title: Docetaxel and epirubicin supported by granulocyte colony-stimulating factor first-line in advanced breast cancer.
abstract: This phase II trial studied the efficacy and toxicity of docetaxel-epirubicin, supported by granulocyte colony-stimulating factor, as first-line chemotherapy in metastatic breast cancer. Patients received epirubicin (60 mg/m2) followed 1 hour later by docetaxel (80 mg/m2) every 3 weeks for a maximum of 8 cycles or until disease progression. Prophylactic granulocyte colony-stimulating factor (5 micrograms/kg) was administered daily for 5 days. Sixty-nine patients were evaluable for efficacy and toxicity. Objective responses occurred in 45 patients (65%; 95% confidence interval: 53-76%), with 11 (16%) complete responses and 34 (49%) partial responses. Responses were observed at all metastatic sites. The median response duration was 8 months (range 4-68), median time to progression was 10 months (range 4-68) and median overall survival was 24 months (range 7-68): neutropenia was dose limiting (46% grade 3-4 toxicity). The left ventricular ejection, fraction measured in 50 patients, fell below normal in 14 patients (28%), 8 patients had grade 1 and 6 grade 2 cardiotoxicity, but none developed congestive cardiac failure. The docetaxel-epirubicin regimen is extremely effective in poor prognosis breast cancer patients with visceral metastases, with significant overall and complete responses, followed by prolonged survival in responders. Although myelosuppression remains the major toxicity, prophylactic GCSF administration was associated with a small percentage of neutropenic fever.
authors.affiliation: Medical Oncology Unit, Laikon General Hospital, Athens University School of Medicine, 17 Agiou Thoma Street, Goudi, GR 11527, Athens, Greece.
authors.forename: Aristides
authors.initials: A
authors.lastname: Polyzos
authors.forename: Nicholas
authors.initials: N
authors.lastname: Tsavaris
authors.forename: Christos
authors.initials: C
authors.lastname: Kosmas
authors.forename: Helen
authors.initials: H
authors.lastname: Gogas
authors.forename: Maria
authors.initials: M
authors.lastname: Vadiaka
authors.forename: Christos
authors.initials: C
authors.lastname: Markopoulos
authors.forename: Athanasios
authors.initials: A
authors.lastname: Giannopoulos
authors.forename: Nicholas
authors.initials: N
authors.lastname: Kalahanis
authors.forename: Demetrios
authors.initials: D
authors.lastname: Stamatiadis
authors.forename: Gregory
authors.initials: G
authors.lastname: Kouraklis
authors.forename: Gabriel
authors.initials: G
authors.lastname: Karatzas
authors.forename: Christos
authors.initials: C
authors.lastname: Liapis
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Syrigos
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006331:Heart Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013318:Stroke Volume / Q000187:drug effects; D043823:Taxoids
chemical_list: D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D015251:Epirubicin; D017239:Paclitaxel