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Paclitaxel and Epirubicin Followed by Cyclophosphamide, Methotrexate and 5-Fluorouracil for Patients With Stage IIIC Breast Cancer With Ten or More Involved Axillary Lymph Nodes

2006; Lippincott Williams & Wilkins; Volume: 29; Issue: 4 Linguagem: Inglês

10.1097/01.coc.0000221356.81769.52

1537-453X

Nicola Battelli, Cristian Massacesi, Chiara Braconi, Alberta Pilone, Luigi Manzione, Angelo Dinota, S. Cobelli, A. Scanni, F. Sturba, Giusi Giacomini, Donatella Morale, Francesca Giorgi, Diego Tummarello, Stefano Cascinu,

HER2/EGFR in Cancer Research

Objective: The aim of this study was to evaluate the feasibility of a combination of epirubicin and paclitaxel followed by intravenous (iv) cyclophosphamide, methotrexate, and 5-fluorouracile (CMF) as adjuvant treatment of breast cancer patients with 10 or more metastatic axillary lymph nodes. Methods: Forty-four patients entered this multicenter study and received 4 cycles of epirubicin (E 120 mg/m2 day 1, q3 weeks) and paclitaxel (T 135 mg/m2 day 1, q3 weeks), followed by 4 cycles of iv CMF (days 1 and 8, q4 weeks). Patients with positive hormonal receptors received sequentially tamoxifen associated with LH-RH analogue if premenopausal. The endpoints were the evaluation of the feasibility of this schedule and disease free survival (DFS). Results: Median age of patients was 55; median number of positive axillary nodes was 14 (range, 10–47). Hormonal receptor status was positive in 57% of patients. The combination of epirubicin and paclitaxel was well tolerated; NCI grade 3/4 events were: leucopenia in 27% of patients, neutropenic fever in 5 patients, anemia in 7%, thrombocytopenia in 7%, nausea in 18%, vomiting in 14%, and neurotoxicity in 4%. CMF regimen caused a few cases of grade 3/4 hematologic toxicity. No cardiac toxicity was recorded. With a median follow-up of 59 months, 18 (41%) patients relapsed. Sites of relapse were mainly bone, skin/soft tissues, liver, and lung. Median DFS was 78 months, with a 5-year rate of 60%. Conclusions: The combination of paclitaxel at low dose and epirubicin followed by CMF is a feasible regimen, which seems to be effective in high-risk node positive breast cancer patients and requires further investigations.