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.

MedStar author(s):
Citation: Journal of Translational Medicine. 17(1):429, 2019 12 26.PMID: 31878938Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *B7-H1 Antigen/me [Metabolism] | *Biomarkers, Tumor/me [Metabolism] | *Neoplasm Recurrence, Local/me [Metabolism] | *Squamous Cell Carcinoma of Head and Neck/me [Metabolism] | *Squamous Cell Carcinoma of Head and Neck/pa [Pathology] | Adult | Aged | Aged, 80 and over | Disease-Free Survival | Female | Humans | Male | Middle Aged | Multivariate Analysis | Neoplasm Metastasis | Prognosis | Retrospective Studies | Risk Factors | Treatment OutcomeYear: 2019Local holdings: Available online through MWHC library: 2003 - presentISSN:
  • 1479-5876
Name of journal: Journal of translational medicineAbstract: 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.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.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).All authors: Baste N, Clayburgh D, Cohen EEW, Fountzilas G, Fujii T, Khaliq A, Kim ES, Lin D, Lipworth L, Mehlhorn H, Melillo G, Pai SI, Resteghini C, Shara N, Shire N, Stokes M, Twumasi-Ankrah P, Wang H, Wildsmith S, Zhang JOriginally published: Journal of Translational Medicine. 17(1):429, 2019 Dec 26.Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2020-01-31
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 31878938 Available 31878938

Available online through MWHC library: 2003 - present

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.

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.

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).

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