Phase II trial of UFT activity in pretreated breast cancer patients

Seventy metastatic breast adenocarcinoma patients, pretreated with standard hormonotherapy or chemotherapy, received continuous UFT at 10 mg/kg/day, orally, for at least two months. There were one complete response (1.5%), 12 partial responses (17%), one minor response and 37 disease stabilizations. The median duration of response was nine months. A greater efficacy was demonstrated in 29 patients with soft tissue disease, with a rate of 38% objective responses. The major toxicity was gastrointestinal, with 45% of patients developing nausea and vomiting and 30%, diarrhea. Bone marrow toxicity was slight. UFT has shown antitumor activity in our group of pretreated patients, especially these with the cutaneous tumoral and/or inflammatory form of the disease.