title: 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.
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.
authors.affiliation: Clinica di Oncologia Medica, Dipartimento di Oncologia e Radioterapia, Ospedali Riuniti Umberto I-G. M. Lancisi-G. Salesi, Polo Ospedale-Università, Ancona, Italy. n.battelli@tin.it
authors.forename: Nicola
authors.initials: N
authors.lastname: Battelli
authors.forename: Cristian
authors.initials: C
authors.lastname: Massacesi
authors.forename: Chiara
authors.initials: C
authors.lastname: Braconi
authors.forename: Alberta
authors.initials: A
authors.lastname: Pilone
authors.forename: Luigi
authors.initials: L
authors.lastname: Manzione
authors.forename: Angelo
authors.initials: A
authors.lastname: Dinota
authors.forename: Stefano
authors.initials: S
authors.lastname: Cobelli
authors.forename: Alberto
authors.initials: A
authors.lastname: Scanni
authors.forename: Fabio
authors.initials: F
authors.lastname: Sturba
authors.forename: Giusi
authors.initials: G
authors.lastname: Giacomini
authors.forename: Donatella
authors.initials: D
authors.lastname: Morale
authors.forename: Francesca
authors.initials: F
authors.lastname: Giorgi
authors.forename: Diego
authors.initials: D
authors.lastname: Tummarello
authors.forename: Stefano
authors.initials: S
authors.lastname: Cascinu
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008207:Lymphatic Metastasis; D008408:Mastectomy; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016019:Survival Analysis
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil; D008727:Methotrexate