UFT/oral calcium folinate plus weekly paclitaxel for metastatic breast cancer

Paclitaxel (Taxol) is one of the mast active drugs irt the treatment of ova rian and breast cancers. Combination therapy with paclitaxel and 5-fluorour acil (5-FU) exhibits high activity in anthracycline-pretreated breast cance r, yielding response rates of 54% to 69% in recent studies. Weekly dosing o f paclitaxel produces notable activity, while maintaining relatively low to xicity in heavily pretreated metastatic breast cancer patients, Uracil and tegafur (UFT) plus oral calcium folinate constitute an orally administered compound known as Orzel, This agent provides activity comparable to that of intravenously administered 5-FU plus calcium folinate,with the additional attributes of ease of administration and a more favorable side-effect profi le. We initiated a phase I dose-finding trial to determine the maximum tole rated dose and dose-limiting toxicities of the combination of weekly paclit axel by 1-hour infusion plus UFT/oral calcium folinate administered to pati ents with anthracycline-resistant metastatic breast cancer.