3-year results of docetaxel-based sequential and combination regimens in the adjuvant therapy of node-positive breast cancer: A pilot study

Background,: Docetaxel has proven efficacy in metastatic breast cancer. In this pilot study, we, explored the efficacy/feasibility of docetaxel-based sequential and combination regimens as adjuvant therapy of node-positive breast cancer. Patients and Methods: From March 1996 till March 1998, four consecutive groups of patients with stages II and III breast cancer, aged :5 70 years, received one of the following regimens: a) sequential Doxorubicin (A) --> Docetaxel (T)--> CMF (Cyclophosphamide+Methotrexate+5-Fluorouracil): A 75 mg/m(2) q 3. wks x 3, followed by T100 mg/m(2) q 3 wks x 3, followed by IV CMF Days 1+8 q 4wks x 3; b) sequential accelerated A-->T-->CMF: A and T administered at the same doses q 2 wks with Lenograstin support; c) combination therapy: A 50 mg/m(2) + T75 mg/m(2) q 3 wks x 4, followed by CMF x 4; d) sequential T-->A -->CMF: T and A, administered as in group a), with the reverse sequence. When indicated, radiotherapy was administered during or after CMF, and Tamoxifen after CMF. Results: Ninety-three patients were treated. The median age was 48 years (29-66) and the median number of positive axillary nodes was 6 (1-25). Tumors were operable in 94% and locally advanced in 6% of cases. Pathological tumor size was >2 cm in 72% of cases. There were 21 relapses, (18 systemic, 3 locoregional) and 11 patients (12%) have died from disease progression. At median follow-up of 39 months (6-57), overall survival (OS) was 87% (95% CI, 79-94%) and disease-free survival (DFS) was 76% (95% CI, 67%-85%). Conclusion: The efficacy of these docetaxel-based regimens, in terms of OS and DFS, appears to be at least as good as standard anthracycline-based adjuvant chemotherapy (CT), in similar high-risk patient populations.