In cancer patients, rivaroxaban reduced VTE recurrence, major bleeding

In cancer patients, rivaroxaban reduced VTE recurrence, major bleeding

October 1, 2014

In patients with active cancer who experienced venous thromboembolism (VTE), rivaroxaban (Xarelto) was as effective as standard of care, with lower rates of major bleeding, according to data presented at the European Society for Medical Oncology 2014 congress in Madrid, Spain.

Dr Prins

In patients with active cancer who experienced venous thromboembolism (VTE), rivaroxaban (Xarelto, Janssen) was as effective as standard of care, with lower rates of major bleeding, according to data presented at the European Society for Medical Oncology 2014 congress in Madrid, Spain.

These results findings from a pooled analysis, to be published in Lancet Haematology, also suggest rivaroxaban may be an alternative for this fragile patient population, with comparable efficacy and lower rates of major bleeding. The findings are from the most extensive set of phase 3 data for a novel anticoagulant in cancer patients.

“Rivaroxaban offers practical benefits over long-term anticoagulation with low-molecular-weight-heparin [LMWH] including no injections, no weight-adjusted dosing and no risk of heparin-induced thrombocytopenia,” according to lead investigator Martin Prins, MD, Maastricht University Medical Centre, Maastricht, The Netherlands.

“The findings from this analysis demonstrate that oral single-drug treatment with rivaroxaban has similar efficacy and mortality with less major bleeding complications compared with standard of care,” Dr Prin said. “Rivaroxaban offers an alternative to patients with cancer and VTE, in whom physicians are considering long-term anticoagulation with vitamin K antagonists rather than long-term LMWH.”

The researchers did a subgroup analysis of patients with active cancer (either at baseline or diagnosed during the study), a history of cancer, or no cancer who were enrolled in the EINSTEIN-DVT and EINSTEIN-PE trials. Eligible patients with deep-vein thrombosis (EINSTEIN-DVT) or pulmonary embolism (EINSTEIN-PE) were randomly assigned in a 1:1 ratio to receive rivaroxaban (15 mg twice daily for 21 days, followed by 20 mg once daily) or standard therapy (enoxaparin 1 mg/kg twice daily and warfarin or acenocoumarol; international normalized ratio 2.0–3.0). Randomization with a computerized voice-response system was stratified according to country and intended treatment duration (3, 6, or 12 months). The prespecified primary efficacy and safety outcomes of both the trials and this subanalysis were symptomatic recurrent venous thromboembolism and clinically relevant bleeding, respectively.

 

“We did efficacy and mortality analyses in the intention-to-treat population, and bleeding analyses for time spent receiving treatment plus 2 days in the safety population-all patients who received at least 1 dose of study drug,” said Dr Prin.

In patients with venous thromboembolism and active cancer (diagnosed at baseline or during treatment), recurrent venous thromboembolism occurred in 16 (5%) of 354 patients allocated to rivaroxaban and 20 (7%) of 301 patients allocated to enoxaparin and vitamin K antagonist (hazard ratio [HR] 0.67, 95% CI, 0.35–1.30). Clinically relevant bleeding occurred in 48 (14%) of 353 patients receiving rivaroxaban and in 49 (16%) of 298 patients receiving standard therapy (HR 0.80, 95% CI, 0.54–1.20). Major bleeding occurred in eight (2%) of 353 patients receiving rivaroxaban and in 15 (5%) of 298 patients receiving standard therapy (HR 0.42, 95% CI, 0.18–0.99).

“Patients with VTE and a history of cancer or active cancer have a substantial risk of recurrent VTE and major bleeding during anticoagulant therapy,” Dr Prin said. “Although long-term therapy with an injectable LMWH is recommended for these patients-medical, economic and quality of life considerations often lead many physicians to prescribe initial treatment with LMWH, followed by long-term care with warfarin. Yet, a treatment dilemma exists in this highly vulnerable patient population, as warfarin carries not only a residual high risk of recurrent VTE, but also an increased risk of major bleeding.

“Based on these results, a head-to-head comparison of rivaroxaban with long-term LMWH in patients with cancer is warranted,” added Dr Prin. “We believe that in the meantime, in patients with active cancer and VTE, rivaroxaban can be considered as an alternative in those cases in which the attending physician would have given therapy including a vitamin K antagonist rather than LMWH."

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