PHASE-II TRIAL WITH 5-FU, HIGH-DOSE METHOTREXATE, EPIRUBICIN AND CISPLATIN (FEMTX-P) IN ADVANCED GASTRIC-CANCER

In this phase II study, fifty patients with unresectable locally advanced and/or metastatic gastric carcinoma were treated with methotrexate 1.5 g/m2 iv and 5-fluorouracil 1.5 g/m2 iv on day 1; leucovorin rescue 15 mg/m2 orally every 6 h for 8 doses on day 2 and 3; epirubicin 60 mg/m2 iv and cisplatin 50 mg/m2 iv on day 15, q 4 weeks. The median age of the patients was 59 years and their median performance status 1. In forty-eight patients evaluable for response, five (10. 4%) of the patients achieved a complete response and seventeen (35.6%) obtained a partial response (total response rate 46%; 95% confidence interval: 32%-60%). The median duration of response was 8 + months (range: 5 25 months). The median duration of survival of all patients was 10 months (range: 1-25 + months). Toxicities > grade 2 included vomiting grade 3 (31%), leucopenia grade 4 (18%) and thrombocytopenia grade 4 (4%). Treatment postponement or dose reduction for hematologic toxicity was necessary in 54% of patients. Median survival was 10 months. In conclusion, the FEMTX-P regimen is an active treatment in advanced gastric carcinoma with acceptable toxicity.