表柔比星联合奥沙利铂和短期5-FU 持续滴注的EOF5方案一线治疗晚期胃癌的疗效评估

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背景与目的:晚期胃癌治疗中,ECF(表柔比星、顺铂及5-FU持续滴注21 d)方案系经典一线方案,2004年起我们以奥沙利铂取代顺铂,以低剂量5-FU持续滴注120 h取代标准剂量持续滴注21 d,组成EOF5方案,以期提高疗效及依从性,先后开展了小样本探索性研究及扩大样本的Ⅱ期研究。方法:本研究回顾性分析了该两项Ⅱ期研究结果。患者均接受了表柔比星50 mg/m2,静脉推注,第1天;奥沙利铂130 mg/m2,静脉滴注2 h,第1天;每天5-FU的剂量为375~425 mg/m2,低剂量持续输注5 d共120 h;每3周重复,每6周评价疗效。治疗到进展、不能耐受或患者退出,对于6~8个疗程后稳定以上疗效的患者根据医师推荐及患者的意愿,选择氟尿嘧啶类药物维持治疗或观察。结果:178例晚期胃癌患者纳入本研究,170例可行疗效及不良反应评估,7例(3.9%)完全缓解(complete response,CR),76例(42.7%)部分缓解(partial response,PR),总有效率(overall response rate,ORR,CR+PR)为46.6%,69例(38.8%)疾病稳定(stable disease,SD),18例(10.1%)疾病进展(progressive disease,PD)。中位无进展生存期(progress free survival,PFS)为6.0个月(95%CI:5.2~6.8),中位总生存期(overall survival,OS)为12.6个月(95%CI:8.9~16.3),1、2年生存率分别为50.9%和28.0%。3~4度以上不良反应主要有白细胞及中性粒细胞减少23.0%及38.8%、血红蛋白下降6.5%、血小板下降23.5%、恶心呕吐14.1%、手足麻木1.2%。接受二线治疗的75例患者,二线治疗中位生存时间8.0个月(95%CI:4.8~11.2)。结论:EOF5方案治疗晚期胃癌有效率高,PFS和OS同ECF及其改良方案类似,不良反应可控,是安全有效的晚期胃癌一线治疗方案。 BACKGROUND & OBJECTIVE: In the treatment of advanced gastric cancer, ECF (epirubicin, cisplatin and 5-FU continuous infusion of 21 d) program is a classic first-line program, we replaced oxaliplatin in 2004, cisplatin, low dose Continuous infusion of 5-FU for 120 h instead of the standard dose continued for 21 days to form EOF5 regimen in order to improve the efficacy and compliance. A series of exploratory studies of small samples and phase Ⅱ studies of expanding samples were carried out. Methods: This study retrospectively analyzed the two phase Ⅱ study results. Patients received epirubicin 50 mg / m2 intravenously on day 1; oxaliplatin 130 mg / m2 intravenously for 2 h on day 1; and daily doses of 5-FU were 375-425 mg / m2, low-dose continuous infusion of 5 d a total of 120 h; repeated every 3 weeks, 6 weeks to evaluate the curative effect. Treatment to progress, can not tolerate or patient withdrawal, for 6 to 8 months after the treatment of patients with more than stable response to the doctor’s recommendation and the wishes of patients, select fluorouracil drugs to maintain treatment or observation. Results: A total of 178 patients with advanced gastric cancer were enrolled in this study. The efficacy and adverse reactions were evaluated in 170 patients, complete response (CR) in 7 patients (3.9%), partial response (PR) in 76 patients (42.7% The overall response rate (ORR, CR + PR) was 46.6%, 69 cases (38.8%) were stable disease (SD) and 18 cases (10.1%) were progressive disease (PD). The median progression-free survival (PFS) was 6.0 months (95% CI: 5.2-6.8) and the median overall survival (OS) was 12.6 months (95% CI: 8.9-16.3 ). The 1-year and 2-year survival rates were 50.9% and 28.0% respectively. More than 3 ~ 4 degrees of adverse reactions are mainly white blood cells and neutrophils decreased 23.0% and 38.8%, hemoglobin decreased 6.5%, thrombocytopenia 23.5%, nausea and vomiting 14.1%, 1.2% numb hands and feet. For the 75 patients receiving second-line therapy, median survival time for second-line therapy was 8.0 months (95% CI: 4.8 to 11.2). Conclusion: The EOF5 regimen is effective in treating advanced gastric cancer. PFS and OS are similar to those of ECF and its modified regimen. Adverse reactions are controllable. It is a safe and effective first-line treatment for advanced gastric cancer.
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