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  • Title: Reliability of PD-L1 assays using small tissue samples compared with surgical specimens.
    Author: Kim I, Kim A, Lee CH, Lee G, Kim A, Jo EJ, Kim MH, Mok J, Lee K, Kim KU, Park HK, Lee MK, Eom JS.
    Journal: Medicine (Baltimore); 2019 Apr; 98(14):e14972. PubMed ID: 30946323.
    Abstract:
    Programmed death ligand 1 (PD-L1) immunohistochemistry (IHC) assays are widely used for complementary or companion diagnostic purposes during treatment with immune checkpoint inhibitors. However, limited information is available on the clinical reliability of the PD-L1 IHC assay using small biopsy samples.Participants included 46 patients with nonsmall cell lung cancer who underwent PD-L1 testing using 3 PD-L1 IHC assays (22C3, SP142, and SP263) for both small biopsy samples and surgical specimens from November 2017 to June 2018. The PD-L1 IHC assay results were analyzed with cut-off values of 1%, 5%, 10%, and 50%. The PD-L1 IHC results obtained from the surgical specimens were regarded as the reference values.The 22C3, SP142, and SP263 PD-L1 IHC assays were performed in 26 (57%), 20 (43%), and 46 (100%) patients, respectively. Biopsy methods included radial probe endobronchial ultrasound using a guide sheath, endobronchial ultrasound-guided transbronchial needle aspiration, bronchoscopic biopsy, and percutaneous needle aspiration in 26 (57%), 4 (9%), 12 (25%), and 4 (9%) patients, respectively. The 22C3, SP142, and SP263 PD-L1 assays had concordance rates of 73-96, 65-80, and 72%-91%, respectively, compared with the reference values.PD-L1 testing with 3 commercial PD-L1 IHC assays using small biopsy samples is reliable in patients with nonsmall cell lung cancer.
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