Proteomic testing (VeriStrat®) is proposed as a blood-based predictive and prognostic test for individuals with non-small-cell lung cancer (NSCLC) who test negative for epidermal growth factor receptor (EGFR) mutations (EGFR wild-type) or whose EGFR mutation status is unknown and for individuals who have not responded to first line therapies. The test relies on a predictive algorithm analysis of pretreatment serum to generate a good or poor assessment for response to tyrosine kinase inhibitors (TKIs).
POLICY
The use of proteomic testing in the management of non-small-cell lung cancer (NSCLC) is considered investigational.
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
The evidence for the use of serum proteomic testing in individuals with non-small-cell lung cancer (NSCLC) is insufficient to determine the effects of the technology on health outcomes.
SOURCES
BlueCross BlueShield Association. Evidence Positioning System. (12:2022). Proteomic testing for targeted therapy in non-small-cell lung cancer (2.04.125). Retrieved September 19, 2023 from http://www.evidencepositioningsystem.com. (51 articles and/or guidelines reviewed)
Chae, Y.K., Kim, W.B., Davis, A.A., Park, L.C., Anker, J.F., Simon, N.I., et al. (2020). Mass spectrometry-based serum proteomic signature as a potential biomarker for survival in patients with non-small cell lung cancer receiving immunotherapy. Translational Lung Cancer Research, 9 (4), 1015-1028. (Level 4 evidence)
eviCore healthcare. (2023, July). VeriStrat testing for NSCLC TKI response guidelines. Retrieved September 19, 2023 from www.evicore.com. (33 articles and/or guidelines reviewed)
Grossi, F., Rijavec, E., Genova, C., Barletta, G., Biello, F., Maggioni, C., et al. (2016). Serum proteomic test in advanced non-squamous non-small cell lung cancer treated in first line with standard chemotherapy. British Journal of Cancer, 116, 36-43. (Level 2 evidence)
Hornberger, J., Hirsch, F., Q, Li., & Page, R. (2015). Outcome and economic implications of proteomic test-guided second-or third-line treatment for advanced non-small cell lung cancer: extended analysis of the PROSE trial. Lung Cancer, 88 (2), 223-230, Abstract retrieved March 3, 2016 from PubMed database.
Leal, T.A., Argento, A.C., Bhadra, K., Hogarth, D.K., Grigorieva, J., Hartfield, R.M., et al. (2020). Prognostic performance of proteomic testing in advanced non-small cell lung cancer: a systematic literature review and meta-analysis. Current Medical Research and Opinion, 36 (9), 1497-150. (Level 1 evidence)
National Comprehensive Cancer Network. (2023, April). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-small cell lung cancer. Version 3.2023. Retrieved September 19, 2023 from the National Comprehensive Cancer Network.
Peters, S., Stahel, R.A., Dafni, U., Ponce, A., Massuti, B., Gautschi, O, et al. (2017). Randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer failing first-line platinum-based doublet chemotherapy stratified by VeriStrat good versus VeriStrat poor. The European thoracic oncology platform (ETOP) EMPHASIS-lung trial. Journal of Thoracic Oncology, 12 (4), 752-762. (Level 2 evidence)
Tanvetyanon, T., Creelan, B., Chiappori, A. (2014). Current clinical application of genomic and proteomic profiling in non-small-cell lung cancer. Cancer Control, 21 (1), 32-39. (Level 4 evidence)
ORIGINAL EFFECTIVE DATE: 4/9/2015
MOST RECENT REVIEW DATE: 11/9/2023
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