title: Circulating tumor cells predict progression-free and overall survival in Chinese patients with metastatic breast cancer, HER2-positive or triple-negative (CBCSG004): a multicenter, double-blind, prospective trial.
abstract: BACKGROUND
  The aim of this multicenter, double-blind, prospective study was to evaluate the potential utility of circulating tumor cell (CTC) measurements in predicting responses to anticancer therapies, including response to human epidermal growth factor receptor-2 (HER-2)-targeted agents, progression-free survival (PFS), and overall survival (OS) in Chinese women with metastatic breast cancer (MBC).
  
  
  METHODS
  Three hundred MBC patients planned to complete three CTC blood draws and two imaging studies.
  
  
  RESULTS
  A total of 294 of the 300 MBC patients enrolled from six leading Chinese cancer centers were assessable. In multivariate Cox regression analyses, the baseline CTC number remained an independent prognostic factor for PFS [hazard ratio (HR) = 1.93; 95% confidence interval (CI) = 1.39-2.69; P < 0.001) and OS (HR = 3.76; 95% CI = 2.35-6.01; P < 0.001). Similar results were observed for CTC counts at the first follow-up visit for both PFS (P = 0.049) and OS (P < 0.001).
  
  
  CONCLUSIONS
  Enumeration of CTCs in Chinese MBC patients provides substantial prognostic information and is an independent factor associated with PFS and OS. Moreover, we demonstrated the prognostic value in the various disease subtypes, including HER-2-positive disease irrespective of therapy.
authors.affiliation: Department of Breast Cancer, Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China.
authors.forename: Z F
authors.initials: ZF
authors.lastname: Jiang
authors.forename: M
authors.initials: M
authors.lastname: Cristofanilli
authors.forename: Z M
authors.initials: ZM
authors.lastname: Shao
authors.forename: Z S
authors.initials: ZS
authors.lastname: Tong
authors.forename: E W
authors.initials: EW
authors.lastname: Song
authors.forename: X J
authors.initials: XJ
authors.lastname: Wang
authors.forename: N
authors.initials: N
authors.lastname: Liao
authors.forename: X C
authors.initials: XC
authors.lastname: Hu
authors.forename: Y
authors.initials: Y
authors.lastname: Liu
authors.forename: Y
authors.initials: Y
authors.lastname: Wang
authors.forename: L
authors.initials: L
authors.lastname: Zeng
authors.forename: M
authors.initials: M
authors.lastname: Zhang
mesh_terms: D000328:Adult; D002681:China; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009360:Neoplastic Cells, Circulating; D016016:Proportional Hazards Models; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics*; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human
keywords: circulating tumor cells; metastatic breast cancer; overall survival; progression-free survival