ADVANCED BREAST-CANCER - A RANDOMIZED STUDY OF DIFFERENT DOSES OF EPIRUBICIN ASSOCIATED WITH FIXED DOSES OF CYCLOPHOSPHAMIDE AND 5-FLUOROURACIL

A moderate increase in the dose of anthracycline could be feasible and of clinical benefit in advanced breast cancer. Between April 1991 and April 1994, 69 consecutive patients with recurrent or metastatic brea st cancer were randomly treated with two regimens, including different dosages of epirubicin (75 versus 100 mg/m(2)) associated with the sam e dosage (600 mg/m(2)) of cyclophosphamide and 5-fluoruracil (75-FEC v s 100-FEC). Patients were planned to receive 6 courses at 21 day-inter vals. Thirty-six patients received the 75-FEC regimen and 33 received the 100-FEC regimen. The two groups were comparable for age, menopausa l status, disease-free interval, previous therapy, performance status and sites of disease: Over the whole study, the 100-FEC regimen has al lowed a 18% actual increase in the epirubicin dosage over the 75-FEC r egimen. Overall response rate was 56% for the 100-FEC and 51% for the 75-FEC, with the 100-FEC inducing some more complete responses than th e 75-FEC (38% vs 23%). Survival (but not time to progression) tended t o be longer with the 100- than with the 75-FEC (median: 20 vs 13 mos, p<0.09). Nonhematologic side effects Were similar. Hematologic toxicit y was slightly higher with 100- than with 75-FEC, with granulocyte col ony stimulating factors used to recycle in the scheduled time in the 1 5 and 4% of courses, respectively.