Advertisement
Original Study|Articles in Press

Real-world Biomarker Testing Patterns in Patients with Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) in a US Community-based Oncology Practice Setting

Published:March 18, 2023DOI:https://doi.org/10.1016/j.cllc.2023.03.002

      Highlights

      • This real-world study evaluated biomarker testing and targeted therapy in mNSCLC
      • At least one biomarker test was received by 89.4% of patients with mNSCLC
      • Targeted therapy was used in 62.4% of patients with a positive biomarker test
      • Increases in biomarker testing were observed after national guideline updates
      • Despite recent improvements, there remain gaps in biomarker testing and treatment

      ABSTRACT

      Purpose

      : This study was designed to describe real-world changes in biomarker testing among patients with non-squamous, metastatic non-small-cell lung cancer (mNSCLC) in a community oncology setting from 2015 to 2020.

      Patients and Methods

      : This retrospective study randomly selected 500 adult patients diagnosed with non-squamous mNSCLC to undergo chart review and data extraction. Data were extracted and validated by two independent abstractors. Biomarker testing rates were described before and after national guideline updates and FDA approval of targeted agents.

      Results

      : At least one biomarker test was received by 89.4% of patients with mNSCLC. Of all patients, 46.6%, 34.6%, and 8.2% received both single-gene and next generation sequencing (NGS)-based testing, single-gene testing only, and NGS-based testing only, respectively. However, there were changes in testing rates at the time of drug approvals for targeted agents. Biomarker testing increased for ALK (45.0% before to 78.3% after ALK-targeted drug approval), BRAF (20.0% to 67.8%), EGFR (20.0% to 78.2%), NTRK (34.6% to 55.7%), and ROS1 (29.6% to 74.2%). Biomarker testing increased after changes were made to national guidelines for BRAF (from 18.8% before to 68.1% after inclusion in guidelines), NTRK (37.2% to 56.5%), and ROS1 (40.8% to 74.5%). Targeted therapy was used in 62.4% of patients with a positive biomarker.

      Conclusion

      : Increases in biomarker testing rates were observed relative to targeted agent approvals and national guideline updates. However, many patients with non-squamous mNSCLC did not receive full genotyping in accordance with national guidelines and represent an opportunity to identify reasons and solutions for barriers to care.

      Microabstract

      : This real-world chart review study observed increases in biomarker testing after both targeted drug approvals and after inclusion in national treatment guidelines. Despite these improvements, approximately 10% of patients never received any biomarker testing, and more than one third of patients with positive biomarker tests do not receive targeted therapy. Further work is needed to understand barriers in patient care.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Clinical Lung Cancer
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      REFERENCES

        • Siegel RL
        • Miller KD
        • Fuchs HE
        • Jemal A
        Cancer Statistics.
        CA: A Cancer Journal for Clinicians. 2021; 71 (2021): 7-33
        • Howlader N
        • Noone A
        • Krapcho M
        • Miller D
        • Brest A
        • Yu M
        • Ruhl J
        • Tatalovich Z
        • Mariotto A
        • Lewis D
        • et al.
        SEER Cancer Statistics Review. 2019; : 1975-2016
        • Travis WD
        • Brambilla E
        • Nicholson AG
        • Yatabe Y
        • Austin JHM
        • Beasley MB
        • Chirieac LR
        • Dacic S
        • Duhig E
        • Flieder DB
        • et al.
        The 2015 World Health Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification.
        Journal of Thoracic Oncology. 2015; 10: 1243-1260
        • Barlesi F
        • Mazieres J
        • Merlio J-P
        • Debieuvre D
        • Mosser J
        • Lena H
        • Ouafik LH
        • Besse B
        • Rouquette I
        • Westeel V
        • et al.
        Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT).
        The Lancet. 2016; 387: 1415-1426
        • Kris MG
        • Johnson BE
        • Berry LD
        • Kwiatkowski DJ
        • Iafrate AJ
        • Wistuba II
        • Varella-Garcia M
        • Franklin WA
        • Aronson SL
        • Su P-F
        • et al.
        Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs.
        JAMA. 2014; 311: 1998
        • Abrahams E
        Right Drug—Right Patient—Right Time: Personalized Medicine Coalition.
        Clinical and Translational Science. 2008; 1: 11-12
        • Mehta A
        • Vasudevan S
        • Sharma SK
        • Panigrahi M
        • Suryavanshi M
        • Saifi M
        • Batra U
        Biomarker testing for advanced lung cancer by next-generation sequencing; a valid method to achieve a comprehensive glimpse at mutational landscape.
        Applied Cancer Research. 2020; 40: 4
        • Yu TM
        • Morrison C
        • Gold EJ
        • Tradonsky A
        • Layton AJ
        Multiple Biomarker Testing Tissue Consumption and Completion Rates With Single-gene Tests and Investigational Use of Oncomine Dx Target Test for Advanced Non–Small-cell Lung Cancer: A Single-center Analysis.
        Clinical Lung Cancer. 2019; 20 (e28): 20-29
        • Vanderwalde AM
        • Ma E
        • Yu E
        • Szado T
        • Price R
        • Shah A
        • Meyer CS
        • Abbass IM
        • Grothey A
        • Staszewski H
        • et al.
        NGS testing patterns in advanced non-small cell lung cancer (aNSCLC) and metastatic breast cancer (mBC): OneOncology (OO) sites compared to Flatiron Health Nationwide (NAT).
        Journal of Clinical Oncology. 2021; 39 (_suppl288-288)
        • Robert NJ
        • Nwokeji ED
        • Espirito JL
        • Chen L
        • Karhade M
        • Evangelist MC
        • Spira AI
        • Neubauer MA
        • Bullock SA
        • Coleman RL
        • et al.
        Biomarker tissue journey among patients (pts) with untreated metastatic non-small cell lung cancer (mNSCLC) in the U.S. Oncology Network community practices.
        Journal of Clinical Oncology. 2021; 39 (_suppl9004-9004)
        • Nadler E
        • Pavilack M
        • Clark J
        • Espirito J
        • Fernandes A
        Biomarker Testing Rates in Patients with Advanced Non-Small Cell Lung Cancer Treated in the Community.
        Journal of Cancer Therapy. 2019; 10: 971-984
        • John A
        • Yang B
        • Shah R
        Clinical Impact of Adherence to NCCN Guidelines for Biomarker Testing and First-Line Treatment in Advanced Non-Small Cell Lung Cancer (aNSCLC) Using Real-World Electronic Health Record Data.
        Advances in Therapy. 2021; 38: 1552-1566
        • Pennell NA
        • Mutebi A
        • Zhou Z-Y
        • Ricculli ML
        • Tang W
        • Wang H
        • Guerin A
        • Arnhart T
        • Dalal A
        • Sasane M
        • et al.
        Economic Impact of Next-Generation Sequencing Versus Single-Gene Testing to Detect Genomic Alterations in Metastatic Non–Small-Cell Lung Cancer Using a Decision Analytic Model.
        JCO Precision Oncology. 2019; : 1-9
        • Kris MG
        • Johnson BE
        • Berry LD
        • Kwiatkowski DJ
        • Iafrate AJ
        • Wistuba II
        • Varella-Garcia M
        • Franklin WA
        • Aronson SL
        • Su P-F
        • et al.
        Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs.
        JAMA. 2014; 311: 1998-2006
        • Pennell NA
        • Zhou J
        • Hobbs B
        A model comparing the value of broad next-gen sequencing (NGS)-based testing to single gene testing (SGT) in patients with nonsquamous non-small cell lung cancer (NSCLC) in the United States.
        Journal of Clinical Oncology. 2020; 38 (_suppl9529-9529)
        • Ettinger DS
        • Wood DE
        • Aisner DL
        • Akerley W
        • Bauman JR
        • Bharat A
        • Bruno DS
        • Chang JY
        • Chirieac LR
        • D'Amico TA
        • et al.
        NCCN Guidelines Insights: Non–Small Cell Lung Cancer, Version 2.2021.
        Journal of the National Comprehensive Cancer Network. 2021; 19: 254-266
        • Lindeman NI
        • Cagle PT
        • Aisner DL
        • Arcila ME
        • Beasley MB
        • Bernicker EH
        • Colasacco C
        • Dacic S
        • Hirsch FR
        • Kerr K
        • et al.
        Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors. Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology.
        Journal of Thoracic Oncology. 2018; 13: 323-358
        • Kalemkerian GP
        • Narula N
        • Kennedy EB
        • Biermann WA
        • Donington J
        • Leighl NB
        • Lew M
        • Pantelas J
        • Ramalingam SS
        • Reck M
        • et al.
        Molecular Testing Guideline for the Selection of Patients With Lung Cancer for Treatment With Targeted Tyrosine Kinase Inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Association for the.
        Journal of Clinical Oncology. 2018; 36: 911-919
        • Bruno DS
        • Hess LM
        • Li X
        • Su EW
        • Zhu YE
        • Patel M
        Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC).
        Journal of Clinical Oncology. 2021; 39 (_suppl9005-9005)
      1. FDA U: Oncology (Cancer) /Hematologic Malignancies Approval Notifications. 2021.

      2. Bernicker EH, Xiao Y, Abraham A, Yang B, Croix DA, Redpath S, Engstrom-Melnyk J, Shah R, Madala J, Allen TC: Adherence to National Comprehensive Cancer Network ALK Testing Guidelines for Patients with Advanced Non-Small Cell Lung Cancer in U.S. Community Medical Centers. The Oncologist 2021, 26(6).

        • Bristow RE
        • Chang J
        • Ziogas A
        • Anton-Culver H
        Adherence to treatment guidelines for ovarian cancer as a measure of quality care.
        Obstetrics & Gynecology. 2013; 121: 1226-1234
        • Kumar P
        • Rosario MD
        • Chang J
        • Ziogas A
        • Jafari MD
        • Bristow RE
        • Tanjasiri SP
        • Zell JA
        Population-based analysis of National Comprehensive Cancer Network (NCCN) guideline adherence for patients with anal squamous cell carcinoma in California.
        Journal of Clinical Oncology. 2021; 39 (_suppl1-1)
        • Molena D
        • Mungo B
        • Stem M
        • Poupore AK
        • Chen SY
        • Lidor AO
        Does quality of care matter? A study of adherence to national comprehensive cancer network guidelines for patients with locally advanced esophageal cancer.
        Journal of Gastrointestinal Surgery. 2015; 19: 1739-1747
        • Boehmer L
        Perceptions of Biomarker Testing for Underserved Patients With Lung Cancer: A Mixed-Methods Survey of US-Based Oncology Clinicians.
        in: International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer. 2021 (2021)