Cabozantinib Safety With Different Anticoagulants in Patients With Renal Cell Carcinoma |
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| Institution: | 1. University of California San Diego, La Jolla, CA;2. Duke University, Durham, NC;3. Mount Auburn Hospital – Harvard Medical School, Cambridge, MA;4. Yale School of Medicine, CT;5. City of Hope, Duarte, CA;6. Emory University, Atlanta, GA;7. Tom Baker Cancer Center, Calgary, Alberta, Canada;8. University Hospitals Seidman Cancer Center, Cleveland, OH;9. Massachusetts General Hospital, Boston, MA;10. Medical College of Wisconsin, Milwaukee, WI;11. Dana Farber Cancer Institute, Boston, MA;1. Faculty of Medicine and Health Technology, Tampere University, Tampere, Pirkanmaa, Finland;2. Tampere University Hospital Cancer Center, Tampere, Pirkanmaa, Finland;3. Faculty of Information Technology and Communication Sciences, Tampere, Pirkanmaa, Finland;4. Research, Development and Innovation Center, Tampere University Hospital, Tampere, Pirkanmaa, Finland;6. Department of Public Health, University of Helsinki, Helsinki, Uusimaa, Finland;1. Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA;2. Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT;3. School of Medicine, University of California San Francisco, San Francisco, CA;4. Yale University School of Medicine, New Haven, CT;1. University of Massachusetts Medical School, Worcester, MA;2. University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center, Miami, FL;3. Dana-Farber Cancer Institute and Brigham and Women''s Hospital, Boston, MA;4. Decipher Biosciences Inc., San Diego, CA;1. Department of Surgical Sciences, Urology, Uppsala University, Sweden;2. Department of Mathematics, Uppsala University, Sweden;3. Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden;4. Department of Surgery, Oncology section, Capio ST: Görans Hospital, Stockholm, Sweden;5. Department of Urology and CLINTEC Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden;6. Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden Department of Pelvic Cancer, Genitourinary Oncology and Urology Unit, Karolinska University Hospital, Stockholm, Sweden;7. Department of Pelvic Cancer, Genitourinary Oncology and Urology Unit, Karolinska University Hospital, Stockholm, Sweden;8. Bayer US, Whippany, New Jersey;9. Pharmacoepidemiology and Risk Management, RTI Health Solutions, Barcelona, Spain;1. Department of Radiation Oncology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran;2. Department of Urology, Tehran University of Medical Sciences, School of Medicine, Tehran, Iran;3. Department of Radiation Oncology, Iran University of Medical Sciences, School of Medicine, Tehran, Iran;4. Department of psychiatry, Iran University of Medical Sciences, School of Medicine, Tehran, Iran;1. Department of Oncology, PSG Institute of Medical Science and Research, Coimbatore, Tamil Nadu, India;2. Department of Pathology, Tata Memorial Hospital, Mumbai, HBNI, Maharashtra, India;3. Department of Surgical Oncology, Tata Memorial Hospital, HBNI, Mumbai, Maharashtra, India;4. Department of Medical Oncology, Tata Memorial Hospital, HBNI, Mumbai, Maharashtra, India;5. Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, Maharashtra, India;6. Department of Radiology, Tata Memorial Hospital, Mumbai, HBNI, Maharashtra, India;7. Department of Nuclear Medicine, Tata Memorial Hospital, HBNI, Mumbai, Maharashtra, India |
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| Abstract: | BackgroundIn 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.MethodsIn 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.ResultsBetween 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]).ConclusionThis 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. |
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