Lung cancer kills more people in the UK than any other type of cancer. The overall 1-year survival for patients across all stages is 38% in England and Wales (NLCA, 2017). The majority of patients (61%) present with advanced disease (IIIB/IV) (NLCA, 2017). The one year survival of patients with advanced disease is 15.5% (NLCA, 2017). Over the last decade, the evolution of tyrosine kinase inhibitors in the treatment of patients with advanced NSCLC has led to improvements in survival and quality of life (Lindeman et al., 2018). The traditional, binary diagnosis of NSCLC or small cell lung cancer is therefore no longer adequate; a more detailed pathological diagnosis is necessary to plan therapy for patients with advanced disease.

Lung cancer kills more people in the UK than any other type of cancer.

National and international guidelines have recommended the inclusion of molecular testing for mutations in the epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) gene re-arrangements since 2013 (Lindeman et al., 2013; NICE, 2013). Identification of these mutations/translocations is essential in determining the correct choice of tyrosine kinase inhibitor (TKI) in advanced NSCLC. Increasingly, recommendations for molecular testing have also included the quantification of tumour PD-L1 expression. Monoclonal antibody therapies can target the PD receptor and ligand, reducing the capabilities of a tumour to evade the immune system thus providing a further therapeutic option (Cree et al., 2016). NICE approved nivolumab and pembrolizumab) in 2017 but both agents require positive molecular testing for PD-L1 as a prerequisite for use.

The one year survival of patients with advanced disease is 15.5%.

While the necessity for expanding molecular testing in advanced NSCLC is evident, widespread implementation of recommendations can be challenging. Previous studies have suggested that the frequency of molecular testing for patients with advanced NSCLC has been estimated to be in the region of 16%-38% (Ellis et al., 2011; Enewold and Thomas, 2016; McKeage et al., 2017; Shen et al., 2017). Common difficulties citied included inadequate biopsy sampling, lack of awareness, difficulties with funding, lack of appropriate laboratory infrastructure, remote geography and co-morbidity and age of the patient (Cree et al., 2016; Enewold and Thomas, 2016; Lim et al., 2017; Shen et al., 2017).

Spotlight audit

The NLCA team now plans to launch a spotlight audit evaluating the frequency and efficacy of molecular testing in eligible patients with advanced NSCLC. The spotlight will aim to:

1. assess the variation in practice across the organisations
2. identify recurrent challenges in completing molecular testing
3. understand the impact of molecular testing on treatment options and outcomes

Preparation for the audit has taken place in collaboration with our colleagues at Public Health England and the University of Nottingham. A portal has been designed to create a streamlined process for participant’s data entry and has been piloted by members of the NLCA user’s group.

This year we are delighted to report that trusts will receive individualised reports providing a summary of their results. The report will also include an overview of the nationalised data which trusts can use to benchmark their performance.

Like our previous spotlight audit, we will be asking every trust in England which contributes to the NLCA to also submit to this spotlight audit. All participants will require an NHS email to register with the portal. As registration may take a few working days, trusts are urged to register as soon as possible. In addition to the trusts’ reports, the data will be published in a peer-reviewed journal and included in the annual report.

This year, trusts will receive individualised reports providing a summary of their results.

The spotlight audit has proven to be an essential new workstream for the NLCA. The previous spotlight audit of early-stage disease not treated with surgery provided major insights into the management of these patients. As molecular testing plays a critical role in the treatment of advanced lung cancer, to ensure the best care, it is imperative that we understand its current position in the diagnosis of NSCLC in order to support trusts and individuals to provide the highest standards of care.

Judith Tweedie (Research Fellow at the Royal College of Physicians) and Neal Navani (NLCA co-clinical lead)

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References

• Cree, I. A. et al. (2016) ‘PD-L1 testing for lung cancer in the UK: recognizing the challenges for implementation’, Histopathology, 69(2), pp. 177–186. doi: 10.1111/his.12996.
• Ellis, P. M. et al. (2011) ‘A Systematic Review and Canadian Consensus Recommendations on the Use of Biomarkers in the Treatment of Non-small Cell Lung Cancer’, Journal of Thoracic Oncology, 6(8), pp. 1379–1391. doi: 10.1097/JTO.0b013e318220cb8e.
• Enewold, L. and Thomas, A. (2016) ‘Real-world patterns of EGFR testing and treatment with erlotinib for non-small cell lung cancer in the United States’, PLoS ONE, 11(6), pp. 1–14. doi: 10.1371/journal.pone.0156728.
• Lim, C. et al. (2017) ‘Improving molecular testing and personalized medicine in Non-Small-Cell lung cancer in ontario’, Current Oncology, 24(2), pp. 103–110. doi: 10.3747/co.24.3495.
• Lindeman, N. I. et al. (2013) ‘Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: Guideline from the college of american pathologists, international association for the study of lung cancer, and association for molecular patho’, Journal of Molecular Diagnostics, 15(4), pp. 415–453. doi: 10.1016/j.jmoldx.2013.03.001.
• Lindeman, N. I. et al. (2018) ‘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 ’, Archives of Pathology & Laboratory Medicine, p. arpa.2017-0388-CP. doi: 10.5858/arpa.2017-0388-CP.
• McKeage, M. et al. (2017) ‘EGFR Mutation Testing of non-squamous NSCLC: Impact and Uptake during Implementation of Testing Guidelines in a Population-Based Registry Cohort from Northern New Zealand’, Targeted Oncology. Springer International Publishing, 12(5), pp. 663–675. doi: 10.1007/s11523-017-0515-4.
• National Lung Cancer Audit (2017) NLCA Annual Report 2017. London. Available at: https://www.rcplondon.ac.uk/projects/outputs/nlca-annual-report-2017 (Accessed: 29 August 2018).
• NICE (2013) EGFR‑TK mutation testing in adults with locally advanced or metastatic non-small-cell lung cancer | Guidance and guidelines | NICE. London: NICE. Available at: https://www.nice.org.uk/guidance/dg9/chapter/12-Sources-of-evidence-considered-by-the-Committee (Accessed: 29 August 2018).
• Shen, C. et al. (2017) ‘Utilization Patterns and Trends in Epidermal Growth Factor Receptor (EGFR) Mutation Testing Among Patients With Newly Diagnosed Metastatic Lung Cancer’, Clinical Lung Cancer. Elsevier, 18(4), pp. e233–e241. doi: 10.1016/J.CLLC.2016.11.002.