title: Effects of a green tea extract, Polyphenon E, on systemic biomarkers of growth factor signalling in women with hormone receptor-negative breast cancer.
abstract: BACKGROUND
  Observational and experimental data support a potential breast cancer chemopreventive effect of green tea.
  
  
  METHODS
  We conducted an ancillary study using archived blood/urine from a phase IB randomised, placebo-controlled dose escalation trial of an oral green tea extract, Polyphenon E (Poly E), in breast cancer patients. Using an adaptive trial design, women with stage I-III breast cancer who completed adjuvant treatment were randomised to Poly E 400 mg (n = 16), 600 mg (n = 11) and 800 mg (n = 3) twice daily or matching placebo (n = 10) for 6 months. Blood and urine collection occurred at baseline, and at 2, 4 and 6 months. Biological endpoints included growth factor [serum hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF)], lipid (serum cholesterol, triglycerides), oxidative damage and inflammatory biomarkers.
  
  
  RESULTS
  From July 2007-August 2009, 40 women were enrolled and 34 (26 Poly E, eight placebo) were evaluable for biomarker endpoints. At 2 months, the Poly E group (all dose levels combined) compared to placebo had a significant decrease in mean serum HGF levels (-12.7% versus +6.3%, P = 0.04). This trend persisted at 4 and 6 months but was no longer statistically significant. For the Poly E group, serum VEGF decreased by 11.5% at 2 months (P = 0.02) and 13.9% at 4 months (P = 0.05) but did not differ compared to placebo. At 2 months, there was a trend toward a decrease in serum cholesterol with Poly E (P = 0.08). No significant differences were observed for other biomarkers.
  
  
  CONCLUSIONS
  Our findings suggest potential mechanistic actions of tea polyphenols in growth factor signalling, angiogenesis and lipid metabolism.
authors.affiliation: Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.
authors.forename: K D
authors.initials: KD
authors.lastname: Crew
authors.affiliation: Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.
authors.forename: K A
authors.initials: KA
authors.lastname: Ho
authors.affiliation: University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: P
authors.initials: P
authors.lastname: Brown
authors.affiliation: Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.
authors.forename: H
authors.initials: H
authors.lastname: Greenlee
authors.affiliation: University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: T B
authors.initials: TB
authors.lastname: Bevers
authors.affiliation: University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: B
authors.initials: B
authors.lastname: Arun
authors.affiliation: University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: N
authors.initials: N
authors.lastname: Sneige
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: C
authors.initials: C
authors.lastname: Hudis
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: H L
authors.initials: HL
authors.lastname: McArthur
authors.affiliation: The Methodist Hospital Cancer Center, Houston, TX, USA.
authors.forename: J
authors.initials: J
authors.lastname: Chang
authors.affiliation: Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA.
authors.forename: M
authors.initials: M
authors.lastname: Rimawi
authors.affiliation: Divison of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.
authors.forename: T L
authors.initials: TL
authors.lastname: Cornelison
authors.affiliation: Louisiana State University Health Sciences Center, Shreveport, LA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Cardelli
authors.affiliation: Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.
authors.forename: R M
authors.initials: RM
authors.lastname: Santella
authors.affiliation: Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.
authors.forename: A
authors.initials: A
authors.lastname: Wang
authors.affiliation: University of California San Diego Moores Cancer Center, San Diego, CA, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Lippman
authors.affiliation: Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.
authors.forename: D L
authors.initials: DL
authors.lastname: Hershman
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood*; D001943:Breast Neoplasms / Q000097:blood*; D002392:Catechin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002784:Cholesterol / Q000097:blood; D005260:Female; D017228:Hepatocyte Growth Factor / Q000097:blood; D006801:Humans; D036341:Intercellular Signaling Peptides and Proteins / Q000378:metabolism*; D008875:Middle Aged; D010919:Placebos; D010936:Plant Extracts / Q000737:chemistry*; D012307:Risk Factors; D015398:Signal Transduction / Q000187:drug effects; D013662:Tea / Q000737:chemistry*; D014280:Triglycerides / Q000097:blood; D042461:Vascular Endothelial Growth Factor A / Q000097:blood
chemical_list: D015415:Biomarkers; D036341:Intercellular Signaling Peptides and Proteins; D010919:Placebos; D010936:Plant Extracts; D013662:Tea; D014280:Triglycerides; D042461:Vascular Endothelial Growth Factor A; D017228:Hepatocyte Growth Factor; D002392:Catechin; D002784:Cholesterol; C472086:polyphenon E
keywords: breast cancer; chemoprevention; tea polyphenols