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dc.contributor.authorAlderson, Den_US
dc.contributor.authorCunningham, Den_US
dc.contributor.authorNankivell, Men_US
dc.contributor.authorBlazeby, JMen_US
dc.contributor.authorGriffin, SMen_US
dc.contributor.authorCrellin, Aen_US
dc.contributor.authorGrabsch, HIen_US
dc.contributor.authorLanger, Ren_US
dc.contributor.authorPritchard, Sen_US
dc.contributor.authorOkines, Aen_US
dc.contributor.authorKrysztopik, Ren_US
dc.contributor.authorCoxon, Fen_US
dc.contributor.authorThompson, Jen_US
dc.contributor.authorFalk, Sen_US
dc.contributor.authorRobb, Cen_US
dc.contributor.authorStenning, Sen_US
dc.contributor.authorLangley, REen_US
dc.identifier.citationThe Lancet. Oncology, 2017, 18 (9), pp. 1249 - 1260en_US
dc.description.abstract<h4>Background</h4>Neoadjuvant chemotherapy before surgery improves survival compared with surgery alone for patients with oesophageal cancer. The OE05 trial assessed whether increasing the duration and intensity of neoadjuvant chemotherapy further improved survival compared with the current standard regimen.<h4>Methods</h4>OE05 was an open-label, phase 3, randomised clinical trial. Patients with surgically resectable oesophageal adenocarcinoma classified as stage cT1N1, cT2N1, cT3N0/N1, or cT4N0/N1 were recruited from 72 UK hospitals. Eligibility criteria included WHO performance status 0 or 1, adequate respiratory, cardiac, and liver function, white blood cell count at least 3 × 10<sup>9</sup> cells per L, platelet count at least 100 × 10<sup>9</sup> platelets per L, and a glomerular filtration rate at least 60 mL/min. Participants were randomly allocated (1:1) using a computerised minimisation program with a random element and stratified by centre and tumour stage, to receive two cycles of cisplatin and fluorouracil (CF; two 3-weekly cycles of cisplatin [80 mg/m<sup>2</sup> intravenously on day 1] and fluorouracil [1 g/m<sup>2</sup> per day intravenously on days 1-4]) or four cycles of epirubicin, cisplatin, and capecitabine (ECX; four 3-weekly cycles of epirubicin [50 mg/m<sup>2</sup>] and cisplatin [60 mg/m<sup>2</sup>] intravenously on day 1, and capecitabine [1250 mg/m<sup>2</sup>] daily throughout the four cycles) before surgery, stratified according to centre and clinical disease stage. Neither patients nor study staff were masked to treatment allocation. Two-phase oesophagectomy with two-field (abdomen and thorax) lymphadenectomy was done within 4-6 weeks of completion of chemotherapy. The primary outcome measure was overall survival, and primary and safety analyses were done in the intention-to-treat population. This trial is registered with the ISRCTN registry (number 01852072) and (NCT00041262), and is completed.<h4>Findings</h4>Between Jan 13, 2005, and Oct 31, 2011, 897 patients were recruited and 451 were assigned to the CF group and 446 to the ECX group. By Nov 14, 2016, 327 (73%) of 451 patients in the CF group and 302 (68%) of 446 in the ECX group had died. Median survival was 23·4 months (95% CI 20·6-26·3) with CF and 26·1 months (22·5-29·7) with ECX (hazard ratio 0·90 (95% CI 0·77-1·05, p=0·19). No unexpected chemotherapy toxicity was seen, and neutropenia was the most commonly reported event (grade 3 or 4 neutropenia: 74 [17%] of 446 patients in the CF group vs 101 [23%] of 441 people in the ECX group). The proportions of patients with postoperative complications (224 [56%] of 398 people for whom data were available in the CF group and 233 [62%] of 374 in the ECX group; p=0·089) were similar between the two groups. One patient in the ECX group died of suspected treatment-related neutropenic sepsis.<h4>Interpretation</h4>Four cycles of neoadjuvant ECX compared with two cycles of CF did not increase survival, and cannot be considered standard of care. Our study involved a large number of centres and detailed protocol with comprehensive prospective assessment of health-related quality of life in a patient population confined to people with adenocarcinomas of the oesophagus and gastro-oesophageal junction (Siewert types 1 and 2). Alternative chemotherapy regimens and neoadjuvant chemoradiation are being investigated to improve outcomes for patients with oesophageal carcinoma.<h4>Funding</h4>Cancer Research UK and Medical Research Council Clinical Trials Unit at University College London.en_US
dc.format.extent1249 - 1260en_US
dc.subjectEsophageal Neoplasmsen_US
dc.subjectAntineoplastic Agentsen_US
dc.subjectNeoadjuvant Therapyen_US
dc.subjectDrug Therapy, Combinationen_US
dc.subjectSurvival Rateen_US
dc.subjectQuality of Lifeen_US
dc.subjectAged, 80 and overen_US
dc.subjectMiddle Ageden_US
dc.titleNeoadjuvant cisplatin and fluorouracil versus epirubicin, cisplatin, and capecitabine followed by resection in patients with oesophageal adenocarcinoma (UK MRC OE05): an open-label, randomised phase 3 trial.en_US
dc.typeJournal Article
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfThe Lancet. Oncologyen_US
pubs.notesNo embargoen_US
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/Medicine (RMH Smith Cunningham)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.embargo.termsNo embargoen_US
icr.researchteamMedicine (RMH Smith Cunningham)en_US
dc.contributor.icrauthorCunningham, Daviden_US

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