title: Concordance rates of biomarkers uPA and PAI-1 results in primary breast cancer vs. consecutive tumor board decision and therapy performed in clinical hospital routine: Results of a prospective multi-center study at certified breast centers.
abstract: OBJECTIVE
  Biomarkers uPA and PAI-1 are guideline recommended by ASCO (USA) and AGO (Germany) in primary breast cancer to avoid unnecessary CTX in patients at medium risk for recurrence. For clinical quality assurance of uPA/PAI-1 testing, analysis of test-therapy concordance was performed.
  
  
  METHODS
  Prospective non-interventional multi-center study over 2 years among six Certified Breast Centers in Germany to investigate uPA/PAI-1 results in consecutive decision making for tumor board recommendation and actual therapy in uninfluenced clinical setting. Concordance and discordance rates of uPA/PAI-1 testing were calculated and individual reasons for decision making analyzed.
  
  
  RESULTS
  Among n = 93 uPA/PAI-1 tests evaluated n = 42/93 (45.2%) were uPA + PAI-1 negative and n = 51/93 (54.8%) uPA and/or PAI-1 positive. In uPA + PAI-1 negative test results in n = 35/42 (83.3%) CTX was avoided as recommended. But in n = 7/42 (16.7%) CTX was performed despite, resulting in over treatment. In uPA and/or PAI-1 positive test results in n = 26/51 (51.0%) CTX was performed but in n = 25/51 (49.0%) not despite recommendation for CTX which is under treatment. The conformity of uPA/PAI-1 test result vs. tumor board decision was n = 73/93 (78.5%). The overall concordance of uPA/PAI-1 test result vs. consecutive therapy was n = 61/93 (65.6%). A variety of reasons for individual result-deviating decisions were identified.
  
  
  CONCLUSIONS
  Clinical quality assurance of uPA/PAI-1 biomarker testing showed inconsistency of test results with consecutive tumor board decision and/or final therapy performed in up to 1/3 of patients. To close this clinical quality gap in application of uPA/PAI-1 biomarkers, individual analysis of deviations is suggested with process optimization accordingly.
authors.affiliation: Frauenklinik (OB/GYN), Paracelsus Medical University (PMU), Müllner Hauptstr. 48, A-5020 Salzburg, Austria; Frauenklinik (OB/GYN), Technical University Munich (TUM), Ismaninger Str. 22, D-81675 Munich, Germany. Electronic address: volkerjacobs@hotmail.com.
authors.forename: Volker R
authors.initials: VR
authors.lastname: Jacobs
authors.affiliation: Breast Center, Klinikum Deggendorf, Perlasberger Straße 41, D-94469 Deggendorf, Germany.
authors.forename: Doris
authors.initials: D
authors.lastname: Augustin
authors.affiliation: Breast Center, Klinikum Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany.
authors.forename: Arthur
authors.initials: A
authors.lastname: Wischnik
authors.affiliation: Frauenklinik (OB/GYN), Technical University Munich (TUM), Ismaninger Str. 22, D-81675 Munich, Germany.
authors.forename: Marion
authors.initials: M
authors.lastname: Kiechle
authors.affiliation: Cooperative Breast Center Ebersberg-Rosenheim, Kreisklinikum Ebersberg, Pfarrer-Guggetzer-Straße 3, D-85560 Ebersberg, Germany.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Hoess
authors.affiliation: Breast Center, Klinikum Dritter Orden, Menzinger Straße 44, D-80638 Munich, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Steinkohl
authors.affiliation: Breast Center and Frauenklinik, Ludwig-Maximilian-University (LMU), Maistr. 11, D-80337 Munich, Germany.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Rack
authors.affiliation: Sachverstaendigenbuero Kapitza, Ludwigstr. 3, 82110 Germering, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kapitza
authors.affiliation: AOK Bayern, Carl-Wery-Str. 28, 81739 Munich, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Krase
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D024221:Antineoplastic Protocols / Q000592:standards*; D014408:Biomarkers, Tumor / Q000097:blood; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy*; D000066491:Clinical Decision-Making / Q000379:methods*; D005260:Female; D005858:Germany; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D008875:Middle Aged; D017395:Plasminogen Activator Inhibitor 1 / Q000097:blood; D017410:Practice Guidelines as Topic / Q000592:standards*; D011446:Prospective Studies; D012307:Risk Factors; D014568:Urokinase-Type Plasminogen Activator / Q000097:blood; D055815:Young Adult
chemical_list: D014408:Biomarkers, Tumor; D017395:Plasminogen Activator Inhibitor 1; C051321:SERPINE1 protein, human; D014568:Urokinase-Type Plasminogen Activator
keywords: Biomarker; Breast cancer; Cost; Decision making; Quality assurance; Tumor board