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.

FIG 1.

Step-by-step approach for analyzing the number of patients with advanced non–small-cell lung cancer lost at each step of the precision oncology pathway. CNB, core-needle biopsies; ddPCR, droplet digital polymerase chain reaction; FISH, fluorescence in situ hybridization; FNA, fine-needle aspirates; IHC, immunohistochemistry; IO, immuno-oncology; aNSCLS, advanced non-small-cell lung cancer; NGS, next-generation sequencing; PD-L1, programmed death-ligand 1; RT-PCR, reverse transcriptase polymerase chain reaction; TKI, tyrosine kinase inhibitor.

FIG 2.

The precision oncology care pathway: Overall impact of clinical practice gaps on the loss of eligible patients to the delivery of personalized advanced NSCLC care. CMS, Centers for Medicare & Medicaid Services; NSCLC, non–small-cell lung cancer; TAT, turnaround time; TNP, test not performed; QNS, quantity not sufficient.

FIG 3.

Barriers to receiving biomarker-based therapy for patients with actionable mutations. FDA, US Food and Drug Administration; FP, false positive; ICI, immune checkpoint inhibitor; TKI, tyrosine kinase inhibitor.

FIG 4.

Impact of clinical practice gaps on the delivery of precision oncology for aNSCLC. aNSCLC, advanced non-small cell lung cancer.