Shaun Treweek1, Ruth Dryden2, Colin McCowan3, Alison Harrow4, Alastair M Thompson5. 1. Health Services Research Unit, University of Aberdeen, AB25 2ZD, UK. Electronic address: streweek@mac.com. 2. Institute for Research and Innovation in Social Services, Glasgow G1 1UZ, UK. Electronic address: ruth.dryden@iriss.org.uk. 3. Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, G12 8QQ, UK. Electronic address: Colin.McCowan@glasgow.ac.uk. 4. Dundee Cancer Centre, University of Dundee, Dundee DD1 9SY, UK. Electronic address: A.Harrow@dundee.ac.uk. 5. Department of Surgical Oncology, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston Texas 77030, USA. Electronic address: AThompson1@mdanderson.org.
Abstract
AIM: To describe the proportion of women in Tayside, Scotland diagnosed with early breast cancer who would have been eligible for influential adjuvant breast cancer trials. METHODS: Phase III trials of adjuvant treatment for breast cancer referenced in five national guidelines were shortlisted by breast cancer specialists to identify the twelve considered most influential. Eligibility criteria were extracted from protocols and applied to a 16-year cohort of women who had received a diagnosis of breast cancer and the proportion meeting trial criteria calculated. The criteria used clinically in Tayside to make decisions about use of the trial treatments were also applied to the cohort. Finally, the proportion of women receiving adjuvant endocrine therapy as part of their care and who would have been eligible for the trial evaluating that therapy was calculated. RESULTS: Of the cohort's 4811 women, 3535 (73%) were eligible for at least one trial but eligibility for an individual trial rarely exceeded 45%. There were substantial differences between the proportion of women meeting trial eligibility criteria and the proportion considered clinically eligible for the same treatment. The proportion of women receiving an endocrine therapy as part of their care who would also have been eligible for the trial evaluating that treatment ranged from 17% to 56%. CONCLUSION: Clinical eligibility criteria may be at variance with trial criteria. For adjuvant endocrine therapy, a substantial proportion of women who would have been ineligible for a trial nevertheless received the trial treatment as part of their care.
AIM: To describe the proportion of women in Tayside, Scotland diagnosed with early breast cancer who would have been eligible for influential adjuvant breast cancer trials. METHODS: Phase III trials of adjuvant treatment for breast cancer referenced in five national guidelines were shortlisted by breast cancer specialists to identify the twelve considered most influential. Eligibility criteria were extracted from protocols and applied to a 16-year cohort of women who had received a diagnosis of breast cancer and the proportion meeting trial criteria calculated. The criteria used clinically in Tayside to make decisions about use of the trial treatments were also applied to the cohort. Finally, the proportion of women receiving adjuvant endocrine therapy as part of their care and who would have been eligible for the trial evaluating that therapy was calculated. RESULTS: Of the cohort's 4811 women, 3535 (73%) were eligible for at least one trial but eligibility for an individual trial rarely exceeded 45%. There were substantial differences between the proportion of women meeting trial eligibility criteria and the proportion considered clinically eligible for the same treatment. The proportion of women receiving an endocrine therapy as part of their care who would also have been eligible for the trial evaluating that treatment ranged from 17% to 56%. CONCLUSION: Clinical eligibility criteria may be at variance with trial criteria. For adjuvant endocrine therapy, a substantial proportion of women who would have been ineligible for a trial nevertheless received the trial treatment as part of their care.
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Authors: Miles D Witham; Eleanor Anderson; Camille Carroll; Paul M Dark; Kim Down; Alistair S Hall; Joanna Knee; Rebecca H Maier; Gail A Mountain; Gary Nestor; Laurie Oliva; Sarah R Prowse; Amanda Tortice; James Wason; Lynn Rochester Journal: Trials Date: 2020-08-01 Impact factor: 2.279