Purpose: To investigate programmed cell death-ligand 1 (PD-L1) expression status and the clinical and pathological factors related to its expression in urothelial carcinoma (UC) patients. Materials and Methods: Data from 761 UC patients who underwent testing for PD-L1 expression using the VENTANA (SP-142 immunohistochemistry assay) for measuring PD-L1 expression according to the manufacturer's protocol between February 2016 and July 2019 were retrospectively reviewed. Patients were categorized into three groups based on the percentage of tumor area covered by PD-L1-expressing tumor-infiltrating immune cells (ICs) as follows: IC0 (<1%), IC1 (≥1% and <5%), and IC2/3 (≥5%). Positive PD-L1 expression was defined as IC2/3 (≥5%). The factors related to positive PD-L1 expression were assessed by using unadjusted and adjusted logistic regression analyses. Results: In the entire cohort, 213 (28%) patients showed positive PD-L1 expression. Final adjusted regression analyses for positive PD-L1 expression revealed that several factors, including intravesical BCG prior to PD-L1 testing (odds ratio [OR] 0.57, 95% confidence interval [CI] 0.37–0.96), advanced tumor stage (stage III/IV) (OR 2.04, 95% CI 1.41–2.93), and high tumor grade (OR 5.31, 95% CI 2.38–11.83) were significantly associated with positive PD-L1 expression. Conclusions: This study showed that the PD-L1 expression is associated with several clinical and pathological factors for the first time in a real-world setting. Further follow-up clinical trials should consider adjusting these factors, including intravesical BCG treatment, tumor stage and grade to clarify the utility of PD-L1 as a biomarker.
Bibliographical noteFunding Information:
This work was supported by Roche Korea Co., Ltd. (Protocol Number: ML41597). The funding source had no role in the study design, data collection, data analysis, data interpretation,
We thank all of the researchers who gathered the data from the nine Korean academic institutions, including those from the Dongguk University Ilsan Medical Center, Yonsei University Severance Hospital, Chonnam National University Hwasun Hospital, Ewha Womans University Mokdong Hospital, Seoul National University Hospital, Pusan National University Hospital, Chung-Ang University Hospital, Kyung Hee University Hospital at Gangdong, and National Cancer Center. Also, we would like to thank Editage (www.editage.co.kr) for english language editing. Funding. This work was supported by Roche Korea Co., Ltd. (Protocol Number: ML41597). The funding source had no role in the study design, data collection, data analysis, data interpretation, or the writing of this report. The corresponding author had full access to all data and final responsibility to submit the paper for publication.
© Copyright © 2020 Kim, Jang, Ham, Jung, Lee, Ku, Ha, Ku, Choi, Chang, Choi, Song, Jeon, Jeong, Kim and Seo.
- immune cell
- immune checkpoint
- programmed cell death-ligand 1
- urothelial carcinoma