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dc.contributor.authorFaivre-Finn, Cen_US
dc.contributor.authorSnee, Men_US
dc.contributor.authorAshcroft, Len_US
dc.contributor.authorAppel, Wen_US
dc.contributor.authorBarlesi, Fen_US
dc.contributor.authorBhatnagar, Aen_US
dc.contributor.authorBezjak, Aen_US
dc.contributor.authorCardenal, Fen_US
dc.contributor.authorFournel, Pen_US
dc.contributor.authorHarden, Sen_US
dc.contributor.authorLe Pechoux, Cen_US
dc.contributor.authorMcMenemin, Ren_US
dc.contributor.authorMohammed, Nen_US
dc.contributor.authorO'Brien, Men_US
dc.contributor.authorPantarotto, Jen_US
dc.contributor.authorSurmont, Ven_US
dc.contributor.authorVan Meerbeeck, JPen_US
dc.contributor.authorWoll, PJen_US
dc.contributor.authorLorigan, Pen_US
dc.contributor.authorBlackhall, Fen_US
dc.contributor.authorCONVERT Study Teamen_US
dc.coverage.spatialEnglanden_US
dc.date.accessioned2018-02-16T10:16:00Z
dc.date.issued2017-08en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/28642008en_US
dc.identifierS1470-2045(17)30318-2en_US
dc.identifier.citationLancet Oncol, 2017, 18 (8), pp. 1116 - 1125en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1177
dc.identifier.eissn1474-5488en_US
dc.identifier.doi10.1016/S1470-2045(17)30318-2en_US
dc.description.abstractBACKGROUND: Concurrent chemoradiotherapy is the standard of care in limited-stage small-cell lung cancer, but the optimal radiotherapy schedule and dose remains controversial. The aim of this study was to establish a standard chemoradiotherapy treatment regimen in limited-stage small-cell lung cancer. METHODS: The CONVERT trial was an open-label, phase 3, randomised superiority trial. We enrolled adult patients (aged ≥18 years) who had cytologically or histologically confirmed limited-stage small-cell lung cancer, Eastern Cooperative Oncology Group performance status of 0-2, and adequate pulmonary function. Patients were recruited from 73 centres in eight countries. Patients were randomly assigned to receive either 45 Gy radiotherapy in 30 twice-daily fractions of 1·5 Gy over 19 days, or 66 Gy in 33 once-daily fractions of 2 Gy over 45 days, starting on day 22 after commencing cisplatin-etoposide chemotherapy (given as four to six cycles every 3 weeks in both groups). The allocation method used was minimisation with a random element, stratified by institution, planned number of chemotherapy cycles, and performance status. Treatment group assignments were not masked. The primary endpoint was overall survival, defined as time from randomisation until death from any cause, analysed by modified intention-to-treat. A 12% higher overall survival at 2 years in the once-daily group versus the twice-daily group was considered to be clinically significant to show superiority of the once-daily regimen. The study is registered with ClinicalTrials.gov (NCT00433563) and is currently in follow-up. FINDINGS: Between April 7, 2008, and Nov 29, 2013, 547 patients were enrolled and randomly assigned to receive twice-daily concurrent chemoradiotherapy (274 patients) or once-daily concurrent chemoradiotherapy (273 patients). Four patients (one in the twice-daily group and three in the once-daily group) did not return their case report forms and were lost to follow-up; these patients were not included in our analyses. At a median follow-up of 45 months (IQR 35-58), median overall survival was 30 months (95% CI 24-34) in the twice-daily group versus 25 months (21-31) in the once-daily group (hazard ratio for death in the once daily group 1·18 [95% CI 0·95-1·45]; p=0·14). 2-year overall survival was 56% (95% CI 50-62) in the twice-daily group and 51% (45-57) in the once-daily group (absolute difference between the treatment groups 5·3% [95% CI -3·2% to 13·7%]). The most common grade 3-4 adverse event in patients evaluated for chemotherapy toxicity was neutropenia (197 [74%] of 266 patients in the twice-daily group vs 170 [65%] of 263 in the once-daily group). Most toxicities were similar between the groups, except there was significantly more grade 4 neutropenia with twice-daily radiotherapy (129 [49%] vs 101 [38%]; p=0·05). In patients assessed for radiotherapy toxicity, was no difference in grade 3-4 oesophagitis between the groups (47 [19%] of 254 patients in the twice-daily group vs 47 [19%] of 246 in the once-daily group; p=0·85) and grade 3-4 radiation pneumonitis (4 [3%] of 254 vs 4 [2%] of 246; p=0·70). 11 patients died from treatment-related causes (three in the twice-daily group and eight in the once-daily group). INTERPRETATION: Survival outcomes did not differ between twice-daily and once-daily concurrent chemoradiotherapy in patients with limited-stage small-cell lung cancer, and toxicity was similar and lower than expected with both regimens. Since the trial was designed to show superiority of once-daily radiotherapy and was not powered to show equivalence, the implication is that twice-daily radiotherapy should continue to be considered the standard of care in this setting. FUNDING: Cancer Research UK (Clinical Trials Awards and Advisory Committee), French Ministry of Health, Canadian Cancer Society Research Institute, European Organisation for Research and Treatment of Cancer (Cancer Research Fund, Lung Cancer, and Radiation Oncology Groups).en_US
dc.format.extent1116 - 1125en_US
dc.languageengen_US
dc.language.isoengen_US
dc.subjectAdulten_US
dc.subjectAgeden_US
dc.subjectAged, 80 and overen_US
dc.subjectAntineoplastic Combined Chemotherapy Protocolsen_US
dc.subjectChemoradiotherapyen_US
dc.subjectCisplatinen_US
dc.subjectDose Fractionation, Radiationen_US
dc.subjectEsophagitisen_US
dc.subjectEtoposideen_US
dc.subjectFemaleen_US
dc.subjectFollow-Up Studiesen_US
dc.subjectHumansen_US
dc.subjectIntention to Treat Analysisen_US
dc.subjectLung Neoplasmsen_US
dc.subjectMaleen_US
dc.subjectMiddle Ageden_US
dc.subjectNeoplasm Stagingen_US
dc.subjectNeutropeniaen_US
dc.subjectRadiation Pneumonitisen_US
dc.subjectSmall Cell Lung Carcinomaen_US
dc.subjectSurvival Rateen_US
dc.titleConcurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial.en_US
dc.typeJournal Article
dcterms.dateAccepted2017-04-25en_US
rioxxterms.versionofrecord10.1016/S1470-2045(17)30318-2en_US
rioxxterms.licenseref.startdate2017-08en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfLancet Oncolen_US
pubs.issue8en_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/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Treatment of thoracic tumours
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Treatment of thoracic tumours/Treatment of thoracic tumours (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume18en_US
pubs.embargo.termsNot knownen_US
icr.researchteamTreatment of thoracic tumoursen_US
dc.contributor.icrauthorO'Brien, Maryen_US
dc.contributor.icrauthorMarsden,en_US


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