Abstract:

Background and purpose: Although there is still no standard first line chemotherapy regimen for metastatic gastric cancer (MGC), the doublet and triplet regimens containing platinum and fluorouracil were most popular worldwidely. The ECF regimen is the classical and one of the most popular treatment choices in this setting, while the marrow suppression, the renal toxicity and poor compliance inhibits its usage. In order to improve its efficacy and tolerability, this study conducted 2 phase Ⅱ trials by modified ECF regimen, the EOF5 regimen (substituting cisplatin with oxaliplatin, shortening the continuous infusion period to 120 h), to treat patients with MGC since 2004.This paper reported the comprehensive results of the 2 studies. Methods: All the patients who enrolled in our previous 2 phase Ⅱ trials and received EOF5 as first line treatment entered this study. Each patient received the treatment of epirubicin 50 mg/m2 iv d1, oxaliplatin 130 mg/m2 iv gtt d1 and 5-FU 375-425 mg/m2·d-1 civ 120 h, and repeated every 3 weeks. Efficacy was analyzed every 6 weeks. Results: A total number of 178 patients (all were metastatic patients but 2 advanced patients with unresectable lesions) were included into this study. One hundred and seventy patients were evaluable, and 7 patients (3.9%) achieved complete response (CR), 76 patients (42.7%) achieved partial response (PR), 46.6% patients achieved overall response rate (ORR, CR+PR), and the cases of stable disease (SD) and progressive disease (PD) were 69 (38.8%) and 18 (10.1%), respectively. The median progress free survival (PFS) and overall survival (OS) were 6.0 months (95%CI: 5.2-6.8) and 12.6 months (95%CI: 8.9-16.3), 1-year and 2-year survival rate were 50.9% and 28.0%, respectively. Grade 3, 4 toxicity including: leucopenia (23.0), neutropenia (38.8%), anemia (6.5%), thrombocytopenia (23.5%), nausea/vomiting (14.1%), and peripheral neuropathy toxicity (1.2%). Among 75 patients who received second line treatment, the median survival from second line treatment was 8.0 months (95%CI: 4.8-11.2). Conclusion: EOF5 regimen is a highly effective regimen with moderate and manageable toxicity, and it providesa suitable alternative for the first-line treatment of MGC.

Key words: Gastric cancer, Combination chemotherapy, Epirubicin, Oxaliplatin, 5-fluorouracil