Evidence map›Paper›PMID 31878938›Full record

ArticleJournal of translational medicine2019

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.

Sara I Pai, Ezra E W Cohen, Derrick Lin, George Fountzilas, Edward S Kim, Holger Mehlhorn, Neus Baste, Daniel Clayburgh, Loren Lipworth, Carlo Resteghini and 10 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of translational medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02543476 (SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02543476 completednot on this map

SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

TypeobservationalSponsorAstraZenecaRan2015 to 2016Enrolled412ConditionsSquamous Cell Carcinoma of the Head and Neck
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. CD4Cancer science · 2021
    Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 16 institutions in 7 countries.

Sara I PaiMassachusetts General Hospital Cancer Center, Harvard Medical School, 55 Fruit Street, GRJ 9-904G, Boston, MA, 02114, USA. sara.pai@mgh.harvard.edu.ORCID 0000-0002-6341-9971
Ezra E W CohenUC San Diego Health System, Moores Cancer Center, La Jolla, CA, USA.
Derrick LinMassachusetts General Hospital Cancer Center, Harvard Medical School, 55 Fruit Street, GRJ 9-904G, Boston, MA, 02114, USA.
George FountzilasAristotle University of Thessaloniki, Thessaloniki, Greece.
Edward S KimLevine Cancer Institute, Atrium Health, Charlotte, NC, USA.
Holger MehlhornUniversitaetsklinikum Leipzig, Klinik und Poliklinik fur HNO-Heilkunde, Leipzig, Germany.
Neus BasteDepartment of Oncology, Hospital Universitari Vall d'Hebron & Vall Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Daniel ClayburghOregon Health & Science University, Portland, OR, USA.
Loren LipworthVanderbilt University Medical Center, Nashville, TN, USA.
Carlo ResteghiniFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Nawar SharaMedStar Health Research Institute, Hyattsville, MD, USA.
Takashi FujiiOsaka International Cancer Institute, Osaka, Japan.
Jun ZhangBaylor College of Medicine, Houston, TX, USA.
Michael StokesEvidera, Lexington, MA, USA.
Huifen WangAstraZeneca, Gaithersburg, MD, USA.
Philip Twumasi-AnkrahAstraZeneca, Gaithersburg, MD, USA.
Sophie WildsmithAstraZeneca, Cambridge, UK.
Asud KhaliqAstraZeneca, Gaithersburg, MD, USA.
Giovanni MelilloAstraZeneca, Gaithersburg, MD, USA.
Norah ShireAstraZeneca, Gaithersburg, MD, USA.
AstraZeneca (United States) · USAristotle University of Thessaloniki · GRAstraZeneca (United Kingdom) · GBBaylor College of Medicine · USFondazione IRCCS Istituto Nazionale dei Tumori · ITHarvard University · USIthaka Harbors · USKlinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde · DELevine Cancer Institute · USMassachusetts Eye and Ear Infirmary · USMedStar Health · USOregon Health & Science University · USOsaka International Cancer Institute · JPUC San Diego Health System · USVall d'Hebron Hospital Universitari · ESVanderbilt University Medical Center · US

Funding

Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
Strategies to Overcome Immune Resistance in Head and Neck CancersP01CA240239 · NCI · YALE UNIVERSITY · PI MEMPEL, THORSTEN ROMAN · 2019 to 2023
$8.4M
NCATS NIH HHS UL1 TR001409NCI NIH HHS P01 CA240239
6 · The paper itself

Abstract

backgroundProgrammed 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.

methodsThis 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.

results412 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).

conclusionsPD-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.

Indexed as

AdultAgedAged, 80 and overB7-H1 AntigenBiomarkers, TumorDisease-Free SurvivalFemaleHumansMaleMiddle AgedMultivariate AnalysisNeoplasm MetastasisNeoplasm Recurrence, LocalPrognosisRetrospective StudiesRisk FactorsB7-H1 AntigenBiomarkers, TumorBiomarkerHead and neck squamous cell carcinomaImmuno-oncologyPD-L1PrognosisProgrammed cell death ligand-1

Identifiers

PMID31878938
PMCPMC6933901
OpenAlexW2997608354

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.