Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial

作者：A. Murray Brunt, J. Haviland, Duncan A Wheatley, M. Sydenham, A. Alhasso, D. Bloomfield, C. Chan, Mark J. Churn, S. Cleator, Charlotte E Coles, A. Goodman, A. Harnett, Penelope Hopwood, Anna M Kirby, C. Kirwan, C. Morris, Z. Nabi, Elinor J. Sawyer, N. Somaiah, L. Stones, I. Syndikus, Judith M. Bliss, John R. Yarnold, Abdulla Anne Judith David Jo Murray Charlie Hannah Mark Su Alhasso Armstrong Bliss Bloomfield Bowen Brunt Cha, A. Alhasso, A. Armstrong, Judith M. Bliss, D. Bloomfield, J. Bowen, M. Brunt, C. Chan, H. Chantler, Mark J. Churn, S. Cleator, Charlotte E. Coles, E. Donovan, Andy Goodman, S. Griffin, J. Haviland, Penelope Hopwood, Anna M Kirby, J. Kirk, C. Kirwan, M. Maclennan, C. Morris, Z. Nabi, Elinor Sawyer, M. Sculphur, J. Sinclair, N. Somaiah, L. Stones, Mark Sydenham, Isabel Syndikus, Jean Tremlett, K. Venables, Duncan A Wheatley, John R. Yarnold · 发表于：The Lancet · 年份：2020 · DOI：10.1016/s0140-6736(20)30932-6 · 被引用次数：851 · 研究领域：Medicine

Background We aimed to identify a five-fraction schedule of adjuvant radiotherapy (radiation therapy) delivered in 1 week that is non-inferior in terms of local cancer control and is as safe as an international standard 15-fraction regimen after primary surgery for early breast cancer. Here, we present 5-year results of the FAST-Forward trial. Methods FAST-Forward is a multicentre, phase 3, randomised, non-inferiority trial done at 97 hospitals (47 radiotherapy centres and 50 referring hospitals) in the UK. Patients aged at least 18 years with invasive carcinoma of the breast (pT1–3, pN0–1, M0) after breast conservation surgery or mastectomy were eligible. We randomly allocated patients to either 40 Gy in 15 fractions (over 3 weeks), 27 Gy in five fractions (over 1 week), or 26 Gy in five fractions (over 1 week) to the whole breast or chest wall. Allocation was not masked because of the nature of the intervention. The primary endpoint was ipsilateral breast tumour relapse; assuming a 2% 5-year incidence for 40 Gy, non-inferiority was predefined as ≤1·6% excess for five-fraction schedules (critical hazard ratio [HR] of 1·81). Normal tissue effects were assessed by clinicians, patients, and from photographs. This trial is registered at isrctn.com, ISRCTN19906132. Findings Between Nov 24, 2011, and June 19, 2014, we recruited and obtained consent from 4096 patients from 97 UK centres, of whom 1361 were assigned to the 40 Gy schedule, 1367 to the 27 Gy schedule, and 1368 to the 2...