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Rivaroxaban reduced VTE recurrence, major bleeding in patients with cancer
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Rivaroxaban demonstrated comparable efficacy to and a better safety profile than standard therapy in patients with venous thromboembolism and cancer, according to a pooled subgroup analysis of two randomized trials.
Patients with cancer and venous thromboembolism (VTE) are at considerable risk for VTE recurrence and bleeding while they undergo therapy with anticoagulants. Monotherapy with low–molecular-weight heparin is recommended for these patients, but many do not receive this treatment in the clinical setting, according to background information provided by researchers.
The phase 3 EINSTEIN-DVT and EINSTEIN-PE trials compared oral rivaroxaban (Xarelto, Janssen) with standard therapy for the prevention of symptomatic recurrent VTE, as well as major bleeding and clinically relevant nonmajor bleeding.
In the current study, Martin H. Prins, MD, of Maastricht University Medical Center in Maastricht, the Netherlands, and colleagues compared outcomes between two regimens — monotherapy with oral rivaroxaban, or enoxaparin followed by vitamin K antagonists — in a subset of 655 participants in the EINSTEIN-DVT and EINSTEIN-PE trials who had cancer.
The 354 patients assigned rivaroxaban received 15 mg twice daily for 21 days, followed by 20 mg once daily. The 301 patients assigned standard therapy received enoxaparin 1 mg/kg twice daily, plus warfarin or acenocoumarol.
Symptomatic recurrent VTE served as the primary efficacy outcome measure. Clinically relevant bleeding served as the primary safety outcome measure. Secondary outcomes included all-cause mortality and major bleeding.
Results showed 16 patients (4.5%) assigned rivaroxaban and 20 (6.6%) assigned standard therapy experienced recurrent VTE (HR=0.67; 95% CI, 0.35-1.3), equating to an absolute risk difference of -1.7% (95% CI, -5.2 to 1.8%).
Researchers reported major bleeding in eight patients (2.3%) assigned rivaroxaban and 15 patients (5%) assigned standard therapy (HR=0.42; 95% CI, 0.18-0.99), equating to an absolute risk difference of -3% (95% CI, -5.9% to 0%).
Mortality rates were 16.4% among those assigned rivaroxaban and 17.6% among those assigned standard therapy (HR=0.93; 95% CI, 0.64-1.35), equating to an absolute risk difference of -1.6% (95% CI, -7.4% to 4.2%).
“In patients with active cancer and VTE, rivaroxaban had similar efficacy and improved safety compared with standard therapy,” Prins and colleagues wrote. “Rivaroxaban can be considered as an alternative in patients with cancer-associated VTE in whom the attending physician would have given standard therapy rather than long-term low–molecular-weight heparin. Based on the observed results in patients with cancer, a head-to-head comparison of rivaroxaban with long-term low–molecular-weight heparin is warranted.”
For more information:
Prins MH. Abstract #LBA48. Presented at: European Society for Medical Oncology Congress; Sept. 26-30, 2014; Madrid, Spain.
Disclosure: The EINSTEIN-DVT and EINSTEIN-PE studies, from which the results of the current analysis were derived, were funded by Bayer and Janssen.