![]() ![]() The FLAURA trial of osimertinib (Tagrisso) established the agent as the new standard of care for patients with NSCLC who have EGFR sensitizing mutations. This method may circumvent the need for tissue biopsies, he added. Shedding of cfDNA is a product of apoptosis and necrosis, and now more sensitive diagnostic platforms have the capability to genetically interrogate isolate DNA from the blood, explained Levy. "How do we find the tissue? Where is it? Once it is pinned down, how do you report it? There are challenges with tissue, even in the best of circumstances."ĬfDNA is captured by a simple noninvasive blood test, often referred to as a liquid biopsy. "Where does the tissue go? You do the biopsy, it is sent to the pathology lab, then it goes to a whole different bunch of labs," Levy explained. ![]() Additionally, every institution has a different way of reporting results from the tissue biopsy, Levy said. Traditional tissue biopsies are invasive, and there are questions regarding tissue stewardship. There are also issues with tissue procurement. This is a hypothetical patient population, but there is a lot more work we need to do to understand whether this is cost effective or not," summarized Levy.Although NGS is a beneficial option, Levy noted that the turnaround time is often long. "NGS was cost effective when compared with sequential, exclusionary, and a hotspot panel, both for a CMS and Medicare perspective, and for commercial payers. 2 This model included 1 million hypothetical newly diagnosed patients with Medicare and commercial health plans.įindings showed that that NGS could save Center for Medicare and Medicaid Services (CMS) payers $1.4 million to $2.1 million, and commercial insurance providers more than $250,000. In a study presented at the 2018 ASCO Annual Meeting, the economic impact of NGS compared with sequential single-gene testing modalities to detect genomic alterations in patients with metastatic NSCLC was analyzed using a decision analytic model. He added that there is a deeper clinical value in getting information from a broad-based genomic sequencing assay than just survival.Ĭommunity practices are often worried about the cost of doing these broad-based genomic sequencing assays. Levy advised that clinicians read the study and decipher the meaning for themselves, but consider that this is not necessarily real-world data. This was a surprising result, Levy explained. This retrospective analysis of over 5000 patients showed no difference in outcomes, and broad-based genomic sequencing only directly informed treatment in a minority of patients. 1 This study looked at the difference between patients who had comprehensive genomic profiling of their lung cancer versus those who had only had EGFR and ALK panel testing. This goes beyond lung cancer, he added, as basket trials such as ASCO’s TAPUR study and the NCI-MATCH trial include patients from multiple tumor types.A recently published study in JAMA on advanced NSCLC sought to determine the association of broad-based genomic sequencing and survival in the community oncology setting. This list of targets answers the question of why genomic testing should be done in patients with NSCLC, according to Levy. In addition, there are patients with NSCLC who express MET exon 14 alterations, as well as those who express HER2, RET, and NTRK abnormalities. We now have other actionable mutations, like ROS1 and BRAF, that have approved therapies." Questions on Implementing Sequencing "The story of molecular profiling began with EGFR and ALK, but that is the tip of the iceberg. "Adenocarcinoma now can be parsed out into molecular subsets, and based on the molecular subsets identified, they can be wed to a targeted therapy," Levy said. In a presentation during the 2018 OncLive ® State of the Science Summit™ on Advanced Non-Small Cell Lung Cancer, Levy, assistant professor of Oncology, clinical director of Medical Oncology, Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins Medicine, discussed optimal strategies for molecular interrogation of NSCLC. The introduction of next-generation sequencing (NGS) platforms and cell-free DNA (cfDNA) have provided the opportunity for clinicians to be more specific in targeting mutations in patients with non-small cell lung cancer (NSCLC), according to Benjamin P. ![]()
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