Biomarker testing patterns in patients with stage IV non-small cell lung cancer (NSCLC) in U.S. community-based oncology practice setting.

Abstract

300 Background: This study evaluated rates of biomarker testing for patients with stage IV non-squamous NSCLC, which is known to have a ̃40% biomarker-positive rate (AMP, 2020), in a community-based oncology practice setting in the United States (US). Methods: A retrospective study was performed using data from a US electronic medical record database of patients aged ≥18 years with an initial diagnosis (index dx) of stage IV non-squamous NSCLC between Jan 1, 2015 and Dec 31, 2019. Unstructured data on molecular biomarker testing (single-gene and next-generation sequencing [NGS]-based) were abstracted from patient charts utilizing Natural Language Processing for EGFR mutation, ALK rearrangement, BRAF mutation, ROS1 rearrangement, MET exon14 mutation, RET fusion, NTRK fusion, and PD-L1 expression. Systemic therapy was obtained from structured data. Data were summarized using descriptive statistics. This study received a waiver of consent from Advarra IRB. Results: Of 646 patients identified in the database, 500 met all inclusion criteria and are included in this analysis. The majority (73.8%) were diagnosed in 2018 (n = 162; 32.4%) and 2019 (n = 207; 41.4%). Mean age (SD) was 70.0 (10.1) years, with 53.2% female. A total of 447 (89.4%) were tested for at least one biomarker after index diagnosis of which 81.2% (n = 406) had at least one single-gene test; 54.8% (n = 274) had an NGS test and 66.8% were tested for PD-L1. Single-gene or NGS-based testing was > 85% of patients across all index years. The use of NGS-based tests ranged from 35.0% among patients whose first diagnosis was in 2015 to 59.4% in 2019. Overall, 85.4% (n = 427) of the cohort received first-line treatment with chemotherapy (53.6%), immunotherapy (48.2%), or targeted therapy (14.2%). Among patients who received biomarker tests, 15.4% received targeted treatment and 49.7% received immunotherapy treatment, including checkpoint inhibitors, during first-line treatment. Conclusions: NGS testing utilization increased during the study period and by 2019, 59% of patients received NGS-based testing. Opportunities persist for practices to improve testing and achieve guideline recommendations. PD-L1 biomarker testing was performed amongst the highest proportion of patients in this study and nearly 50% of all patients received immunotherapy, including checkpoint inhibitors. Targeted therapy was used in 14.2% of this population, suggesting that patients with actionable biomarkers may not be receiving targeted treatment for their disease, potentially due to gaps in testing among patients in this dataset.

Biomarker Testing for Patients With Advanced/Metastatic Nonsquamous NSCLC in the United States of America, 2015 to 2021

“… 22 Another single community-based practice study found that 59% of patients received NGS-based testing. 15 Although the findings from this study suggest that NGS-based testing may be higher among the clinical practices in the Flatiron Health network, it is clear that underutilization of recommended testing is a national problem.…”

“… 11 , 12 , 13 There is emerging work that has begun to explore diagnostic testing in real-world settings, but gaps remain in the knowledge of current practices in biomarker testing and its utilization across community and academic practice settings. 5 , 14 , 15 This study, therefore, was designed to evaluate the utilization of single-gene and panel-based biomarker testing (by NGS) among patients with nonsquamous advanced or metastatic NSCLC in community and academic practice settings across the United States to quantify the rates of testing in current practice to inform the development of guidelines or initiatives to address gaps in the receipt of biomarker testing.…”

Biomarker Testing, Treatment, and Outcomes in Patients With Advanced/Metastatic Non–Small Cell Lung Cancer Using a Real-World Database

“…18,24 Despite recommendations that biomarker testing be conducted to guide first-line treatment selection, many patients do not have broad molecular testing performed on their tumor tissue as reported in multiple studies. [25][26][27][28][29] Data from the MYLUNG study reported changes in rates of molecular testing from April 2018 to March 2020 for genes including EGFR (71%!71%), BRAF (51%!59%), ROS1 (69%!67%), and ALK (71%!70%), and reported an overall increase of 33% to 45% in the use of next-generation sequencing (NGS)-based testing in patients with a/mNSCLC. 28 In another study, despite a reported increase in the use of NGS-based testing from 28% (2015) to 68% (2020) in patients with a/mNSCLC in the United States, approximately 33% of patients did not receive testing for all guidelinerecommended biomarkers.…”