title: Monthly docetaxel and weekly gemcitabine in metastatic breast cancer: a phase II trial.
abstract: BACKGROUND
  Docetaxel and gemcitabine are active against breast cancer. The purpose of this phase II study was to evaluate the efficacy and safety of monthly docetaxel combined with weekly gemcitabine in patients with chemotherapy-pretreated metastatic breast cancer.
  
  
  METHODS
  Thirty-nine patients were enrolled, of whom thirty had received prior chemotherapy in the adjuvant setting, seven for metastatic disease, and two for both, including prior anthracycline in 33 patients. Treatment was gemcitabine 800 mg/m2 days 1, 8, 15 and docetaxel 100 mg/M2 on day 1, with cycles repeated every four weeks.
  
  
  RESULTS
  Response rate was 79% (95% confidence interval (CI): 63%-91%), with 2 complete and 29 partial responses. Twenty-five of the responders remained progression-free for more than six months. Median survival was 24.5 months. Delivered dose intensity of gemcitabine was lower than expected (63% of planned). The predominant hematologic toxicity was grade 4 neutropenia in 36 patients, complicated by fever in three patients. With the exception of asthenia, severe non-hematological toxicities were infrequent.
  
  
  CONCLUSIONS
  Monthly docetaxel, combined with weekly gemcitabine, has significant but manageable hematologic toxicity. Despite frequent dose adjustments, this doublet is very active in metastatic breast cancer, producing a high proportion of durable responses associated with favorable survival.
authors.affiliation: Hematology Oncology Consultants Incorporated, Columbus, Ohio 43235, USA. llhoci@aol.com
authors.forename: L R
authors.initials: LR
authors.lastname: Laufman
authors.forename: C H
authors.initials: CH
authors.lastname: Spiridonidis
authors.forename: J
authors.initials: J
authors.lastname: Pritchard
authors.forename: R
authors.initials: R
authors.lastname: Roach
authors.forename: J
authors.initials: J
authors.lastname: Zangmeister
authors.forename: N
authors.initials: N
authors.lastname: Larrimer
authors.forename: T
authors.initials: T
authors.lastname: Moore
authors.forename: M
authors.initials: M
authors.lastname: Segal
authors.forename: J
authors.initials: J
authors.lastname: Jones
authors.forename: T
authors.initials: T
authors.lastname: Patel
authors.forename: L
authors.initials: L
authors.lastname: Gutterman
authors.forename: L
authors.initials: L
authors.lastname: Carman
authors.forename: D
authors.initials: D
authors.lastname: Colborn
authors.forename: J P
authors.initials: JP
authors.lastname: Kuebler
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016019:Survival Analysis; D043823:Taxoids; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D017239:Paclitaxel; D000093542:Gemcitabine