Highlights
- •Data regarding direct oral anticoagulants (DOACs) appear safe for venous thromboembolism (VTE) treatment for patients with RCC on cabozantinib
- •No. of major bleeding events similar between no anticoagulant, low molecular weight heparin (LMWH) or DOAC groups.
- •The rate of new/recurrent VTE was similar among anticoagulant groups
- •Patients with a VTE had significantly worse survival than those without a VTE
Abstract
Background
In patients with renal cell carcinoma (RCC) on cabozantinib, venous thromboembolism
(VTE) management remains challenging due to limited safety data regarding direct oral
anticoagulants (DOACs) use in conjunction with cabozantinib. We investigated the safety
of cabozantinib with different anticoagulants in patients with RCC.
Methods
In this retrospective multicenter study (9 sites), patients with advanced RCC were
allocated into 4 groups: (1) cabozantinib without anticoagulation, cabozantinib with
concomitant use of (2) DOACs, (3) low molecular weight heparin (LMWH), or (4) warfarin.
The primary safety endpoint was the proportion of major bleeding events (defined per
International Society on Thrombosis and Hemostasis criteria). The primary efficacy
endpoint was the proportion of new/recurrent VTE while anticoagulated.
Results
Between 2016 and 2020, 298 patients with RCC received cabozantinib (no anticoagulant = 178,
LMWH = 41, DOAC = 64, and warfarin = 15). Most patients had clear cell histology (78.5%)
and IMDC intermediate/poor disease (78.2%). Cabozantinib was first, second, or ≥ third
line in 21.8%, 31.9%, 43.3% of patients, respectively. Overall, there was no difference
in major bleeding events between the no anticoagulant, LMWH, and DOAC groups (P = .088). Rate of new/recurrent VTE was similar among anticoagulant groups. Patients
with a VTE had a statistically significantly worse survival than without a VTE (HR
1.48 [CI 95% 1.05-2.08, P = .02]).
Conclusion
This real-world cohort provides first data on bleeding and thrombosis complications
in patients with RCC treated with cabozantinib with or without concurrent anticoagulation.
DOACs appear safe for VTE treatment for patients with RCC on cabozantinib, but optimized
anticoagulation management, including individualized risk-benefit discussion, remains
important in clinical practice.
Graphical Abstract
Graphical Abstract
Keywords
Abbreviations:
AXL (Growth arrest-specific protein 6 receptor), CAT (Cancer-associated thrombosis), c-MET (Hepatocyte growth factor receptor), CT (Computerized tomography), DOAC (Direct oral anticoagulant), DVT (Deep venous thrombosis), IMDC (International Metastatic RCC Database Consortium), IO (Immunotherapy), ISTH (International Society on Thrombosis and Hemostasis), LMWH (Low molecular weight heparin), PE (Pulmonary embolism), RCC (Renal cell carcinoma), TKI (Tyrosine kinase inhibitor), VEGFR (Vascular endothelial growth factor receptor), VTE (Venous thromboembolism)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: November 02, 2022
Accepted:
October 24,
2022
Received in revised form:
October 23,
2022
Received:
September 29,
2022
Identification
Copyright
© 2022 Elsevier Inc. All rights reserved.
