MUNICH, August 6, 2018 /PRNewswire/ --
- Hokusai-VTE CANCER study showed that oral edoxaban is non-inferior to subcutaneous injectable dalteparin, for the composite outcome of recurrent venous thromboembolism (VTE) and major bleeding in cancer-associated VTE - This analysis provides benefit/risk assessment in different types of cancer patient populations[1] - In those with non-gastrointestinal cancer, the risk of major bleeding was comparable[1]
Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo), today announced the publication of a new analysis, focusing on the clinical presentation, course and outcome of bleeding events, and the associated tumour types from the Hokusai-VTE CANCER study.[1] The data, published in the journal Thrombosis and Haemostasis, identified that edoxaban is an appropriate alternative to dalteparin and that further consideration is needed for the treatment of patients with gastrointestinal cancer.[1]
The study found that the rate of recurrent VTE was 3.4% lower with edoxaban compared to dalteparin (HR: 0.71; p = 0.09), whilst the rate of major bleeding (as defined by the International Society on Thrombosis and Haemostasis [ISTH]), was 2.9% higher (HR: 1.77; p = 0.04).[1] Major bleeding occurred in 32 out of 522 patients on edoxaban, with 20 of the 32 (62.5%) requiring hospitalisation, whilst in the dalteparin group, 16 out of 524 patients experienced major bleeding, with 13 of the 16 (81.3%) requiring hospitalisation. The number of patients needing admission to the intensive care unit was 18 (56.3%) in the edoxaban group versus 12 (75.0%) in the dalteparin group.[1] It was identified that no patients had more than one major bleed and that the additional instances of major bleeding with edoxaban were confined to patients with gastrointestinal cancer and predominantly occurred in the upper gastrointestinal tract.[1] Major bleeding was classified according to the ISTH definition, though most events only required red blood cell transfusion.[1] Among patients with non-gastrointestinal cancer, the risk of major bleeding was comparable.[1]
In patients with gastrointestinal cancer, the risk of bleeding in the edoxaban group was 12.7%, compared to 3.6% among those treated with dalteparin (HR: 4.0; 95% CI, 1.5-10.6; p = 0.005).[1] The risk of severe major bleeding (ISTH category 3 or 4) in patients with gastrointestinal cancer was comparable between patients on edoxaban and dalteparin.[1] There were no fatal bleeds among those treated with edoxaban versus two in the dalteparin group.[1]
"We've seen previously that edoxaban offers an alternative to treatment with dalteparin for patients with cancer-associated VTE and these findings provide valuable clarity on its optimum use in patients with different types of cancer," said Professor Peter Verhamme, Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium. "It has been shown that for those with non-gastrointestinal cancer, the risk of major bleeding is comparable across patients treated with edoxaban versus dalteparin. While we are still investigating what specifically causes the higher risk of bleeding with edoxaban in gastrointestinal cancer patients, these data provide important insights that we need to weigh up in treatment decisions, considering the risk of recurrent VTE, patient preference regarding drug administration and the possible severity of bleeding."
The Hokusai-VTE CANCER study was conducted in 1,050 patients with cancer-associated VTE, and included a broad spectrum of cancer patients, representative of those seen in clinical practice. Most patients had solid tumours originating from the gastrointestinal tract, lung or breast that were metastatic in over half of the cases at randomisation.[1]
VTE is a common complication in cancer patients and is a leading cause of morbidity and mortality.[1] It is estimated that 3-15% of patients with active cancer suffer from VTE, depending on cancer type,[1] and that the prevalence of VTE in hospitalised patients is increasing.[2] VTE can interrupt cancer treatment, which could have a negative impact on patient outcomes.[3]
The new findings reported in Thrombosis and Haemostasis are further supported by a paper published in Expert Opinion on Pharmacotherapy, which reviewed expert opinion and guidance in cancer-associated thrombosis (CAT).[4] The review noted that edoxaban is non-inferior to dalteparin, with a trend towards fewer recurrent VTE events, but with more major bleeding events.[4] It was cited that similar findings to these were reported with rivaroxaban, though the study was not powered to allow definitive conclusions and no information was reported on concomitant cancer drugs.[4] The review states that The National Comprehensive Cancer Network (NCCN) (US) recently updated their guidelines giving edoxaban a level 1 recommendation for treatment of patients with CAT, indicating a uniform consensus that edoxaban is appropriate based on a high level of evidence.[4] By comparison, other non-vitamin K oral anticoagulants (NOACs; apixaban, rivaroxaban and dabigatran) received a level 2A recommendation, indicating that the consensus is based on lower level evidence.[4],[5] The review concluded that NOACs are an alternative to low molecular weight heparin (LMWH) for the treatment of CAT for the majority of patients with active cancer.[4]
The Scientific and Standardization Committee of the ISTH also issued guidance recently, suggesting NOACs for the treatment of cancer-associated VTE. Reporting that only two NOACs, edoxaban and rivaroxaban, have been compared to LMWH in randomised clinical trials, their use was recommended in patients with a low risk of bleeding and no drug-drug interactions with current system therapy.[6]
About Edoxaban
Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting. Edoxaban is currently marketed in Japan, the U.S., South Korea, Hong Kong, Taiwan, Thailand, Canada, Germany, the U.K., Switzerland, Ireland, the Netherlands, Italy, Spain, Belgium, Austria, Portugal, and other European countries.
The edoxaban Summary of Product Characteristics can be viewed here: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_... .
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