多西他赛联合顺铂及氟尿嘧啶(DCF)改良方案治疗晚期胃癌疗效观察

摘要

Objective To assess the efficacy of modified docetaxel, cisplatin and 5 -fluorouracil ( mDCF) chemotherapy in patients with advanced gastric adenocarcinoma. Methods Since January 2006, 45 patients with advanced gastric cancer were enrolled and treated with mDCF protocol. The mDCF protocol included docetaxel 60 mg/m2 on dl, cisplatin 12 mg/m on dl ~5 and 5-fluorouracil 2 500 mg/m2 continuous infusion (civ) for 120 h, at an interval of 3 weeks. The primary endpoint was progression-free survival ( PFS ) and the secondary endpoints were overall survival (OS) , response rate(RR) and side effects. Results In 40 patients who received mDCF as first-line palliative chemotherapy, no patient achieved complete response, 7(17.5%) had partial response, 9(47.5%) had stable disease, and 14(35%) showed progressive disease. Overall response rate was 17. 5% (95% CI 7. 5% ~ 30. 0% ) and disease control rate was 65. 0% (95% CI 50. 0% -11.5%). Median PFS was 5. 2 months(95% CI 3. 6 ~6. 8 months)and median OS was 11. 0 months(95% CI 6. 9 ~ 15. 1 months). In 5　patients who received mDCF as second-line palliative chemotherapy, 3 achieved stable disease and 2 had progressive disease. Median PFS was 5. 3 months(95% CI 0 ~ 11. 3 months) and median OS was 8. 5 months(95% CI 0 ~ 17. 1 months). Major side effects were hematologic effects. The rates of grade 3/4 neutropenia, neutropenia with fever, nausea, vomiting and diarrhea were 26. 7% ,11. 1% , 8. 9% , 8. 9% and 11. 1% respectively. ConclusionsrnThe mDCF regimen is effective with a folerable toxicity profile.%目的 研究多西他赛联合顺铂及氟尿嘧啶改良方案(mDCF)治疗晚期胃癌的疗效及安全性.方法 2006年1月起,采用改良DCF方案治疗45例晚期胃癌患者.化疗方案:多西他赛60 mg/m2,d1；顺铂12 mg/m2,d1 ～5;氟尿嘧啶2500 mg/m2,持续输注(civ) 120 h；每21天一个周期.主要研究终点:无进展生存期(PFS).次要研究终点:总生存期(OS),总缓解率(ORR)及不良反应.结果 接受一线解救化疗患者40例,完全缓解0例(0％),部分缓解7例(17.5％),疾病稳定19例(47.5％),疾病进展14例(35.0％),总缓解率17.5％(95％ CI 7.5％ ～30.0％),疾病控制率65.0％ (95％ CI 50.0％ ～77.5％).中位PFS 5.2个月(95％ CI 3.6～6.8月),中位OS 11.0个月(95％CI6.9～15.1月).接受二线解救化疗患者5例,疾病稳定3例,疾病进展2例,中位PFS 5.3个月(95％ CI 0 ～11.3月),中位OS 8.5个月(95％ CI0～17.1月).主要不良反应为血液学毒性,Ⅲ～Ⅳ度粒细胞减少及粒细胞减少伴发热发生率分别为26.7％及11.1％,Ⅲ～Ⅳ度恶心、呕吐及腹泻发生率分别为8.9％、8.9％及11.1％.结论 改良DCF方案有效,不良反应可耐受.