Cell Block as a Surrogate for Programmed Death-Ligand 1 Staining Testing in Patients of Non-Small Cell Lung Cancer

Dong, Zhengwei; Liu, Yiwei; Jiang, Tao; Hou, Likun; Wu, Fengying; Gao, Guanghui; Li, Xuefei; Zhao, Chao; Wang, Yan; Yang, Shuo; Mao, Shiqi; Liu, Qian; Li, Yumei; Xu, Chuan; Wu, Chunyan; Ren, Shengxiang; Zhou, Caicun; Zhang, Jun; Hirsch, Fred R.

doi:10.7150/jca.35810

Cited by 9 publications

(16 citation statements)

References 32 publications

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“…In studies with cytology fixed in formalin, that is, excluding studies with nonformalin or mixed formalin/nonformalin fixation, the concordance with paired histological specimens was 81–82% (333–336/410 cases) at cutoff 1% and 88–89% (316–317/358 cases) at cutoff 50% based on 7 studies [38, 39, 48, 50, 58, 60, 62]. If instead, only including studies with cytology fixed in nonformalin fixatives, excluding mixed formalin/nonformalin fixation, the concordance with paired histological specimens was 79–81% (500–512/633 cases) at cutoff 1% and 88–89% (554–565/633 cases) at cutoff 50% based on 9 studies including the Lund cohort from the present study [41, 45, 46, 49, 52, 55, 56, 62].…”

Section: Resultsmentioning

confidence: 75%

PD-L1 Testing in Cytological Non-Small Cell Lung Cancer Specimens: A Comparison with Biopsies and Review of the Literature

Mansour¹,

Lindquist²,

Seidal³

et al. 2021

Acta Cytologica

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Introduction: Programmed death-ligand 1 (PD-L1) expression is used for treatment prediction in non-small cell lung cancer (NSCLC). While cytology may be the only available material in the routine clinical setting, testing in clinical trials has mainly been based on biopsies. Methods: We included 2 retrospective cohorts of paired, concurrently sampled, cytological specimens and biopsies. Also, the literature on PD-L1 in paired cytological/histological samples was reviewed. Focus was on the cutoff levels ≥1 and ≥50% positive tumor cells. Results: Using a 3-tier scale, PD-L1 was concordant in 40/47 (85%) and 66/97 (68%) of the paired NSCLC cases in the 2 cohorts, with kappa 0.77 and 0.49, respectively. In the former cohort, all discordant cases had lower score in cytology. In both cohorts, concordance was lower in samples from different sites (e.g., biopsy from primary tumor and cytology from pleural effusion). Based on 25 published studies including about 1,700 paired cytology/histology cases, the median (range) concordance was 81–85% (62–100%) at cutoff 1% for a positive PD-L1 staining and 89% (67–100%) at cutoff 50%. Conclusions: The overall concordance of PD-L1 between cytology and biopsies is rather good but with significant variation between laboratories, which calls for local quality assurance.

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Section: Resultsmentioning

confidence: 75%

PD-L1 Testing in Cytological Non-Small Cell Lung Cancer Specimens: A Comparison with Biopsies and Review of the Literature

Mansour¹,

Lindquist²,

Seidal³

et al. 2021

Acta Cytologica

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“…to the cellularity of the cytology specimens. 61 In this study, the authors demonstrated that the concordance rate at a cut-off of 50% was near perfect (>0.80) for cell count of 400 for clone 28-8 and cell count of 500 for clone SP142 compared to moderate concordance at cellularity between 100 and 500 cells.…”

Section: Studies Have Shown That Concordance Rates Vary In Direct Pro...mentioning

confidence: 62%

Program death ligand‐1 immunocytochemistry in lung cancer cytological samples: A systematic review

Satturwar

Girolami

Munari

et al. 2022

Diagnostic Cytopathology

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In this era of personalized medicine, targeted immunotherapies like immune checkpoint inhibitors (ICI) blocking the programmed death-1 (PD-1)/program death ligand-1 (PD-L1) axis have become an integral part of treating advanced stage non-small cell lung carcinoma (NSCLC) and many other cancer types. Multiple monoclonal antibodies are available commercially to detect PD-L1 expression in tumor cells by immunohistochemistry (IHC). As most clinical trials initially required tumor biopsy for PD-L1 detection by IHC, many of the currently available PD-1/PD-L1 assays have been developed and validated on formalin fixed tissue specimens. The majority (>50%) of lung cancer cases do not have a surgical biopsy or resection specimen available for ancillary testing and instead must rely primarily on fine needle aspiration biopsy specimens for diagnosis, staging and ancillary tests. Review of the literature shows multiple studies exploring the feasibility of PD-L1 IHC on cytological samples. In addition, there are studies addressing various aspects of IHC validation on cytology preparations including pre-analytical (e.g., different fixatives), analytical (e.g., antibody clone, staining platforms, inter and intra-observer agreement, cytology-histology concordance) and post-analytical (e.g., clinical outcome) issues. Although promising results in this field have emerged utilizing cytology samples, many important questions still need to be addressed. This review summarizes the literature of PD-L1 IHC in lung cytology specimens and provides practical tips for optimizing analysis.

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“…Torous et al observed a similar distribution of cases, with no significant differences of cases with high PD‐L1 expression between cell blocks (35.1%) and surgical pathology group (34.8%, consisting of biopsies and surgical specimens) 18 . Dong detected lower values with the PD‐L1 28‐8 assay, with high PD‐L1 positivity in 20.5% of cell blocks and 27.7% of surgical specimens 19 . Vigliar et al observed fewer cases with high expression of PD‐L1 in cell blocks (4.9%) in comparison to biopsies (28.7%) and surgical specimens (15.7%) 20 ; however, cell blocks represented a limited number of their study (41 cell blocks).…”

Section: Discussionmentioning

confidence: 78%

PD‐L1 expression in NSCLC: Role of cell blocks and concordance between samples

Ambrosini-Spaltro

Dubini

Pieri

et al. 2020

Diagnostic Cytopathology

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BackgroundPD‐L1 immunohistochemistry is currently performed in patients with advanced non‐small cell lung carcinoma (NSCLC) to identify responders to immune checkpoint inhibitors. Cell blocks from fine needle aspiration of NSCLC are frequently used for diagnostic purposes. The aims of the study are to analyze: (a) the distribution of PD‐L1 in cell blocks, in comparison to biopsies and surgical specimens; (b) the concordance of PD‐L1 in specimens of the same patients.MethodsPD‐L1 analyses conducted in NSCLCs were retrieved. Cell blocks were prepared with the self‐clotting method. PD‐L1 was performed with Dako 22C3 on the Ventana BenchMark ULTRA platform. Results were divided by tumor proportion score (TPS) in 3 categories: <1%; 1% to 49%; ≥50%.ResultsA total of 483 samples from 456 patients was collected: 120 cell blocks (24.8%), 307 endoscopic or transthoracic biopsies (63.6%), 56 surgical specimens (11.6%). TPS was: <1% in 230 samples (47.8%), 1% to ‐49% in 136 (28.3%) and ≥ 50% in 115 (23.9%); in two samples material was insufficient. Statistics did not reveal significant differences in PD‐L1 expression among the various materials (χ2 = 2.905; P = .574). In 50 samples from 25 patients, PD‐L1 was carried out in two samples of the same patients, with moderate agreement (concordance rate: 68.0%, k = 0.469).Conclusion(a) PD‐L1 is similarly distributed in the different materials; (b) PD‐L1 shows moderate concordance in different samples of the same patients. PD‐L1 may be routinely tested in cell blocks, but interpreted with caution and repeated whenever possible.

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Cell Block as a Surrogate for Programmed Death-Ligand 1 Staining Testing in Patients of Non-Small Cell Lung Cancer

Cited by 9 publications

References 32 publications

PD-L1 Testing in Cytological Non-Small Cell Lung Cancer Specimens: A Comparison with Biopsies and Review of the Literature

PD-L1 Testing in Cytological Non-Small Cell Lung Cancer Specimens: A Comparison with Biopsies and Review of the Literature

Program death ligand‐1 immunocytochemistry in lung cancer cytological samples: A systematic review

PD‐L1 expression in NSCLC: Role of cell blocks and concordance between samples

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