title: Alternating intravenous and oral vinorelbine plus epirubicin with pegfilgrastim as neoadjuvant treatment of locally advanced breast cancer.
abstract: In order to downstage locally advanced breast cancer, neoadjuvant chemotherapy consisting of intravenous vinorelbine 25 mg/m plus epirubicin 75 mg/m given on day 1 and oral vinorelbine 60 mg/m on day 8 was administered every 3 weeks for four courses. On day 2, all patients received a single subcutaneous injection of pegfilgrastim (6 mg). From March 2004 to June 2005, 22 patients were enrolled. Patients characteristics were: median age, 53 years (range: 39-70 years); postmenopausal, 7/22; clinical TNM stage, T2 (n=14), T3 (n=8), N0 (n=17) and N1 (n=5). The median number of courses was four (range: two to six courses) with full dose intensity. National Cancer Institute grade 3 haematological toxicities observed were neutropenia in 9% of patients, anaemia in 13% of patients and thrombocytopenia in 9% of patients; no toxicity grade 4 occurred. Two patients (9%) registered grade 2 polyneuropathy; no cardiac failure was observed. Conservative surgery was performed in 14 patients (63%). All patients were evaluable for response: complete pathological response was documented in three patients (13.6%); three patients (13.6%) obtained more than 75% of tumour size reduction; 11 other patients (50%) had 50% of tumour size reduction; stable disease was observed in five patients (22.7%). The present findings indicate that vinorelbine in combination with epirubicin is an effective and safe treatment in locally advanced breast cancer: this regimen obtained more than 50% of tumour size reduction in 77% of patients; the use of pegfilgrastim allowed full dose intensity. Oral vinorelbine on day 8 offers greater convenience to the patient by reducing the need for intravenous injection and the time spent in hospital.
authors.affiliation: Department of Radiotherapy-Oncology, Radiotherapy Unit, University of Florence, Florence, Italy. l.livi@dfc.unifi.it
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Livi
authors.forename: Fabiola
authors.initials: F
authors.lastname: Paiar
authors.forename: Roberto
authors.initials: R
authors.lastname: Santini
authors.forename: Carla
authors.initials: C
authors.lastname: De Luca Cardillo
authors.forename: Alessandra
authors.initials: A
authors.lastname: Galardi
authors.forename: Dora
authors.initials: D
authors.lastname: Di Cosmo
authors.forename: Simona
authors.initials: S
authors.lastname: Borghesi
authors.forename: Benedetta
authors.initials: B
authors.lastname: Agresti
authors.forename: Fabiano
authors.initials: F
authors.lastname: Nosi
authors.forename: Sergio
authors.initials: S
authors.lastname: Gavilli
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Biti
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D015251:Epirubicin; D014747:Vinblastine; D000069585:Filgrastim; D000077235:Vinorelbine