This study looked at whether a low dose (10 mg daily) of the blood-thinning tablet rivaroxaban can prevent blood clots in high-risk people with cancer treated as outpatients. Over the whole 180-day study period, the reduction in clots (6.0% versus 8.8% with placebo) was not statistically significant. But while patients were actually taking the drug, clots were clearly less common (2.6% versus 6.4%). Serious bleeding with rivaroxaban was low (2.0% versus 1.0% with placebo). Whether preventive treatment is right for you depends on your risk of clots and your risk of bleeding, and should be decided with your doctor.
High-risk outpatient (Khorana ≥2) on systemic treatment, without DVT on screening
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Rivaroxaban | 10 mg once a day | Oral | Continuous |
In CASSINI, the reduction in VTE over the whole 180 days was not significant, but during the on-treatment period it was 2.6% vs 6.4%; major bleeding 2.0% vs 1.0%.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Rivaroxaban 10 mg orally daily for up to 180 days, with screening every 8 weeks.
Placebo daily for up to 180 days, double-blind, with screening every 8 weeks.
Source of the regimen details: Abstract of the paper (N Engl J Med 2019)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
High-risk ambulatory patients with cancer and a Khorana score ≥2 (on a scale of 0 to 6; higher scores indicate a greater risk of venous thromboembolism) who had no deep-vein thrombosis (DVT) on initial screening. Of the 1080 enrolled patients, 49 (4.5%) had thrombosis at screening and were not randomised. Other inclusion criteria are not given in the abstract.
Primary efficacy endpoint: a composite of objectively confirmed proximal lower-limb DVT, pulmonary embolism, symptomatic upper-limb DVT or distal lower-limb DVT, and death from venous thromboembolism, up to day 180.
Prespecified supporting analysis: the same endpoint during the intervention period (from the first dose of trial drug to 2 days after the last dose).
Primary safety endpoint: major bleeding.
Major bleeding occurred in 8 of 405 patients (2.0%) in the rivaroxaban group and 4 of 404 patients (1.0%) in the placebo group (hazard ratio 1.96; 95% CI 0.59–6.49). Other adverse events are not reported in the abstract.
In CASSINI, rivaroxaban 10 mg daily did not significantly reduce venous thromboembolism over the whole 180-day period, but it markedly reduced events during the on-treatment period, and major bleeding was low. After this trial and the AVERT trial (apixaban) were published, the 2020 update of the ASCO guideline allowed prophylaxis with apixaban, rivaroxaban or low-molecular-weight heparin (LMWH) for selected high-risk ambulatory patients (Key NS et al., J Clin Oncol 2020). The 2022 international ITAC guideline recommends primary prophylaxis with rivaroxaban or apixaban for ambulatory patients with a Khorana score ≥2 who are not at high risk of bleeding (grade 1B; Farge D et al., Lancet Oncol 2022). The 10 mg daily dose in this trial was a prophylactic dose and differs from the DVT/PE treatment dose in the FDA label for rivaroxaban (15 mg twice daily with food for 21 days, then 20 mg once daily with food).
According to the abstract: the primary endpoint over the whole 180-day period was not statistically significant (P=0.10), and a significant reduction in events was seen only in the prespecified supporting analysis of the intervention period. Major bleeding events were few and the confidence interval of the hazard ratio was wide (0.59–6.49). Patients with thrombosis on initial screening were excluded. Cancer types, adherence and other inclusion criteria are not given in the abstract.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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