Implementation assessment of the 70-gene prognosis signature for breast cancer diagnostics

Abstract

6575 Background: A Constructive Technology Assessment (CTA) in the early phase of controlled implementation of the 70-gene prognosis signature (MammaPrint™) for node-negative breast cancer in community hospitals in The Netherlands (van de Vijver et al, 2002) as part of the prospective MicroarRAy PrognoSTics in Breast CancER (RASTER) study (Bueno de Mesquita et al, 2007). Methods: A multi-center, pre-post controlled prospective study between 2004–2006, using CTA. Four aspects were studied: I) Clinical effectiveness: treatment advice based on guidelines, and/or prognosis signature versus actual treatment decision. II) Efficiency: pre-post structured surveys in participating hospitals concerning changes in logistics and teamfunctioning. III) Patient centeredness: questionnaires and interviews on involvement in decision making and psychological impact. IV) Scenario: involvement of scientific and medical-oncology professionals as a way to anticipate diffusion and possible future developments. Results: I) Out of 812 patients, 427 signatures were obtained, 30% was discordant (guidelines versus signature), which resulted in change of treatment in 54% of the discordant cases. II) Surveys were performed in 15 hospitals. Duration of implementation varied from 0.2–9.4 months (mean 2.2). Most changes were seen in pathology processes and multidisciplinary teammeetings concerning adjuvant treatment decision. III) 77 patients were interviewed or returned a questionnaire (response 78%). High risk and discordant clinical low/poor signature patients showed significantly more negative emotions compared to low risk patients. Dissatisfaction was expressed by discordant patients, caused by the successive communication of the two risk assessments. IV) Scenario drafting will lead to input for model-based cost-effectiveness analysis. Conclusions: Introduction of the 70-gene signature showed 30% discordance, differences in implementationspeed and influenced treatment decisions. Impact on patients seems especially related to discordance and the successive communication. Physicians valued the addition of the 70-gene signature information as beneficial for patient management. CTA is appropriate for the study of early implementation of this technology. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Agendia Agendia