Efficacy and safety of epirubicin, leucovorin, 5-fluorouracil and cisplatin (ECF-L) regimen in chemotherapy for advanced gastric cancer / 中国癌症杂志

ABSTRACT

Purpose:To evaluate the efficacy and safety of combination regimen of Epirubicin, Leucovorin, 5 Fluorouracil and Cisplatin (ECF L) in treatment of patients with unresectable or recurrent gastric carcinoma, a phase IV study was conducted.Methods:Patient who was pathologically confirmed as primary gastric carcinoma or its metastatic foci with at least one measurable focus was enrolled in nine sites. The chemotherapy regimen was composed of Epirubicin 50mg/m 2 d1, Lecuovorin 200mg/m 2 d1～3, 5 Fu 600mg/m 2 d1～3, and Cisplatin 20mg/m 2 d1～3 given intravenously, which was designed to be three cycles (three weeks per cycle) per patient. Supportive treatment is allowed if necessary. Written informed consent form was obtained from each patient.Results:From 2000 March to 2001 August a total of 79 patients (16/79 of stage Ⅲ, 63/79 of stage Ⅳ; 37/79 of initial chemotherapy, 42/79 of secondary chemotherapy, and 53/79 of recurrent after surgical intervention) were enrolled and finally there were 66 evaluable patients. Among them 4 achieved CR and 18 of PR, the overall response rate (RR) was 33.3% (22/66), the RR of initial patient was 36.7% (11/30), secondary patient was 30.6% (11/36), and subject with lymph node and/or soft tissue metastasis achieved 50.0% (15/30). There were 25 patients with NC, 19 of PD, and 13 withdrew during the study. Most common adverse event occurred was bone marrow suppression (WHO standard degree Ⅲ～Ⅳ, 20.1%), alopecia (Ⅲ～Ⅳ, 5.1%), and nausea/vomiting (Ⅲ～Ⅳ, 2.3%).Conclusions:Current data indicated the ECF L regimen was feasible to treat the unresectable gastric carcinoma with tolerable toxicity.