Oral Edoxaban Non-inferior to Dalteparin for Cancer-associated Venous Thromboembolism
Nearly 13% of patients in the edoxaban had first recurrent VTE or other major bleeding events during the 12-month follow-up compared with 13.5% of patients in the dalteparin arm.
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Oral edoxaban is non-inferior to subcutaneous dalteparin when administered over 12 months to patients with cancer-associated venous thromboembolism (VTE), according to a late-breaking abstract presented at the 2017 American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia.1
For this non-inferiority study, investigators randomly assigned 1050 patients with cancer with acute symptomatic or incidental VTE to treatment with low-molecular-weight-heparin (LMWH) for at least 5 days followed by oral edoxaban 60 mg once daily (30 mg for patients with CrCl 30 to 50 mL/min or body weight under 60 kg), or to subcutaneous dalteparin 200 units/kg once daily for 1 month followed by 150 units/kg daily. Patients received treatment for 12 months.
At baseline, 657 patients had a pulmonary embolism with or without deep-vein thrombosis (DVT) and the rest of the study patients had isolated DVT; 706 patients had symptomatic VTE and the rest had incidental VTE. Ninety-eight percent of patients had active cancer, and 53% had metastatic disease.
Nearly 13% of patients in the edoxaban had first recurrent VTE or other major bleeding events during the 12-month follow-up compared with 13.5% of patients in the dalteparin arm (hazard ratio [HR], 0.97; 95% CI, 0.70-1.36; P = .0056 for non-inferiority).
Recurrent VTE occurred in 6.5% of patients in the edoxaban arm compared with 10.3% in the dalteparin arm, leading to a risk difference (edoxaban minus dalteparin) of -3.8% (95% CI, -7.1 to -0.4). Major bleeding occurred in 6.3% of edoxaban patients vs 3.2% in dalteparin patients; the difference in risk for major bleeding was 3.1% (95% CI, 0.5-5.7).
Category 3 and 4 bleeding events occurred among 2.3% of patients in both arms during the course of treatment (12 for each arm).
Twelve-month event-free survival (EFS) was 55% and 56.5% among patients in the edoxaban and dalteparin arms, respectively.
Read more of Cancer Therapy Advisor's coverage of the American Society of Hematology (ASH) 2017 meeting by visiting the conference page.
- Raskob GE, Van Es N, Verhamme P, et al. A randomized, open-label, blinded outcome assessment trial evaluating the efficacy and safety of LMWH/edoxaban versus dalteparin for venous thromboembolism associated with cancer: Hokusai VTE-cancer study. Oral presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.