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 breast cancer were randomly treated with two regimens, including different dosages of epirubicin (75 versus 100 mg/m(2)) associated with the same dosage (600 mg/m(2)) of cyclophosphamide and 5-fluoruracil (75-FEC vs 100-FEC). Patients were planned to receive 6 courses at 21 day-intervals. Thirty-six patients received the 75-FEC regimen and 33 received the 100-FEC regimen. The two groups were comparable for age, menopausal status, disease-free interval, previous therapy, performance status and sites of disease: Over the whole study, the 100-FEC regimen has allowed a 18% actual increase in the epirubicin dosage over the 75-FEC regimen. 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 the 75-FEC (38% vs 23%). Survival (but not time to progression) tended to be longer with the 100- than with the 75-FEC (median: 20 vs 13 mos, p<0.09). Nonhematologic side effects Were similar. Hematologic toxicity was slightly higher with 100- than with 75-FEC, with granulocyte colony stimulating factors used to recycle in the scheduled time in the 15 and 4% of courses, respectively.

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