title: Multicenter phase II trial of first-line docetaxel/gemcitabine in advanced breast cancer pretreated with adjuvant anthracyclines.
abstract: The aim of this study was to evaluate activity and tolerability of docetaxel-gemcitabine combination as first-line treatment in patients with metastatic breast cancer previously treated with adjuvant anthracyclines.
  
  
  METHODS
  Sixty-eight women received gemcitabine 1,000 mg/m(2) as 30-minute infusion on days 1 and 8, and docetaxel 80 mg/m(2) as 1-hour infusion on day 8, with cycles repeated every 3 weeks.
  
  
  RESULTS
  Objective responses were observed in 32 out of 68 evaluable patients (45%; 95% confidence interval, 35.2-58.8%). Responses were 44%, 42%, 49% in soft tissue, bone and visceral lesions, respectively, 50% /52% in HER2-positive/-negative tumors, and 50% in both ER- positive/-negative tumors. Median time to progression and overall survival were 6 and 16 months, respectively. Treatment was usually well tolerated, with grade 3-4 neutropenia in 32% - 7% of the patients, and neutropenic fever, grade 3 vomiting, mucositis and peripheral neurotoxicity in 3% of the patients.
  
  
  CONCLUSIONS
  Gemcitabine-docetaxel combination is effective and well tolerated as first-line treatment in advanced breast cancer previously treated with adjuvant anthracyclines.
authors.affiliation: Division of Medical Oncology B, Regina Elena Institute for Cancer Research, Via E. Chianesi, 53, 00144 Rome, Italy. pvici@ifo.it
authors.forename: Patrizia
authors.initials: P
authors.lastname: Vici
authors.forename: Francesco
authors.initials: F
authors.lastname: Giotta
authors.forename: Luigi
authors.initials: L
authors.lastname: DI Lauro
authors.forename: Mario
authors.initials: M
authors.lastname: Brandi
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Paolo
authors.initials: P
authors.lastname: Foggi
authors.forename: Vito
authors.initials: V
authors.lastname: Lorusso
authors.forename: Carlo
authors.initials: C
authors.lastname: Vitucci
authors.forename: Domenico
authors.initials: D
authors.lastname: Sergi
authors.forename: Silvia Ileana
authors.initials: SI
authors.lastname: Fattoruso
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.forename: Giuditta
authors.initials: G
authors.lastname: Viola
authors.forename: Serena
authors.initials: S
authors.lastname: Corsetti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
authors.forename: Massimo
authors.initials: M
authors.lastname: Lopez
mesh_terms: D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine