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

Battelli, N. et al. (2006) 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. American Journal of Clinical Oncology, 29(4), pp. 380-384. (doi: 10.1097/01.coc.0000221356.81769.52) (PMID:16891866)

Abstract

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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Braconi, Professor Chiara
• Authors: Battelli, N., Massacesi, C., Braconi, C., Pilone, A., Manzione, L., Dinota, A., Cobelli, S., Scanni, A., Sturba, F., Giacomini, G., Morale, D., Giorgi, F., Tummarello, D., and Cascinu, S.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: American Journal of Clinical Oncology
• Publisher: Lippincott, Williams & Wilkins
• ISSN: 0277-3732
• ISSN (Online): 1537-453X