PHASE-II STUDY OF SEQUENTIAL HIGH-DOSE METHOTREXATE (MTX) AND 5-FLUOROURACIL (F) ALTERNATED WITH EPIRUBICIN (E) AND CISPLATIN (P) [FEMTX-P]IN ADVANCED GASTRIC-CANCER

Background: FAMTX (5-fluorouracil, adriamycin, methotrexate) is one of the most effective drug combinations in gastric cancer. Therefore, mo difications of FAMTX appear of interest and the FEMTX-P regiment was c onceived. Patients and methods: Fifty patients with unresectable local ly advanced and/or metastatic gastric carcinoma were treated with meth otrexate 1500 mg/m2 i.v. and 5-fluorouracil 1500 mg/m2 i.v. on day 1; leucovorin rescue 15 mg/m2 orally every 6 hours for 8 doses on days 2 and 3; epirubicin 60 mg m2 i.v. and cisplatin 50 mg/m2 i.v. on day 15, q 4 weeks. five (11%) achieved complete responses and seventeen (36%) partial responses (total response rate 47%). The median duration of r esponse was 8+ months (range: 5-25+ months). Four of 14 patients with locally advanced disease were successfully downstaged and subsequently resected. The median duration of survival of all patients was 10 mont hs (range: 1-25+ months). Leukopenia grade 4 occurred in 18% of patien ts and thrombocytopenia grade 4 and mucositis grade 4 in 4% and 2%, re spectively. Treatment postponement for hematologic toxicity was necess ary in 54% of patients. Conclusions: The FEMTX-P regimen is an active regimen in advanced gastric carcinoma, with acceptable toxicity.