The first clinical study investigating the use of the direct oral anticoagulant, rivaroxaban, to prevent blood clots in patients with cancer at high-risk published today in the New England Journal of Medicine. The study found no significant reduction in venous thromboembolism or death in the overall 180-day trial period; however, the researchers did observe a lower incidence of these events while patients were actively on the study drug, or during the on-treatment period.
Known as the CASSINI Trial, the study was led by senior author Dr. Gary H. Lyman, senior lead for health care quality and policy at Fred Hutchinson Cancer Research Center, and first author and primary study lead, Dr. Alok Khorana, Director of Gastrointestinal Malignancies at the Cleveland Clinic, and included co-senior author, Dr. Nicole M. Kuderer, who performed this research in part at the Advanced Cancer Research Group and at the University of Washington. The CASSINI Trial was a multicenter, randomized Phase IIIb trial that enrolled 1,080 patients from the U.S. and internationally.
Cancer patients have an increased risk of blood clots, which are elevated by biologic factors of cancer that can alter and thicken the blood and by many types of cancer treatments, including chemotherapy.
“After the cancer itself, blood clots are the second leading cause of death, along with infection, in real-world cancer outpatients receiving chemotherapy, and a major cause of morbidity, mortality and increased costs among patients hospitalized with a blood clot,” said Lyman. “The results of this study will help us understand how we should weigh the potential benefits of reducing blood clots with potential risks, and how to establish a standard for assessing which cancer patients are at the highest risk of developing blood clots.”
