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Enoxaparin effectively prevented VTE in advanced pancreatic cancer
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ISTH 2009
The low–molecular-weight heparin enoxaparin is a safe and effective therapy to prevent symptomatic venous thromboembolism in patients undergoing chemotherapy for advanced pancreatic cancer, according to the results of the CONKO 004 trial.
H.B. Riess, MD, from the University Medicine in Berlin, presented the results during the late-breaking abstract session of the XXII Congress of the International Society on Thrombosis and Hemostasis.
“Patients with advanced pancreatic cancer have an extremely high risk for symptomatic and clinically relevant venous thromboembolism when undergoing first-line therapy,” Riess said. “The low–molecular-weight heparin enoxaparin (Lovenox, Sanofi Aventis) can be applied safely on an outpatient basis. It significantly and clinically relevantly reduced the rate of symptomatic thromboembolism rates, and this effect is maintained even after dose reduction of enoxaparin after three months.”
Riess and colleagues expected the use of enoxaparin to reduce symptomatic venous thromboembolism, the primary endpoint, from 10% to 3% after 12 weeks of treatment. In an intent-to-treat analysis, enoxaparin reduced the risk of venous thromboembolism by 65% with no increased safety complications, Riess said.
Three hundred twelve venous thromboembolism- and chemotherapy-naive patients were enrolled between April 2004 and January 2009. Patients were randomly assigned to placebo or enoxaparin parallel to chemotherapy. During the first 12 weeks, enoxaparin was given at 1 mg/kg once daily; the dose was then reduced to 40 mg once daily.
Patients in the placebo group had a 9.9% rate of symptomatic venous thromboembolism compared with 1.3% in the enoxaparin group (P<.01). This was an absolute risk reduction of 8.6% and a RR reduction of about 90%, Riess said.
Bleeding incidence was similar in patients assigned enoxaparin and placebo (3.75% vs. 2.63%). Although the rate of venous thromboembolism and bleeding events increased at 30 weeks compared with three months, patients assigned enoxaparin still had reduced rates of both compared with patients assigned to placebo.
The effect of enoxaparin on response rate, PFS and OS will be analyzed and reported after more adequate follow-up, Riess said.
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