Beyond biomarker testing: Aligning the needs of oncologist and diagnostic companies to improve biomarker results reports for accurate clinical treatment selection.

Abstract

e18611 Background: The benefits of precision medicine, including targeted therapies and immunotherapy, for lung cancer patients are well-documented. National clinical guidelines recommend broad multiplex molecular panels for advanced stage NSCLC. Increased understanding of the molecular heterogeneity of lung cancer has led to novel biomarkers being discovered, increasing the potential to match patients to new treatments. Pairing a patient to the correct biomarker-defined therapy is dependent on both biomarker test being ordered and accurate interpretation of test results. However, the increasing complexity of biomarker reports could contribute to inaccurate diagnoses and suboptimal therapeutic selections. Our objective was to understand the extent of the problem of report interpretation and identify opportunities for harmonizing key elements of the reports, in order to improve report interpretability and patient care. Methods: A multi-stakeholder group comprised of 40 leaders from thoracic medical oncology, professional societies, government agencies, and diagnostic companies was convened by LUNGevity Foundation. Participants responded to pre-and-post meeting surveys to capture insights on the main challenges of results report generation (diagnostic companies) and accurate interpretation for patient care (oncologists) as well as recommended solutions and areas to jointly address. Recommendations were informed by an audit of 12 biomarker reports from commercial/ governmental labs for similarities and differences regarding report structure, terminology, and content. Results: Pre-meeting survey results and discussion from diagnostic companies (N = 12) and academic and community cancer center oncologists (N = 8) revealed multiple challenges with report generation as well as interpretation. Diagnostic companies highlighted the need for superior, time-intensive attention to detail for accurate evidence curation and report generation. Oncologists highlighted challenges reviewing and interpreting results such as inconsistencies in nomenclature for genomic variants, alignment of genomic alterations with approved therapies, and lack of clarification of the level of evidence for therapeutic selection. In post-meeting surveys, participants proposed solutions to harmonize specific aspects of biomarker testing reports to improve patient care. Top areas for alignment included establishing consensus on harmonization of clinical nomenclature, refining report structure, and shortening report length. Conclusions: It is not enough to only promote biomarker testing for lung cancer patients. Attention is also needed to systematically unify and streamline clinical biomarker reports to best serve the oncology community. These efforts may also serve as a model for application in other cancers beyond lung cancer.