Rivaroxaban reduces VTE recurrence in patients with cancer

Rivaroxaban significantly reduced venous thromboembolism recurrence among patients who had cancer and VTE compared with dalteparin, according to findings published in Journal of Clinical Oncology.

However, the drug appeared associated with higher clinically relevant nonmajor bleeding.

“Clinicians were already adopting the oral drug into practice for noncancer 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,” Annie M. Young, PhD, professor at Warwick Medical School in Coventry, U.K., said in a press release.

Young and colleagues performed a multicenter, randomized, open-label pilot trial of 406 patients in the U.K. with cancer and symptomatic pulmonary embolism, incidental PE or symptomatic lower extremity proximal deep vein thrombosis.

Researchers randomly assigned patients to receive either 200 IU/kg of dalteparin once daily for a month, followed by 150 IU/kg daily for months 2 through 6 (n = 203), or 15 mg of rivaroxaban (Xarelto, Janssen) twice daily for 3 weeks, followed by 20 mg once daily for a total of 6 months (n = 203).

Recurrence of VTE over the course of 6 months served as the main endpoint. The researchers used major bleeding and clinically relevant nonmajor bleeding to evaluate safety.

Most patients (58%) had metastatic cancer.

One-fourth (25%) of patients had colorectal cancer, and most (69%) were undergoing cancer treatment — 83% chemotherapy — at the time of VTE.

A total of 26 patients had recurrent VTE (dalteparin, n = 18; rivaroxaban, n = 8).

Eleven percent of patients in the dalteparin group experienced recurrent VTE by 6 months compared with 4% of the rivaroxaban group (HR = 0.43; 95% CI, 0.19-0.99).

However, patients in the rivaroxaban group had a slightly higher 6-month cumulative rate of major bleeding compared with those in the dalteparin group (6% vs. 4%; HR = 1.83; 95% CI, 0.68-4.96).

The rivaroxaban group also had a significantly higher rate of clinically relevant nonmajor bleeding (13% vs. 4%; HR = 3.76; 95% CI, 1.63-8.69).

The increased bleeding may have been due to the “enhanced antithrombotic effect of rivaroxaban,” the researchers wrote.

“At the end of the day, a patient’s preference for a specific anticoagulant is based on a careful discussion between patient and physician about the benefits and risks of the treatment alternatives,” the researchers wrote.

“We now need to be sitting down with each one of our cancer patients with VTE, discussing their preference alongside looking at all their clinical details including whether the cancer lesion is still there, what other medications are being taken and what other conditions the patient has so that we can choose the optimal VTE treatment for each patient,” Young said. – by Andy Polhamus

Disclosures: Young reports honoraria from Bayer AG, Helsinn Healthcare, LEO Pharma and Merck Sharpe & Dohme, as well as research funding to her institution from Bayer AG. Please see the study for a list of all other authors’ relevant financial disclosures.