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dc.contributor.authorThiruchelvam, PTR
dc.contributor.authorLeff, DR
dc.contributor.authorGodden, AR
dc.contributor.authorCleator, S
dc.contributor.authorWood, SH
dc.contributor.authorKirby, AM
dc.contributor.authorJallali, N
dc.contributor.authorSomaiah, N
dc.contributor.authorHunter, JE
dc.contributor.authorHenry, FP
dc.contributor.authorMicha, A
dc.contributor.authorO'Connell, RL
dc.contributor.authorMohammed, K
dc.contributor.authorPatani, N
dc.contributor.authorTan, MLH
dc.contributor.authorGujral, D
dc.contributor.authorRoss, G
dc.contributor.authorJames, SE
dc.contributor.authorKhan, AA
dc.contributor.authorRusby, JE
dc.contributor.authorHadjiminas, DJ
dc.contributor.authorMacNeill, FA
dc.contributor.authorPRADA Trial Management Group
dc.date.accessioned2022-04-19T11:30:20Z
dc.date.available2022-04-19T11:30:20Z
dc.date.issued2022-04-07
dc.identifier.citationThe Lancet. Oncology, 2022en
dc.identifier.issn1470-2045
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5088
dc.identifier.eissn1474-5488en_US
dc.identifier.eissn1474-5488
dc.identifier.doi10.1016/s1470-2045(22)00145-0en_US
dc.identifier.doi10.1016/s1470-2045(22)00145-0
dc.description.abstract<h4>Background</h4>Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. However, evidence for this treatment sequence is sparse. We aimed to explore the feasibility of preoperative radiotherapy followed by skin-sparing mastectomy and deep inferior epigastric perforator (DIEP) flap reconstruction in patients with breast cancer requiring mastectomy.<h4>Methods</h4>We conducted a prospective, non-randomised, feasibility study at two National Health Service trusts in the UK. Eligible patients were women aged older than 18 years with a laboratory diagnosis of primary breast cancer requiring mastectomy and post-mastectomy radiotherapy, who were suitable for DIEP flap reconstruction. Preoperative radiotherapy started 3-4 weeks after neoadjuvant chemotherapy and was delivered to the breast, plus regional nodes as required, at 40 Gy in 15 fractions (over 3 weeks) or 42·72 Gy in 16 fractions (over 3·2 weeks). Adverse skin radiation toxicity was assessed preoperatively using the Radiation Therapy Oncology Group toxicity grading system. Skin-sparing mastectomy and DIEP flap reconstruction were planned for 2-6 weeks after completion of preoperative radiotherapy. The primary endpoint was the proportion of open breast wounds greater than 1 cm width requiring a dressing at 4 weeks after surgery, assessed in all participants. This study is registered with ClinicalTrials.gov, NCT02771938, and is closed to recruitment.<h4>Findings</h4>Between Jan 25, 2016, and Dec 11, 2017, 33 patients were enrolled. At 4 weeks after surgery, four (12·1%, 95% CI 3·4-28·2) of 33 patients had an open breast wound greater than 1 cm. One (3%) patient had confluent moist desquamation (grade 3). There were no serious treatment-related adverse events and no treatment-related deaths.<h4>Interpretation</h4>Preoperative radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe, with rates of breast open wounds similar to those reported with post-mastectomy radiotherapy. A randomised trial comparing preoperative radiotherapy with post-mastectomy radiotherapy is required to precisely determine and compare surgical, oncological, and breast reconstruction outcomes, including quality of life.<h4>Funding</h4>Cancer Research UK, National Institute for Health Research.en_US
dc.formatPrint-Electronicen_US
dc.languageengen_US
dc.language.isoengen
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en
dc.subjectPRADA Trial Management Groupen_US
dc.titlePrimary radiotherapy and deep inferior epigastric perforator flap reconstruction for patients with breast cancer (PRADA): a multicentre, prospective, non-randomised, feasibility study.en
dc.typeJournal Article
dcterms.dateAccepted2022-02-28
rioxxterms.versionVoRen
rioxxterms.versionofrecord10.1016/s1470-2045(22)00145-0en
rioxxterms.licenseref.startdate2022-04-07
dc.relation.isPartOfThe Lancet. Oncologyen_US
pubs.notesNot knownen_US
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/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Translational Breast Radiobiology
pubs.publication-statusPublisheden_US
pubs.embargo.termsNot knownen_US
icr.researchteamTranslational Breast Radiobiology
dc.contributor.icrauthorSomaiah, Navitaen_US


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