A trial investigating how to prevent blood clots in cancer patients has found that the use of the direct oral anticoagulant rivaroxaban does not result in a significant reduction in venous thromboembolism or death during the 180-day study period.
However, the trial did find the drug reduced the incidence of these events while the participants were taking it.
Writing in the New England Journal of Medicine, the authors said the overall safety profile of rivaroxaban was good, and there was a low risk for major bleeding during both the 180-day trial and on-treatment periods.
The researchers say that the study also highlighted the benefits of screening patients for thromboembolism using the new Khorana Risk Score.
Senior author Dr Gary H. Lyman, senior lead for health care quality and policy at Fred Hutchinson Cancer Research Center, said: “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."
The CASSINI Trial was a multicentre, randomised Phase IIIb trial that enrolled 1,080 patients from the USA and internationally. The trial represents the first large-scale data on the safety and efficacy of new oral anticoagulants as preventive agents for blood clots in cancer patients.
While a significant reduction in risk of venous thromboembolism was observed during the on-treatment period, the study did not find that the drug had a significant impact on its primary outcome of venous thromboembolism during the first 180 days. During this time, many of the participants came off the study drug to a similar extent in both the intervention and placebo arms.
Alongside the AVERT Trial, a second oral anticoagulant study, they are the first Phase III studies to use the Khorana Risk Score to identify cancer outpatient at increased risk for venous thromboembolism.
Co-senior author, Dr Nicole Kuderer, said when they screened patients for blood clots prior to the study, they identified nearly 5% who had a Khorana Risk Score of two or greater who already had unrecognised blood clots.
“This confirmed our previous study where screening identified blood clots in nearly 9% of higher-risk patients who had a Khorana Risk Score greater than or equal to three,” she said.
“These blood clots would otherwise have remained untreated for some time, potentially only being recognised once they travelled to the lungs, at which point some of these clots can be deadly.”
Dr Lyman and colleagues are now hoping to undertake a cost utility analysis, which incorporates impact on patients’ quality of life with drug and other health care costs.
Source: Khorana, A.A., Soff, G.A., Kakkar, A.K., Vadhan-Raj, S., Riess, H., Wun, T., Streiff, M.B., Garcia, D.A., Liebman, H.A., Belani, C.P., O’Reilly, E.M., Patel, J.N., Yimer, H.A., Wildgoose, P., Burton, P., Vijapurkar, U., Kaul, S., Eikelboom, J., McBane, R., Bauer, K.A., Kuderer, N.M., Lyman, G.H., and CASSINI Investigators (2019) “Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer”, New England Journal of Medicine, available at doi: 10.1056/NEJMoa1814630
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