title: Gemcitabine and epirubicin in patients with metastatic breast cancer: a phase I/II study.
abstract: Gemcitabine and epirubicin were evaluated in metastatic breast cancer (MBC) patients to determine the maximum tolerated dose (MTD), efficacy, and toxicity of the combination. Patients initially received 800 mg/m(2) of gemcitabine (days 1 and 8) and 50 mg/m(2) of epirubicin (day 1) every 21 days. Each dose level had three to eight patients. Phase II used the dose level preceding the MTD. Forty-eight patients enrolled without reaching MTD; therefore, phase II used the highest dose level (1500 mg/m(2) of gemcitabine, 90 mg/m(2) of epirubicin). After 23 patients (group A) experienced hematologic toxicities and frequent dose reductions, 15 received 1250 mg/m(2) gemcitabine (days 1 and 4) and 90 mg/m(2) epirubicin (day 1) every 21 days (group B). Out of 38 patients, 46% responded (group A 32%, group B 67%). Median response duration was 8.5 months; median time to progression 8.4 months; and median time to treatment failure 4.8 months. Gemcitabine and epirubicin are well tolerated and active in MBC patients, and the group B regimen warrants further investigation.
authors.affiliation: Centre René Gauducheau, 44805 Nantes-St. Herblain, France.
authors.forename: Mario
authors.initials: M
authors.lastname: Campone
authors.forename: Pierre
authors.initials: P
authors.lastname: Fumoleau
authors.forename: Patrice
authors.initials: P
authors.lastname: Viens
authors.forename: Véronique
authors.initials: V
authors.lastname: Diéras
authors.forename: Eric
authors.initials: E
authors.lastname: Pujade-Lauraine
authors.forename: Daniel
authors.initials: D
authors.lastname: Serin
authors.forename: Thierry
authors.initials: T
authors.lastname: Petit
authors.forename: Marc
authors.initials: M
authors.lastname: Espié
authors.forename: Louis
authors.initials: L
authors.lastname: Kayitalire
authors.forename: Laurence
authors.initials: L
authors.lastname: Bozec
authors.forename: Pierre
authors.initials: P
authors.lastname: Pouillart
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005602:France; D006801:Humans; D007262:Infusions, Intravenous; D008593:Menopause; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D000093542:Gemcitabine