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 1000mg/m² or the same with weight-adjusted dalteparin (WAD) for 12weeks. 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 (<100days 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 <100days 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 12weeks 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.