{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T14:43:33Z","timestamp":1788273813458,"version":"build-2803163510"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2024,3,13]],"date-time":"2024-03-13T00:00:00Z","timestamp":1710288000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"MDACC","award":["P30 CA016672"],"award-info":[{"award-number":["P30 CA016672"]}]},{"DOI":"10.13039\/100012287","name":"Andrew Sabin Family Foundation","doi-asserted-by":"publisher","award":["KC200096P1"],"award-info":[{"award-number":["KC200096P1"]}],"id":[{"id":"10.13039\/100012287","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000005","name":"United States Department of Defense","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000005","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,7,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Tivozanib has been approved as a third-line or later therapy for advanced renal cell carcinoma based on the TIVO-3 trial, which was conducted before immune checkpoint therapies (ICT), cabozantinib, and lenvatinib\/everolimus became incorporated in the current sequential treatment paradigm for advanced clear cell RCC (ccRCC).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We performed a retrospective study of patients with advanced ccRCC treated with tivozanib at MD Anderson Cancer Center during 6\/2021-7\/2023. A blinded radiologist assessed tumor response by RECIST v1.1. We assessed overall response rate (ORR), clinical benefit rate (CBR) [percentage of all treated patients who achieved radiologic response or stable disease (SD) for\u2005\u2265\u20056 months], progression-free survival (PFS), overall survival (OS), and safety.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 30 analyzed patients, 23% had performance status\u2005\u2265\u20052; 47% had International Metastatic RCC Database Consortium (IMDC) poor-risk disease. Median number of prior therapies was 4 (range 1-8). All patients received prior ICT, 87% cabozantinib and 60% lenvatinib \u00b1 everolimus. Of 26 evaluable patients, 2 patients had confirmed partial response (ORR 7.7%); 5 patients had SD for\u2005\u2265\u20056 months (CBR 23.3%). Median PFS was 3.8 months (range 0.7-13.9); median OS was 14.1 months (range 0.3-28.5). Fifteen patients (50%) had\u2005\u2265\u20051 treatment-related adverse event (TRAE). There were 6 grade\u2005\u2265\u20053 TRAEs [hypertension, congestive heart failure (3), mucositis, and GI perforation (grade 5)].<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In this cohort of heavily pretreated patients with advanced ccRCC, tivozanib yielded a modest clinical benefit in a minority of patients who received prior ICT, cabozantinib, and lenvatinib \u00b1 everolimus. TRAEs were consistent with previously published reports.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyae037","type":"journal-article","created":{"date-parts":[[2024,3,13]],"date-time":"2024-03-13T21:17:01Z","timestamp":1710364621000},"page":"589-595","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy, Safety, and Tolerability of Tivozanib in Heavily Pretreated Patients With Advanced Clear Cell Renal Cell Carcinoma"],"prefix":"10.1093","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9821-8662","authenticated-orcid":false,"given":"Andrew C","family":"Johns","sequence":"first","affiliation":[{"name":"Division of Cancer Medicine, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew T","family":"Campbell","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mamie","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Abdominal Imaging, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew W","family":"Hahn","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zita","family":"Lim","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Wang","sequence":"additional","affiliation":[{"name":"Pharmacy Clinical Programs, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6138-4472","authenticated-orcid":false,"given":"Jianjun","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amishi Y","family":"Shah","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6505-8308","authenticated-orcid":false,"given":"Pavlos","family":"Msaouel","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5559-8060","authenticated-orcid":false,"given":"Nizar M","family":"Tannir","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,3,13]]},"reference":[{"key":"2024070511375471000_CIT0001","first-page":"2147","article-title":"Tivozanib, a highly potent and selective inhibitor of VEGF receptor tyrosine kinases, for the treatment of metastatic renal cell carcinoma","volume-title":"Future Oncol","author":"Jacob","year":"2020"},{"key":"2024070511375471000_CIT0002","first-page":"95","article-title":"Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study","volume-title":"Lancet Oncol","author":"Rini","year":"2020"},{"key":"2024070511375471000_CIT0003","author":"US Food and Drug Administration","year":"2021"},{"key":"2024070511375471000_CIT0004","first-page":"829","article-title":"Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma","volume-title":"N Engl J Med","author":"Choueiri","year":"2021"},{"key":"2024070511375471000_CIT0005","first-page":"1116","article-title":"Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma","volume-title":"N Engl J Med","author":"Rini","year":"2019"},{"key":"2024070511375471000_CIT0006","first-page":"1289","article-title":"Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma","volume-title":"N Engl J Med","author":"Motzer","year":"2021"},{"key":"2024070511375471000_CIT0007","first-page":"1277","article-title":"Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma","volume-title":"N Engl J Med","author":"Motzer","year":"2018"},{"key":"2024070511375471000_CIT0008","author":"US Food and Drug Administration","year":"2016"},{"key":"2024070511375471000_CIT0009","author":"US Food and Drug Administration","year":"2016"},{"key":"2024070511375471000_CIT0010","first-page":"476","article-title":"Lenvatinib with or without everolimus in patients with metastatic renal cell carcinoma after immune checkpoint inhibitors and vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapies","volume-title":"Oncologist","author":"Wiele","year":"2021"},{"key":"2024070511375471000_CIT0011","first-page":"102","article-title":"Outcomes of patients with metastatic renal cell carcinoma treated with targeted therapy after immuno-oncology checkpoint inhibitors","volume-title":"Eur Urol Oncol","author":"Graham","year":"2021"},{"key":"2024070511375471000_CIT0012","first-page":"102652","article-title":"Vascular endothelial growth factor-targeted therapy in patients with renal cell carcinoma pretreated with immune checkpoint inhibitors: a systematic literature review","volume-title":"Cancer Treat Rev","author":"Albiges","year":"2023"},{"key":"2024070511375471000_CIT0013","first-page":"67","article-title":"Outcomes of patients with metastatic clear-cell renal cell carcinoma treated with second-line VEGFR-TKI after first-line immune checkpoint inhibitors","volume-title":"Eur J Cancer","author":"Shah","year":"2019"},{"key":"2024070511375471000_CIT0014","first-page":"1411","article-title":"Efficacy and safety of telaglenastat plus cabozantinib vs placebo plus cabozantinib in patients with advanced renal cell carcinoma: the CANTATA randomized clinical trial","volume-title":"JAMA Oncol","author":"Tannir","year":"2022"},{"key":"2024070511375471000_CIT0015","first-page":"185","article-title":"Atezolizumab plus cabozantinib versus cabozantinib monotherapy for patients with renal cell carcinoma after progression with previous immune checkpoint inhibitor treatment (CONTACT-03): a multicentre, randomised, open-label, phase 3 trial","volume-title":"Lancet (London, England)","author":"Pal","year":"2023"},{"key":"2024070511375471000_CIT0016","first-page":"TPS405","article-title":"TiNivo-2: a phase 3, randomized, controlled, multicenter, open-label study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma who have progressed following one or two lines of therapy where one line has an immune checkpoint inhibitor","volume-title":"J Clin Oncol","author":"Choueiri","year":"2022"},{"key":"2024070511375471000_CIT0017","first-page":"97","article-title":"TiNivo: safety and efficacy of tivozanib-nivolumab combination therapy in patients with metastatic renal cell carcinoma","volume-title":"Ann Oncol","author":"Albiges","year":"2021"},{"key":"2024070511375471000_CIT0018","first-page":"S1329","article-title":"LBA88 Belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC): randomized open-label phase III LITESPARK-005 study","volume-title":"Ann Oncol","author":"Albiges","year":"2023"},{"key":"2024070511375471000_CIT0019","first-page":"123","article-title":"Belzutifan (MK-6482): biology and clinical development in solid tumors","volume-title":"Curr Oncol Rep","author":"Choi","year":"2023"}],"container-title":["The Oncologist"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/oncolo\/advance-article-pdf\/doi\/10.1093\/oncolo\/oyae037\/58448963\/oyae037.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/oncolo\/advance-article-pdf\/doi\/10.1093\/oncolo\/oyae037\/58448963\/oyae037.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,5]],"date-time":"2024-07-05T11:38:10Z","timestamp":1720179490000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/oncolo\/article\/29\/7\/589\/7628287"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,13]]},"references-count":19,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2024,3,13]]},"published-print":{"date-parts":[[2024,7,5]]}},"URL":"https:\/\/doi.org\/10.1093\/oncolo\/oyae037","relation":{},"ISSN":["1083-7159","1549-490X"],"issn-type":[{"value":"1083-7159","type":"print"},{"value":"1549-490X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,7]]},"published":{"date-parts":[[2024,3,13]]}}}