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dc.contributor.authorClive, AO
dc.contributor.authorTaylor, H
dc.contributor.authorDobson, L
dc.contributor.authorWilson, P
dc.contributor.authorde Winton, E
dc.contributor.authorPanakis, N
dc.contributor.authorPepperell, J
dc.contributor.authorHowell, T
dc.contributor.authorStewart, SA
dc.contributor.authorPenz, E
dc.contributor.authorJordan, N
dc.contributor.authorMorley, AJ
dc.contributor.authorZahan-Evans, N
dc.contributor.authorSmith, S
dc.contributor.authorBatchelor, TJP
dc.contributor.authorMarchbank, A
dc.contributor.authorBishop, L
dc.contributor.authorIonescu, AA
dc.contributor.authorBayne, M
dc.contributor.authorCooper, S
dc.contributor.authorKerry, A
dc.contributor.authorJenkins, P
dc.contributor.authorToy, E
dc.contributor.authorVigneswaran, V
dc.contributor.authorGildersleve, J
dc.contributor.authorAhmed, M
dc.contributor.authorMcDonald, F
dc.contributor.authorButton, M
dc.contributor.authorLewanski, C
dc.contributor.authorComins, C
dc.contributor.authorDakshinamoorthy, M
dc.contributor.authorLee, YCG
dc.contributor.authorRahman, NM
dc.contributor.authorMaskell, NA
dc.date.accessioned2016-09-20T13:24:57Z
dc.date.issued2016-08
dc.identifier.citationThe Lancet. Oncology, 2016, 17 (8), pp. 1094 - 1104
dc.identifier.issn1470-2045
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/115
dc.identifier.eissn1474-5488
dc.identifier.doi10.1016/s1470-2045(16)30095-x
dc.description.abstractBackground The use of prophylactic radiotherapy to prevent procedure-tract metastases (PTMs) in malignant pleural mesothelioma remains controversial, and clinical practice varies worldwide. We aimed to compare prophylactic radiotherapy with deferred radiotherapy (given only when a PTM developed) in a suitably powered trial.Methods We did a multicentre, open-label, phase 3, randomised controlled trial in 22 UK hospitals of patients with histocytologically proven mesothelioma who had undergone large-bore pleural interventions in the 35 days prior to recruitment. Eligible patients were randomised (1:1), using a computer-generated sequence, to receive immediate radiotherapy (21 Gy in three fractions within 42 days of the pleural intervention) or deferred radiotherapy (same dose given within 35 days of PTM diagnosis). Randomisation was minimised by histological subtype, surgical versus non-surgical procedure, and pleural procedure (indwelling pleural catheter vs other). The primary outcome was the incidence of PTM within 7 cm of the site of pleural intervention within 12 months from randomisation, assessed in the intention-to-treat population. This trial is registered with ISRCTN, number ISRCTN72767336.Findings Between Dec 23, 2011, and Aug 4, 2014, we randomised 203 patients to receive immediate radiotherapy (n=102) or deferred radiotherapy (n=101). The patients were well matched at baseline. No significant difference was seen in PTM incidence in the immediate and deferred radiotherapy groups (nine [9%] vs 16 [16%]; odds ratio 0·51 [95% CI 0·19-1·32]; p=0·14). The only serious adverse event related to a PTM or radiotherapy was development of a painful PTM within the radiotherapy field that required hospital admission for symptom control in one patient who received immediate radiotherapy. Common adverse events of immediate radiotherapy were skin toxicity (grade 1 in 50 [54%] and grade 2 in four [4%] of 92 patients vs grade 1 in three [60%] and grade 2 in two [40%] of five patients in the deferred radiotherapy group who received radiotherapy for a PTM) and tiredness or lethargy (36 [39%] in the immediate radiotherapy group vs two [40%] in the deferred radiotherapy group) within 3 months of receiving radiotherapy.Interpretation Routine use of prophylactic radiotherapy in all patients with mesothelioma after large-bore thoracic interventions is not justified.Funding Research for Patient Benefit Programme from the UK National Institute for Health Research.
dc.formatPrint-Electronic
dc.format.extent1094 - 1104
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectHumans
dc.subjectMesothelioma
dc.subjectLung Neoplasms
dc.subjectPleural Neoplasms
dc.subjectNeoplasms, Second Primary
dc.subjectPain
dc.subjectPostoperative Complications
dc.subjectNeoplasm Staging
dc.subjectPrognosis
dc.subjectRadiotherapy, Adjuvant
dc.subjectSurvival Rate
dc.subjectFollow-Up Studies
dc.subjectResearch Design
dc.subjectQuality of Life
dc.subjectAged
dc.subjectFemale
dc.subjectMale
dc.subjectMesothelioma, Malignant
dc.titleProphylactic radiotherapy for the prevention of procedure-tract metastases after surgical and large-bore pleural procedures in malignant pleural mesothelioma (SMART): a multicentre, open-label, phase 3, randomised controlled trial.
dc.typeJournal Article
dcterms.dateAccepted2016-04-15
rioxxterms.funderThe Institute of Cancer Research
rioxxterms.identifier.projectUnspecified
rioxxterms.versionofrecord10.1016/s1470-2045(16)30095-x
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2016-08
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfThe Lancet. Oncology
pubs.issue8
pubs.notesNo embargo
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/Lung Radiotherapy
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/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Lung Radiotherapy
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume17
pubs.embargo.termsNo embargo
icr.researchteamLung Radiotherapyen_US
dc.contributor.icrauthorAhmed, Merinaen


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