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Review
. 2019 Jul;53(4):199-206.
doi: 10.4132/jptm.2019.04.24. Epub 2019 May 2.

PD-L1 Testing in Non-small Cell Lung Cancer: Past, Present, and Future

Affiliations
Review

PD-L1 Testing in Non-small Cell Lung Cancer: Past, Present, and Future

Hyojin Kim et al. J Pathol Transl Med. 2019 Jul.

Erratum in

Abstract

Blockade of the programmed cell death-1 (PD-1) axis has already been established as an effective treatment of non-small cell lung cancer. Immunohistochemistry (IHC) for programmed death-ligand 1 (PD-L1) protein is the only available biomarker that can guide treatment with immune checkpoint inhibitors in non-small cell lung cancer. Because each PD-1/PD-L1 blockade was approved together with a specific PD-L1 IHC assay used in the clinical trials, pathologists have been challenged with performing various assays with a limited sample. To provide a more unified understanding of this, several cross-validation studies between platforms have been performed and showed consistent results. However, the interchangeability of assays may be limited in practice because of the risk of misclassification of patients for the treatment. Furthermore, several issues, including the temporal and spatial heterogeneity of PD-L1 expression in the tumor, and the potential for cytology specimens to be used as an alternative to tissue samples for PD-L1 testing, have still not been resolved. In the future, one of the main aims of immunotherapy research should be to find a novel predictive biomarker for PD-1 blockade therapy and a way to combine it with PD-L1 IHC and other tests.

Keywords: Carcinoma, non-small cell lung; Immunohistochemistry; Immunotherapy; Predictive biomarker; Programmed cell death-ligand 1.

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Conflict of interest statement

Conflicts of Interest

The authors declare that they have no potential conflicts of interest.

Figures

Fig. 1.
Fig. 1.
Representative images stained with the programmed death-ligand 1 immunohistochemical assays: 22C3 (A), SP263 (B), and SP142 (C).

References

    1. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373:1627–39. - PMC - PubMed
    1. Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015;373:123–35. - PMC - PubMed
    1. Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375:1823–33. - PubMed
    1. Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016;387:1540–50. - PubMed
    1. Fehrenbacher L, Spira A, Ballinger M, et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016;387:1837–46. - PubMed