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

George Fountzilas¹  Sophie Wildsmith²  Norah Shire²  Huifen Wang²  Giovanni Melillo²  Philip Twumasi-Ankrah²  Asud Khaliq²  Jun Zhang³  Neus Baste⁴  Michael Stokes⁵  Carlo Resteghini⁶  Edward S. Kim⁷  Sara I. Pai⁸  Derrick Lin⁸  Nawar Shara⁹  Daniel Clayburgh^1,10  Takashi Fujii^1,11  Ezra E. W. Cohen^1,12  Holger Mehlhorn^1,13  Loren Lipworth^1,14 

[1] Aristotle University of Thessaloniki;AstraZeneca;Baylor College of Medicine;Department of Oncology, Hospital Universitari Vall d’Hebron & Vall Hebron Institute of Oncology (VHIO);Evidera;Fondazione IRCCS Istituto Nazionale dei Tumori;Levine Cancer Institute, Atrium Health;Massachusetts General Hospital Cancer Center, Harvard Medical School;MedStar Health Research Institute;Oregon Health & Science University;Osaka International Cancer Institute;UC San Diego Health System, Moores Cancer Center;Universitaetsklinikum Leipzig, Klinik und Poliklinik fur HNO-Heilkunde;Vanderbilt University Medical Center;

关键词: Biomarker;    Head and neck squamous cell carcinoma;    Immuno-oncology;    PD-L1;    Programmed cell death ligand-1;    Prognosis;   

DOI  :  10.1186/s12967-019-02182-1

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown