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dc.contributor.authorNeoptolemos, JP
dc.contributor.authorPalmer, DH
dc.contributor.authorGhaneh, P
dc.contributor.authorPsarelli, EE
dc.contributor.authorValle, JW
dc.contributor.authorHalloran, CM
dc.contributor.authorFaluyi, O
dc.contributor.authorO'Reilly, DA
dc.contributor.authorCunningham, D
dc.contributor.authorWadsley, J
dc.contributor.authorDarby, S
dc.contributor.authorMeyer, T
dc.contributor.authorGillmore, R
dc.contributor.authorAnthoney, A
dc.contributor.authorLind, P
dc.contributor.authorGlimelius, B
dc.contributor.authorFalk, S
dc.contributor.authorIzbicki, JR
dc.contributor.authorMiddleton, GW
dc.contributor.authorCummins, S
dc.contributor.authorRoss, PJ
dc.contributor.authorWasan, H
dc.contributor.authorMcDonald, A
dc.contributor.authorCrosby, T
dc.contributor.authorMa, YT
dc.contributor.authorPatel, K
dc.contributor.authorSherriff, D
dc.contributor.authorSoomal, R
dc.contributor.authorBorg, D
dc.contributor.authorSothi, S
dc.contributor.authorHammel, P
dc.contributor.authorHackert, T
dc.contributor.authorJackson, R
dc.contributor.authorBüchler, MW
dc.contributor.authorEuropean Study Group for Pancreatic Cancer
dc.date.accessioned2017-03-27T12:32:04Z
dc.date.issued2017-03
dc.identifier.citationLancet (London, England), 2017, 389 (10073), pp. 1011 - 1024
dc.identifier.issn0140-6736
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/534
dc.identifier.eissn1474-547X
dc.identifier.doi10.1016/s0140-6736(16)32409-6
dc.description.abstractBackground The ESPAC-3 trial showed that adjuvant gemcitabine is the standard of care based on similar survival to and less toxicity than adjuvant 5-fluorouracil/folinic acid in patients with resected pancreatic cancer. Other clinical trials have shown better survival and tumour response with gemcitabine and capecitabine than with gemcitabine alone in advanced or metastatic pancreatic cancer. We aimed to determine the efficacy and safety of gemcitabine and capecitabine compared with gemcitabine monotherapy for resected pancreatic cancer.Methods We did a phase 3, two-group, open-label, multicentre, randomised clinical trial at 92 hospitals in England, Scotland, Wales, Germany, France, and Sweden. Eligible patients were aged 18 years or older and had undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection). We randomly assigned patients (1:1) within 12 weeks of surgery to receive six cycles of either 1000 mg/m 2 gemcitabine alone administered once a week for three of every 4 weeks (one cycle) or with 1660 mg/m 2 oral capecitabine administered for 21 days followed by 7 days' rest (one cycle). Randomisation was based on a minimisation routine, and country was used as a stratification factor. The primary endpoint was overall survival, measured as the time from randomisation until death from any cause, and assessed in the intention-to-treat population. Toxicity was analysed in all patients who received trial treatment. This trial was registered with the EudraCT, number 2007-004299-38, and ISRCTN, number ISRCTN96397434.Findings Of 732 patients enrolled, 730 were included in the final analysis. Of these, 366 were randomly assigned to receive gemcitabine and 364 to gemcitabine plus capecitabine. The Independent Data and Safety Monitoring Committee requested reporting of the results after there were 458 (95%) of a target of 480 deaths. The median overall survival for patients in the gemcitabine plus capecitabine group was 28·0 months (95% CI 23·5-31·5) compared with 25·5 months (22·7-27·9) in the gemcitabine group (hazard ratio 0·82 [95% CI 0·68-0·98], p=0·032). 608 grade 3-4 adverse events were reported by 226 of 359 patients in the gemcitabine plus capecitabine group compared with 481 grade 3-4 adverse events in 196 of 366 patients in the gemcitabine group.Interpretation The adjuvant combination of gemcitabine and capecitabine should be the new standard of care following resection for pancreatic ductal adenocarcinoma.Funding Cancer Research UK.
dc.formatPrint-Electronic
dc.format.extent1011 - 1024
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectEuropean Study Group for Pancreatic Cancer
dc.subjectHumans
dc.subjectCarcinoma, Pancreatic Ductal
dc.subjectPancreatic Neoplasms
dc.subjectDeoxycytidine
dc.subjectAntimetabolites, Antineoplastic
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectTreatment Outcome
dc.subjectChemotherapy, Adjuvant
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectKaplan-Meier Estimate
dc.subjectCapecitabine
dc.titleComparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial.
dc.typeJournal Article
dcterms.dateAccepted2016-09-28
rioxxterms.versionofrecord10.1016/s0140-6736(16)32409-6
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2017-03
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfLancet (London, England)
pubs.issue10073
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/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.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/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.publication-statusPublished
pubs.volume389
pubs.embargo.termsNo embargo
icr.researchteamMedicine (RMH Smith Cunningham)en_US
dc.contributor.icrauthorCunningham, Daviden
dc.contributor.icrauthorMarsden,en


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