Cabozantinib Safety With Different Anticoagulants in Patients With Renal Cell Carcinoma
•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...
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Veröffentlicht in: | Clinical genitourinary cancer 2023-02, Vol.21 (1), p.55-62 |
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creator | Shayeb, Akram M. McManus, Hannah Dzimitrowicz Urman, Danielle Jani, Chinmay Zhang, Tian Dizman, Nazli Meza, Luis Sivakumar, Akhilesh Gan, Chun L. Barata, Pedro Bilen, Mehmet A. Gao, Xin Heng, Daniel Pal, Sumanta Narra, Ravi Kilari, Deepak Kaymakcalan, Marina D. McGregor, Bradley Choueiri, Toni K. McKay, Rana R. |
description | •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
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.
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.
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]).
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.
[Display omitted]
In this retrospective multicenter study (9 sites), including 298 patients with advanced RCC, we investigated the safety of cabozantinib with different anticoagulants. DOACs appear safe for VTE treatment for patients with RCC on cabozan |
doi_str_mv | 10.1016/j.clgc.2022.10.013 |
format | Article |
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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.
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.
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]).
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.
[Display omitted]
In this retrospective multicenter study (9 sites), including 298 patients with advanced RCC, we investigated the safety of cabozantinib with different anticoagulants. DOACs appear safe for VTE treatment for patients with RCC on cabozantinib as we did not observe any difference in major bleeding events between the no anticoagulant, LMWH, and DOAC groups. Optimized anticoagulation management remains vital in clinical practice.</description><identifier>ISSN: 1558-7673</identifier><identifier>EISSN: 1938-0682</identifier><identifier>DOI: 10.1016/j.clgc.2022.10.013</identifier><identifier>PMID: 36411184</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Administration, Oral ; Anticoagulants - adverse effects ; Bleeding ; Carcinoma, Renal Cell - complications ; Carcinoma, Renal Cell - drug therapy ; DOAC ; Hemorrhage - chemically induced ; Hemorrhage - complications ; Hemorrhage - epidemiology ; Heparin, Low-Molecular-Weight - adverse effects ; Humans ; Kidney Neoplasms - complications ; Kidney Neoplasms - drug therapy ; LMWH ; Neoplasms - chemically induced ; Neoplasms - complications ; Neoplasms - drug therapy ; Thrombosis ; Venous Thromboembolism - drug therapy ; VTE ; Warfarin - adverse effects</subject><ispartof>Clinical genitourinary cancer, 2023-02, Vol.21 (1), p.55-62</ispartof><rights>2022 Elsevier Inc.</rights><rights>Copyright © 2022 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-76293328180c901eb5f3df4c7072e1bdc735359097feb4185c549403471f9b83</citedby><cites>FETCH-LOGICAL-c356t-76293328180c901eb5f3df4c7072e1bdc735359097feb4185c549403471f9b83</cites><orcidid>0000-0002-1675-8479 ; 0000-0002-8298-0289 ; 0000-0002-6917-5568 ; 0000-0002-5063-2191 ; 0000-0003-4956-9129 ; 0000-0001-7846-2326 ; 0000-0002-8890-2951 ; 0000-0002-3907-8513 ; 0000-0003-1455-2976 ; 0000-0002-0235-297X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36411184$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shayeb, Akram M.</creatorcontrib><creatorcontrib>McManus, Hannah Dzimitrowicz</creatorcontrib><creatorcontrib>Urman, Danielle</creatorcontrib><creatorcontrib>Jani, Chinmay</creatorcontrib><creatorcontrib>Zhang, Tian</creatorcontrib><creatorcontrib>Dizman, Nazli</creatorcontrib><creatorcontrib>Meza, Luis</creatorcontrib><creatorcontrib>Sivakumar, Akhilesh</creatorcontrib><creatorcontrib>Gan, Chun L.</creatorcontrib><creatorcontrib>Barata, Pedro</creatorcontrib><creatorcontrib>Bilen, Mehmet A.</creatorcontrib><creatorcontrib>Gao, Xin</creatorcontrib><creatorcontrib>Heng, Daniel</creatorcontrib><creatorcontrib>Pal, Sumanta</creatorcontrib><creatorcontrib>Narra, Ravi</creatorcontrib><creatorcontrib>Kilari, Deepak</creatorcontrib><creatorcontrib>Kaymakcalan, Marina D.</creatorcontrib><creatorcontrib>McGregor, Bradley</creatorcontrib><creatorcontrib>Choueiri, Toni K.</creatorcontrib><creatorcontrib>McKay, Rana R.</creatorcontrib><title>Cabozantinib Safety With Different Anticoagulants in Patients With Renal Cell Carcinoma</title><title>Clinical genitourinary cancer</title><addtitle>Clin Genitourin Cancer</addtitle><description>•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
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.
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.
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]).
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.
[Display omitted]
In this retrospective multicenter study (9 sites), including 298 patients with advanced RCC, we investigated the safety of cabozantinib with different anticoagulants. DOACs appear safe for VTE treatment for patients with RCC on cabozantinib as we did not observe any difference in major bleeding events between the no anticoagulant, LMWH, and DOAC groups. Optimized anticoagulation management remains vital in clinical practice.</description><subject>Administration, Oral</subject><subject>Anticoagulants - adverse effects</subject><subject>Bleeding</subject><subject>Carcinoma, Renal Cell - complications</subject><subject>Carcinoma, Renal Cell - drug therapy</subject><subject>DOAC</subject><subject>Hemorrhage - chemically induced</subject><subject>Hemorrhage - complications</subject><subject>Hemorrhage - epidemiology</subject><subject>Heparin, Low-Molecular-Weight - adverse effects</subject><subject>Humans</subject><subject>Kidney Neoplasms - complications</subject><subject>Kidney Neoplasms - drug therapy</subject><subject>LMWH</subject><subject>Neoplasms - chemically induced</subject><subject>Neoplasms - complications</subject><subject>Neoplasms - drug therapy</subject><subject>Thrombosis</subject><subject>Venous Thromboembolism - drug therapy</subject><subject>VTE</subject><subject>Warfarin - adverse effects</subject><issn>1558-7673</issn><issn>1938-0682</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMtOwzAQRS0EoqXwAyxQlmxa_IjjRGJThadUCQSVurQcZ1xc5VHsBKl8PQ4Flmzs0fjM1fggdE7wjGCSXG1mulrrGcWUhsYME3aAxiRj6RQnKT0MNefpVCSCjdCJ9xuMY04EPkYjlsSEkDQeo1WuivZTNZ1tbBG9KgPdLlrZ7i26scaAg6aL5uFVt2rdV4HzkW2iZ9VZGOpv8gUaVUU5VOFQTtumrdUpOjKq8nD2c0_Q8u52mT9MF0_3j_l8MdWMJ11YjmaM0ZSkWGeYQMENK02sBRYUSFFqwTjjGc6EgSImKdc8zmLMYkFMVqRsgi73sVvXvvfgO1lbr8MmqoG295IKluEkoSwJKN2j2rXeOzBy62yt3E4SLAefciMHn3LwOfSCzzB08ZPfFzWUfyO_AgNwvQcgfPLDgpNeBzUaSutAd7Js7X_5X6FJhSs</recordid><startdate>202302</startdate><enddate>202302</enddate><creator>Shayeb, Akram M.</creator><creator>McManus, Hannah Dzimitrowicz</creator><creator>Urman, Danielle</creator><creator>Jani, Chinmay</creator><creator>Zhang, Tian</creator><creator>Dizman, Nazli</creator><creator>Meza, Luis</creator><creator>Sivakumar, Akhilesh</creator><creator>Gan, Chun L.</creator><creator>Barata, Pedro</creator><creator>Bilen, Mehmet A.</creator><creator>Gao, Xin</creator><creator>Heng, Daniel</creator><creator>Pal, Sumanta</creator><creator>Narra, Ravi</creator><creator>Kilari, Deepak</creator><creator>Kaymakcalan, Marina D.</creator><creator>McGregor, Bradley</creator><creator>Choueiri, Toni K.</creator><creator>McKay, Rana R.</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-1675-8479</orcidid><orcidid>https://orcid.org/0000-0002-8298-0289</orcidid><orcidid>https://orcid.org/0000-0002-6917-5568</orcidid><orcidid>https://orcid.org/0000-0002-5063-2191</orcidid><orcidid>https://orcid.org/0000-0003-4956-9129</orcidid><orcidid>https://orcid.org/0000-0001-7846-2326</orcidid><orcidid>https://orcid.org/0000-0002-8890-2951</orcidid><orcidid>https://orcid.org/0000-0002-3907-8513</orcidid><orcidid>https://orcid.org/0000-0003-1455-2976</orcidid><orcidid>https://orcid.org/0000-0002-0235-297X</orcidid></search><sort><creationdate>202302</creationdate><title>Cabozantinib Safety With Different Anticoagulants in Patients With Renal Cell Carcinoma</title><author>Shayeb, Akram M. ; McManus, Hannah Dzimitrowicz ; Urman, Danielle ; Jani, Chinmay ; Zhang, Tian ; Dizman, Nazli ; Meza, Luis ; Sivakumar, Akhilesh ; Gan, Chun L. ; Barata, Pedro ; Bilen, Mehmet A. ; Gao, Xin ; Heng, Daniel ; Pal, Sumanta ; Narra, Ravi ; Kilari, Deepak ; Kaymakcalan, Marina D. ; McGregor, Bradley ; Choueiri, Toni K. ; McKay, Rana R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-76293328180c901eb5f3df4c7072e1bdc735359097feb4185c549403471f9b83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Administration, Oral</topic><topic>Anticoagulants - adverse effects</topic><topic>Bleeding</topic><topic>Carcinoma, Renal Cell - complications</topic><topic>Carcinoma, Renal Cell - drug therapy</topic><topic>DOAC</topic><topic>Hemorrhage - chemically induced</topic><topic>Hemorrhage - complications</topic><topic>Hemorrhage - epidemiology</topic><topic>Heparin, Low-Molecular-Weight - adverse effects</topic><topic>Humans</topic><topic>Kidney Neoplasms - complications</topic><topic>Kidney Neoplasms - drug therapy</topic><topic>LMWH</topic><topic>Neoplasms - chemically induced</topic><topic>Neoplasms - complications</topic><topic>Neoplasms - drug therapy</topic><topic>Thrombosis</topic><topic>Venous Thromboembolism - drug therapy</topic><topic>VTE</topic><topic>Warfarin - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shayeb, Akram M.</creatorcontrib><creatorcontrib>McManus, Hannah Dzimitrowicz</creatorcontrib><creatorcontrib>Urman, Danielle</creatorcontrib><creatorcontrib>Jani, Chinmay</creatorcontrib><creatorcontrib>Zhang, Tian</creatorcontrib><creatorcontrib>Dizman, Nazli</creatorcontrib><creatorcontrib>Meza, Luis</creatorcontrib><creatorcontrib>Sivakumar, Akhilesh</creatorcontrib><creatorcontrib>Gan, Chun L.</creatorcontrib><creatorcontrib>Barata, Pedro</creatorcontrib><creatorcontrib>Bilen, Mehmet A.</creatorcontrib><creatorcontrib>Gao, Xin</creatorcontrib><creatorcontrib>Heng, Daniel</creatorcontrib><creatorcontrib>Pal, Sumanta</creatorcontrib><creatorcontrib>Narra, Ravi</creatorcontrib><creatorcontrib>Kilari, Deepak</creatorcontrib><creatorcontrib>Kaymakcalan, Marina D.</creatorcontrib><creatorcontrib>McGregor, Bradley</creatorcontrib><creatorcontrib>Choueiri, Toni K.</creatorcontrib><creatorcontrib>McKay, Rana R.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical genitourinary cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shayeb, Akram M.</au><au>McManus, Hannah Dzimitrowicz</au><au>Urman, Danielle</au><au>Jani, Chinmay</au><au>Zhang, Tian</au><au>Dizman, Nazli</au><au>Meza, Luis</au><au>Sivakumar, Akhilesh</au><au>Gan, Chun L.</au><au>Barata, Pedro</au><au>Bilen, Mehmet A.</au><au>Gao, Xin</au><au>Heng, Daniel</au><au>Pal, Sumanta</au><au>Narra, Ravi</au><au>Kilari, Deepak</au><au>Kaymakcalan, Marina D.</au><au>McGregor, Bradley</au><au>Choueiri, Toni K.</au><au>McKay, Rana R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cabozantinib Safety With Different Anticoagulants in Patients With Renal Cell Carcinoma</atitle><jtitle>Clinical genitourinary cancer</jtitle><addtitle>Clin Genitourin Cancer</addtitle><date>2023-02</date><risdate>2023</risdate><volume>21</volume><issue>1</issue><spage>55</spage><epage>62</epage><pages>55-62</pages><issn>1558-7673</issn><eissn>1938-0682</eissn><abstract>•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
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.
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.
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]).
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.
[Display omitted]
In this retrospective multicenter study (9 sites), including 298 patients with advanced RCC, we investigated the safety of cabozantinib with different anticoagulants. DOACs appear safe for VTE treatment for patients with RCC on cabozantinib as we did not observe any difference in major bleeding events between the no anticoagulant, LMWH, and DOAC groups. Optimized anticoagulation management remains vital in clinical practice.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>36411184</pmid><doi>10.1016/j.clgc.2022.10.013</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-1675-8479</orcidid><orcidid>https://orcid.org/0000-0002-8298-0289</orcidid><orcidid>https://orcid.org/0000-0002-6917-5568</orcidid><orcidid>https://orcid.org/0000-0002-5063-2191</orcidid><orcidid>https://orcid.org/0000-0003-4956-9129</orcidid><orcidid>https://orcid.org/0000-0001-7846-2326</orcidid><orcidid>https://orcid.org/0000-0002-8890-2951</orcidid><orcidid>https://orcid.org/0000-0002-3907-8513</orcidid><orcidid>https://orcid.org/0000-0003-1455-2976</orcidid><orcidid>https://orcid.org/0000-0002-0235-297X</orcidid></addata></record> |
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source | MEDLINE; Alma/SFX Local Collection |
subjects | Administration, Oral Anticoagulants - adverse effects Bleeding Carcinoma, Renal Cell - complications Carcinoma, Renal Cell - drug therapy DOAC Hemorrhage - chemically induced Hemorrhage - complications Hemorrhage - epidemiology Heparin, Low-Molecular-Weight - adverse effects Humans Kidney Neoplasms - complications Kidney Neoplasms - drug therapy LMWH Neoplasms - chemically induced Neoplasms - complications Neoplasms - drug therapy Thrombosis Venous Thromboembolism - drug therapy VTE Warfarin - adverse effects |
title | Cabozantinib Safety With Different Anticoagulants in Patients With Renal Cell Carcinoma |
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