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Oncology and Therapy

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Open Access 18-06-2023 | NSCLC | Original Research

Real-World Biomarker Test Utilization and Subsequent Treatment in Patients with Early-Stage Non-small Cell Lung Cancer in the United States, 2011−2021

Authors: Jessie T. Yan, Yue Jin, Ernest Lo, Yilin Chen, Amy E. Hanlon Newell, Ying Kong, Landon J. Inge

Published in: Oncology and Therapy | Issue 3/2023

Abstract

Introduction

Biomarker testing is increasingly crucial for patients with early-stage non-small cell lung cancer (eNSCLC). We explored biomarker test utilization and subsequent treatment in eNSCLC patients in the real-world setting.

Methods

Using COTA’s oncology database, this retrospective observational study included adult patients ≥ 18 years old diagnosed with eNSCLC (disease stage 0–IIIA) between January 1, 2011 and December 31, 2021. Date of first eNSCLC diagnosis was the study index date. We reported testing rates by index year for patients who received any biomarker test within 6 months of eNSCLC diagnosis and by each molecular marker. We also evaluated treatments received among patients receiving the five most common biomarker tests.

Results

Among the 1031 eNSCLC patients included in the analysis, 764 (74.1%) received ≥ 1 biomarker test within 6 months of eNSCLC diagnosis. Overall, epidermal growth factor receptor (EGFR; 64%), anaplastic lymphoma kinase (ALK; 60%), programmed death receptor ligand 1 (PD-L1; 48%), ROS proto-oncogene 1 (ROS1; 46%), B-Raf proto-oncogene (40%), mesenchymal epithelial transition factor receptor (35%), Kirsten rat sarcoma viral oncogene (29%), RET proto-oncogene (22%), human epidermal growth factor receptor 2 (21%), and phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (20%) were the 10 most frequently tested biomarkers. The proportion of patients undergoing biomarker testing rose from 55.3% in 2011 to 88.1% in 2021. The most common testing methods were Sanger sequencing for EGFR (244, 37%), FISH (fluorescence in situ hybridization) for ALK (464, 75%) and ROS1 (357, 76%), immunohistochemical assay for PD-L1 (450, 90%), and next-generation sequencing testing for other biomarkers. Almost all the 763 patients who received the five most common biomarker tests had a test before the initiation of a systemic treatment.

Conclusion

This study suggests a high biomarker testing rate among patients with eNSCLC in the US, with testing rates for various biomarkers increasing over the past decade, indicating a continuous trend towards the personalization of treatment decisions.

American Cancer Society. Cancer facts & figures 2022. 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html. Accessed 6 June 2023.

Inamura K. Lung cancer: understanding its molecular pathology and the 2015 WHO classification. Front Oncol. 2017;7:193. https://doi.org/10.3389/fonc.2017.00193. CrossRefPubMedPubMedCentral

The Cancer Genome Atlas Research Network. Comprehensive molecular profiling of lung adenocarcinoma. Nature. 2014;511(7511):543–50. https://doi.org/10.1038/nature13385. CrossRefPubMedCentral

Travis WD, Brambilla E, Burke AP, Marx A, Nicholson AG. WHO classification of tumours of the lung, pleura, thymus and heart. Lyon: IARC; 2015.

Cancer Treatment Centers of America. Lung cancer types. 2022. https://www.cancercenter.com/cancer-types/lung-cancer/types. Accessed 6 June 2023.

Ganti KA, Klein AB, Cotarla I, Seal B, Chou E. Update of incidence, prevalence, survival, and initial treatment in patients with non-small cell lung cancer in the US. JAMA Oncol. 2021;7(12):1824–32. https://doi.org/10.1001/jamaoncol.2021.4932. CrossRefPubMed

McDonald F, De Waele M, Hendriks LEL, Faivre-Finn C, Dingemans A-MC, Van Schil PE. Management of stage I and II nonsmall cell lung cancer. Euro Respir J. 2017;49(1):1600764. https://doi.org/10.1183/13993003.00764-2016. CrossRef

Rodríguez M, Ajona D, Seijo LM, et al. Molecular biomarkers in early stage lung cancer. Transl Lung Cancer Res. 2021;10(2):1165–85. https://doi.org/10.21037/tlcr-20-750. CrossRefPubMedPubMedCentral

Yang SR, Schultheis AM, Yu H, Mandelker D, Ladanyi M, Büttner R. Precision medicine in non-small cell lung cancer: current applications and future directions. Semin Cancer Biol. 2022;84:184–98. https://doi.org/10.1016/j.semcancer.2020.07.009. CrossRefPubMed

10.

Kerr KM, Bibeau F, Thunnissen E, et al. The evolving landscape of biomarker testing for non-small cell lung cancer in Europe. Lung Cancer. 2021;154:161–75. https://doi.org/10.1016/j.lungcan.2021.02.026. CrossRefPubMed

11.

Aisner DL, Riely GJ. Non–small cell lung cancer: recommendations for biomarker testing and treatment. J Natl Compr Canc Netw. 2021;19(5.5):610–3. https://doi.org/10.6004/jnccn.2021.5020. CrossRef

12.

Pennell NA, Arcila ME, Gandara DR, West H. Biomarker testing for patients with advanced non-small cell lung cancer: real-world issues and tough choices. Am Soc Clin Oncol Educ Book. 2019;39:531–42. https://doi.org/10.1200/edbk_237863.

13.

Douillard JY, Rosell R, De Lena M, et al. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006;7(9):719–27. https://doi.org/10.1016/s1470-2045(06)70804-x. CrossRefPubMed

14.

Pignon JP, Tribodet H, Scagliotti GV, et al. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26(21):3552–9. https://doi.org/10.1200/jco.2007.13.9030. CrossRefPubMed

15.

Burotto M, Thomas A, Subramaniam D, Giaccone G, Rajan A. Biomarkers in early-stage non-small-cell lung cancer: current concepts and future directions. J Thorac Oncol. 2014;9(11):1609–17. https://doi.org/10.1097/jto.0000000000000302. CrossRefPubMedPubMedCentral

16.

Herbst RS, Tsuboi M, John T, et al. Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA. J Clin Oncol. 2020;38(18 Suppl.):Abstract LBA5. https://doi.org/10.1200/JCO.2020.38.18_suppl.LBA5. CrossRef

17.

Wu YL, Tsuboi M, He J, et al. Osimertinib in resected EGFR-mutated non-small-cell lung cancer. N Engl J Med. 2020;383(18):1711–23. https://doi.org/10.1056/NEJMoa2027071. CrossRefPubMed

18.

US Food & Drug Administration (FDA). FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer. Published October 15, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-adjuvant-treatment-non-small-cell-lung-cancer.

19.

National Comprehensive Cancer Network. Non-small cell lung cancer. Version 5.2022. 2022. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed 6 June 2023.

20.

COTA. Bringing clarity to cancer. 2022. https://cotahealthcare.com/. Accessed 6 June 2023.

21.

Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649–55. CrossRefPubMed

22.

Ettinger DS, Wood DE, Aisner DL, et al. Non–small cell lung cancer, version 3.2022, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2022;20(5):497–530. https://doi.org/10.6004/jnccn.2022.0025. CrossRefPubMed

23.

Hess LM, Krein PM, Haldane D, Han Y, Sireci AN. Biomarker testing for patients with advanced/metastatic nonsquamous NSCLC in the United States of America, 2015 to 2021. JTO Clin Res Rep. 2022;3(6):100336. https://doi.org/10.1016/j.jtocrr.2022.100336. CrossRefPubMedPubMedCentral

24.

National Cancer Institute. FDA approves pembrolizumab for patients with non-small cell lung cancer. 2015. https://www.cancer.gov/news-events/cancer-currents-blog/2015/pembrolizumab-nsclc. Accessed 6 June 2023.

25.

Khozin S, Abernethy AP, Nussbaum NC, et al. Rates of PD-L1 expression testing in U.S. community-based oncology practices (USCPs) for patients with metastatic non-small cell lung cancer (mNSCLC) receiving nivolumab (N) or pembrolizumab (P). J Clin Oncol. 2017;35(15 Suppl.):Abstract 11596. https://doi.org/10.1200/JCO.2017.35.15_suppl.11596.

26.

Leapman MS, Presley CJ, Zhu W, et al. Association of programmed cell death ligand 1 expression status with receipt of immune checkpoint Inhibitors in patients with advanced non-small cell lung cancer. JAMA Netw Open. 2020;3(6):e207205. https://doi.org/10.1001/jamanetworkopen.2020.7205. CrossRefPubMedPubMedCentral

27.

US Food & Drug Administration (FDA). FDA approves neoadjuvant nivolumab and platinium-doublet chemotherapy for early-stage non-small cell lung cancer. Published 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-nivolumab-and-platinum-doublet-chemotherapy-early-stage-non-small-cell-lung. Accessed 6 June 2023.

28.

Yanagawa J. Non-small cell lung cancer: managment of patients with resectable disease. In: National Comprehensive Cancer Network (NCCN) 2022 Annual Conf; 2022 Oct 14–15; virtual.

29.

van de Ven M, Koffijberg H, Retèl V, et al. Real-world utilization of biomarker testing for patients with advanced non-small cell lung cancer in a tertiary referral center and referring hospitals. J Mol Diagn. 2021;23(4):484–94. https://doi.org/10.1016/j.jmoldx.2021.01.004. CrossRefPubMed

30.

Steuten L, Goulart B, Meropol NJ, Pritchard D, Ramsey SD. Cost effectiveness of multigene panel sequencing for patients with advanced non-small-cell lung cancer. JCO Clin Cancer Inform. 2019;3:1–10. https://doi.org/10.1200/cci.19.00002. CrossRefPubMed

31.

Mileham KF, Schenkel C, Bruinooge SS, et al. Defining comprehensive biomarker-related testing and treatment practices for advanced non-small-cell lung cancer: results of a survey of U.S. oncologists. Cancer Med. 2022;11(2):530–8. https://doi.org/10.1002/cam4.4459. CrossRefPubMed

32.

Penault-Llorca F, Kerr KM, Garrido P, et al. Expert opinion on NSCLC small specimen biomarker testing—part 1: tissue collection and management. Virchows Arch. 2022;481(3):335–50. https://doi.org/10.1007/s00428-022-03343-2.

33.

Sadik H, Pritchard D, Keeling DM, et al. Impact of clinical gaps on the implementation of personalized medicine in advanced non-small cell lung cancer. JCO Precis Oncol Oncol. 2022. https://doi.org/10.1200/PO.22.00246. CrossRef

34.

American Cancer Society Cancer Action Network and LUNGevity Foundation. Payer coverage policies of tumor biomarker testing. 2020. https://www.fightcancer.org/sites/default/files/ACS%20CAN%20and%20LUNGevity_Payer%20Coverage%20Policies%20of%20Tumor%20Biomarker%20Testing.pdf. Accessed 6 June 2023.

35.

Peck P. Precision medicine: it’s all about biomarker testing. 2022. https://www.physiciansweekly.com/precision-medicine-its-all-about-biomarker-testing. Accessed 6 June 2023.

Title: Real-World Biomarker Test Utilization and Subsequent Treatment in Patients with Early-Stage Non-small Cell Lung Cancer in the United States, 2011−2021
Authors: Jessie T. Yan
Yue Jin
Ernest Lo
Yilin Chen
Amy E. Hanlon Newell
Ying Kong
Landon J. Inge
Publication date: 18-06-2023
Publisher: Springer Healthcare
Keywords: NSCLC
NSCLC
Fluorescence in Situ Hybridization
Biomarkers
Chemotherapy
Published in: Oncology and Therapy / Issue 3/2023
Print ISSN: 2366-1070
Electronic ISSN: 2366-1089
DOI: https://doi.org/10.1007/s40487-023-00234-7

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Keynote Webinar | Spotlight on Diet and Diabetes

Springer Medicine

Real-World Biomarker Test Utilization and Subsequent Treatment in Patients with Early-Stage Non-small Cell Lung Cancer in the United States, 2011−2021

Abstract

Introduction

Methods

Results

Conclusion

European Society for Medical Oncology Congress 2023

ESMO23: Non-small-cell lung cancer highlights

ESMO23: Small-cell lung cancer highlights

Cancer of Unknown Primary: Key results from ESMO 2023

Tisotumab vedotin improves recurrent and metastatic cervical cancer survival

EV-302 heralds practice change for advanced urothelial cancer

First-line selpercatinib supported for RET-mutant medullary thyroid cancer

» View more highlights on the ESMO 2023 hub page

Test your knowledge with Case-Based Clinical Insights

Oncology and Hematology Cases

45/♀ with increasing weakness, loss of appetite, diarrhoea and oedema – Case 29

48/♀ with increasing spontaneous haematomas all over her body – Case 37

49/♀ with lymphoedema of the arm in condition of metastasised triple-negative breast carcinoma – Case 43

53/♂ with movement-dependent pain in the left anterior pelvis and bloody urine – Case 39

Keynote Webinar | Spotlight on Diet and Diabetes

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusion

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