The role of tivozanib in advanced renal cell carcinoma therapy

References

• Escudier B, Porta C, Schmidinger M, et al. Renal cell carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27:v58–v68.
   PubMed Web of Science ®Google Scholar
• Kabaria R, Klaassen Z, Terris MK. Renal cell carcinoma: links and risks. Int J Nephrol Renov Dis. 2016;9:45–52.
   PubMed Web of Science ®Google Scholar
• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66:7–30.
   PubMed Web of Science ®Google Scholar
• Brugarolas J. Molecular genetics of clear-cell renal cell carcinoma. J Clin Oncol. 2014;32:1968–1976.
   PubMed Web of Science ®Google Scholar
• Conti A, Santoni M, Amantini C, et al. Progress of molecular targeted therapies for advanced renal cell carcinoma. BioMed Res Int 2013;2013:419176.
   PubMedGoogle Scholar
• Bi R, Ej S. Biology and clinical development of vascular endothelial growth factor-targeted therapy in renal cell carcinoma. J Clin Oncol. 2005;23:1028–1043.
   PubMed Web of Science ®Google Scholar
• Rodriguez-Vida A, Hutson TE, Bellmunt J, et al. New treatment options for metastatic renal cell carcinoma. ESMO Open. 2017;2:e000185.
   PubMed Web of Science ®Google Scholar
• Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007;370:2103–2111.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007;356:115–124.
   PubMed Web of Science ®Google Scholar
• Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010;28:1061–1068.
   PubMed Web of Science ®Google Scholar
• Massey PR, Okman JS, Wilkerson J, et al. Tyrosine kinase inhibitors directed against the vascular endothelial growth factor receptor (VEGFR) have distinct cutaneous toxicity profiles: a meta-analysis and review of the literature. Support Care Cancer. 2015;23:1827–1835.
   PubMed Web of Science ®Google Scholar
• Schmidinger M. Understanding and managing toxicities of vascular endothelial growth factor (VEGF) inhibitors. EJC Suppl EJC. 2013;11:172–191.
   PubMedGoogle Scholar
• Porta C, Levy A, Hawkins R, et al. Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first-line sunitinib: a medical chart review across ten centers in five European countries. Cancer Med. 2014;3:1517–1526.
   PubMed Web of Science ®Google Scholar
• Wong HH, Eisen T. Tivozanib for the treatment of metastatic renal cancer. Expert Rev Anticancer Ther. 2013;13:649–660.
   PubMed Web of Science ®Google Scholar
• Fotivda (tivozanib) - summary of product characteristics (SPC) [Internet]. [cited 2017 Nov 23]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004131/WC500239033.pdf.
   Google Scholar
• Inlyta 1 mg 3 mg, 5 mg & 7 mg film-coated tablets - summary of product characteristics (SPC) - (eMC) [Internet]. [cited 2017 Nov 23]. Available from: http://www.medicines.org.uk/emc/medicine/27051.
   Google Scholar
• Motzer RJ, Nosov D, Eisen T, et al. Tivozanib versus sorafenib as initial targeted therapy for patients with metastatic renal cell carcinoma: results from a phase III trial. J Clin Oncol. 2013;31:3791–3799.
   PubMed Web of Science ®Google Scholar
• Nakamura K, Taguchi E, Miura T, et al. KRN951, a highly potent inhibitor of vascular endothelial growth factor receptor tyrosine kinases, has antitumor activities and affects functional vascular properties. Cancer Res. 2006;66:9134–9142.
   PubMed Web of Science ®Google Scholar
• Taguchi E, Nakamura K, Miura T, et al. Anti-tumor activity and tumor vessel normalization by the vascular endothelial growth factor receptor tyrosine kinase inhibitor KRN951 in a rat peritoneal disseminated tumor model. Cancer Sci. 2008;99:623–630.
   PubMed Web of Science ®Google Scholar
• Hutson TE, Lesovoy V, Al-Shukri S, et al. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial. Lancet Oncol. 2013;14:1287–1294.
   PubMed Web of Science ®Google Scholar
• AVEO announces complete response letter received for tivozanib new drug application in renal cell carcinoma [Internet]. 2013. Available from: http://www.aveooncology.com/wp-content/uploads/2013/06/AVEO-CRL-PDUFA-PR-FINAL-for-61013.pdf.
   Google Scholar
• Committee for medicinal products for human use summary of positive opinion for fotivda [Internet]. European Medicines Agency; 2017. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004131/WC500229916.pdf.
   Google Scholar
• Fotivda: European public assessment report [Internet]. European Medicines Agency; 2017. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004131/WC500239035.pdf.
   Google Scholar
• Eskens FALM, De Jonge MJA, Bhargava P, et al. Biologic and clinical activity of tivozanib (AV-951, KRN-951), a selective inhibitor of VEGF receptor-1, −2, and −3 tyrosine kinases, in a 4-week-on, 2-week-off schedule in patients with advanced solid tumors. Clin Cancer Res. 2011;17:7156–7163.
   PubMed Web of Science ®Google Scholar
• Fishman MN, Srinivas S, Hauke RJ, et al. Phase Ib study of tivozanib (AV-951) in combination with temsirolimus in patients with renal cell carcinoma. Eur J Cancer. 2013;49:2841–2850.
   PubMed Web of Science ®Google Scholar
• Nosov DA, Esteves B, Lipatov ON, et al. Antitumor activity and safety of tivozanib (AV-951) in a phase II randomized discontinuation trial in patients with renal cell carcinoma. J Clin Oncol. 2012;30:1678–1685.
   PubMed Web of Science ®Google Scholar
• Hutson TE, Rathmell WK, Feng B, et al. Phase 2 clinical evaluation of preclinically defined biomarkers for vascular endothelial growth factor tyrosine kinase inhibitor tivozanib in renal cell carcinoma. Presented at the European Society for Medical Oncology Annual Congress; 2014 Sept 26–30; Madrid, Spain.
   Google Scholar
• Clinicaltrials.gov. A biomarker study of tivozanib in subjects with advanced renal cell carcinoma [Internet]. Available from: www.clinicaltrials.gov/ct2/show/NCT01297244.
   Google Scholar
• A subject treatment preference study of tivozanib hydrochloride versus sunitinib in subjects with metastatic renal cell carcinoma - no study results posted - clinicalTrials.gov [Internet]. [cited 2017 Nov 29]. Available from: https://clinicaltrials.gov/ct2/show/results/NCT01673386.
   Google Scholar
• Needle MN, Hutson TE, Motzer RJ. The effect of geography and the availability of second-line therapy on overall survival in a one-way crossover design study in renal cell carcinoma. J Clin Oncol. Internet cited 1 Dec 2017;34(15_suppl). DOI:10.1200/JCO.2016.34.15_suppl.e16120.
   Web of Science ®Google Scholar
• Molina AM, Hutson TE, Nosov D, et al. Efficacy of tivozanib treatment after sorafenib in patients with advanced renal cell carcinoma: crossover of a phase 3 study. Eur J Cancer. 2018;94:87–94.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Nosov DA, Eisen T, et al. Tivozanib versus sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma: results from a phase III randomized, open-label, multicenter trial. Present Annu Meet Am Soc Oncol. 2012. Abstract No. 4501.
   Google Scholar
• Motzer RJ, Escudier B, Tomczak P, et al. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol. 2013;14:552–562.
   PubMed Web of Science ®Google Scholar
• A study to compare tivozanib hydrochloride to sorafenib in subjects with refractory advanced RCC - full text view - clinicalTrials.gov [Internet]. [cited 2017 Nov 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT02627963.
   Google Scholar
• Phase 1/2 study of tivozanib in combination with nivolumab in subjects with rcc - full text view - clinicalTrials.gov [Internet]. [cited 2017 Nov 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT03136627.
   Google Scholar
• Escudier B, Barthelemy P, Ravaud A, et al. Tivozanib combined with nivolumab: phase ib/ii study in metastatic renal cell carcinoma. Present. 2018 genitourin. Cancers symp. Febr. 8–10 2018 San Franc. CA. J Clin Oncol. 2018;36:618.
   Web of Science ®Google Scholar
• Ljungber B, Bensalah K, Bex A, et al. EAU guidelines on renal cell carcinoma [Internet]. Uroweb. 2017 [cited 2018 Feb 8]. Available from: http://uroweb.org/guideline/renal-cell-carcinoma/.
   Google Scholar
• Choueiri TK, Halabi S, Sanford BL, et al. Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the alliance A031203 CABOSUN trial. J Clin Oncol. 2016;35:591–597.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018;378:1277–1290.
   PubMed Web of Science ®Google Scholar
• Pal SK, Sonpavde G, Agarwal N, et al. Evolution of circulating tumor DNA profile from first-line to subsequent therapy in metastatic renal cell carcinoma. Eur Urol. 2017;72:557–564.
   PubMed Web of Science ®Google Scholar