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dc.contributor.authorMurray Brunt, A
dc.contributor.authorHaviland, JS
dc.contributor.authorWheatley, DA
dc.contributor.authorSydenham, MA
dc.contributor.authorAlhasso, A
dc.contributor.authorBloomfield, DJ
dc.contributor.authorChan, C
dc.contributor.authorChurn, M
dc.contributor.authorCleator, S
dc.contributor.authorColes, CE
dc.contributor.authorGoodman, A
dc.contributor.authorHarnett, A
dc.contributor.authorHopwood, P
dc.contributor.authorKirby, AM
dc.contributor.authorKirwan, CC
dc.contributor.authorMorris, C
dc.contributor.authorNabi, Z
dc.contributor.authorSawyer, E
dc.contributor.authorSomaiah, N
dc.contributor.authorStones, L
dc.contributor.authorSyndikus, I
dc.contributor.authorBliss, JM
dc.contributor.authorYarnold, JR
dc.contributor.authorFAST-Forward Trial Management Group
dc.date.accessioned2020-04-15T11:39:30Z
dc.date.accessioned2020-07-09T12:16:26Z
dc.date.issued2020-05
dc.identifier.citationLancet (London, England), 2020, 395 (10237), pp. 1613 - 1626
dc.identifier.issn0140-6736
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3842
dc.identifier.eissn1474-547X
dc.identifier.doi10.1016/s0140-6736(20)30932-6
dc.description.abstractBackground 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, p<0·0001) for 27 Gy in five fractions and 1·12 (0·94 to 1·34, p=0·20) for 26 Gy in five fractions. Patient and photographic assessments showed higher normal tissue effect risk for 27 Gy versus 40 Gy but not for 26 Gy versus 40 Gy.Interpretation 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.
dc.formatPrint-Electronic
dc.format.extent1613 - 1626
dc.languageeng
dc.language.isoeng
dc.relation.replaceshttps://repository.icr.ac.uk/handle/internal/3593
dc.relation.replacesinternal/3593
dc.relation.replacesinternal/3833
dc.relation.replaceshttps://repository.icr.ac.uk/handle/internal/3833
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectFAST-Forward Trial Management Group
dc.subjectHumans
dc.subjectBreast Neoplasms
dc.subjectNeoplasm Metastasis
dc.subjectNeoplasm Recurrence, Local
dc.subjectRadiation Injuries
dc.subjectNeoplasm Staging
dc.subjectTreatment Outcome
dc.subjectRadiotherapy, Adjuvant
dc.subjectMastectomy
dc.subjectRisk Assessment
dc.subjectFollow-Up Studies
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectKaplan-Meier Estimate
dc.subjectNeoplasm Grading
dc.subjectUnited Kingdom
dc.subjectRadiation Dose Hypofractionation
dc.titleHypofractionated 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.
dc.typeJournal Article
dcterms.dateAccepted2020-04-09
rioxxterms.versionofrecord10.1016/s0140-6736(20)30932-6
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2020-05
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfLancet (London, England)
pubs.issue10237
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy/Breast Cancer Radiotherapy (hon.)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Translational Breast Radiobiology
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Breast Cancer Radiotherapy/Breast Cancer Radiotherapy (hon.)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Translational Breast Radiobiology
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume395
pubs.embargo.termsNot known
icr.researchteamClinical Trials & Statistics Uniten_US
icr.researchteamBreast Cancer Radiotherapyen_US
icr.researchteamTranslational Breast Radiobiologyen_US
dc.contributor.icrauthorSydenham, Marken
dc.contributor.icrauthorHaviland, Joanneen
dc.contributor.icrauthorKirby, Annaen
dc.contributor.icrauthorSomaiah, Navitaen
dc.contributor.icrauthorBliss, Judithen
dc.contributor.icrauthorYarnold, Johnen


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