Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non–Small-Cell Lung Cancer

Abstract

PURPOSE Personalized medicine presents new opportunities for patients with cancer. However, many patients do not receive the most effective personalized treatments because of challenges associated with integrating predictive biomarker testing into clinical care. Patients are lost at various steps along the precision oncology pathway because of operational inefficiencies, limited understanding of biomarker strategies, inappropriate testing result usage, and access barriers. We examine the impact of various clinical practice gaps associated with diagnostic testing-informed personalized medicine strategies on the treatment of advanced non–small-cell lung cancer (aNSCLC). METHODS Using Diaceutics' Data Repository, a multisource database including commercial and Medicare claims and laboratory data from over 500,000 patients with non–small-cell lung cancer in the United States, we analyzed the number of patients with newly diagnosed aNSCLC who could have, but did not, benefit from a personalized treatment. The analysis focuses on the independent and cumulative impacts of gaps occurring during seven steps of the precision oncology pathway, from diagnosis to treatment. RESULTS For every 1,000 patients in the study cohort, 497 (49.7%) are lost to precision oncology because of factors associated with getting biomarker test results. Among the 503 of 1,000 patients who did receive results from a biomarker test, 147 (29.2%) did not receive appropriate targeted treatments. Thus, approximately 64% of potentially eligible patients with aNSCLC are not benefiting from precision oncology therapies appropriate for their disease. CONCLUSION Most patients with aNSCLC eligible for precision oncology treatments do not benefit from them because of clinical practice gaps. This finding is likely reflective of similar gaps in other cancer types. An increased understanding of the impact of each practice gap can inform strategies to improve the delivery of precision oncology, helping to fully realize the promise of personalized medicine.

Optimizing molecular testing of lung cancer needle biopsy specimens: potential solutions from an interdisciplinary qualitative study

“…Potential solutions in our study were geared towards crafting a framework that promotes successful molecular testing, including strategies to increase the yield of the biopsy procedure itself, which could be disseminated via workshops at specialty society meetings in addition to the literature. Biopsies should be performed using coaxial technique and target the periphery of large tumors to avoid central necrosis [31]. Review of pre-procedural imaging, such as fluorodeoxyglucose-PET and contrastenhanced CT, facilitates the identification of necrotic areas [31].…”

“…Biopsies should be performed using coaxial technique and target the periphery of large tumors to avoid central necrosis [31]. Review of pre-procedural imaging, such as fluorodeoxyglucose-PET and contrastenhanced CT, facilitates the identification of necrotic areas [31]. The shorter procedure time afforded by realtime CT, often referred to as "CT fluoroscopy, " creates time for ROSE and the collection of additional samples [32].…”

Impact of Simultaneous Circulating Tumor DNA and Tissue Genotyping in the Workup of Stage IV Lung Adenocarcinoma on Quality of Care in an Academic Community Medical Center

“…5,10,19 Strategies that reduce the time required for tumor genotyping may improve adherence to testing guidelines and patient outcomes. 16,17 An ASCO taskforce survey of US oncologists found that 23% of the respondents agreed that delaying treatment while waiting for test results was always or often a reason to not order biomarker testing. 17 Most providers (98%) considered 1-2 weeks as the acceptable wait time for biomarker test results.…”

“…In addition, these diagnostic methods are profoundly underutilized, primarily because of failures in biospecimen processing, testing, and result reporting. 16,17 Therefore, optimization of the diagnostic paradigm for tumor genotyping may improve the delivery of precision oncology treatments to patients with lung adenocarcinoma.…”

A rapid, multiplex digital PCR assay forEGFR,KRAS,BRAF,ERBB2variants andALK,RET,ROS1,NTRK1gene fusions in non-small cell lung cancer

“…Challenges such as insufficient or poor quality samples, and slow turnaround time [5], have further hindered broad adoption. For example, in a 2022 multisource database investigation, nearly 50% of patients were unable to benefit from precision medicines due to factors linked with obtaining biomarker results; 18% received inaccurate results due to test limitations or errors; and 4% started on a less precise treatment due to prolonged test turnaround time [6]. Therefore, there is an outstanding need for rapid, comprehensive, reliable, and low-cost methods that can identify patients as eligible for precision treatment and clinical trials.…”