Volker R Jacobs1, Doris Augustin2, Arthur Wischnik3, Marion Kiechle4, Cornelia Hoess5, Oliver Steinkohl6, Brigitte Rack7, Thomas Kapitza8, Peter Krase9. 1. 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. 2. Breast Center, Klinikum Deggendorf, Perlasberger Straße 41, D-94469 Deggendorf, Germany. 3. Breast Center, Klinikum Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany. 4. Frauenklinik (OB/GYN), Technical University Munich (TUM), Ismaninger Str. 22, D-81675 Munich, Germany. 5. Cooperative Breast Center Ebersberg-Rosenheim, Kreisklinikum Ebersberg, Pfarrer-Guggetzer-Straße 3, D-85560 Ebersberg, Germany. 6. Breast Center, Klinikum Dritter Orden, Menzinger Straße 44, D-80638 Munich, Germany. 7. Breast Center and Frauenklinik, Ludwig-Maximilian-University (LMU), Maistr. 11, D-80337 Munich, Germany. 8. Sachverstaendigenbuero Kapitza, Ludwigstr. 3, 82110 Germering, Germany. 9. AOK Bayern, Carl-Wery-Str. 28, 81739 Munich, Germany.
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.
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.