Evidence map›Paper›PMID 36549127›Full record

ReviewESMO open2023

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

J R Platt, O M Todd, P Hall, Z Craig, A Quyn, M Seymour, M Braun, J Roodhart, C Punt, N Christou and 7 more

Open access · goldAbstract readReview
In one paragraph

Review in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 27% 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

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. Review
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

17 authors at 9 institutions in 4 countries.

J R PlattDepartment of Oncology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds. Electronic address: https://twitter.com/Jplatt_19.
O M ToddAcademic Unit for Ageing and Stroke Research, University of Leeds, Leeds. Electronic address: https://twitter.com/ToddOly.
P HallUniversity of Edinburgh Cancer Research Centre, Edinburgh.
Z CraigLeeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds.
A QuynThe John Goligher Colorectal Surgery Unit, St James's University Hospital, The Leeds Teaching Hospitals NHS Trust, Leeds.
M SeymourDepartment of Oncology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds.
M BraunDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester; School of Medical Sciences, University of Manchester, Manchester, UK.
J RoodhartDepartment of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht.
C PuntDepartment of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, The Netherlands.
N ChristouDepartment of Digestive Surgery, University Hospital of Limoges, Limoges. Electronic address: https://twitter.com/CNikinc.
J TaiebDepartment of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, Assistance publique-Hôpitaux de Paris, Sorbonne Paris Cité, University Paris-Cité (Paris Descartes), Paris.
M KarouiDepartment of Digestive and Oncological Surgery, Georges Pompidou European Hospital, Assistance publique-Hôpitaux de Paris, Paris Cité University, Paris, France.
J BrownLeeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds.
D A CairnsLeeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds. Electronic address: https://twitter.com/kennycairns.
D MortonInstitute of Cancer and Genomic Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
A GilbertDepartment of Oncology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds.
J F SeligmannDepartment of Oncology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds. Electronic address: j.seligmann@leeds.ac.uk.
University of Leeds · GBTwitter (United States) · USUtrecht University · NLDélégation Paris 5 · FREdinburgh Cancer Research · GBLeeds Teaching Hospitals NHS Trust · GBUniversité Paris Cité · FRUniversity of Birmingham · GBUniversity of Manchester · GB

Funding

Cancer Research UK 25447Cancer Research UK 28301
6 · The paper itself

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.

Indexed as

Colonic NeoplasmsFrailtyAgedDisease-Free SurvivalHumansNeoadjuvant Therapyclinical trialcolon cancerfrailtyneoadjuvant chemotherapyolder age

Identifiers

PMID36549127
PMCPMC9800329
OpenAlexW4312084840

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.