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 Adams⁵, Prajnan Das⁶, Jennifer Dorth⁷, David Finch^{1

8}, Marianne G Guren⁹, Maria A Hawkins¹⁰, Susan Moug¹¹, Lakshmi Rajdev¹², David Sebag-Montefiore², Andrew G Renehan^{1

8}, Rebecca Fish^{1

8}; plus the CORMAC-2 collaborators

Collaborators, Affiliations

Collaborators

plus the CORMAC-2 collaborators:
Miguel A Rodriguez-Bigas, Pratik Adusumilli, Ahmed Allam Mohamed, Mario Alvarez Gallego, Eva Angenete, Ane Appelt, Maaike Berbee, Danielle Brogden, Peter Brown, Lucy Buckley, Nathalie Casanova, Rachel Cooper, Nuno Couto, Peter Coyne, Tamzin Cuming, Charlotte Deijin, Kristopher Dennis, Cathy Eng, Alexandra Gilbert, Duncan Gilbert, Karyn Goodman, Rashmi Jadon, Anders Johnsson, Arunansu Kar, Ethan Ludmir, Marie-Louise Lydrup, Ivan Lyra-Gonzalez, Stefania Manfrida, Rebecca Muirhead, Sarah O'Dwyer, Thomas Rackley, Lukasz Raszewski, Leslie Samuel, Mark Saunders, Andrew Scarsbrook, Eva Segelov, Timothy Simmons, Paul Sutton, Nicholas Symons, Deborah Williamson

Affiliations

¹ NIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.
² University of Leeds, Leeds Institute for Medical Research, St. James's University Hospital, Leeds, UK.
³ Centre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, UK.
⁴ School of Health and Wellbeing, University of Glasgow, Glasgow, UK.
⁵ Centre for Trials Research, Cardiff University School of Medicine, Cardiff, UK.
⁶ University of Texas MD Anderson Cancer Center, USA.
⁷ Department of Radiation Oncology, University Hospitals Cleveland Medical Centre, Cleveland, USA.
⁸ Colorectal and Peritoneal Oncology Centre, The Christie NHS FT, Manchester.
⁹ Department of Oncology, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
¹⁰ Department of Medical Physics and Biomedical Engineering, University College London, London, UK.
¹¹ Department of Colorectal Surgery, Royal Alexandra Hospital, Paisley, UK.
¹² Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

PMID: 39720423
PMCID: PMC11667046
DOI: 10.1016/j.eclinm.2024.102939

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. 2024.

. 2024 Dec 5:78:102939.

doi: 10.1016/j.eclinm.2024.102939. eCollection 2024 Dec.

Authors

Collaborators

plus the CORMAC-2 collaborators:
Miguel A Rodriguez-Bigas, Pratik Adusumilli, Ahmed Allam Mohamed, Mario Alvarez Gallego, Eva Angenete, Ane Appelt, Maaike Berbee, Danielle Brogden, Peter Brown, Lucy Buckley, Nathalie Casanova, Rachel Cooper, Nuno Couto, Peter Coyne, Tamzin Cuming, Charlotte Deijin, Kristopher Dennis, Cathy Eng, Alexandra Gilbert, Duncan Gilbert, Karyn Goodman, Rashmi Jadon, Anders Johnsson, Arunansu Kar, Ethan Ludmir, Marie-Louise Lydrup, Ivan Lyra-Gonzalez, Stefania Manfrida, Rebecca Muirhead, Sarah O'Dwyer, Thomas Rackley, Lukasz Raszewski, Leslie Samuel, Mark Saunders, Andrew Scarsbrook, Eva Segelov, Timothy Simmons, Paul Sutton, Nicholas Symons, Deborah Williamson

Affiliations

¹ NIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.
² University of Leeds, Leeds Institute for Medical Research, St. James's University Hospital, Leeds, UK.
³ Centre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, UK.
⁴ School of Health and Wellbeing, University of Glasgow, Glasgow, UK.
⁵ Centre for Trials Research, Cardiff University School of Medicine, Cardiff, UK.
⁶ University of Texas MD Anderson Cancer Center, USA.
⁷ Department of Radiation Oncology, University Hospitals Cleveland Medical Centre, Cleveland, USA.
⁸ Colorectal and Peritoneal Oncology Centre, The Christie NHS FT, Manchester.
⁹ Department of Oncology, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
¹⁰ Department of Medical Physics and Biomedical Engineering, University College London, London, UK.
¹¹ Department of Colorectal Surgery, Royal Alexandra Hospital, Paisley, UK.
¹² Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

PMID: 39720423
PMCID: PMC11667046
DOI: 10.1016/j.eclinm.2024.102939

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.

PubMed Disclaimer

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**
**Screenshot of the Delphi questionnaire, showing a link to further reading and summarised PPI group comments**.

See this image and copyright information in PMC

References

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1. Anal cancer incidence statistics | Cancer Research UK. https://www.cancerresearchuk.org/health-professional/cancer-statistics/s...
1. James R.D., Glynne-Jones R., Meadows H.M., et al. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2×2 factorial trial. Lancet Oncol. 2013;14:516–524. - PubMed
1. Peiffert D., Tournier-Rangeard L., Gérard J.P., et al. Induction chemotherapy and dose intensification of the radiation boost in locally advanced anal canal carcinoma: final analysis of the randomized UNICANCER ACCORD 03 trial. J Clin Oncol. 2012;30:1941–1948. - PubMed

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

LinkOut - more resources

Full Text Sources