Abstract P5-14-06: Analysis of test-therapy concordance for biomarkers uPA and PAI-1 in primary breast cancer in clinical hospital routine: Results of a prospective multi-center study at Certified Breast Cancers in Germany

Abstract

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.

Breast Cancer 2013 - Interpretation of New and Known Data

“…Hierbei wurden die Kosten des Tests gegenüber den gewonnenen QALYs (qualitätsadjustierte Lebensjahre) und den Kosten für die eingesparten Therapien verglichen. Die kalkulierten Kosten lagen bei 8023 $ pro gewonnenem QALY (im amerikanischen Gesundheitswesen wer-In a prospective, multicentre trial, the use of the test in 93 patients helped to avoid 35 therapies or, respectively, for 210 cycles 12.1 years of chemotherapy application time [68]. In addition, costs of 221 816 € for systemic therapy, 25 749 € for GCS-F, and 34 353 $ for further accompanying therapies were saved (in total 281 918 $).…”

“…In einer prospektiven, multizentrischen Studie konnten durch den Einsatz des Tests bei 93 Patientinnen 35 Therapien bzw. bei 210 Zyklen 12,1 Jahre Chemotherapieapplikationszeit vermieden werden [68]. Es wurden zudem Kosten von 221 816 € für Systemtherapien, 25 749 € für GCS-F, und 34 353 $ für weitere Begleittherapien eingespart (gesamt 281 918 $).…”

Health Economic Evaluation of Different Decision Aids for the Individualised Treatment of Patients with Breast Cancer

“…Testing for the biomarkers uPA and PAI can be done to avoid unnecessary chemotherapy in patients with primary breast cancer classified as medium risk (G2, N−, HR+, HER2/neu−, > 35 years). A prospective, multi-centre study found that use of these biomarkers in 93 patients prevented 35 chemotherapies or 12.1 years of chemotherapy application (calculation based on 210 cycles) [14]. Costs of € 221 816 for systemic therapy, € 25 749 for GCS-F and $ 34 353 for additional supportive therapies were saved (total savings: $ 281 918).…”