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• W2894073670 abstract "Russell-Goldman et al1 recently published in Cancer Cytopathology an article on the cytologic-histologic correlation of programmed death-ligand 1 (PD-L1) in lung carcinomas. We congratulate the authors for this useful work, but we think that some important points have to be underlined with respect to PD-L1 feasibility for non–small cell lung cancer (NSCLC) in smeared cytological material. Currently, PD-L1 testing is recommended for stage IIIB and IV NSCLC, adenocarcinoma, and squamous cell carcinoma. At this point, no other clinical or histological parameters are perfectly sensitive or specific for identifying a PD-L1–positive patient, even if high PD-L1 expression seems to be associated with poor tumor differentiation.2 For this reason, PD-L1 testing is mandatory for all patients with advanced NSCLC for whom pembrolizumab is indicated. The use of a specific antibody and platform is required by the US Food and Drug Administration to select patients for treatment with the anti-programmed death 1 (PD1)/PD-L1 drug.3 Conversely, the European Medicines Agency does not restrict the use of specific PD-L1 antibodies and platforms.4 The lack of strictly indicated guidelines can lead to discrepancies in technical and/or clinical validation procedures. Only a prospective clinical validation based on the clinical outcomes of the treatment will be able to establish whether the antibodies used on specific platforms are really equal and able to select patients responsive to pembrolizumab. We reckon that PD-L1 is “special” but is not a perfect marker. It has some advantages but also several limitations, including technical problems (pre-analytical phases and immunohistochemistry methodology) and intrinsic limits of PD-L1 as a marker. Immunohistochemistry is cheap and easy to perform, but an expert reader is required to evaluate specimens properly in terms of the types of cells and the immunostaining scoring system. Only viable tumor cells with membranous positivity have to be considered. Given that macrophages, other inflammatory cells, endothelial cells and necrotic cells may be positive for PD-L1 expression, they must not be taken into account. On the basis of the antibody used, a minimum number of tumor cells are necessary (eg, 100 cancer cells for the Dako 22C3 antibody). We point out that cytoplasmic immunoreactivity could not be considered by the reader but can represent real positivity for PD-L1 expression. The localization of cytoplasmic immunopositivity could be due to problems in the pre-analytical phase, and only an awareness of the time and type of fixation can ensure proper specimen interpretation. This can become an outstanding problem for those laboratories that do not manage the pre-analytical phase because the specimen setup has already been performed at another center. Moreover, PD-L1 expression, which may be missed in small biopsies, is characterized by high dynamicity and varies on the basis of tumor sites. Despite the high concordance between PD-L1 evaluations of the primary tumor and the metastasis (89%), this marker has to be tested in all the biological material available for a patient because testing only the primary or metastatic tumor may not be sufficient to reflect the real PD-L1 status of the tumor.5 Cytological material for a PD-L1 assessment is usually excluded from clinical trials; consequently, PD-L1 testing is approved for histological specimens only. PD-L1 detection can also be performed on cell blocks as an alternative to histological samples. Anyway, to date, the reason that this test cannot be performed optimally on smeared cytological samples is not fully clear. As shown in Figure 1A, we have documented these limitations with a smeared cytological sample obtained by endoscopic ultrasound–guided fine-needle aspiration from a patient with NSCLC evaluated at our center; the sample was immunostained for PD-L1. The specimen was PD-L1–negative: criticisms were due to the presence of blood, inflammatory cells, necrosis, and overlapping cells. In Figure 1B, we show a paraffin-embedded, PD-L1–immunostained section obtained from a cell block from the same patient. PD-L1 was highly expressed in the membranes of the tumor cells, which appeared quite distinguishable from macrophages. Considering that biological material embedded in a cell block allows multiple biomarkers to be tested, we have made these points to suggest how the biological material needs to be collected for good detection of PD-L1. The limitation of immunocytochemistry with a smeared sample also suggests the unique possibility of using it only once. Therefore, further efforts are required to allow an accurate assessment of this biomarker on a smeared cytological sample. We thank Sara Ravaioli, BSc, and Maria Maddalena Tumedei, BSc, for their technical support and Maurizio Puccetti, MD, for reading the specimens. No specific funding was disclosed. The authors made no disclosures." @default.
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• W2894073670 date "2018-09-01" @default.
• W2894073670 modified "2023-09-23" @default.
• W2894073670 title "Petals and thorns in programmed death-ligand 1 testing: Is all non-small cell lung cancer diagnostic material suitable?" @default.
• W2894073670 cites W2368001341 @default.
• W2894073670 cites W2531247827 @default.
• W2894073670 doi "https://doi.org/10.1002/cncy.22033" @default.
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