Rivaroxaban -New treatment for DVT in cancer patients

Current international guidelines recommend cancer patients are injected with an anticoagulant (a low molecular weight heparin) to treat and prevent recurrence of VTE. A daily tablet, rivaroxaban, could be a beneficial alternative for treating venous thromboembolism(VTE), according to a large pilot trial called 'select-d'.

Rivaroxaban inhibits both free Factor Xa and Factor Xa bound in the prothrombinase complex. It is a highly selective direct Factor Xa inhibitor with oral bioavailability and rapid onset of action.

Deep vein thrombosis (DVT) occurs when a thrombus forms in one or more of the deep veins in the body, usually in the legs. Pulmonary embolism occurs when a clump of material, most often a blood clot, gets wedged into an artery in your lungs. These two conditions combined together are referred to as VTE - a dangerous and potentially deadly medical condition affecting 10 million people worldwide

Annie M Young and her associates conducted a study to assess if an oral factor Xa inhibitor, rivaroxaban, would offer an alternative treatment for VTE in patients with cancer.

A total of 206 patients with active cancer who had symptomatic pulmonary embolism (PE), incidental PE, or symptomatic lower-extremity proximal deep vein thrombosis (DVT) were included in the multicenter, randomized, open-label, pilot trial in the United Kingdom

Half were randomly assigned to receive low-molecular-weight heparin (dalteparin) and half were given the oral drug rivaroxaban. The treatment followed dalteparin (200 IU/kg daily during month 1, then 150 IU/kg daily for months 2-6) or rivaroxaban (15 mg twice daily for 3 weeks, then 20 mg once daily for a total of 6 months). The primary outcome was VTE recurrence over 6 months. Safety was assessed by major bleeding and clinically relevant nonmajor bleeding (CRNMB).

After six months of treatment, the VTE recurrence rate was four percent among those taking the tablet and 11 percent in those receiving dalteparin.

The results for secondary outcomes were mixed. In patients receiving rivaroxaban, there were around the same percentage of major bleeding events (6%) as those receiving dalteparin (4%) but a marked and significant increase in clinically relevant non-major bleeds (13%) with rivaroxaban compared to those having low molecular weight heparin (4%)..

"Clinicians were already adopting the oral drug into practice for non-cancer patients and now they have data from this study to indicate that this form of treatment is an alternative option for many cancer patients who have a clot, “said Young

The study concluded that Rivaroxaban was associated with relatively low VTE recurrence but higher clinically relevant nonmajor bleeding (CRNMB). compared with dalteparin.

The study was published in the Journal of Clinical Oncology