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Comparison of adjuv...
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
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- Neoptolemos, John P. (författare)
- Univ Liverpool, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.,University of Liverpool
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- Palmer, Daniel H. (författare)
- Univ Liverpool, Liverpool, Merseyside, England.;Clatterbridge Canc Ctr, Wirral, Merseyside, England.,University of Liverpool
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- Ghaneh, Paula (författare)
- Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.,Royal Liverpool University Hospital
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- Psarelli, Eftychia E. (författare)
- Univ Liverpool, Liverpool, Merseyside, England.,University of Liverpool
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- Valle, Juan W. (författare)
- Univ Manchester, Christie NHS Fdn Trust, Manchester, Lancs, England.,University of Manchester
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- Halloran, Christopher M. (författare)
- Univ Liverpool, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England.,University of Liverpool
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- Faluyi, Olusola (författare)
- Clatterbridge Canc Ctr, Wirral, Merseyside, England.,Clatterbridge Cancer Centre
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- O'Reilly, Derek A. (författare)
- Manchester Royal Infirm, Manchester, Lancs, England.,Manchester Royal Infirmary
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- Cunningham, David (författare)
- Royal Marsden Hosp, London, England.,Royal Marsden Hospital, London
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- Wadsley, Jonathan (författare)
- Weston Pk Hosp, Sheffield, S Yorkshire, England.,Weston Park Hospital
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- Darby, Suzanne (författare)
- Weston Pk Hosp, Sheffield, S Yorkshire, England.
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- Meyer, Tim (författare)
- Royal Free Hosp, London, England.
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- Gillmore, Roopinder (författare)
- Royal Free Hosp, London, England.
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- Anthoney, Alan (författare)
- St James Univ Hosp, Leeds, W Yorkshire, England.
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- Lind, Pehr (författare)
- Karolinska Institutet
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- Glimelius, Bengt (författare)
- Uppsala universitet,Experimentell och klinisk onkologi
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- Falk, Stephen (författare)
- Bristol Haematol & Oncol Ctr, Bristol, Avon, England.
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- Izbicki, Jakob R. (författare)
- Univ Hamburg, Med Inst UKE, Hamburg, Germany.
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- Middleton, Gary William (författare)
- Royal Surrey Cty Hosp, Guildford, Surrey, England.
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- Cummins, Sebastian (författare)
- Royal Surrey Cty Hosp, Guildford, Surrey, England.
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- Ross, Paul J. (författare)
- Guys Hosp, London, England.
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- Wasan, Harpreet (författare)
- Hammersmith Hosp, London, England.
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- McDonald, Alec (författare)
- Beatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland.
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- Crosby, Tom (författare)
- Velindre Hosp, Cardiff, S Glam, Wales.
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- Ma, Yuk Ting (författare)
- Queen Elizabeth Hosp, Birmingham, W Midlands, England.
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- Patel, Kinnari (författare)
- Churchill Hosp, Oxford, England.
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- Sherriff, David (författare)
- Derriford Hosp, Plymouth, Devon, England.
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- Soomal, Rubin (författare)
- Ipswich Hosp, Ipswich, Suffolk, England.
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- Borg, David (författare)
- 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 Hospital
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- Sothi, Sharmila (författare)
- Univ Hosp Coventry, Coventry, W Midlands, England.
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- Hammel, Pascal (författare)
- Hop Beaujon, Clichy, France.
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- Hackert, Thilo (författare)
- Heidelberg Univ, Heidelberg, Germany.
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- Jackson, Richard (författare)
- Univ Liverpool, Liverpool, Merseyside, England.
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- Buechler, Markus W. (författare)
- Heidelberg Univ, Heidelberg, Germany.
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Univ Liverpool, Liverpool, Merseyside, England;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England. University of Liverpool (creator_code:org_t)
- 2017
- 2017
- Engelska.
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Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 389:10073, s. 1011-1024
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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http://dx.doi.org/10... (free)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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https://lup.lub.lu.s...
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Abstract
Ämnesord
Stäng
- 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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
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- ref (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Neoptolemos, Joh ...
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Palmer, Daniel H ...
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Ghaneh, Paula
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Psarelli, Eftych ...
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Valle, Juan W.
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Halloran, Christ ...
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visa fler...
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Faluyi, Olusola
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O'Reilly, Derek ...
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Cunningham, Davi ...
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Wadsley, Jonatha ...
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Darby, Suzanne
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Meyer, Tim
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Gillmore, Roopin ...
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Anthoney, Alan
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Lind, Pehr
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Glimelius, Bengt
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Falk, Stephen
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Izbicki, Jakob R ...
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Middleton, Gary ...
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Cummins, Sebasti ...
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Ross, Paul J.
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Wasan, Harpreet
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McDonald, Alec
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Crosby, Tom
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Ma, Yuk Ting
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Patel, Kinnari
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Sherriff, David
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Soomal, Rubin
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Borg, David
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Sothi, Sharmila
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Hammel, Pascal
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Hackert, Thilo
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Jackson, Richard
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Buechler, Markus ...
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Cancer och onkol ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kirurgi
- Artiklar i publikationen
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The Lancet
- Av lärosätet
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Uppsala universitet
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Karolinska Institutet
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Lunds universitet