Oral Edoxaban Non-inferior to Dalteparin for Cancer-associated Venous Thromboembolism

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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.
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.
The following article features coverage from the American Society of Hematology (ASH) 2017 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.

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.

Reference

  1. 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.

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