Rivaroxaban Reduces VTE in Patients with Pancreatic Cancer

Rivaroxaban is an effective thromboprophylactic for patients with pancreatic cancer receiving systemic therapy, according to a subanalysis of the CASSINI trial presented at the American Society of Clinical Oncology’s 2019 annual meeting.

The multicenter, risk-adapted CASSINI trial demonstrated that rivaroxaban significantly reduces venous thromboembolism (VTE) and VTE-related deaths for outpatient, at-risk cancer patients during the intervention period. Alok Khorana, MD, Vice Chair of Clinical Services and Director of the Gastrointestinal Malignancies Program, was co-chair of the steering committee of the trial and presented the results as a late-breaking abstract at the 2018 American Society of Hematology meeting. The results were also published in the New England Journal of Medicine in February 2019.

The current study sought to establish rivaroxaban’s efficacy in ambulatory patients with pancreatic cancer, who are at particular risk of VTE. “Patients with pancreatic cancer have among the highest risk of VTE observed in any solid tumor,” says Dr. Khorana.

A change in practice is warranted

CASSINI included 841 patients, of which 273 (32.6%) had pancreatic cancer; median age of this subgroup was 66 years, and 57% were male. Patients at high risk for VTE (Khorana score ≥ 2) were randomized one-to-one to rivaroxaban 10 mg once daily or a placebo for 180 days. Patients received a screening ultrasound as well as a blood draw every eight weeks starting at baseline.

Only 2.75% of patients with pancreatic cancer who took rivaroxaban developed blood clots (symptomatic deep vein thrombosis, asymptomatic proximal DVT, pulmonary embolism and VTE-related death) compared with 10.1% of the placebo group (HR 0.35; 95% CI, 0.13- 0.97; P = 0.03) during intervention. The rate of International Society on Thrombosis and Hemostasis-defined major bleeding, the primary safety endpoint, did not increase and occurred in 1.5% of patients in the treatment arm and 2.3% in the placebo arm.

When adding secondary endpoints (arterial/visceral events) to primary, benefit from rivaroxaban increased further, with only 4% of patients experiencing events on rivaroxaban versus 12% in the placebo arm (HR, 0.34; 95% CI, 0.14-0.87, P = 0.02).

“This study provides further evidence for what we hope becomes a change in practice in our approaches to preventing cancer-associated VTE,” says Dr. Khorana. “For pancreatic cancer patients, prevention of these events is even more important given the known high rate of thrombosis and lack of increased bleeding observed in our analysis.”