1. Protocol for the development of a core outcome set and reporting guidelines for locoregional treatment in neoadjuvant systemic breast cancer treatment trials: the PRECEDENT project.
- Author
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Potter S, Avery K, Ahmed R, de Boniface J, Chatterjee S, Dodwell D, Dubsky P, Iwata H, Jiang M, Lee HB, MacKenzie M, Poulakaki F, Richardson AL, Sepulveda K, Spillane A, Thompson AM, Werutsky G, Wright JL, Zdenkowski N, Cowan K, and McIntosh S
- Subjects
- Humans, Female, Delphi Technique, Consensus, Outcome Assessment, Health Care, Breast Neoplasms therapy, Neoadjuvant Therapy, Research Design
- Abstract
Introduction: Neoadjuvant systemic anticancer therapy (neoSACT) is increasingly used in the treatment of early breast cancer. Response to therapy is prognostic and allows locoregional and adjuvant systemic treatments to be tailored to minimise morbidity and optimise oncological outcomes and quality of life. Accurate information about locoregional treatments following neoSACT is vital to allow the translation of downstaging benefits into practice and facilitate meaningful interpretation of oncological outcomes, particularly locoregional recurrence. Reporting of locoregional treatments in neoSACT studies, however, is currently poor. The development of a core outcome set (COS) and reporting guidelines is one strategy by which this may be improved., Methods and Analysis: A COS for reporting locoregional treatment (surgery and radiotherapy) in neoSACT trials will be developed in accordance with Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development guidelines. Reporting guidance will be developed concurrently.The project will have three phases: (1) generation of a long list of relevant outcome domains and reporting items from a systematic review of published neoSACT studies and interviews with key stakeholders. Identified items and domains will be categorised and formatted into Delphi consensus questionnaire items. (2) At least two rounds of an international online Delphi survey in which at least 250 key stakeholders (surgeons/oncologists/radiologists/pathologists/trialists/methodologists) will score the importance of reporting each outcome. (3) A consensus meeting with key stakeholders to discuss and agree the final COS and reporting guidance., Ethics and Dissemination: Ethical approval for the consensus process will be obtained from the Queen's University Belfast Faculty Ethics Committee. The COS/reporting guidelines will be presented at international meetings and published in peer-reviewed journals. Dissemination materials will be produced in collaboration with our steering group and patient advocates so the results can be shared widely., Registration: The study has been prospectively registered on the COMET website (https://www.comet-initiative.org/Studies/Details/2854)., Competing Interests: Competing interests: SM reports speaker honoraria from MSD, Roche, BD and Astra Zeneca; advisory boards for Lilly, Novartis, MSD, Roche and Astra Zeneca; conference travel and support from Roche, Lilly and MSD; and institutional research funding from Novartis. HI reports consulting fees from Daiichi Sankyo, Chugai, Astra Zeneca, Lilly, MSD, Pfizer and Gilead; honoraria from Daiichi Sankyo, Chugai, Astra Zeneca, Lilly, MSD, Pfizer, Taiho and Kyowa Kirin; and institutional research funding from Chugai, Daiichi Sankyo and Astra Zeneca. PD reports institutional research funding from Cepheid and Roche; consulting fees from Roche, and honoraria from Astra Zeneca and Oncoviews; and conference and travel support from Roche. H-BL reports research funding from Devicor Medical Product Inc. and is a co-founder and director of DCGen Co. Ltd. ALR reports consulting fees from Astra Zeneca and royalties from Myriad Genetics. GW reports consulting fees from Astra Zeneca, MSD, Novartis, Daiichi Sankyo and Roche; honoraria from Astra Zeneca, MSD, Novartis, Roche, Pfizer and Daiichi-Sankyo; and institutional research funding from Astra Zeneca/Medimmune, Roche/Genentech, GlaxoSmithKline, Novartis, Pfizer, Roche, MSD, Merck, Bayer, Janssen, Astellas Pharma, Libbs and Takeda. NZ reports consulting fees from Lilly, Eisai, Astra Zeneca, MSD, Novartis and Gilead; honoraria from Roche, Pfizer, Eisai, Amgen, Gilead, Novartis, Lilly and Astra Zeneca; and conference travel and support from Novartis, Astra Zeneca and Lilly. The remaining authors have no conflicts of interest to declare., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2024
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