CASSINI
Trial question
What is the role of rivaroxaban in high-risk ambulatory patients with cancer?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 841
841 patients (413 female, 428 male).
Inclusion criteria: high-risk ambulatory adult patients with cancer.
Key exclusion criteria: primary brain tumor or known brain metastases; active bleeding or at risk for bleeding; ECOG performance-status score of ≥ 3.
Interventions
N=420 rivaroxaban (a dose of 10 mg daily for 6 months).
N=421 placebo (matching placebo daily for 6 months).
Primary outcome
Thrombotic events at 6 months
6%
8.8%
8.8 %
6.6 %
4.4 %
2.2 %
0.0 %
Rivaroxaban
Placebo
No significant
difference ↔
No significant difference in thrombotic events at 6 months (6% vs. 8.8%; HR 0.66, 95% CI 0.4 to 1.09).
Secondary outcomes
No significant difference in death at day 180 (20% vs. 23.8%; HR 0.83, 95% CI 0.62 to 1.11).
No significant difference in symptomatic proximal DVT in the lower limb at day 180 (2.1% vs. 1.9%; HR 1.12, 95% CI 0.43 to 2.91).
No significant difference in symptomatic distal DVT in the lower limb at day 180 (0.5% vs. 1.2%; HR 0.4, 95% CI 0.08 to 2.07).
Safety outcomes
No significant differences in major bleeding, clinically relevant nonmajor bleeding, adverse and serious adverse events.
Conclusion
In high-risk ambulatory adult patients with cancer, rivaroxaban was not superior to placebo with respect to thrombotic events at 6 months.
Reference
Alok A Khorana, Gerald A Soff, Ajay K Kakkar et al. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728.
Open reference URL