PD‐L1 testing for lung cancer in the UK: recognizing the challenges for implementation |
| |
| Authors: | Ian A Cree Richard Booton Paul Cane John Gosney Merdol Ibrahim Keith Kerr Rohit Lal Conrad Lewanski Neal Navani Andrew G Nicholson Marianne Nicolson Yvonne Summers |
| |
| Affiliation: | 1. Department of Pathology, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK;2. Respiratory and Allergy Research Group, Institute of Inflammation & Repair, North West Lung Centre, University of Manchester, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK;3. Department of Histopathology, Guy's and St Thomas' NHS Foundation Trust, London, UK;4. Department of Pathology, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK;5. UK National External Quality Assessment Service for Immunocytochemistry and In Situ Hybridisation, London, UK;6. Department of Pathology, Aberdeen Royal Infirmary/Aberdeen University Medical School, Aberdeen, UK;7. Guy's and St Thomas' NHS Foundation Trust, London, UK;8. Oncology Department, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK;9. Lungs for Living Research Centre, UCL Respiratory, University College London Hospitals NHS Foundation Trust, London, UK;10. Royal Brompton and Harefield Hospitals NHS Foundation Trust and National Heart and Lung Division, Imperial College, London, UK;11. Department of Oncology, NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, UK;12. The Christie Hospital NHS Foundation Trust, Manchester, UK |
| |
| Abstract: | A new approach to the management of non‐small‐cell lung cancer (NSCLC) has recently emerged that works by manipulating the immune checkpoint controlled by programmed death receptor 1 (PD‐1) and its ligand programmed death ligand 1 (PD‐L1). Several drugs targeting PD‐1 (pembrolizumab and nivolumab) or PD‐L1 (atezolizumab, durvalumab, and avelumab) have been approved or are in the late stages of development. Inevitably, the introduction of these drugs will put pressure on healthcare systems, and there is a need to stratify patients to identify those who are most likely to benefit from such treatment. There is evidence that responsiveness to PD‐1 inhibitors may be predicted by expression of PD‐L1 on neoplastic cells. Hence, there is considerable interest in using PD‐L1 immunohistochemical staining to guide the use of PD‐1‐targeted treatments in patients with NSCLC. This article reviews the current knowledge about PD‐L1 testing, and identifies current research requirements. Key factors to consider include the source and timing of sample collection, pre‐analytical steps (sample tracking, fixation, tissue processing, sectioning, and tissue prioritization), analytical decisions (choice of biomarker assay/kit and automated staining platform, with verification of standardized assays or validation of laboratory‐devised techniques, internal and external quality assurance, and audit), and reporting and interpretation of the results. This review addresses the need for integration of PD‐L1 immunohistochemistry with other tests as part of locally agreed pathways and protocols. There remain areas of uncertainty, and guidance should be updated regularly as new information becomes available. |
| |
| Keywords: | immunohistochemistry immunotherapy non‐small‐cell lung cancer programmed death ligand 1 programmed death receptor 1 quality assurance specimen handling treatment stratification |
|
|
