• Login
    View Item 
    •   Home
    • The Christie Research Publications Repository
    • All Christie Publications
    • View Item
    •   Home
    • The Christie Research Publications Repository
    • All Christie Publications
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of ChristieCommunitiesTitleAuthorsIssue DateSubmit DateSubjectsThis CollectionTitleAuthorsIssue DateSubmit DateSubjects

    My Account

    LoginRegister

    Local Links

    The Christie WebsiteChristie Library and Knowledge Service

    Statistics

    Display statistics

    Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Thumbnail
    Name:
    34656227.pdf
    Size:
    602.6Kb
    Format:
    PDF
    Description:
    From UNPAYWALL
    Download
    Authors
    Fennell, D. A.
    Ewings, S.
    Ottensmeier, C.
    Califano, Raffaele
    Hanna, G. G.
    Hill, K.
    Danson, S.
    Steele, N.
    Nye, M.
    Johnson, L.
    Lord, J.
    Middleton, C.
    Szlosarek, P.
    Chan, S.
    Gaba, A.
    Darlison, L.
    Wells-Jordan, P.
    Richards, C.
    Poile, C.
    Lester, J. F.
    Griffiths, G.
    Show allShow less
    Affiliation
    Mesothelioma Research Programme, Leicester Cancer Research Centre, University of Leicester, Leicester, UK; University Hospitals of Leicester NHS Trust, Leicester, UK
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Background: No phase 3 trial has yet shown improved survival for patients with pleural or peritoneal malignant mesothelioma who have progressed following platinum-based chemotherapy. The aim of this study was to assess the efficacy and safety of nivolumab, an anti-PD-1 antibody, in these patients. Methods: This was a multicentre, placebo-controlled, double-blind, parallel group, randomised, phase 3 trial done in 24 hospitals in the UK. Adult patients (aged ?18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed pleural or peritoneal mesothelioma, who had received previous first-line platinum-based chemotherapy and had radiological evidence of disease progression, were randomly assigned (2:1) to receive nivolumab at a flat dose of 240 mg every 2 weeks over 30 min intravenously or placebo until disease progression or a maximum of 12 months. The randomisation sequence was generated within an interactive web response system (Alea); patients were stratified according to epithelioid versus non-epithelioid histology and were assigned in random block sizes of 3 and 6. Participants and treating clinicians were masked to group allocation. The co-primary endpoints were investigator-assessed progression-free survival and overall survival, analysed according to the treatment policy estimand (an equivalent of the intention-to-treat principle). All patients who were randomly assigned were included in the safety population, reported according to group allocation. This trial is registered with Clinicaltrials.gov, NCT03063450. Findings: Between May 10, 2017, and March 30, 2020, 332 patients were recruited, of whom 221 (67%) were randomly assigned to the nivolumab group and 111 (33%) were assigned to the placebo group). Median follow-up was 11�6 months (IQR 7�2-16�8). Median progression-free survival was 3�0 months (95% CI 2�8-4�1) in the nivolumab group versus 1�8 months (1�4-2�6) in the placebo group (adjusted hazard ratio [HR] 0�67 [95% CI 0�53-0�85; p=0�0012). Median overall survival was 10�2 months (95% CI 8�5-12�1) in the nivolumab group versus 6�9 months (5�0-8�0) in the placebo group (adjusted HR 0�69 [95% CI 0�52-0�91]; p=0�0090). The most frequently reported grade 3 or worse treatment-related adverse events were diarrhoea (six [3%] of 221 in the nivolumab group vs two [2%] of 111 in the placebo group) and infusion-related reaction (six [3%] vs ). Serious adverse events occurred in 90 (41%) patients in the nivolumab group and 49 (44%) patients in the placebo group. There were no treatment-related deaths in either group.
    Citation
    Fennell DA, Ewings S, Ottensmeier C, Califano R, Hanna GG, Hill K, et al. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial. The Lancet Oncology. Elsevier BV; 2021.
    Journal
    Lancet Oncology
    URI
    http://hdl.handle.net/10541/624687
    DOI
    10.1016/s1470-2045(21)00471-x
    PubMed ID
    34656227
    Additional Links
    https://dx.doi.org/10.1016/s1470-2045(21)00471-x
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/s1470-2045(21)00471-x
    Scopus Count
    Collections
    All Christie Publications

    entitlement

     
    DSpace software (copyright © 2002 - 2023)  DuraSpace
    Quick Guide | Contact Us
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.