Moving Forward Fast with FAST-Forward

نویسندگان

چکیده

Hypofractionated radiotherapy for the adjuvant treatment of breast cancer has been standard practice in UK since 2009. Ten-year follow-up data from START-B have confirmed efficacy 40 Gy 15 fractions, with reduced toxicity when compared previous 50 25 fractions [[1]Haviland J.S. Owen J.R. Dewar J.A. Agrawal R.K. Barrett J. Barrett-Lee P.J. et al.The Standardisation Breast Radiotherapy (START) trials hypofractionation early cancer: 10-year results two randomised controlled trials.Lancet Oncol. 2013; 14: 1086-1094Abstract Full Text PDF PubMed Scopus (780) Google Scholar]. The FAST-Forward trial began recruiting 2011 to identify a five-fraction regimen that was non-inferior 15-fraction prevention ipsilateral relapse and as safe adverse effects. During design, protocol development group, including clinicians expert patients, defined non-inferiority margin 1.6% increase primary end point 5-year (whether local or new tumour), assuming incidence 2% control group. In total, 4096 patients were recruited 47 centres referring hospitals across UK. They randomly allocated on 1:1:1 basis 27 26 five daily fractions. median 71.5 months. published online Lancet 28 April 2020 [[2]Brunt A.M. Haviland Wheatley D.A. Sydenham M.A. Alhasso A. Bloomfield D.J. al.Hypofractionated 1 week versus 3 weeks (FAST-Forward): late normal tissue effects multicentre, non-inferiority, randomised, phase trial.Lancet. 2020; 395: 1613-1626Abstract (205) It reported specified criteria had met investigational groups. Key secondary points included clinician-, patient- photograph-assessed treated breast. showed risk experiencing these higher those group (when group), but there no increased study authors concluded over tumour control, terms up 5 years. publication findings came at critical time. Following declaration coronavirus pandemic March 2020, National Health Service quickly define mitigation strategies undergoing hospital treatment, context national lockdown measures reduce virus transmission clinical services facing staff shortages due illness isolation. Just days after announced its first lockdown, Institute Care Excellence (NICE) rapid guideline during COVID-19 [[3]NICE Guidance guideline: delivery radiotherapy.https://www.nice.org.uk/guidance/ng162Date accessed: 8, 2021Google Scholar], designed guide match capacity patient needs event limited by pandemic. same week, Royal College Radiologists (RCR) an repository advisory documents recommending having [[4]Royal Coronavirus (COVID-19): documents.https://www.rcr.ac.uk/college/coronavirus-covid-19-what-rcr-doing/clinical-information/coronavirus-covid-19-cancerDate document cited recommended use cancer. Across country, this rapidly adopted, facilitated large part majority participated necessary quality assurance place hypofractionated regimen. This adoption significantly attendances departments. Data Dataset (RTDS) show 60.6% courses used just 0.2% 2019 [[5]Spencer K. Jones C.M. Girdler R. Roe C. Sharpe M. Lawton S. impact England, UK: population-based study.Lancet 2021; 22: 309-320Abstract (34) Consensus statements are developed experts topic which ‘consensus is sought using explicit methodology areas agreement disagreement’ [[6]Rosenfield R.M. Nnacheta L.C. Corrigan M.D. Clinical consensus statement manual.Otolaryngol Head Neck Surg. 2015; 153: S1-S14Crossref (39) not be confused guidelines. guidelines usually based formal systematic review high-level evidence, whereas most appropriate topics where evidence lacking therefore approach offers best way address variability improve outcomes. RCR established rolling programme produce different sites, aim reducing practice. A key component process meeting representatives each centre vote pre-drafted opportunity discuss working Adjuvant covered 2016. Recommendations cardiac sparing, boost radiotherapy, omission internal mammary chain partial [[7]Royal Postoperative statements.2016https://www.rcr.ac.uk/publication/postoperative-radiotherapy-breast-cancer-uk-consensus-statementsDate 2016 reviewed changes made. widespread prompted Professional Support Standards Board commission update statements. June multidisciplinary drawn party, asked develop focussing hypofractionation. appraisal other research literature, seven drafted refined 6-week period. leads all identified invited share draft their teams provide feedback. also complete survey past, current future Feedback received incorporated into subsequent statements, formed October 2020. Prior meeting, detailed presentation recorded made available via open access website. virtual run parts. session webinar members team. presentations question answer Professor Murray Brunt (FAST-Forward chief investigator), Charlotte Coles (RCR Working Group Chair) Dr Imogen Locke (NHS England Reference pre-meeting regarding centres' implementation results. second one nominated lead per final Fifty-five 62 represented. discussions around then discussions, representative behalf centre. One allowed centre, voting app. system ‘strength agreement’ categorisation assigned (see Table 1). finalised January 2021, will https://www.rcr.ac.uk/publication/postoperative-radiotherapy-breast-cancer-hypofractionation-rcr-consensus-statements 13th May. agreed can found 2, together category indicating strength support group.Table 1Strength statementsUnanimous support100%Very strongly supported90–99%Strongly supported70–89%Majority support60–69%Equipoise50–59%Rejected<50% Open table tab 2Royal Radiologists' 2021Offer Gy/5 whole radiotherapyVery supportedOffer chest wall supportedConsider reconstructionStrongly 28.5 instead fraction significant comorbidity and/or frailty make difficultVery nodal (excluding chain) only comorbidities while awaiting 2-year substudyStrongly supportedFor requiring boost, offer:26 plus either sequential normofractionated (delivered more than fractions) simultaneous integrated e.g. 48 volume rest weeksStrongly supported 2021 intended read conjunction existing document, does cover aspects radiotherapy. Nodal publication, substudy main study. expected 2021. Therefore, remains care should considered except comorbidity, who would still probably benefit If used, potential risks, benefits uncertainties discussed documented. consensus. permissive fractionation adopted given lack area. revisited following IMPORT High report need reflect Using incorporating collective opinion analysis evaluation input providers agreed. These supplement offer outcomes experience.

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ژورنال

عنوان ژورنال: Clinical Oncology

سال: 2021

ISSN: ['0936-6555', '1433-2981']

DOI: https://doi.org/10.1016/j.clon.2021.04.007