Daiichi Sankyo has announced the results of a prespecified subgroup analysis of 771 cancer patients enrolled in the phase 3 Hokusai-VTE study. Patients with either a history of cancer or with active cancer treated with the once-daily factor Xa inhibitor Edoxaban ( Lixiana, Savaysa ) had a numerically lower incidence of recurrent symptomatic venous thromboembolism ( VTE ) compared to Warfarin.
Once-daily edoxaban also had a lower incidence of clinically relevant bleeding ( major or non-major ) compared to Warfarin ( Coumadin ) in cancer patients.
These findings are consistent with the results from the wider study population of 8,292 patients, which found once-daily Edoxaban met the primary efficacy endpoint of non-inferiority for the treatment and prevention of venous thromboembolism and superiority for the pre-specified principal safety outcome of clinically relevant bleeding compared to Warfarin.
The data from this subgroup analysis of the phase 3 Hokusai-VTE study were presented at the 2013 American Society of Hematology Annual Meeting.
Venous thromboembolism is a common complication in cancer patients and it is a major cause of morbidity and mortality in these patients, with an annual incidence that can be as high as 20% depending on the cancer type, background risk, and time since diagnosis.
In the subset of 208 patients with active cancer, once-daily Edoxaban had a rate of venous thromboembolism recurrence of 3.7% compared to 7.1% for Warfarin, and an incidence of clinically relevant bleeding of 18.3% compared to 25.3% for Warfarin.
In cancer patients, there is a significantly increased risk of venous thromboembolism compared to the general population due to proteins released by malignant tumors that promote coagulation. Studies have suggested that patients with cancers of the pancreas, lung, stomach and adenocarcinomas of unknown primary origin are at the highest risk of venous thromboembolism due to the release of mucin, a protein commonly found in these types of cancers that can contribute to coagulation through the aggregation of platelets. Certain anticancer therapies, such as chemotherapy, immunomodulatory agents and antiangiogenic agents also increase the risk of venous thromboembolism in this patient population. ( Xagena )
Source: Daiichi Sankyo, 2013