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Gemcitabine versus gemcitabine plus dalteparin thromboprophylaxis in pancreatic cancer

Ettelaie, C.; Gardiner, E.; Maraveyas, A.; Bozas, G.; Fyfe, D.; Lofts, F.; Propper, D.; Roy, R.; Sgouros, J.; Waters, J.; Wedgwood, K.

Authors

E. Gardiner

G. Bozas

D. Fyfe

F. Lofts

D. Propper

R. Roy

J. Sgouros

J. Waters

K. Wedgwood



Abstract

Background: Annualised figures show an up to 7-fold higher incidence of vascular thromboembolism (VTE) in patients with advanced pancreatic cancer (APC) compared to other common malignancies. Concurrent VTE has been shown to confer a worse overall prognosis in APC. Methods: One hundred and twenty three APC patients were randomised to receive either gemcitabine 1000 mg/m 2 or the same with weight-adjusted dalteparin (WAD) for 12 weeks. Primary end-point was the reduction of all-type VTE during the study period. NCT00462852, ISRCTN: 76464767. Findings: The incidence of all-type VTE during the WAD treatment period ( < 100 days from randomisation) was reduced from 23% to 3.4% (p = 0.002), with a risk ratio (RR)of 0.145, 95% confidence interval (CI) (0.035-0.612) and an 85% risk reduction. All-type VTE throughout the whole follow-up period was reduced from 28% to 12% (p = 0.039), RR = 0.419, 95% CI (0.187-0.935) and a 58% risk reduction. Lethal VTE < 100 days was seen only in the control arm, 8.3% compared to 0% (p = 0.057), RR = 0.092, 95% CI (0.005-1.635). Interpretation: Weight adjusted dalteparin used as primary prophylaxis for 12 weeks is safe and produces a highly significant reduction of all-type VTE during the prophylaxis period. The benefit is maintained after dalteparin withdrawal although decreases with time. © 2011 Elsevier Ltd. All rights reserved.

Citation

Ettelaie, C., Gardiner, E., Maraveyas, A., Bozas, G., Fyfe, D., Lofts, F., …Wedgwood, K. (2012). Gemcitabine versus gemcitabine plus dalteparin thromboprophylaxis in pancreatic cancer. European Journal of Cancer, 48(9), 1283-1292. https://doi.org/10.1016/j.ejca.2011.10.017

Journal Article Type Article
Acceptance Date Oct 16, 2011
Online Publication Date Nov 17, 2011
Publication Date Jun 1, 2012
Deposit Date Nov 13, 2014
Journal European journal of cancer (Oxford, England : 1990)
Print ISSN 1879-0852
Electronic ISSN 1879-0852
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 48
Issue 9
Pages 1283-1292
DOI https://doi.org/10.1016/j.ejca.2011.10.017
Keywords Cancer Research; Oncology
Public URL https://hull-repository.worktribe.com/output/464312
Publisher URL https://www.sciencedirect.com/science/article/pii/S0959804911008240?via%3Dihub