title: Serum levels of shed Her2/neu protein in men with prostate cancer correlate with disease progression.
abstract: OBJECTIVE
  We determined the association between serum levels of shed Her-2/neu protein and disease progression in men with prostate cancer.
  
  
  METHODS
  Serum from 279 patients enrolled in a prospective serum bank and database at New York University Medical Center was analyzed using the Food and Drug Administration approved Immuno-1 Her-2/neu assay. Patients were classified by the Prostate-Specific Antigen Working Group model into 5 groups, namely group 1-no evidence of cancer in 60, group 2-clinically localized disease in 67, group 3-prostate specific antigen increasing after therapy and no clinical metastases in 77, group 4-clinical metastases and castration sensitivity in 42, and group 5-clinical metastases and castration resistance in 33. A cutoff of 14 ng/ml for normal serum Her-2/neu was established based on the 95th order statistic in group 1.
  
  
  RESULTS
  Of 279 patients 37 (13.3%) had increased serum Her-2/neu, that is 5%, 11.9%, 10.4%, 16.7% and 33.3% in groups 1 to 5, respectively. There was a significant difference between patients with (groups 4 and 5) and without (groups 2 and 3) clinical metastases (p = 0.006). In group 5 patients serum Her-2/neu was significantly higher than in group 2 patients (p <0.02). The risk of cause specific death increased significantly with each unit increase in serum Her-2/neu (p <0.001).
  
  
  CONCLUSIONS
  Increased serum Her-2/neu correlates with the presence of metastatic disease and it may indicate an increased risk of death in patients with castrate, metastatic prostate cancer. The detection of serum Her-2/neu is a minimally invasive alternative to tumor sampling for identifying potential candidates for anti-Her-2/neu treatment strategies. Further studies are needed to optimize this assay for application in the clinical setting.
authors.affiliation: Department of Urology, New York University School of Medicine, New York, NY 10016, USA.
authors.forename: Iman
authors.initials: I
authors.lastname: Osman
authors.forename: Maryann
authors.initials: M
authors.lastname: Mikhail
authors.forename: Brian
authors.initials: B
authors.lastname: Shuch
authors.forename: Megan
authors.initials: M
authors.lastname: Clute
authors.forename: Carol D
authors.initials: CD
authors.lastname: Cheli
authors.forename: Farooq
authors.initials: F
authors.lastname: Ghani
authors.forename: Robert P
authors.initials: RP
authors.lastname: Thiel
authors.forename: Samir S
authors.initials: SS
authors.lastname: Taneja
mesh_terms: D000368:Aged; D014408:Biomarkers, Tumor / Q000097:blood*; D018450:Disease Progression; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood; D011237:Predictive Value of Tests; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood* / Q000401:mortality; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000097:blood*; D012307:Risk Factors; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen; D018719:Erb-b2 Receptor Tyrosine Kinases