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  • Neoptolemos, John P.Univ Liverpool, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.,University of Liverpool (författare)

Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4) : a multicentre, open-label, randomised, phase 3 trial

  • Artikel/kapitelEngelska2017

Förlag, utgivningsår, omfång ...

  • 2017
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-318923
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-318923URI
  • https://doi.org/10.1016/S0140-6736(16)32409-6DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:135270581URI
  • https://lup.lub.lu.se/record/0b3ec941-303e-4c06-933f-e471df933297URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

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Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Background: 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.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Palmer, Daniel H.Univ Liverpool, Liverpool, Merseyside, England.;Clatterbridge Canc Ctr, Wirral, Merseyside, England.,University of Liverpool (författare)
  • Ghaneh, PaulaRoyal Liverpool Univ Hosp, Liverpool, Merseyside, England.,Royal Liverpool University Hospital (författare)
  • Psarelli, Eftychia E.Univ Liverpool, Liverpool, Merseyside, England.,University of Liverpool (författare)
  • Valle, Juan W.Univ Manchester, Christie NHS Fdn Trust, Manchester, Lancs, England.,University of Manchester (författare)
  • Halloran, Christopher M.Univ Liverpool, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.,University of Liverpool (författare)
  • Faluyi, OlusolaClatterbridge Canc Ctr, Wirral, Merseyside, England.,Clatterbridge Cancer Centre (författare)
  • O'Reilly, Derek A.Manchester Royal Infirm, Manchester, Lancs, England.,Manchester Royal Infirmary (författare)
  • Cunningham, DavidRoyal Marsden Hosp, London, England.,Royal Marsden Hospital, London (författare)
  • Wadsley, JonathanWeston Pk Hosp, Sheffield, S Yorkshire, England.,Weston Park Hospital (författare)
  • Darby, SuzanneWeston Pk Hosp, Sheffield, S Yorkshire, England. (författare)
  • Meyer, TimRoyal Free Hosp, London, England. (författare)
  • Gillmore, RoopinderRoyal Free Hosp, London, England. (författare)
  • Anthoney, AlanSt James Univ Hosp, Leeds, W Yorkshire, England. (författare)
  • Lind, PehrKarolinska Institutet (författare)
  • Glimelius, BengtUppsala universitet,Experimentell och klinisk onkologi(Swepub:uu)bengglim (författare)
  • Falk, StephenBristol Haematol & Oncol Ctr, Bristol, Avon, England. (författare)
  • Izbicki, Jakob R.Univ Hamburg, Med Inst UKE, Hamburg, Germany. (författare)
  • Middleton, Gary WilliamRoyal Surrey Cty Hosp, Guildford, Surrey, England. (författare)
  • Cummins, SebastianRoyal Surrey Cty Hosp, Guildford, Surrey, England. (författare)
  • Ross, Paul J.Guys Hosp, London, England. (författare)
  • Wasan, HarpreetHammersmith Hosp, London, England. (författare)
  • McDonald, AlecBeatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland. (författare)
  • Crosby, TomVelindre Hosp, Cardiff, S Glam, Wales. (författare)
  • Ma, Yuk TingQueen Elizabeth Hosp, Birmingham, W Midlands, England. (författare)
  • Patel, KinnariChurchill Hosp, Oxford, England. (författare)
  • Sherriff, DavidDerriford Hosp, Plymouth, Devon, England. (författare)
  • Soomal, RubinIpswich Hosp, Ipswich, Suffolk, England. (författare)
  • Borg, DavidLund University,Lunds universitet,Tumörmikromiljö,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Tumor microenvironment,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)onk-dbo (författare)
  • Sothi, SharmilaUniv Hosp Coventry, Coventry, W Midlands, England. (författare)
  • Hammel, PascalHop Beaujon, Clichy, France. (författare)
  • Hackert, ThiloHeidelberg Univ, Heidelberg, Germany. (författare)
  • Jackson, RichardUniv Liverpool, Liverpool, Merseyside, England. (författare)
  • Buechler, Markus W.Heidelberg Univ, Heidelberg, Germany. (författare)
  • Univ Liverpool, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.University of Liverpool (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:The Lancet389:10073, s. 1011-10240140-67361474-547X

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