Abstract

A prospective clinical trial, phase III, multicentric, open, comparative and randomized, was performed. Sixty patients with locally advanced breast cancer, stage IIIA, were divided in two groups and submitted to primary chemotherapy, with and without intensification of doses, for 4 cycles and surgery.

It has been used regimen FEC 50 in arm A (5-FU 500 mg/m², epirubicin 50 mg/m² and cyclophosphamide 500 mg/m²) and FEC 100 in arm B (5-FU 500 mg/m2, epirubicin 100 mg/m² and cyclophosphamide 500 mg/m²).

It has been cyclically analyzed: the performance status, weight change, hair loss, digestive and hematologic disorders and cardiotoxicity. After the primary chemotherapy, the clinical objective response rate and pathological response in the surgical specimens were evaluated.

The clinical response (complete + partial response) was 93% in arm A and 96% in arm B. There was a higher proportion of complete responses in arm B.

The residual tumor was analyzed in the surgical specimens. In arm A there were 4 (13%) complete pathological responses, 12 (40%) microscopic residual tumor and 14 (47%) macroscopic. In arm B there were 10 (33%) complete pathological responses, 7 (23%) microscopic residual tumor and 13 (44%) macroscopic.

It has been concluded that the primary chemotherapy with intensification of doses promoted higher clinical objective and pathological response rates. The toxicity, reversible and tolerable, was more intense in the arm of high doses.

Key words: locally advanced breast cancer; primary chemotherapy; dose intensification