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
Hiroji Iwata,
Kerry Avery,
Shelley Potter,
Katherine Cowan,
Andrew Spillane,
Stuart McIntosh,
David Dodwell,
Alastair M Thompson,
Rosina Ahmed,
Mairead MacKenzie,
Jana de Boniface,
Peter Dubsky,
Gustavo Werutsky,
Sanjoy Chatterjee,
Michael Jiang,
Han-Byoel Lee,
Fiorita Poulakaki,
Andrea L Richardson,
Karla Sepulveda,
Jean L Wright,
Nicholas Zdenkowski
Affiliations
Hiroji Iwata
11 Aichi Cancer Center, Nagoya, Japan
Kerry Avery
National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
Shelley Potter
National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
Katherine Cowan
4James Lind Alliance, Southampton, United Kingdom
Andrew Spillane
19 University of Sydney, Sydney, New South Wales, Australia
Stuart McIntosh
25 Patrick G Johnston Centre for Cancer Research, Queen`s University Belfast, Belfast, UK
David Dodwell
8 University of Oxford, Oxford, UK
Alastair M Thompson
20 Department of Surgical Oncology, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, Texas, USA
Rosina Ahmed
5 Tata Medical Center, Kolkata, West Bengal, India
Mairead MacKenzie
14 Independent Cancer Patients` Voice, London, UK
Jana de Boniface
6 Breast Unit, Capio St. Göran’s Hospital, Stockholm, Sweden
Peter Dubsky
9 Hirslanden Klinik St Anna, Lucerne, Switzerland
Gustavo Werutsky
21 Latin American Cooperative Oncology Group, Porto Alegre, Brazil
Sanjoy Chatterjee
5 Tata Medical Center, Kolkata, West Bengal, India
Michael Jiang
1 Bristol Surgical and Perioperative Care Complex Intervention Collaboration, Bristol Medical School, University of Bristol, Bristol, UK
Han-Byoel Lee
12 Breast Care Centre, Dept. of Surgery, Seoul National University Hospital, Seoul, South Korea
Fiorita Poulakaki
15 Breast Surgery Department, Athens Medical Centre, Athens, Greece
Andrea L Richardson
17 Johns Hopkins University, Baltimore, Maryland, USA
Karla Sepulveda
18 Baylor College of Medicine, Houston, Texas, USA
Jean L Wright
22 Johns Hopkins Medicine, Baltimore, Maryland, USA
Nicholas Zdenkowski
23 The University of Newcastle, Newcastle, New South Wales, Australia
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).
