Abstract
The development of venous thromboembolism is one of the major causes of morbidity and mortality in patients with cancer. The standard treatment of deep venous thrombosis or pulmonary embolism occurring in patients with active malignancy remains the use of low molecular weight heparins. However, in clinical practice, practitioners are frequently asked about the efficacy and safety of various new oral anticoagulants in cancer patients. In the United States, there are currently 4 different novel oral anticoagulants commercially available with the indication of the treatment of acute venous thromboembolism. These include dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa). Use of these new medications is appealing due to the ease of administration, avoidance of injections, ability to use in patients with decreased renal or liver function, and consistent efficacy without fooddrug interactions. Currently, the only available data for the use of these new oral anticoagulants in cancer patients is from subgroup analysis of larger studies with no statistical significance. However, this preliminary data is encouraging that the novel oral anticoagulants may be effective and safe for primary and secondary prevention of venous thromboembolism in cancer patients. Further clinical trials are greatly needed for the head-tohead comparison of these novel oral anticoagulants versus low molecular weight heparins. Although the routine use of novel oral anticoagulants for the prevention or treatment of venous thromboembolism in cancer patients cannot be recommended at this time, we strongly support the development of Phase III trials assessing their efficacy and safety in patients with active malignancies compared to the current standard of care treatment with low molecular weight heparin.
Highlights
Active malignancy is a significant risk factor for the development of venous thromboembolism (VTE)
The pooled incidence rate of recurrent VTE/VTE-related death was 4.6% in patients treated with novel oral anticoagulants (NOACs) and 5.5% in patients treated with low molecular weight heparin (LMWH)/vitamin K antagonists (VKA)/placebo
The only available data for the use of NOACs in cancer patients is from subgroup analysis of larger studies with no statistical significance
Summary
Active malignancy is a significant risk factor for the development of venous thromboembolism (VTE). The EINSTEIN-PE study enrolled 4832 patients who had acute symptomatic pulmonary embolism and compared rivaroxaban to enoxaparin followed by VKA for 3, 6 or 12 months [24] Both studies concluded that rivaroxaban had non-inferior efficacy in preventing recurrent VTE and PE compared to standard therapy of enoxaparin bridge followed by warfarin. The EINSTEIN-DVT study included 207 (6%) patients with active cancer and the EINSTEIN-PE study included 223 (4.6%) patients with active cancer [23,24] Pooled analysis of these studies showed that treatment with Rivaroxaban or LMWH followed by VKA had similar rates of recurrent VTE in patients with active cancer [25]. In January 2015, the FDA approved edoxaban in the US for prevention of stroke in non-valvular atrial fibrillation and for the treatment of acute VTE (Table 2)
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