Bayer Pharma AG

Essence of this Article

Clinical data on the novel oral direct Factor Xa inhibitors and direct thrombin inhibitors for the prevention of venous thromboembolism (VTE) and the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with cancer are relatively limited. Clinical trials of the novel oral anticoagulants involving patients with cancer include the phase III MAGELLAN trial, which investigated rivaroxaban for VTE prevention in medically ill patients, the phase III studies of novel oral anticoagulants for the treatment of DVT and PE, and a phase II trial of apixaban in patients with metastatic cancer (NCT00320255). Pooled data from the EINSTEIN DVT and EINSTEIN PE trials have shown reassuring efficacy and safety for rivaroxaban compared with LMWH/VKA therapy in patients with cancer, and similar outcomes have been observed with other novel oral anticoagulants. An ongoing prospective clinical study programme is investigating the efficacy and safety of rivaroxaban compared with LMWH in patients with cancer.

Investigational Strategies

Clinical data on the novel oral direct Factor Xa inhibitors and direct thrombin inhibitors for the prevention of VTE and the treatment of DVT and PE in patients with cancer are relatively limited. Clinical trials of the novel oral anticoagulants involving patients with cancer include the phase III MAGELLAN trial, which investigated rivaroxaban for VTE prevention in medically ill patients,310 the phase III studies of novel oral anticoagulants for the treatment of DVT and PE,311-315 and a phase II trial of apixaban in patients with metastatic cancer (NCT00320255).316 Pooled data from the EINSTEIN DVT and EINSTEIN PE trials of rivaroxaban compared with LMWH/VKA therapy have been published.317 This analysis represents the largest group of patients with cancer in any of the phase III studies of the novel oral anticoagulants (both absolute numbers and proportion of the total population), and shows a reassuring efficacy and safety profile for rivaroxaban compared with LMWH/VKA therapy in patients with cancer. Similar outcomes have been observed in analyses of the phase III studies of other novel oral anticoagulants.318-320 It should be noted that these studies used LMWH/VKA as the comparator regimen, which is the established standard of care in most patients but not in those with cancer, who usually receive LMWH alone. A programme of prospective studies is now underway to investigate the pharmacokinetics, efficacy and safety of rivaroxaban for the prophylaxis and treatment of VTE specifically in patients with cancer.


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