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Nadroparin did not improve survival in patients with cancer
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ISTH 2009
The low–molecular-weight heparin nadroparin did not improve OS among patients with cancer, according to preliminary data from the INPACT trials.
Harry R. Büller, MD, of the department of vascular medicine at Academic Medical Center in Amsterdam, presented the results during a late-breaking abstract session at the XXII Congress of the International Society on Thrombosis and Hemostasis.
INPACT was designed to confirm the findings from two prior trials where nadroparin prolonged survival in patients with cancer who had not had venous thromboembolism. Researchers enrolled 503 patients with hormone-refractory prostate cancer, locally advanced pancreatic cancer or stage IIIb non–small cell lung cancer in the multicenter, randomized, open-label study.
The researchers randomly assigned patients to a control group or to subcutaneous nadroparin once daily for two weeks, followed by half therapeutic doses for four weeks, and then six cycles of therapeutic dose nadroparin for two weeks with a four-week wash-out.
The primary outcome was death due to all causes. The secondary endpoint was time to cancer progression. The safety endpoint was major bleeding.
At the time of the presentation, the median survival was 12.5 months for nadroparin patients vs. 11.9 months for patients not assigned the drug (P=.48). This was a nonstatistically significant, nonclinically relevant difference, Büller said. In addition, the survival difference did not vary over time. In the prostate cancer subgroup, there was a trend towards better survival.
The use of nadroparin was not associated with any increased risk for bleeding. Patients assigned to nadroparin had a 4.1% incidence of major bleeding vs. 3.5% for patients in the control group. Nine percent of patients assigned to nadroparin had one major bleed or a nonmajor clinically relevant bleed vs. 8.1% of patients in the control group. Further detailed analyses need to focus on identifying responders vs. non-responders, Büller said.
Editor's note: Dr. Büller is a paid consultant for GlaxoSmithKline.
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