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FältnamnIndikatorerMetadata
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001oai:DiVA.org:uu-318923
003SwePub
008170405s2017 | |||||||||||000 ||eng|
009oai:prod.swepub.kib.ki.se:135270581
009oai:lup.lub.lu.se:0b3ec941-303e-4c06-933f-e471df933297
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3189232 URI
0247 a https://doi.org/10.1016/S0140-6736(16)32409-62 DOI
0247 a http://kipublications.ki.se/Default.aspx?queryparsed=id:1352705812 URI
0247 a https://lup.lub.lu.se/record/0b3ec941-303e-4c06-933f-e471df9332972 URI
040 a (SwePub)uud (SwePub)kid (SwePub)lu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Neoptolemos, John P.u Univ Liverpool, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.,University of Liverpool4 aut
2451 0a Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4) :b a multicentre, open-label, randomised, phase 3 trial
264 1c 2017
338 a electronic2 rdacarrier
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kirurgi0 (SwePub)302122 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Surgery0 (SwePub)302122 hsv//eng
7001 a Palmer, Daniel H.u Univ Liverpool, Liverpool, Merseyside, England.;Clatterbridge Canc Ctr, Wirral, Merseyside, England.,University of Liverpool4 aut
7001 a Ghaneh, Paulau Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.,Royal Liverpool University Hospital4 aut
7001 a Psarelli, Eftychia E.u Univ Liverpool, Liverpool, Merseyside, England.,University of Liverpool4 aut
7001 a Valle, Juan W.u Univ Manchester, Christie NHS Fdn Trust, Manchester, Lancs, England.,University of Manchester4 aut
7001 a Halloran, Christopher M.u Univ Liverpool, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.,University of Liverpool4 aut
7001 a Faluyi, Olusolau Clatterbridge Canc Ctr, Wirral, Merseyside, England.,Clatterbridge Cancer Centre4 aut
7001 a O'Reilly, Derek A.u Manchester Royal Infirm, Manchester, Lancs, England.,Manchester Royal Infirmary4 aut
7001 a Cunningham, Davidu Royal Marsden Hosp, London, England.,Royal Marsden Hospital, London4 aut
7001 a Wadsley, Jonathanu Weston Pk Hosp, Sheffield, S Yorkshire, England.,Weston Park Hospital4 aut
7001 a Darby, Suzanneu Weston Pk Hosp, Sheffield, S Yorkshire, England.4 aut
7001 a Meyer, Timu Royal Free Hosp, London, England.4 aut
7001 a Gillmore, Roopinderu Royal Free Hosp, London, England.4 aut
7001 a Anthoney, Alanu St James Univ Hosp, Leeds, W Yorkshire, England.4 aut
7001 a Lind, Pehru Karolinska Institutet4 aut
7001 a Glimelius, Bengtu Uppsala universitet,Experimentell och klinisk onkologi4 aut0 (Swepub:uu)bengglim
7001 a Falk, Stephenu Bristol Haematol & Oncol Ctr, Bristol, Avon, England.4 aut
7001 a Izbicki, Jakob R.u Univ Hamburg, Med Inst UKE, Hamburg, Germany.4 aut
7001 a Middleton, Gary Williamu Royal Surrey Cty Hosp, Guildford, Surrey, England.4 aut
7001 a Cummins, Sebastianu Royal Surrey Cty Hosp, Guildford, Surrey, England.4 aut
7001 a Ross, Paul J.u Guys Hosp, London, England.4 aut
7001 a Wasan, Harpreetu Hammersmith Hosp, London, England.4 aut
7001 a McDonald, Alecu Beatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland.4 aut
7001 a Crosby, Tomu Velindre Hosp, Cardiff, S Glam, Wales.4 aut
7001 a Ma, Yuk Tingu Queen Elizabeth Hosp, Birmingham, W Midlands, England.4 aut
7001 a Patel, Kinnariu Churchill Hosp, Oxford, England.4 aut
7001 a Sherriff, Davidu Derriford Hosp, Plymouth, Devon, England.4 aut
7001 a Soomal, Rubinu Ipswich Hosp, Ipswich, Suffolk, England.4 aut
7001 a Borg, Davidu Lund 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 Hospital4 aut0 (Swepub:lu)onk-dbo
7001 a Sothi, Sharmilau Univ Hosp Coventry, Coventry, W Midlands, England.4 aut
7001 a Hammel, Pascalu Hop Beaujon, Clichy, France.4 aut
7001 a Hackert, Thilou Heidelberg Univ, Heidelberg, Germany.4 aut
7001 a Jackson, Richardu Univ Liverpool, Liverpool, Merseyside, England.4 aut
7001 a Buechler, Markus W.u Heidelberg Univ, Heidelberg, Germany.4 aut
7102 a Univ Liverpool, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.b University of Liverpool4 org
7730 t The Lancetg 389:10073, s. 1011-1024q 389:10073<1011-1024x 0140-6736x 1474-547X
8564 u https://doi.org/10.1016/S0140-6736(16)32409-6y Fulltext
8564 u https://uu.diva-portal.org/smash/get/diva2:1087070/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print
8564 u http://dx.doi.org/10.1016/S0140-6736(16)32409-6x freey FULLTEXT
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-318923
8564 8u https://doi.org/10.1016/S0140-6736(16)32409-6
8564 8u http://kipublications.ki.se/Default.aspx?queryparsed=id:135270581
8564 8u https://lup.lub.lu.se/record/0b3ec941-303e-4c06-933f-e471df933297

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