Purpose: 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.
Methods: 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.
Results: 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).
Conclusions: 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.