• 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

    Efficacy of reduced-intensity chemotherapy with oxaliplatin and capecitabine on quality of life and cancer control among older and frail patients with advanced gastroesophageal cancer: The GO2 phase 3 randomized clinical trial

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Thumbnail
    Name:
    33983395.pdf
    Size:
    442.4Kb
    Format:
    PDF
    Description:
    FROM CORE
    Download
    Authors
    Hall, P. S.
    Swinson, D.
    Cairns, D. A.
    Waters, J. S.
    Petty, R.
    Allmark, C.
    Ruddock, S.
    Falk, S.
    Wadsley, J.
    Roy, R.
    Tillett, T.
    Nicoll, J.
    Cummins, S.
    Mano, J.
    Grumett, S.
    Stokes, Z.
    Konstantinos-Velios, K.
    Chatterjee, A.
    Garcia, A.
    Waddell, Thomas
    Guptal, K.
    Maisey, N.
    Khan, M.
    Dent, J.
    Lord, S.
    Crossley, A.
    Katona, E.
    Marshall, H.
    Grabsch, H. I.
    Velikova, G.
    Ow, P. L.
    Handforth, C.
    Howard, H
    Seymour, M. T.
    Show allShow less
    Affiliation
    University of Leeds, Leeds, United Kingdom.
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Importance: Older and/or frail patients are underrepresented in landmark cancer trials. Tailored research is needed to address this evidence gap. Objective: The GO2 randomized clinical trial sought to optimize chemotherapy dosing in older and/or frail patients with advanced gastroesophageal cancer, and explored baseline geriatric assessment (GA) as a tool for treatment decision-making. Design, setting, and participants: This multicenter, noninferiority, open-label randomized trial took place at oncology clinics in the United Kingdom with nurse-led geriatric health assessment. Patients were recruited for whom full-dose combination chemotherapy was considered unsuitable because of advanced age and/or frailty. Interventions: There were 2 randomizations that were performed: CHEMO-INTENSITY compared oxaliplatin/capecitabine at Level A (oxaliplatin 130 mg/m2 on day 1, capecitabine 625 mg/m2 twice daily on days 1-21, on a 21-day cycle), Level B (doses 0.8 times A), or Level C (doses 0.6 times A). Alternatively, if the patient and clinician agreed the indication for chemotherapy was uncertain, the patient could instead enter CHEMO-BSC, comparing Level C vs best supportive care. Main outcomes and measures: First, broad noninferiority of the lower doses vs reference (Level A) was assessed using a permissive boundary of 34 days reduction in progression-free survival (PFS) (hazard ratio, HR = 1.34), selected as acceptable by a forum of patients and clinicians. Then, the patient experience was compared using Overall Treatment Utility (OTU), which combines efficacy, toxic effects, quality of life, and patient value/acceptability. For CHEMO-BSC, the main outcome measure was overall survival. Results: A total of 514 patients entered CHEMO-INTENSITY, of whom 385 (75%) were men and 299 (58%) were severely frail, with median age 76 years. Noninferior PFS was confirmed for Levels B vs A (HR = 1.09 [95% CI, 0.89-1.32]) and C vs A (HR = 1.10 [95% CI, 0.90-1.33]). Level C produced less toxic effects and better OTU than A or B. No subgroup benefited from higher doses: Level C produced better OTU even in younger or less frail patients. A total of 45 patients entered the CHEMO-BSC randomization: overall survival was nonsignificantly longer with chemotherapy: median 6.1 vs 3.0 months (HR = 0.69 [95% CI, 0.32-1.48], P = .34). In multivariate analysis in 522 patients with all variables available, baseline frailty, quality of life, and neutrophil to lymphocyte ratio were independently associated with OTU, and can be combined in a model to estimate the probability of different outcomes. Conclusions and relevance: This phase 3 randomized clinical trial found that reduced-intensity chemotherapy provided a better patient experience without significantly compromising cancer control and should be considered for older and/or frail patients. Baseline geriatric assessment can help predict the utility of chemotherapy but did not identify a group benefiting from higher-dose treatment.
    Citation
    Hall PS, Swinson D, Cairns DA, Waters JS, Petty R, Allmark C, et al. Efficacy of Reduced-Intensity Chemotherapy With Oxaliplatin and Capecitabine on Quality of Life and Cancer Control Among Older and Frail Patients With Advanced Gastroesophageal Cancer. JAMA Oncol. 2021 Jun 1;7(6):869.
    Journal
    JAMA Oncology
    URI
    http://hdl.handle.net/10541/624085
    DOI
    10.1001/jamaoncol.2021.0848
    PubMed ID
    33983395
    Additional Links
    https://dx.doi.org/10.1001/jamaoncol.2021.0848
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1001/jamaoncol.2021.0848
    Scopus Count
    Collections
    All Christie Publications

    entitlement

    Related articles

    • Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): an open-label, randomised factorial trial.
    • Authors: Seymour MT, Thompson LC, Wasan HS, Middleton G, Brewster AE, Shepherd SF, O'Mahony MS, Maughan TS, Parmar M, Langley RE, FOCUS2 Investigators, National Cancer Research Institute Colorectal Cancer Clinical Studies Group
    • Issue date: 2011 May 21
    • Chemotherapy for advanced gastric cancer.
    • Authors: Wagner AD, Syn NL, Moehler M, Grothe W, Yong WP, Tai BC, Ho J, Unverzagt S
    • Issue date: 2017 Aug 29
    • Association of Proton Pump Inhibitors and Capecitabine Efficacy in Advanced Gastroesophageal Cancer: Secondary Analysis of the TRIO-013/LOGiC Randomized Clinical Trial.
    • Authors: Chu MP, Hecht JR, Slamon D, Wainberg ZA, Bang YJ, Hoff PM, Sobrero A, Qin S, Afenjar K, Houe V, King K, Koski S, Mulder K, Hiller JP, Scarfe A, Spratlin J, Huang YJ, Khan-Wasti S, Chua N, Sawyer MB
    • Issue date: 2017 Jun 1
    • Frailty and treatment outcome in advanced gastro-oesophageal cancer: An exploratory analysis of the GO2 trial.
    • Authors: Pearce J, Swinson D, Cairns D, Nair S, Baxter M, Petty R, Seymour M, Hall P, Velikova G, GO2 trial investigators
    • Issue date: 2022 Apr
    • Assessment of Capecitabine and Bevacizumab With or Without Atezolizumab for the Treatment of Refractory Metastatic Colorectal Cancer: A Randomized Clinical Trial.
    • Authors: Mettu NB, Ou FS, Zemla TJ, Halfdanarson TR, Lenz HJ, Breakstone RA, Boland PM, Crysler OV, Wu C, Nixon AB, Bolch E, Niedzwiecki D, Elsing A, Hurwitz HI, Fakih MG, Bekaii-Saab T
    • Issue date: 2022 Feb 1
    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.