Interobserver Reproducibility of PD-L1 Biomarker in Non-small Cell Lung Cancer: A Multi-Institutional Study by 27 Pathologists

Journal of Pathology and Translational Medicine

Yoon-La Choi¹  Se Jin Jang²  Sunhee Chang³  Hyung Kyu Park^{4  5} 

[1] Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea;Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;Department of Pathology, Inje University Ilsan Paik Hospital, Goyang, Korea;Department of Pathology, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea;;

关键词: programmed cell death-ligand 1;    reproducibility;    observer variation;    immunohistochemistry;   

DOI  :  10.4132/jptm.2019.09.29

来源: DOAJ

【 摘 要 】

Background Assessment of programmed cell death-ligand 1 (PD-L1) immunohistochemical staining is used for treatment decisions in non-small cell lung cancer (NSCLC) regarding use of PD-L1/programmed cell death protein 1 (PD-1) immunotherapy. The reliability of the PD-L1 22C3 pharmDx assay is critical in guiding clinical practice. The Cardiopulmonary Pathology Study Group of the Korean Society of Pathologists investigated the interobserver reproducibility of PD-L1 staining with 22C3 pharmDx in NSCLC samples. Methods Twenty-seven pathologists individually assessed the tumor proportion score (TPS) for 107 NSCLC samples. Each case was divided into three levels based on TPS: <1%, 1%–49%, and ≥50%. Results The intraclass correlation coefficient for TPS was 0.902±0.058. Weighted κ coefficient for 3-step assessment was 0.748±0.093. The κ coefficients for 1% and 50% cut-offs were 0.633 and 0.834, respectively. There was a significant association between interobserver reproducibility and experience (formal PD-L1 training, more experience for PD-L1 assessment, and longer practice duration on surgical pathology), histologic subtype, and specimen type. Conclusions Our results indicate that PD-L1 immunohistochemical staining provides a reproducible basis for decisions on anti–PD-1 therapy in NSCLC.

【 授权许可】

Unknown