PHASE I-II STUDY OF SEQUENTIAL HIGH-DOSE METHOTREXATE AND 5-FLUOROURACIL COMBINED WITH EPIRUBICIN (FEMTX) AT DIFFERENT DOSE LEVELS IN ADVANCED GASTRIC-CANCER

In a phase I-II multicentre trial, sixty patients with advanced measur able or non-measurable gastric cancer were treated with FEMTX (methotr exate, 5-fluorouracil and epirubicin). Epirubicin was administered at doses of 50, 60 and 70 mg/m(2). No major differences in the toxicity, response rates and survival were observed between the three different dose levels. Results appeared to be comparable with those achieved wit h FAMTX (methotrexate, 5-fluorouracil and adriamycin) in other studies . The FAMTX or FEMTX protocol could be the reference treatment in futu re clinical trials, which seek to improve the therapeutic outcome in a dvanced gastric cancer. FEMTX with epirubicin at a dose of 70 mg/m(2) can be considered as a first attempt to modify FAMTX and the potential role of the higher dose of this anthracycline-containing regimen is n ow under study in the adjuvant setting.