Epirubicin combined with oxaliplatin and 5-day continuous infusion of 5-fluorouracil as a first-line treatment for metastatic gastric cancer: treatment outcomes and analysis of prognostic factors.

In order to confirm the efficacy, tolerability, and baseline prognostic factors of an epirubicin (EPR)-containing triplet regimen, the EOF5 regimen, in patients with metastatic gastric cancer (MGC), we conducted the phase II trial and retrospective analysis. MGC patients received the EOF5 regimen (EPR 50 mg/m(2) and oxaliplatin (OX) 130 mg/m(2) on day 1 followed by continuous infusion of 5-fluorouracil (5-FU) 375-425 mg/m(2)/days for 5 days every 3 weeks). Log-rank tests were used for univariate analysis of time to progression (TTP) and overall survival rate (OS), and stepwise Cox proportional hazards regression modeling was performed to generate a prognostic index. A total of 158 patients received the EOF5 regimen. Of the 150 evaluable patients, complete remission, partial remission, and stable disease were observed in 5 (3.3%), 70 (46.7%), and 58 patients (38.7%), respectively. The median TTP and OS were 6.0 (95% CI 5.4-6.6) and 12.6 months (95% CI 8.2-16.9), respectively. Grade 3-4 neutropenia (44.0%), thrombocytopenia (25.3%), and anemia (6.7%) were recorded. A prognostic index that included liver and lung metastasis, ascites/pleural effusion, and baseline serum CA19-9 was used to categorize the patients into three groups: good risk (0 risk factors), moderate risk (1 or 2 risk factors), and poor risk (3 or 4 risk factors). The median OS for these groups was 30.4, 12.4, and 5.6 months, respectively (P < 0.001). EOF5 is an effective regimen and a suitable alternative for the first-line treatment of MGC. According to the prognostic index used in our study, patients with no risk factors have a better OS when treated with EOF5 than those with one or more risk factors.