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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
- Source :
- Lancet (London, England), FAST-Forward Trial Management Group 2020, ' 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 ', Lancet (London, England), vol. 395, no. 10237, pp. 1613-1626 . https://doi.org/10.1016/S0140-6736(20)30932-6
- Publication Year :
- 2020
- Publisher :
- Elsevier BV, 2020.
-
Abstract
- 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 26 Gy schedule. At a median follow-up of 71·5 months (IQR 71·3 to 71·7), the primary endpoint event occurred in 79 patients (31 in the 40 Gy group, 27 in the 27 Gy group, and 21 in the 26 Gy group); HRs versus 40 Gy in 15 fractions were 0·86 (95% CI 0·51 to 1·44) for 27 Gy in five fractions and 0·67 (0·38 to 1·16) for 26 Gy in five fractions. 5-year incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions). At 5 years, any moderate or marked clinician-assessed normal tissue effects in the breast or chest wall was reported for 98 of 986 (9·9%) 40 Gy patients, 155 (15·4%) of 1005 27 Gy patients, and 121 of 1020 (11·9%) 26 Gy patients. Across all clinician assessments from 1-5 years, odds ratios versus 40 Gy in 15 fractions were 1·55 (95% CI 1·32 to 1·83, pINTERPRETATION: 26 Gy in five fractions over 1 week is non-inferior to the standard of 40 Gy in 15 fractions over 3 weeks for local tumour control, and is as safe in terms of normal tissue effects up to 5 years for patients prescribed adjuvant local radiotherapy after primary surgery for early-stage breast cancer.FUNDING: National Institute for Health Research Health Technology Assessment Programme.
- Subjects :
- medicine.medical_treatment
Kaplan-Meier Estimate
030204 cardiovascular system & hematology
law.invention
0302 clinical medicine
Randomized controlled trial
law
Radiotherapy, Adjuvant/adverse effects
Clinical endpoint
030212 general & internal medicine
Neoplasm Metastasis
Mastectomy
Neoplasm Recurrence, Local/epidemiology
Aged, 80 and over
Manchester Cancer Research Centre
United Kingdom/epidemiology
Hazard ratio
General Medicine
Middle Aged
Treatment Outcome
Female
Radiation Dose Hypofractionation
Adult
Breast Neoplasms/mortality
Breast Neoplasms
Risk Assessment
Article
03 medical and health sciences
Breast cancer
medicine
Humans
Risk Assessment/methods
Radiation Injuries
Aged
Neoplasm Staging
business.industry
ResearchInstitutes_Networks_Beacons/mcrc
medicine.disease
R1
United Kingdom
Mastectomy/methods
Radiation therapy
Clinical trial
Regimen
Radiation Injuries/epidemiology
Radiotherapy, Adjuvant
Neoplasm Grading
Neoplasm Recurrence, Local
business
Nuclear medicine
RA
Follow-Up Studies
Subjects
Details
- ISSN :
- 01406736
- Database :
- OpenAIRE
- Journal :
- Lancet (London, England), FAST-Forward Trial Management Group 2020, ' 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 ', Lancet (London, England), vol. 395, no. 10237, pp. 1613-1626 . https://doi.org/10.1016/S0140-6736(20)30932-6
- Accession number :
- edsair.doi.dedup.....53e395035946033bfb3c8db03e2d044a
- Full Text :
- https://doi.org/10.17863/cam.52844