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Cabozantinib Safety with Different Anticoagulants in Patients With Renal Cell Carcinoma (RCC)

1University of California San Diego, San Diego, California, United States, 2Duke University, Durham, North Carolina, United States, 3City of Hope, Duarte, California, United States, 4Emory University, Atlanta, Georgia, United States, 5Tom Baker Cancer Center, Calgary, Alberta, Canada, 6Tulane University, New Orleans, Louisiana, United States, 7Massachusetts General Hospital, Boston, Massachusetts, United States, 8Dana Farber Cancer Institute, Boston, Massachusetts, United States

Abstract Number: OC 25.2

Meeting: ISTH 2022 Congress

Theme: Venous Thromboembolism » Cancer Associated Thrombosis

Background: Anti-Xa direct oral anticoagulants (DOACs) are widely used for venous thromboembolism (VTE) treatment in patients with cancer. But, in patients with RCC on cabozantinib, VTE management remains a challenge due to poor understanding of bleeding complications with concurrent use DOACs. Thus far, cabozantinib clinical trials excluded patients on DOACs while allowing concurrent use of low molecular weight heparin (LMWH).

Aims: Investigate cabozantinib safety profile with different anticoagulants in patients with RCC.

Methods: In this updated retrospective multicenter study (8 sites), patients with advanced RCC were allocated into four groups: cabozantinib with concomitant use (at least 1 week) of 1) no anticoagulant, 2) DOACs, 3) LMWH, or 4) warfarin. Primary safety endpoint was major bleeding proportions (defined per ISTH criteria) among the four groups. Secondary efficacy endpoint was new/recurrent VTE proportions while anticoagulated. Overall comparison between groups analysis was by Fisher exact test. Median overall survival between individuals with and without VTE was estimated by Kaplan-Meier method and survival distribution by Logrank test.

Results: Between 2016-2020, 298 patients with RCC received cabozantinib (No anticoagulant 178, LMWH 41, DOAC 64, and warfarin 15). Median age was 62 years [IQR 53-69]. Most were White males, underwent nephrectomy, with intermediate/poor IMDC risk stratification stage 4 clear cell RCC, and had pulmonary metastases. No overall difference of major bleeding events was found between the four-group comparison (p=0.088, Table 1). No difference of new/recurrent VTE proportions was found among the different anticoagulant groups. Patients with a VTE had a statistically significant worse survival than patients without a VTE [HR 1.48 (CI 95% 1.05 to 2.08, P value 0.02), figure 1].

Conclusion(s): This cohort provides first real-world experience on bleeding and thrombosis complications in patients with RCC. DOACs are safe and effective as an anticoagulant therapy in patients with RCC on cabozantinib. Importantly, VTE is associated with worse mortality in RCC.

To cite this abstract in AMA style:

Mesleh Shayeb A, Dzimitrowicz H, Urman D, Dizman N, Meza L, Sivakumar A, Gan C, Zhang T, Barata P, Bilen M, Gao X, Heng D, Pal S, Kaymakcalan M, McGregor B, Choueiri T, Mckay R. Cabozantinib Safety with Different Anticoagulants in Patients With Renal Cell Carcinoma (RCC) [abstract]. https://abstracts.isth.org/abstract/cabozantinib-safety-with-different-anticoagulants-in-patients-with-renal-cell-carcinoma-rcc/. Accessed September 22, 2023.

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