dc.contributor.author | Lipworth, Loren | |
dc.date.accessioned | 2020-10-07T17:47:56Z | |
dc.date.available | 2020-10-07T17:47:56Z | |
dc.date.issued | 2019-12-26 | |
dc.identifier.citation | Pai, S. I., Cohen, E., Lin, D., Fountzilas, G., Kim, E. S., Mehlhorn, H., Baste, N., Clayburgh, D., Lipworth, L., Resteghini, C., Shara, N., Fujii, T., Zhang, J., Stokes, M., Wang, H., Twumasi-Ankrah, P., Wildsmith, S., Khaliq, A., Melillo, G., & Shire, N. (2019). SUPREME-HN: a retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Journal of translational medicine, 17(1), 429. https://doi.org/10.1186/s12967-019-02182-1 | en_US |
dc.identifier.other | eISSN: 1479-5876 | |
dc.identifier.uri | http://hdl.handle.net/1803/16193 | |
dc.description | Only Vanderbilt University affiliated authors are listed on VUIR. For a full list of authors, access the version of record at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933901/ | en_US |
dc.description.abstract | Background Programmed cell death ligand-1 (PD-L1) expression on tumor cells (TCs) is associated with improved survival in patients with head and neck squamous cell carcinoma (HNSCC) treated with immunotherapy, although its role as a prognostic factor is controversial. This study investigates whether tumoral expression of PD-L1 is a prognostic marker in patients with recurrent and/or metastatic (R/M) HNSCC treated with standard chemotherapy. Methods This retrospective, multicenter, noninterventional study assessed PD-L1 expression on archival R/M HNSCC tissue samples using the VENTANA PD-L1 (SP263) Assay. PD-L1 high was defined as PD-L1 staining of >= 25% TC, with exploratory scoring at TC >= 10% and TC >= 50%. The primary objective of this study was to estimate the prognostic value of PD-L1 status in terms of overall survival (OS) in patients with R/M HNSCC. Results 412 patients (median age, 62.0 years; 79.9% male; 88.2% Caucasian) were included from 19 sites in seven countries. 132 patients (32.0%) had TC >= 25% PD-L1 expression; 199 patients (48.3%) and 85 patients (20.6%) had TC >= 10% and >= 50%, respectively. OS did not differ significantly across PD-L1 expression (at TC >= 25% cutoff median OS: 8.2 months vs TC < 25%, 10.1 months, P = 0.55) or the >= 10% and >= 50% cutoffs (at TC >= 10%, median OS: 9.6 months vs TC < 10%, 9.4 months, P = 0.32, and at TC >= 50%, median OS 7.9 vs TC < 50%, 10.0 months, P = 0.39, respectively). Conclusions PD-L1 expression, assessed using the VENTANA PD-L1 (SP263) Assay, was not prognostic of OS in patients with R/M HNSCC treated with standard of care chemotherapies. Trial registration ClinicalTrials.gov, NCT02543476. Registered September 4, 2015. | en_US |
dc.description.sponsorship | This study was sponsored by AstraZeneca. The protocol for this study was developed by the sponsor (AstraZeneca) and advisors. Data were col-lected collaboratively by the sponsor and clinical investigators. Statisticians employed by the sponsor analyzed the data. All authors participated in the preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | Journal of Translational Medicine | en_US |
dc.rights | Copyright © The Author(s) 2019
Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | |
dc.source.uri | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6933901/ | |
dc.subject | Biomarker | en_US |
dc.subject | Head and neck squamous cell carcinoma | en_US |
dc.subject | Immuno-oncology | en_US |
dc.subject | PD-L1 | en_US |
dc.subject | Programmed cell death ligand-1 | en_US |
dc.subject | Prognosis | en_US |
dc.title | SUPREME-HN: a retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck | en_US |
dc.type | Article | en_US |
dc.identifier.doi | 10.1186/s12967-019-02182-1 | |