Journal: Blood advances
This publication evaluates thromboembolic risk with cabozantinib using both trial-level and real-world data.
Design:
- – Systematic review and meta-analysis of 14 randomized controlled trials (n=4204) comparing cabozantinib to placebo or usual care in solid tumors.
- – Retrospective cohort study from a single health system including 295 cabozantinib-treated patients.
Key efficacy/safety findings from RCTs:
- – Overall thromboembolism rate: 5% (212/4204 patients).
- – Any thromboembolism:
- – Increased with cabozantinib: RR 2.41 (95% CI, 1.72–3.39).
- – Venous thromboembolism (VTE):
- – Main driver of excess risk: RR 3.21 (95% CI, 1.86–5.55).
- – Arterial thromboembolism (ATE):
- – No statistically significant increase: RR 1.31 (95% CI, 0.76–2.26).
- – After adjusting for differences in progression-free survival (time on treatment):
- – Any thromboembolism: RR 1.47 (95% CI, 1.02–2.12).
- – VTE: RR 1.92 (95% CI, 1.08–3.43).
- – ATE: RR 0.76 (95% CI, 0.41–1.40), still not increased.
Real-world cohort:
- – 295 patients on cabozantinib.
- – Thromboembolism incidence: 180 events per 1000 patient-years.
- – Most events occurred within the first 3 months of therapy.
Clinical implications:
- – Cabozantinib is clearly associated with an increased risk of VTE, but not convincingly with ATE.
- – Risk is highest early after treatment initiation.
- – In practice, this supports careful baseline VTE risk assessment, early-period monitoring, and a low threshold for diagnostic workup of suspected VTE in patients receiving cabozantinib.