title: Clinical and pharmacokinetic data of a docetaxel-epirubicin combination in metastatic breast cancer.
abstract: In order to explore activity and pharmacokinetic data of a docetaxel-epirubicin combination we analyzed a population of 60 metastatic breast cancer patients. All the patients had an ECOG performance status < 3; 41 patients (68%) had visceral metastases as dominant site of disease, including 33% with liver metastases. Three or more involved organs were present in 43% of patients; 35% had received prior hormonotherapy; 10% for metastatic disease. Twenty-five patients (42%) had received prior adjuvant chemotherapy; 15% a CAF regimen. Twenty per cent of patients had less than 12 months disease-free interval. Docetaxel and epirubicin were both given at a dose of 75 mg/m2 i.v. d. 1 every 3 weeks. After a median of six cycles we had 5 CR (8.3%), 40 PR (66.6%), 7 NC (11.6%), and 8 PD (13.3%). Response rates in patients with visceral and liver metastases were 78% and 55% respectively. Premenopausal status, < 1 year disease free survival and > 3 metastatic sites were associated with a lower response rate. After a median follow-up of 19 months (12-36), median disease-free survival is 11 months and median overall survival has not been reached. Grade 4 neutropenia was observed in 75% of courses but with febrile neutropenia in 6.2% of courses only. Non-hematologic toxicity wasn't clinically important. A NYHA class III reversible cardiac failure was observed in one patient (1.6%). The pharmacokinetic evaluation in 16 patients has shown that docetaxel transiently interfered with epirubicin plasma level when docetaxel was administered 1 h after epirubicin.
authors.affiliation: Medical Oncology Department, San Giovanni Antica Sede Hospital, Turin University, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Airoldi
authors.forename: L
authors.initials: L
authors.lastname: Cattel
authors.forename: F
authors.initials: F
authors.lastname: Pedani
authors.forename: S
authors.initials: S
authors.lastname: Marchionatti
authors.forename: V
authors.initials: V
authors.lastname: Tagini
authors.forename: C
authors.initials: C
authors.lastname: Bumma
authors.forename: V
authors.initials: V
authors.lastname: Recalenda
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000493:pharmacokinetics*; D001943:Breast Neoplasms / Q000378:metabolism* / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000378:metabolism* / Q000556:secondary; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D043823:Taxoids
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D017239:Paclitaxel