. 2018 Apr; 10:1758835918763493.
doi: 10.1177/1758835918763493.

PD-L1 expression testing in non-small cell lung cancer

Cristina Teixidó 1 Noelia Vilariño 2 Roxana Reyes 3 Noemí Reguart 4 
  • PMID: 29662547
  •     64 References
  •     51 citations


In recent years, immunotherapy has revolutionized and changed the standard of care in patients with advanced non-small cell lung cancer (NSCLC). Immune checkpoint inhibitors, fundamentally those that act by blocking the programmed cell death receptor-1 (PD-1) and its ligand the programmed cell death ligand-1 (PD-L1) have emerged as novel treatment strategies in NSCLC, demonstrating undoubted superiority over chemotherapy in terms of efficacy. Several of these immune checkpoint modulators have recently gained regulatory approval for the treatment of advanced NSCLC, such as nivolumab, atezolizumab and pembrolizumab in first-line (only the latter) and second-line settings, and more recently, durvalumab as maintenance after chemoradiotherapy in locally advanced disease. There is consensus that PD-L1 expression on tumor cells predicts responsiveness to PD-1 inhibitors in several tumor types. Hence PD-L1 expression evaluated by immunohistochemistry (IHC) is currently used as a clinical decision-making tool to support the use of checkpoint inhibitors in NSCLC patients. However, the value of PD-L1 as the 'definitive' biomarker is controversial as its testing is puzzled by multiple unsolved issues such as the use of different staining platforms and antibodies, the type of cells in which PD-L1 is assessed (tumor versus immune cells), thresholds used for PD-L1-positivity, or the source and timing for sample collection. Therefore, newer biomarkers such as tumor mutation burden and neoantigens as well as biomarkers reflecting host environment (microbiome) or tumor inflamed microenvironment (gene expression signatures) are being explored as more reliable and accurate alternatives to IHC for guiding treatment selection with checkpoint inhibitors in NSCLC.

Keywords: PD-L1 expression testing; immunohistochemistry (IHC); immunotherapy; non-small cell lung cancer (NSCLC); predictive biomarker.

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Simple parameters to solve a complex issue: predicting response to checkpoint inhibitor therapy in lung cancer.
James Newman, Isabel Preeshagul, +2 authors, Nagashree Seetharamu.
Lung Cancer Manag, 2021 Jun 05; 10(2). PMID: 34084210    Free PMC article.
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Boju Pan, Yuxin Kang, +8 authors, Zhiyong Liang.
J Transl Med, 2021 Jun 09; 19(1). PMID: 34098964    Free PMC article.
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Min Hye Kim, Gyung Hyuk Ko, +6 authors, Dae Hyun Song.
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Clinical Trials of Immune Checkpoint Inhibitors in Hepatocellular Carcinoma.
Anne Dyhl-Polk, Marta Kramer Mikkelsen, Morten Ladekarl, Dorte Lisbet Nielsen.
J Clin Med, 2021 Jul 03; 10(12). PMID: 34208788    Free PMC article.
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Kumar Prabhash, Suresh H Advani, +6 authors, Ashok K Vaid.
Adv Ther, 2019 Mar 14; 36(4). PMID: 30864106
Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance.
Annamaria Mascolo, Cristina Scavone, +8 authors, Annalisa Capuano.
Drug Saf, 2021 Jun 20; 44(9). PMID: 34145536    Free PMC article.
Current status and quality of radiomic studies for predicting immunotherapy response and outcome in patients with non-small cell lung cancer: a systematic review and meta-analysis.
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Systematic Review.
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Transl Lung Cancer Res, 2021 Aug 26; 10(7). PMID: 34430348    Free PMC article.
PD-L1 Expression in Non-Small Cell Lung Cancer: Data from a Referral Center in Spain.
Karmele Saez de Gordoa, Ingrid Lopez, +5 authors, Cristina Teixido.
Diagnostics (Basel), 2021 Aug 28; 11(8). PMID: 34441386    Free PMC article.
Therapeutic and Systemic Adverse Events of Immune Checkpoint Inhibitors Targeting the PD-1/PD-L1 axis for Clinical Management of NSCLC.
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Cell Transplant, 2021 Oct 05; 30. PMID: 34606729    Free PMC article.
PD-L1 quantification across tumor types using the reverse phase protein microarray: implications for precision medicine.
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J Immunother Cancer, 2021 Oct 09; 9(10). PMID: 34620701    Free PMC article.
Liquid Biopsy Biomarkers for Immunotherapy in Non-Small Cell Lung Carcinoma: Lessons Learned and the Road Ahead.
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J Pers Med, 2021 Oct 24; 11(10). PMID: 34683113    Free PMC article.
Gene-Guided Treatment Decision-Making in Non-Small Cell Lung Cancer - A Systematic Review.
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The Role of the Innate Immune System in Cancer Dormancy and Relapse.
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Cancers (Basel), 2021 Nov 28; 13(22). PMID: 34830776    Free PMC article.
Combined Consideration of Tumor-Associated Immune Cell Density and Immune Checkpoint Expression in the Peritumoral Microenvironment for Prognostic Stratification of Non-Small-Cell Lung Cancer Patients.
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Front Immunol, 2022 Mar 01; 13. PMID: 35222387    Free PMC article.