Phase II study of an oral combination of doxifluridine, prednimustine and idarubicin (FUPRIDA) for first line treatment of advanced breast cancer

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Abstract
An oral combination chemotherapy for breast cancer may be of advantage for many patients, if its activity is equivalent to that of i.v. treatments. The bioavailability of oral idarubicin and of oral doxifluridin allows for their use in an oral 3 drug regimen. Idarubicin 29 mg/m2 was given on day 1, doxifluridine 1500 mg and prednimustine 60 mg were given daily for 10–14 days (7 days/m2) in 17 patients with advanced breast cancer. Cycles (1 to 18) were repeated every 4 weeks or delayed if required by toxic effects. Nine responses were observed with durations ranging from 2 to 16 months. Responding lesions were the primary tumor, or skin, liver and bone metastases. WHO grade 3–4 toxic effects included leukopenia (7 patients), diarrhea and emesis (2 and 1 patient). There were no toxic deaths. If our results are confirmed, this oral 3-drug-combination is a safe and effective treatment that may improve the quality of lives of breast cancer patients with poor venous access.