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; Stephen R Knight; Richard Adams; Prajnan Das; Jennifer Dorth; David Finch; Marianne G Guren; Maria A Hawkins; Susan Moug; Lakshmi Rajdev; David Sebag-Montefiore; Andrew G Renehan; Rebecca Fish; plus the CORMAC-2 collaborators

doi:10.1016/j.eclinm.2024.102939

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

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

Authors

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

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.

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.

Publication types

Review