In this best-practice guide, the authors begin by describing the broader context of non-small cell lung cancer disease, diagnosis, and treatment into which biomarker testing and directed therapies are being integrated. Biomarker-directed therapy has dramatically improved patient outcomes compared with conventional chemotherapy. Then the authors present, analyze, and discuss seven case scenarios to highlight the importance of securing adequate amounts of tumor for biomarker testing and to draw takeaway lessons and best practices from the analyses.

State legislative trends related to biomarker testing

Sadigh G, Goeckner HG, Kazerooni EA, Johnson BE, Smith RA, Adams DV, Carlos RC. State legislative trends related to biomarker testing. Cancer. 2022;128(15):2865-2870. doi:10.1002/cncr.34271

The authors outline the current state of biomarker testing for lung cancer treatment decisions, including the newer next-generation sequencing (NGS) panel methods. Financial barriers are described for insured and uninsured patients, despite overall cost savings with the incorporation of NGS screening for non-small cell lung cancer before beginning treatment. Insurance reimbursement for comprehensive biomarker testing was found inadequate when compared to established clinical guidelines. The authors also describe current legislation regarding insurance coverage for biomarker testing in three states (Illinois, Louisiana, and California) and recommend ways to improve and expand access to comprehensive biomarker testing by building upon current legislation.

Defining comprehensive biomarker-related testing and treatment practices for advanced non-small-cell lung cancer: Results of a survey of U.S. oncologists

Mileham KF, Schenkel C, Bruinooge SS, Freeman-Daily J, Roy UB, Moore A, Smith RA, Garrett-Mayer E, Rosenthal LS, Garon EB, Johnson BE, Osarogiagbon RU, Jalal S, Virani S, Redman MW, Silvestri GA. Defining comprehensive biomarker-related testing and treatment practices for advanced non-small-cell lung cancer: Results of a survey of U.S. oncologists. Cancer Medicine. 2022;11(2):530-538. doi:10.1002/cam4.4459

The authors sought to characterize lung cancer biomarker testing by both general and thoracic oncologists in cases of non-small cell lung cancer (NSCLC). They distributed a survey to 2374 American Society of Clinical Oncology members and analyzed 170 eligible responses. For NSCLC cases, 97% of respondents reported ordering tests for EGFR, ALK, ROS1, and BRAF biomarkers. Preferences were apparent for specific tests among academic clinicians and thoracic oncologists versus general oncologists. Providers also reported testing for actionable biomarkers before starting therapy. Treatment decisions were influenced by test turnaround time, level of specialization, practice setting, and experience.

Pretreatment Invasive Nodal Staging in Lung Cancer

Henderson LM, Farjah F, Detterbeck F, Smith RA, Silvestri GA, Rivera MP. Pretreatment Invasive Nodal Staging in Lung Cancer: Knowledge, Attitudes, and Beliefs Among Academic and Community Physicians. Chest. 2022;161(3):826-832. doi:10.1016/j.chest.2021.11.010

The authors used a web-based survey to characterize viewpoints on invasive nodal staging among thoracic surgeons and pulmonologists to determine why the practice is underutilized. Of the 453 respondents, 29% were unaware that pretreatment invasive nodal staging guidelines exist. Of the remaining 71% of respondents, 50% reported there was a lack of evidence linking staging guidelines with better patient outcomes, and 90% reported at least one barrier to guideline adherence, including delays in treatment due to the need for further testing. The authors agreed that multilevel interventions are necessary to increase knowledge of and adherence to invasive nodal staging guidelines before treatment for non-small cell lung cancer.

Knowledge and Practice Patterns Among Pulmonologists for Molecular Biomarker Testing in Advanced Non-small Cell Lung Cancer

Fox AH, Jett JR, Roy UB, Johnson BE, King JC, Martin N, Osarogiagbon RU, Rivera MP, Rosenthal LS, Smith RA, Silvestri GA. Knowledge and Practice Patterns Among Pulmonologists for Molecular Biomarker Testing in Advanced Non-small Cell Lung Cancer. Chest. 2021;160(6):2293-2303. doi:10.1016/j.chest.2021.06.027

The authors surveyed more than 7,000 pulmonologists to determine their roles in biomarker testing for non-small cell lung cancer (NSCLC). Of the 453 respondents, academic pulmonologists were more likely than community pulmonologists to perform or refer for an endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) for biomarker testing. In addition, interventional training, academic settings, and higher caseloads for diagnosing NSCLC were associated with more accurate knowledge of biomarker testing guidelines. Interventional training appeared to be more closely correlated than practice setting with the drive for improved knowledge and practice for biomarker testing.

Updates Regarding Biomarker Testing for Non–Small Cell Lung Cancer: Considerations from the National Lung Cancer Roundtable

Kim ES, Roy UB, Ersek JL, King J, Smith RA, Martin N, Martins R, Moore A, Silvestri GA, Jett J. Updates Regarding Biomarker Testing for Non-Small Cell Lung Cancer: Considerations from the National Lung Cancer Roundtable. J Thorac Oncol. 2019;14(3):338-342. doi:10.1016/j.jtho.2019.01.002

In this retrospective study, the authors describe the current state of biomarker testing for the treatment of non-small cell lung cancer. The barriers to screening are described, including perceived delays in treatment due to testing and turnaround time, lack of provider knowledge about reported and actionable biomarkers, and the need for molecular tumor boards at academic and community health systems. The authors describe several considerations for increasing provider education on current best practices, the importance of obtaining sufficient tissue samples, and the necessity for patient awareness and understanding of the benefits of biomarker testing.

The Role of Lung
Advocacy Organizations
in Biomarker Testing

Aldigé C, Roy UB, Boerckel W, Ciupek A, Donaldson D, Grossman H, Langhorne C, Rosenthal LS, Saxton C, Silvestri GA, Smith RA, Wenger L. The Role of Lung Advocacy Organizations in Biomarker Testing (White Paper). New York, NY. CancerCare; 2018.

The whitepaper outlines the advances in lung cancer treatment because of new targeted therapies based on biomarkers, the underutilization of biomarker testing, and suggestions for developing a plan to increase the uptake of biomarker testing by educating both providers and patients. The paper describes some successful lung cancer advocacy biomarker testing and awareness programs. Overall, a multi-factor approach is required to ensure that every advanced-stage lung cancer patient has biomarker testing completed at the time of diagnosis to guide appropriate and timely treatment decisions.