title: Gemcitabine versus gemcitabine plus dalteparin thromboprophylaxis in pancreatic cancer.
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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Queen's Centre for Oncology and Haematology, Castle Hill Hospital, Cottingham, UK. Anthony.maraveyas@hey.nhs.uk
authors.forename: A
authors.initials: A
authors.lastname: Maraveyas
authors.forename: J
authors.initials: J
authors.lastname: Waters
authors.forename: R
authors.initials: R
authors.lastname: Roy
authors.forename: D
authors.initials: D
authors.lastname: Fyfe
authors.forename: D
authors.initials: D
authors.lastname: Propper
authors.forename: F
authors.initials: F
authors.lastname: Lofts
authors.forename: J
authors.initials: J
authors.lastname: Sgouros
authors.forename: E
authors.initials: E
authors.lastname: Gardiner
authors.forename: K
authors.initials: K
authors.lastname: Wedgwood
authors.forename: C
authors.initials: C
authors.lastname: Ettelaie
authors.forename: G
authors.initials: G
authors.lastname: Bozas
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D017985:Dalteparin / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D015999:Multivariate Analysis; D010190:Pancreatic Neoplasms / Q000097:blood* / Q000188:drug therapy*; D015996:Survival Rate; D054556:Venous Thromboembolism / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control*; D000093542:Gemcitabine
chemical_list: D000925:Anticoagulants; D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D017985:Dalteparin; D000093542:Gemcitabine