title: Weekly docetaxel with or without gemcitabine as second-line chemotherapy in paclitaxel-pretreated patients with metastatic breast cancer: a randomized phase II study conducted by the Hellenic Co-Operative Oncology Group.
abstract: OBJECTIVE
  A randomized phase II trial was conducted to test whether the addition of gemcitabine to weekly docetaxel could improve the objective response rate and survival outcomes as second-line chemotherapy in patients with metastatic breast cancer who have failed a paclitaxel-containing regimen.
  
  
  METHODS
  Patients were randomized to receive either weekly docetaxel 40 mg/m(2) (group A, n = 34) or the combination of weekly docetaxel 35 mg/m(2) with gemcitabine 600 mg/m(2) (group B, n = 41). Three consecutive weekly infusions followed by a 1-week rest period represented 1 chemotherapy cycle.
  
  
  RESULTS
  The objective response rate was 18% and 27.5% in group A and B, respectively (p = 0.413). No statistically significant differences were demonstrated in terms of median overall survival and time to disease progression. The rate and grade 3 and 4 neutropenia were higher in group B (23 vs. 3%).
  
  
  CONCLUSIONS
  The weekly administration of docetaxel and gemcitabine did not result in superior clinical outcomes over weekly docetaxel.
authors.affiliation: Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens, Greece.
authors.forename: Christos A
authors.initials: CA
authors.lastname: Papadimitriou
authors.forename: Haralambos
authors.initials: H
authors.lastname: Kalofonos
authors.forename: Flora
authors.initials: F
authors.lastname: Zagouri
authors.forename: Pavlos
authors.initials: P
authors.lastname: Papakostas
authors.forename: George
authors.initials: G
authors.lastname: Bozas
authors.forename: Thomas
authors.initials: T
authors.lastname: Makatsoris
authors.forename: Meletios-A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: George
authors.initials: G
authors.lastname: Fountzilas
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; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D017239:Paclitaxel; D000093542:Gemcitabine