Head-to-head observational analysis showed Xarelto as effective in treating cancer-associated thromboembolism (CAT) as apixaban.
The Janssen Pharmaceutical Companies of Johnson & Johnson have announced observational data from eight years of clinical practice showing that the oral Factor Xa inhibitor Xarelto (rivaroxaban) is associated with comparable effectiveness and safety to the Factor Xa inhibitor apixaban for the treatment of CAT in a broad cohort of patients with various cancer types. Patients with CAT are at a higher risk of venous thromboembolism (VTE), which is the second-leading cause of death in people with cancer.
Data from the OSCAR (Cancer-Associated Thrombosis for Rivaroxaban) study found Xarelto showed non-inferiority for the composite outcome of recurrent VTE or any bleeding resulting in hospitalisation for treatment of patients with CAT. Janssen and its development partner Bayer featured results in an oral presentation at the American Society of Haematology (ASH) 64th Annual Meeting and Exposition (11 December 2022, New Orleans, USA). The study further adds to the robust real-world evidence for Xarelto, with over 300,000 patients having been evaluated in published real-world research since its initial approval in the USA in 2011.
“The OSCAR study provides robust, real-world evidence in patients with CAT and builds upon previous Xarelto safety and efficacy data observed in both clinical practice and in randomised clinical trials. The data show Xarelto can be an effective option for these patients who are at an increased risk of potentially life-threatening blood clots,” said Craig I Coleman (University of Connecticut, Connecticut, USA).
VTE occurs when a blood clot forms in a vein, affecting between 300,000 to 600,000 Americans each year, commonly triggered by surgery, cancer, immobilisation and hospitalisation. VTE is a common cause of morbidity and mortality and people with cancer are at a higher risk for developing VTE than people without cancer. In fact, cancer is known to increase the risk of VTE, with cancer patients having a four to seven times increased risk of developing VTE. These patients also have a higher risk of recurrent VTE and of bleeding.
Previous studies such as SELECT-D and CONKO-11 demonstrated that changing from a low molecular weight heparin (LMWH) to Xarelto was associated with a reduction in risk of recurrent thrombosis and improved patient satisfaction.
“For more than a decade, Xarelto has been a leading DOAC [direct-acting oral anticoagulant], providing an important treatment option for those who prefer an oral alternative over treatment with low molecular weight heparin by injection,” added Avery Ince, vice president of Cardiovascular & Metabolism at Janssen Scientific Affairs. “This retrospective study reasserts the broad clinical utility of Xarelto and the benefit of oral therapy for these patients.”
The OSCAR Study
This observational study used USA Optum de-identified electronic health data from January 2013 to December 2020. A cohort of 2,437 patients 18 years of age and older with CAT for whom DOACs are endorsed by guidelines as alternatives to low molecular weight heparin was included. Patients with active cancer, excluding oesophageal, gastric, unresected colorectal, bladder, leukaemia or central nervous system cancers (except brain cancer, which was included), were enrolled in the study after experiencing a hospital, emergency department or observation unit admission for VTE or pulmonary embolism (PE) event.
The retrospective eight-year study assessed the time to first composite event of recurrent VTE or any bleeding resulting in hospitalisation at a minimum follow-up of three months. Other outcomes assessed included the composite of recurrent VTE or any critical organ bleeding, recurrent VTE, any bleeding resulting in hospitalisation, and any critical organ bleeding at three and six months.
Key OSCAR Findings
At three and six months, Xarelto was as effective and safe as apixaban in the composite outcome of recurrent VTE or bleeding-related hospitalisation. At three months, patients receiving Xarelto had a numerically lower rate of the primary endpoint (5.3% versus 6.0%; HR=0.87, 95% CI=0.60–1.27). No significant differences were observed between groups for this outcome at six months or for other outcomes at three or six months.