Abstract
For patients with advanced non–small cell lung cancer, genomic profiling of tumors to identify potentially targetable alterations and thereby inform treatment selection is now part of standard care. While molecular analyses are primarily focused on actionable biomarkers associated with regulatory agency-approved therapies, there are a number of emerging biomarkers linked to investigational agents in advanced stages of clinical development will become approved agents. A particularly timely example is the reported data and US Food and Drug Administration approval of highly specific small molecule inhibitors of the proto-oncogene tyrosine-protein kinase receptor RET indicate that testing for tumor RET gene fusions in patients with NSCLC has become clinically important. As the number of biomarkers to be tested in NSCLC grows, it becomes increasingly important to optimize and prioritize the use of biopsy tissue, in order to both continue to allow accurate histopathological diagnosis and also to support concurrent genomic profiling to identify perhaps relatively uncommon genetic events. In order to provide practical expert consensus guidance to optimize processes facilitating genomic testing in NSCLC and to overcome barriers to access and implementation, a multidisciplinary advisory board was held in New York, on January 30, 2019. The panel comprised physicians involved in sample procurement (interventional radiologists and a thoracic surgeon), surgical pathologists specializing in the lung, molecular pathologists, and thoracic oncologists. Particular consideration was given to the key barriers faced by these experts in establishing institutional genomic screening programs for NSCLC. Potential solutions have been devised in the form of consensus opinions that might be used to help resolve such issues.
Highlights
Most patients with non–small cell lung cancer (NSCLC) present with advanced stage unresectable disease requiring treatment with systemic therapies
This can be achieved by establishing processes that allow for tissue samples to be clearly marked for molecular-prioritization workflows
Consideration should be given to separately embedding each tissue biopsy from a patient into a single block rather than combining multiple cores into a single block. This allows for shallow facing of individual samples, which is generally sufficient to confirm the presence of tumor cells, while preserving the maximum amount of material for molecular analyses [41]
Summary
Most patients with non–small cell lung cancer (NSCLC) present with advanced stage unresectable disease requiring treatment with systemic therapies. A timely example of the importance of expanded molecular testing in NSCLC are the recent FDA approvals of the specific RET inhibitors selpercatinib and pralsetinib which have resulted in a requirement to test for RET gene fusions in lung cancer, and activating point mutations in medullary thyroid cancer [3,4,5,6,7]. In order to maximize the level of biomarker testing, a shift in practice is required from a biopsy being viewed primarily as a tool for histological diagnosis to one where it is utilized as a route to complete pathologic staging, histological diagnosis, molecular profiling of the tumor, and a patient-specific treatment decision This is of critical importance as unless molecular profiling is specified upfront and that message reaches the surgical pathologist and/or cytopathologist, much or all of the available tissue may be used for diagnostic approaches, including immunohistochemistry. Be advisable to schedule an interventional biopsy at the same time to avoid downstream delays in the event of uninformative cfDNA findings
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