Evidence map›Paper›PMID 37509217›Full record

ArticleCancers2023

Phase 4 Multinational Multicenter Retrospective and Prospective Real-World Study of Nivolumab in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck.

Anagha Gogate, Bryan Bennett, Zia Poonja, Grant Stewart, Ana Medina Colmenero, Petr Szturz, Courtney Carrington, Clara Castro, Eric Gemmen, Ashley Lau and 10 more

Open access · goldAbstract read
In one paragraph

Article in Cancers, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Real-world evaluation of nivolumab in patients with non-nasopharyngeal recurrent or metastatic head and neck cancer: a retrospective multi-center study by the Turkish Oncology Group (TOG).European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Article
  4. Review
  5. Article
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 17 institutions in 5 countries.

Anagha GogateBristol Myers Squibb, Lawrenceville, NJ 08648, USA.ORCID 0000-0003-2891-8457
Bryan BennettBristol Myers Squibb, Uxbridge UB8 1DG, UK.
Zia PoonjaBC Cancer, University of British Columbia, Victoria, BC V8R 6V5, Canada.ORCID 0000-0003-2190-778X
Grant StewartRoyal Cornwall Hospital NHS Trust, Truro TR1 3LJ, UK.
Ana Medina ColmeneroFundación Centro Oncologico de Galicia, 15009 Coruña, Spain.ORCID 0000-0003-2961-1529
Petr SzturzDepartment of Oncology, University of Lausanne (UNIL), Lausanne University Hospital (CHUV), 1011 Lausanne, Switzerland.ORCID 0000-0001-9705-4168
Courtney CarringtonIQVIA, Parsippany-Troy Hills, NJ 07054, USA.
Clara CastroIQVIA, 2740-266 Oeiras, Portugal.
Eric GemmenIQVIA, Falls Church, VA 22042, USA.
Ashley LauIQVIA, Kirkland, QC H9H 5M3, Canada.
Alberto Carral MasedaDepartment of Oncology, Hospital Universitario Lucus Augusti, 27003 Lugo, Spain.
Eric WinquistDepartment of Oncology, London Health Sciences Centre, Western University, London, ON N6A 5W9, Canada.ORCID 0000-0002-8829-5979
Virginia ArrazubiOncology, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Hospital Universitario de Navarra, 31008 Pamplona, Spain.ORCID 0000-0002-1431-2780
Desiree HaoThoracic and Head & Neck Oncology, Tom Baker Cancer Centre, Cumming School of Medicine, University of Calgary, Calgary, AB T2N 4N2, Canada.ORCID 0000-0003-1727-1205
Audrey CookCheltenham General Hospital, Cheltenham GL53 0BG, UK.
Joaquina Martinez GalanInstituto de Investigación Biosanitaria, Hospital Universitario Virgen Nieves, 18014 Granada, Spain.
Lisardo UgidosOncology, Hospital Universitario HM Madrid Sanchinarro, 28050 Madrid, Spain.
David Fernández GarayOncology, Hospital Universitario de Jaén, 23007 Jaén, Spain.ORCID 0009-0006-4789-5384
David Gutierrez AbadOncology, Hospital Universitario de Fuenlabrada, 28942 Madrid, Spain.
Robert MetcalfThe Christie NHS Foundation Trust, Manchester M20 4BX, UK.
IQVIA (United States) · USBristol-Myers Squibb (United Kingdom) · GBBristol-Myers Squibb (United States) · USCentro Oncológico de Galicia · ESCheltenham General Hospital · GBComplejo Hospitalario de Jaén · ESHospital Universitario de Fuenlabrada · ESHospital Universitario HM Madrid · ESHospital Universitario Lucus Augusti · ESInstituto de Investigación Biosanitaria de Granada · ESNavarre Institute of Health Research · ESRoyal Cornwall Hospital Trust · GBThe Christie NHS Foundation Trust · GBUniversity of British Columbia · CAUniversity of Calgary · CAUniversity of Lausanne · CHWestern University · CA

Funding

Bristol-Myers Squibb (United States) Not applicable
6 · The paper itself

Abstract

This study examined the real-world use of nivolumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). This was a multinational retrospective study (VOLUME) assessing treatment effectiveness and safety outcomes and a prospective study (VOLUME-PRO) assessing HRQoL and patient-reported symptoms. There were 447 and 51 patients in VOLUME and VOLUME-PRO, respectively. Across both studies, the median age was 64.0 years, 80.9% were male, and 52.6% were former smokers. Clinical outcomes of interest included real-world overall survival (rwOS) and real-world progression-free survival (rwPFS). The median rwOS was 9.2 months. Among patients with at least one assessment, 21.7% reported their best response as 'partial response', with 3.9% reporting 'complete response'. The median duration of response (DoR) and median rwPFS were 11.0 months and 3.9 months, respectively. At baseline, VOLUME-PRO patients reported difficulties relating to fatigue, physical and sexual functioning, dyspnea, nausea, sticky saliva, dry mouth, pain/discomfort, mobility, and financial difficulties. There were improvements in social functioning and financial difficulties throughout the study; however, no other clinically meaningful changes were noted. No new safety concerns were identified. This real-world, multinational, multicenter, retrospective and prospective study supports the effectiveness and safety of nivolumab for R/M SCCHN patients.

Indexed as

head and neck squamous cell carcinomaHNSCCnivolumabpatient-reported outcomesprospective studyreal-world datarecurrent/metastatic head and neck cancerretrospective studySCCHN

Identifiers

PMID37509217
PMCPMC10377225
OpenAlexW4383722655

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.