Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism

Raskob, Gary E.; Es, Nick van; Verhamme, Peter; Carrier, Marc; Nisio, Marcello Di; García, David; Grosso, Michael; Kakkar, Ajay K.; Kovacs, Michael J.; Mercuri, Michele; Meyer, Guy; Segers, Annelise; Shi, Minggao; Wang, Tzu‐Fei; Yeo, Erik; Zhang, George; Zwicker, Jeffrey I.; Weitz, Jeffrey I.; Büller, Harry R.

doi:10.1056/nejmoa1711948

Cited by 1,345 publications

(1,240 citation statements)

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“…However, in a randomised controlled trial (1050 patients with cancer-associated VTE) oral edoxaban was shown to be non-inferior to daltaparin in terms of VTE recurrence (non-inferiority P=0.006, 95% confidence interval 0.70 to 1.36), but with a higher rate of major bleeding (P=0.04, 95% confidence interval 1.03 to 3.04) 42. More investigation is needed before recommending DOACs in cancer-associated VTE.…”

Section: How Is It Treated?mentioning

confidence: 98%

Deep vein thrombosis

Stubbs

Mouyis

Thomas

2018

BMJ

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Section: How Is It Treated?mentioning

confidence: 98%

Deep vein thrombosis

Stubbs

Mouyis

Thomas

2018

BMJ

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“…Both higher‐dose (HDER) and lower‐dose (LDER) edoxaban regimens were noninferior to well‐managed warfarin in preventing stroke or systemic embolic events (SEEs) in patients with AF, and both regimens reduced bleeding and cardiovascular death 22. To date, data are sparse in patients treated with edoxaban who have both AF and malignancy, although a recent randomized trial in 1046 patients with venous thromboembolism and malignancy showed that edoxaban was noninferior to dalteparin in the prevention of recurrent venous thromboembolism but was associated with a 2.9% absolute increase in the rate of major bleeding 23. In the present analysis, we evaluate the safety and efficacy of edoxaban compared with warfarin in patients with AF who have developed a new or recurrent malignancy, with particular focus on the HDER because this is the regimen approved for clinical use.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Edoxaban in Patients With Active Malignancy and Atrial Fibrillation: Analysis of the ENGAGE AF‐TIMI 48 Trial

Fanola

Ruff

Murphy

et al. 2018

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BackgroundAnticoagulation in patients with malignancy and atrial fibrillation is challenging because of enhanced risks for thrombosis and bleeding and the frequent need for invasive procedures. Data on direct oral antagonists in such patients are sparse.Methods and ResultsThe ENGAGE AF‐TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis in Myocardial Infarction Study 48) trial randomized 21 105 patients with atrial fibrillation to edoxaban or warfarin. Patients with malignancy, defined as a postrandomization new diagnosis or recurrence of remote cancer, were followed up over a median of 2.8 years. Adjusted Cox proportional hazard models were used to evaluate the safety and efficacy of edoxaban versus warfarin. Over a median of 495 days (interquartile range, 230–771 days), 1153 patients (5.5%) were diagnosed with new or recurrent malignancy, most commonly involving the gastrointestinal tract (20.6%), prostate (13.6%), and lung (11.1%). Malignancy was associated with increased risk of death (adjusted hazard ratio [HR], 3.12; 95% confidence interval [CI], 2.78–3.50) and major bleeding (adjusted HR, 2.45; 95% CI, 2.07–2.89), but not stroke/systemic embolism (adjusted HR, 1.08; 95% CI, 0.83–1.42). Relative outcomes with higher‐dose edoxaban versus warfarin were consistent regardless of malignancy status for stroke/systemic embolism (HR, 0.60 [95% CI, 0.31–1.15] for malignancy versus HR, 0.89 [95% CI, 0.76–1.05] for no malignancy; interaction P=0.25) and major bleeding (HR, 0.98 [95% CI, 0.69–1.40] for malignancy versus HR, 0.79 [95% CI, 0.69–1.05] for no malignancy; interaction P=0.31). There was, however, a significant treatment interaction for the composite ischemic end point (ischemic stroke/systemic embolism/myocardial infarction), with greater efficacy of higher‐dose edoxaban versus warfarin in patients with malignancy (HR, 0.54; 95% CI, 0.31–0.93) compared with no malignancy (HR, 1.02; 95% CI, 0.88–1.18; interaction P=0.026).ConclusionsIn patients with atrial fibrillation who develop malignancy, the efficacy and safety profile of edoxaban relative to warfarin is preserved, and it may represent a more practical alternative.

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“…The Hokusai VTE-Cancer Study is a multinational, open label, blinded outcome assessment RCT that compared 5 days of dalteparin followed by direct oral anticoagulant, edoxaban (60 mg daily) with dalteparin (200 IU/kg daily for 1 month followed by 150 IU/kg daily) for treatment of cancer-associated VTE 4. Edoxaban was reduced to 30 mg daily if patients had a creatinine clearance of 30–50 mL/hour, body weight <60 kg or required a P-glycoprotein inhibitor.…”

Section: Methodsmentioning

confidence: 99%

Edoxaban is non-inferior to low-molecular-weight heparin for treating cancer-associated venous thromboembolism

Linkins

2018

BMJ EBM

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Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism

Cited by 1,345 publications

References 16 publications

Deep vein thrombosis

Deep vein thrombosis

Efficacy and Safety of Edoxaban in Patients With Active Malignancy and Atrial Fibrillation: Analysis of the ENGAGE AF‐TIMI 48 Trial

Edoxaban is non-inferior to low-molecular-weight heparin for treating cancer-associated venous thromboembolism

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