title: A retrospective analysis of clinical outcome of patients with chemo-refractory metastatic breast cancer treated in a single institution phase I unit.
abstract: METHODS
  Novel approaches to treat chemo-refractory metastatic breast cancer (MBC) are currently under investigation. This retrospective series reviews the outcome of 70 MBC patients who have participated in 30 phase I trials at the Royal Marsden Hospital from 2002 to 2009.
  
  
  RESULTS
  The median treatment lines before phase I trial entry for MBC was 5 (range: 1-12 lines). The overall response rate was 11.4% (95% CI: 4.0-18.9%) and the clinical benefit rate at 4 months was 20% (95% CI: 10.6-29.3). The median time to progression was 7.0 weeks (95% CI: 6.4-7.5) and median overall survival was 8.7 months (95% CI: 7.6-9.8) from start of first phase I treatment. No patients discontinued trial because of treatment-related toxicities. Abnormal lactate dehydrogenase, serum albumin <35 mg per 100 ml, >or=5 previous treatment lines, liver metastases and Eastern Cooperative Group performance status >or=2 at study entry were significantly associated with poor overall survival in multivariate analysis.
  
  
  CONCLUSIONS
  This retrospective analysis provides evidence that patients with MBC tolerate phase I clinical trials and a significant proportion of patients with chemo-refractory disease, particularly those with triple-negative or Her2-positive breast cancer, may benefit from treatment.
authors.affiliation: The Royal Marsden Hospital Drug Development and Breast Units and Institute of Cancer Research, Sutton, UK.
authors.forename: A T
authors.initials: AT
authors.lastname: Brunetto
authors.forename: D
authors.initials: D
authors.lastname: Sarker
authors.forename: D
authors.initials: D
authors.lastname: Papadatos-Pastos
authors.forename: R
authors.initials: R
authors.lastname: Fehrmann
authors.forename: S B
authors.initials: SB
authors.lastname: Kaye
authors.forename: S
authors.initials: S
authors.lastname: Johnston
authors.forename: M
authors.initials: M
authors.lastname: Allen
authors.forename: J S
authors.initials: JS
authors.lastname: De Bono
authors.forename: C
authors.initials: C
authors.lastname: Swanton
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D017321:Clinical Trials, Phase I as Topic; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D012189:Retrospective Studies; D016896:Treatment Outcome