Ineffectiveness of sequential high dose methotrexate and 5-fluorouracil combined with epirubicin (FEMTX regimen) as a salvage therapy in advanced colorectal cancers and other gastrointestinal tumors.

The combination of sequential high dose methotrexate and 5-fluorouracil (FU) combined with epirubicin (FEMTX regimen) has shown some clinical efficiency as a first line therapy in advanced gastric cancer. We evaluated the therapeutic activity of this combination in advanced colorectal cancer patients who failed the FU + folinic acid regimen, and in advanced gastrointestinal cancer situation where no standard regimen is available. Twelve patients with measurable metastatic colorectal cancer refractory to first line (n = 6) or second line (n = 6) chemotherapy, as well as 9 patients with advanced gastrointestinal cancer, entered this pragmatic pilot study. Eighty-six per cent and 38% of the patients experienced severe haematological or non-haematological toxicities, respectively. Four patients were not evaluable for response due to their early departure from the scheme due to acute toxic events (n = 3) or toxic death (n = 1). No objective response was observed, but 9 stabilisations and 8 progressive diseases were noted. The FEMTX regimen is not of clinical value as a salvage therapy in colorectal and gastrointestinal cancer, because of its toxicity and its lack of efficacy.