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Using 22C3 Anti-PD-L1 Antibody Concentrate on Biopsy and Cytology Samples from Non-small Cell Lung Cancer Patients
Published on: September 25, 2018
Program death ligand-1 immunocytochemistry in lung cancer cytological samples: A systematic review
Swati Satturwar1, Ilaria Girolami2, Enrico Munari3
1Department of Pathology, The Ohio State University, Columbus, Ohio, USA.
Abstract:
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.
Insights
Immune checkpoint inhibitors (ICI) targeting programmed death-1 (PD-1)/program death ligand-1 (PD-L1) are crucial for cancer therapy. This review explores PD-L1 immunohistochemistry (IHC) on lung cytology samples, offering optimization tips.
Area of Science:
- Oncology
- Pathology
- Immunotherapy
Background:
- Immune checkpoint inhibitors (ICI) targeting the programmed death-1 (PD-1)/program death ligand-1 (PD-L1) axis are vital in personalized cancer medicine.
- PD-L1 expression is commonly assessed by immunohistochemistry (IHC) on formalin-fixed tissues, often from surgical biopsies.
- Many lung cancer patients lack surgical specimens, necessitating PD-L1 testing on cytology samples from fine needle aspiration biopsies.
Purpose of the Study:
- To review the current literature on PD-L1 IHC feasibility and validation in lung cytology specimens.
- To identify key pre-analytical, analytical, and post-analytical considerations for PD-L1 IHC on cytology.
- To provide practical guidance for optimizing PD-L1 analysis in cytological samples.
Main Methods:
- Comprehensive literature review of studies investigating PD-L1 IHC on cytological samples.
- Analysis of factors influencing PD-L1 IHC accuracy in cytology, including fixatives, antibody clones, and staining platforms.
- Evaluation of inter/intra-observer agreement and cytology-histology concordance.
Main Results:
- Multiple studies demonstrate the feasibility of PD-L1 IHC on cytology samples, with promising results.
- Various pre-analytical and analytical factors significantly impact assay performance and reliability.
- Addressing these factors is crucial for accurate PD-L1 assessment and clinical decision-making.
Conclusions:
- PD-L1 IHC on lung cytology samples is a viable alternative when tissue biopsies are unavailable.
- Standardization of pre-analytical and analytical variables is essential for reproducible results.
- Further research is needed to fully address remaining questions and optimize clinical utility.
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