Treatment of advanced, refractory breast cancer with alternating docetaxeland epirubicin/cyclophosphamide plus human granulocyte colony-stimulating factor

Purpose. A phase II study was performed to investigate the efficacy and tol erance of alternating docetaxel and epirubicin/cyclophosphamide plus recomb inant human granulocyte colony-stimulating factor (G-CSF) in patients with advanced breast cancer who failed previous non-anthracycline/taxane-contain ing palliative chemotherapy. Patients and methods. Between November 96 and June 98, a total of 45 patien ts participated in this trial. Chemotherapy consisted of docetaxel 100 mg/m (2) given as a 1-h infusion on day 1, and epirubicin 100 mg/m(2) plus cyclo phosphamide 800 mg/m(2) both adminstered on day 21. G-CSF 5 mug/kg/day was given subcutaneously from days 22-28 during each cycle. Treatment courses w ere repeated every 42 days for a total of three courses unless prior eviden ce of progressive disease. Results. The overall response rate was 57.8% (95% confidence interval, 42.1 -72.3%), including seven complete (15.5%) and 19 partial remissions (42.3%) ; nine patients (20%) had stabilization of disease and 10 (22.3%) progresse d. The median time to treatment failure was 7.0 months (range 1.5-26.0), an d the median overall survival time 15.0 months (range 2.0-37.0+) with 12 pa tients (27%) currently still alive with metastatic disease. Myelosuppressio n was commonly observed with WHO grade 3/4 neutropenia in 20 patients (44%) complicated by septicemia in five (11%). Severe nonhematologic toxicity in cluded stomatitis in five patients (11%), skin and peripheral neurotoxicity each in one patient; alopecia was seen in all 45 patients with complete ha ir loss in 26 (58%). Conclusions. Our data suggest that alternating docetaxel and epirubicin/cyc lo-phosphamide plus G-CSF is an effective and tolerable second-line combina tion regimen for the treatment of advanced breast cancer.