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Objective: Biomarkers uPA and PAI-1 are guideline recommended by ASCO, USA, and AGO, Germany, to be used in primary breast cancer to avoid unnecessary CTX in medium risk recurrence patients [G2, N−, HR+, Her2neu−, >35 years]. For quality assurance of uPA/PAI-1 testing an analysis of test-therapy concordance was performed. Methods: Prospective, non-interventional, multi-center study over two years among six Certified Breast Centers in Germany to analyze application of uPA/PAI-1 and use of the result in consecutive decision making in Tumor Board decision and actual therapy in the clinical setting for AOK Bayern-insured patients. Concordance and discordance rates of uPA/PAI-1 testing in daily clinical setting 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 the group of uPA+PAI-1 negative test result in n=35/42 (83.3%) CTX was avoided and and in n=7/42 (16.7%) CTX performed. In the group of uPA and/or PAI-1 positive test result in n=26/51 (51.0%) CTX was performed and in n=25/51 (49.0%) not. Concordance of uPA/PAI-1 test result vs. consecutive therapy was (35+26)/93=65.6% and discordance of uPA/PAI-1 test-therapy (7+25)/93 = 34.4%. However, discordance of uPA/PAI-1 test result vs. Tumor Board recommendation was only n=21/93 (22.6%). As reasons for discordance a variety of influencing and/or interference factors were indentified, affecting use of test and test results or even changing therapy decision, e.g. individual therapy decision by physician, parallel use of competitive biomarkers, study participation, missing CTX therapy option in advance (like advanced age), wrong target group, timing of uPA/PAI-1 test too early, test result in contradiction of physicians' expectations (expected negative result) and rejection of CTX recommended by patients despite uPA/PAI-1 test-proven benefit. Conclusions: Individual process optimization of uPA/PAI-1 test indication, performance and result assessment could improve quality of care, reduce costs and lead to an improved application of uPA/PAI-1 test results as well as more stringency and consistency of test-therapy decisions in daily clinical setting. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P5-14-06.

Das 3-Länder-Manifest „Zeitenwende in der Medizin“ ergänzt die bestehenden Eide, Gelöbnisse und Selbstverpflichtungen der Ärzteschaft. Es soll die inhaltliche Lücke zwischen medizinethischen Grundsätzen und den moralischen Herausforderungen des durch Ökonomisierung, Kommerzialisierung und Industrialisierung geprägten ärztlichen Berufsalltags im Gesundheitswesen füllen. Konkrete Vorschläge sollen helfen, bestehende Hindernisse zu überwinden. Der Vorrang der Medizin gegenüber Ökonomie und Technologie ist auf allen Ebenen beruflichen Handelns durch die Ärzteschaft sicherzustellen.Das 3-Länder-Manifest soll den hierfür notwendigen Diskurs innerhalb der Ärzteschaft und in der Gesellschaft anregen und thematisch unterstützen.In diesem Zusammenhang werden die folgenden Forderungen im 3-Länder-Manifest erhoben:Die Verfasser dieses Manifests fordern dazu auf, die ethischen Werte medizinischen Wirkens zu sichern, und rufen alle Beteiligten im Gesundheitswesen auf danach zu handeln, um somit eine Zeitenwende herbeizuführen.

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