Background Breast cancer genomic assays are emerging as essential tools used by physicians in the cancer treatment decision-making process. This technology is new, and we must interrogate the integration of these assays into clinical practice and their impact on prognosis and treatment for both providers and patients. The objective of this study was to explore provider’s perspectives on the use and integration of breast cancer genomic assays in clinical care.
Methods 15 international physicians/researchers who had conducted studies on breast cancer genomic assays were interviewed. Participants had conducted studies across five different genomic assays. The interview guide was developed through a literature review and leveraged extensive data collected on key clinical utility outcomes for the assays. All interviews were conducted virtually, recorded, and transcribed verbatim. Data were analysed using thematic analysis.
Results Three novel themes emerged from participant’s perspectives on the integration of these assays into clinical practice. The emerging role of genomic assays to identify overtreatment and unnecessary care was highlighted by participants. The primary value of these tools is to identify patients who will not benefit from adjuvant chemotherapy. Participants reported that current standard practice is to overtreat and portrayed the binary or definitive results of these assays as an important tool to reduce overtreatment. Participants also reported how the perspectives and uses of these assays vary significantly in different countries and cultures. This jurisdictional variation in cancer prognosis and treatment was observed as producing uneven and sometimes problematic interpretations of value for the assays. Finally, participants provided insights into industry’s deliberate efforts to integrate the assays into clinical practice and their significant role in marketing and evidence production. The participants detailed how this evidence of improved quality of life and reduction in overtreatment was positioned to justify a premium pricing strategy.
Conclusions The results of this study provide insights into the integration of genomic assays into clinical decision-making processes. The assays are extending the boundaries of their clinical utility through identifying overtreatment and unnecessary care. These results also illuminate the subjectivity of cancer treatment and the contested space within which these tools attempt to add value. Finally, perspectives on industry’s efforts to legitimize these assays, their high prices and situate them as an integral component in the cancer care decision-making process.
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