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Review
. 2024 Dec 5:78:102939.
doi: 10.1016/j.eclinm.2024.102939. eCollection 2024 Dec.

International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set

Robert Samuel  1   2 , Stephen R Knight  3   4 , Richard Adams  5 , Prajnan Das  6 , Jennifer Dorth  7 , David Finch  1   8 , Marianne G Guren  9 , Maria A Hawkins  10 , Susan Moug  11 , Lakshmi Rajdev  12 , David Sebag-Montefiore  2 , Andrew G Renehan  1   8 , Rebecca Fish  1   8 ; plus the CORMAC-2 collaborators
Collaborators, Affiliations
Review

International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set

Robert Samuel et al. EClinicalMedicine. .

Abstract

Variation in outcomes definitions and reporting limit the utility of clinical trial results. The Core Outcome Research Measures in Anal Cancer (CORMAC) project developed a core outcome set (COS) for chemoradiotherapy trials for anal squamous cell carcinoma (ASCC) through an international healthcare professional and patient consensus process. The CORMAC-COS comprises 19 outcomes across 4 domains (disease activity, survival, toxicity, life impact). In CORMAC-2 we have established standardised definitions for the 11 disease activity and survival outcomes in the CORMAC COS. Definitions were agreed through a 3 step process, initially identifying existing definitions through systematic review (registered with PROSPERO, CRD42016036540), using these to populate a two-round Delphi questionnaire completed by 51 experts from 13 countries, and finally ratification through an online consensus meeting. Standardising the definitions for these core outcomes facilitates real world utilisation of the CORMAC-COS, thereby increasing the quality of data available for clinical decision-making and ultimately enhancing patient care.

Keywords: Anal cancer; Chemoradiotherapy; Consensus; Core outcome set; Delphi; Outcomes.

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Conflict of interest statement

Maria Hawkins is supported by the NIHR University College London Hospitals Biomedical Research Centre. Andrew Renehan is supported by the NIHR Manchester Biomedical Research Centre (IS-BRC-1215-20007). Marianne G Guren is on the Data Monitoring and Ethics Committee for the PLATO trials, is a member of the Norwegian Colorectal Cancer Group (incl anal cancer), editor of writing committee for the Norwegian treatment guidelines for anal cancer, member of the Faculty of Nordic Anal Cancer Group (NOAC) and International Multidisciplinary Anal Cancer Consortium (IMACC) and co-editor of ESMO Anal cancer treatment guidelines 2021 and is a PI in clinical trials that receive drugs for the trial. Prajnan Das has received consulting fees for the American Society for Radiation Oncology and payment/honoraria from Imedex and Bayer. The authors would like to thank The COMET initiative and the University of Liverpool for the use of the DelphiManager software for the CORMAC-2 project at no cost.

Figures

Fig. 1
Fig. 1
Screenshot of the Delphi questionnaire, showing a link to further reading and summarised PPI group comments.
See this image and copyright information in PMC

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