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    FOxTROT2: innovative trial design to evaluate the role of neoadjuvant chemotherapy for treating locally advanced colon cancer in older adults or those with frailty

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    Authors
    Platt, J. R.
    Todd, O. M.
    Hall, P.
    Craig, Z.
    Quyn, A.
    Seymour, M.
    Braun, Michael S
    Roodhart, J.
    Punt, C.
    Christou, N.
    Taieb, J.
    Karoui, M.
    Brown, J.
    Cairns, D. A.
    Morton, D.
    Gilbert, A.
    Seligmann, J. F.
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    Affiliation
    Department of Oncology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds
    Issue Date
    2022
    
    Metadata
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    Abstract
    Treating older adults with cancer is increasingly important in modern oncology practice. However, we currently lack the high-quality evidence needed to guide optimal management of this heterogeneous group. Principally, historic under-recruitment of older adults to clinical trials limits our understanding of how existing evidence can be applied to this group. Such uncertainty is particularly prevalent in the management of colon cancer (CC). With CC being most common in older adults, many patients also suffer from frailty, which is recognised as being strongly associated with poor clinical outcomes. Conducting clinical trials in older adults presents several major challenges, many of which impact the clinical relevance of results to a real-world population. When considering this heterogeneous group, it may be difficult to define the target population, recruit participants effectively, choose an appropriate trial design, and ensure participants remain engaged with the trial during follow-up. Furthermore, after overcoming these challenges, clinical trials tend to enrol highly selected patient cohorts that comprise only the fittest older patients, which are not representative of the wider population. FOxTROT1 was the first phase III randomised controlled trial to illustrate the benefit of neoadjuvant chemotherapy (NAC) in the treatment of CC. Patients receiving NAC had greater 2-year disease-free survival compared to those proceeding straight to surgery. Outcomes for older adults in FOxTROT1 were similarly impressive when compared to their younger counterparts. Yet, this group inevitably represents a fitter subgroup of the older patient population. FOxTROT2 has been designed to investigate NAC in a full range of older adults with CC, including those with frailty. In this review, we describe the key challenges to conducting a robust clinical trial in this heterogeneous patient group, highlight our strategies for overcoming these challenges in FOxTROT2, and explain how we hope to provide clarity on the optimal treatment of CC in older adults.
    Citation
    Platt JR, Todd OM, Hall P, Craig Z, Quyn A, Seymour M, et al. FOxTROT2: innovative trial design to evaluate the role of neoadjuvant chemotherapy for treating locally advanced colon cancer in older adults or those with frailty. ESMO open. 2022 Dec 20;8(1):100642. PubMed PMID: 36549127. Pubmed Central PMCID: PMC9800329. Epub 2022/12/23. eng.
    Journal
    ESMO Open
    URI
    http://hdl.handle.net/10541/625927
    DOI
    10.1016/j.esmoop.2022.100642
    PubMed ID
    36549127
    Additional Links
    https://dx.doi.org/10.1016/j.esmoop.2022.100642
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.esmoop.2022.100642
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