Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
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
Univ Liverpool, Liverpool, Merseyside, England.;Royal Liverpool Univ Hosp, Liverpool, Merseyside, England..
Univ Liverpool, Liverpool, Merseyside, England.;Clatterbridge Canc Ctr, Wirral, Merseyside, England..
Royal Liverpool Univ Hosp, Liverpool, Merseyside, England..
Univ Liverpool, Liverpool, Merseyside, England..
Show others and affiliations
2017 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 389, no 10073, 1011-1024 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2017. Vol. 389, no 10073, 1011-1024 p.
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-318923DOI: 10.1016/S0140-6736(16)32409-6ISI: 000396345200023PubMedID: 28129987OAI: oai:DiVA.org:uu-318923DiVA: diva2:1087070
Available from: 2017-04-05 Created: 2017-04-05 Last updated: 2017-04-05Bibliographically approved

Open Access in DiVA

fulltext(593 kB)46 downloads
File information
File name FULLTEXT01.pdfFile size 593 kBChecksum SHA-512
fb011437e0b2e9c7a24d4e00a94707d385edf9199f19e36a0adf0290c2dec9abb6cdc84d42a49623684ab5fa7bb388fbaefdcb81b5c8c2c9e03b6772ac6aea79
Type fulltextMimetype application/pdf

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
Glimelius, Bengt
By organisation
Experimental and Clinical Oncology
In the same journal
The Lancet
Cancer and Oncology

Search outside of DiVA

GoogleGoogle Scholar
Total: 46 downloads
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 305 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf