Between May 1995 and July 1997, paclitaxel (TX) (175 mg/m(2) by 3 h i.
v. infusion every 21 days) was administered to 70 consecutive patients
(median age: 57 years) previously treated with the FEC regimen (cyclo
phosphamide and 5-fluorouracil, 600 mg/m(2), plus epirubicin, 60 or 12
0 mg/m(2)) as an adjuvant setting or as a first-line therapy for metas
tatic disease. Sixty-eight patients were evaluable for response, while
two died early. Patients received a median of 4.7 (3-12 course) of TX
for a total of 211 courses. The overall response and stable disease r
ate was 54% in 11 patients, who relapsed following adjuvant FEC, and 6
0% in 57 patients, who received FEC as first treatment for their metas
tatic disease. No complete respose was obtained. In patients pretreate
d for metastatic disease, response and stable disease rates were simil
ar irrespective of previous response to FEC. Main hematologic toxicity
of TX was of short duration, grade II/III leukopenia (86% of patients
) and non-hematologic toxicity was grade II/III peripheral neuropathy,
related to the cumulative dose of TX. At this schedule, TX offers a s
ignificant rate of partial responses or disease stabilization in patie
nts with metastatic breast cancer previously treated with FEC.