title: Bi-weekly docetaxel and gemcitabine regimen in her-2-negative and anthracycline-pretreated metastatic breast cancer patients: a multicenter phase II trial.
abstract: OBJECTIVE
  Bi-weekly gemcitabine (G) in combination with docetaxel (D) is an effective treatment for metastatic breast cancer (MBC) previously treated with adjuvant/neoadjuvant anthracyclines containing regimens with a good toxicity profile. In the present phase II study, we investigated the activity of the same regimen as first-line treatment.
  
  
  METHODS
  Women with breast cancer pretreated in adjuvant/neoadjuvant setting with anthracyclines received bi-weekly G (1,250 mg/m² days 1, 15) and D (50 mg/m² days 1, 15) every 28 days with restaging after 3 and 6 cycles.
  
  
  RESULTS
  Overall 42 patients were enrolled. Median age is 48 years (range, 31-71 years). Eight patients (19%) achieved complete responses, 18 (43%) partial responses for an overall response rate (ORR) of 62%; five patients (12%) obtained stable disease (SD), and 8 (19%) patients had progressive disease (PD). After a median 17-month follow-up, the median time to disease progression was 12 months (95% CI, 3-26 months) and the median survival time was 27 months (95% CI, 4-57 months). No grade 4 toxicity was seen except in one patient who developed a grade 4 neutropenia. Grade 3 toxicities were leukopenia (2%), neutropenia (14%), anemia (2%), nausea and vomiting (2%), diarrhea (2%), asthenia (2%), and skin toxicity (12%).
  
  
  CONCLUSIONS
  The GD bi-weekly regimen is well tolerated and active as first line in anthracyclines-pretreated women with MBC. It appears as an interesting alternative compared to a 3-week schedule whenever hematological toxicity is the main clinical concern.
authors.affiliation: Department of Internal Medicine, S. Martino Hospital, Viale Benedetto XV 6, 16132, Genoa, Italy. rozzis752000@yahoo.it
authors.forename: R
authors.initials: R
authors.lastname: Murialdo
authors.forename: F
authors.initials: F
authors.lastname: Bertolotti
authors.forename: G
authors.initials: G
authors.lastname: Pastorino
authors.forename: M
authors.initials: M
authors.lastname: Mencoboni
authors.forename: M
authors.initials: M
authors.lastname: Bergaglio
authors.forename: U
authors.initials: U
authors.lastname: Folco
authors.forename: N
authors.initials: N
authors.lastname: Cinzia
authors.forename: F
authors.initials: F
authors.lastname: Vaira
authors.forename: C
authors.initials: C
authors.lastname: Simoni
authors.forename: L
authors.initials: L
authors.lastname: Canobbio
authors.forename: M
authors.initials: M
authors.lastname: Parodi
authors.forename: Fulvio
authors.initials: F
authors.lastname: Brema
authors.forename: Alberto
authors.initials: A
authors.lastname: Ballestrero
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant / Q000379:methods; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009362:Neoplasm Metastasis; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine