen was associated with more frequent nausea, thromboembolic events, abdominal pain and grades 3 -4 neutropenia, but lower incidences of anemia, mucositis and peripheral neuropathy. Conclusion There was no statistically significant d
出处
《临床和实验医学杂志》
2016年第17期1679-1682,共4页
Journal of Clinical and Experimental Medicine
