Tivozanib versus sorafenib as initial targeted therapy for patients with metastatic renal cell carcinoma: Results from a phase III trial

Journal of Clinical Oncology

Volumn 31, Issue 30, 2013, Pages 3791-3799

  Motzer, Robert J ^a   Nosov, Dmitry ^b   Eisen, Timothy ^g   Bondarenko, Igor ^h   Lesovoy, Vladimir ⁱ   Lipatov, Oleg ^d   Tomczak, Piotr ^k   Lyulko, Oleksiy ^j   Alyasova, Anna ^e   Harza, Mihai ^m   Kogan, Mikhail ^f   Alekseev, Boris Y ^c   Sternberg, Cora N ⁿ   Szczylik, Cezary ^l   Cella, David ^o   Ivanescu, Cristina ^q   Krivoshik, Andrew ^p   Strahs, Andrew ^r   Esteves, Brooke ^r   Berkenblit, Anna ^r   Hutson, Thomas E ^s   more..

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b NN Blokhin Cancer Research Center   (United States)

^c Gerzen Moscow Research Oncological Institute   (Russian Federation)

^d Republican Clinical Oncological Dispensary   (Russian Federation)

^e PRIVOLZHSKY RESEARCH MEDICAL UNIVERSITY   (Russian Federation)

^f ROSTOV STATE MEDICAL UNIVERSITY   (Russian Federation)

^g St John's Innovation Centre   (United Kingdom)

^h Dnipropetrovsk State Medical Academy   (Ukraine)

ⁱ Regional Clinical Center of Urology and Nephrology named after VI Shapoval   (Ukraine)

^j Medical Academy of Postgraduate Education   (Ukraine)

^k POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^l MILITARY INSTITUTE OF MEDICINE   (Poland)

^m FUNDENI CLINICAL INSTITUTE   (Romania)

ⁿ SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^o NORTHWESTERN UNIVERSITY   (United States)

^p ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^q IQVIA   (United States)

^r AVEO ONCOLOGY   (United States)

^s BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

SORAFENIB; TIVOZANIB; ANTINEOPLASTIC AGENT; CARBANILAMIDE DERIVATIVE; NICOTINAMIDE; QUINOLINE DERIVATIVE; VASCULOTROPIN RECEPTOR;

ADJUVANT CHEMOTHERAPY; ADULT; AGED; ARTICLE; CANCER PATIENT; CANCER SURGERY; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DISEASE COURSE; DRUG WITHDRAWAL; DYSPHONIA; FEMALE; HAND FOOT SYNDROME; HUMAN; HUMAN TISSUE; HYPERTENSION; KIDNEY METASTASIS; MAJOR CLINICAL STUDY; MALE; MOLECULARLY TARGETED THERAPY; MULTIPLE CYCLE TREATMENT; NEPHRECTOMY; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; VERY ELDERLY; ADJUVANT THERAPY; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; CANCER STAGING; CARCINOMA, RENAL CELL; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; HEALTH STATUS; KAPLAN MEIER METHOD; KIDNEY NEOPLASMS; MIDDLE AGED; PATHOLOGY; PROCEDURES; QUALITY OF LIFE; RISK; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; DISEASE-FREE SURVIVAL; FEMALE; HEALTH STATUS; HUMANS; KAPLAN-MEIER ESTIMATE; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; MOLECULAR TARGETED THERAPY; NEOADJUVANT THERAPY; NEOPLASM STAGING; NEPHRECTOMY; NIACINAMIDE; ODDS RATIO; PHENYLUREA COMPOUNDS; QUALITY OF LIFE; QUINOLINES; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; TREATMENT OUTCOME;

EID: 84891713447     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.47.4940     Document Type: Article

References (42)

1. Costa LJ, Drabkin HA: Renal cell carcinoma: New developments in molecular biology and potential for targeted therapies. Oncologist 12:1404-1415, 2007
2. Escudier B, Eisen T, Stadler WM, et al: Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356:125-134, 2007
3. Rini BI, Escudier B, Tomczak P, et al: Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): A randomised phase 3 trial. Lancet 378:1931-1939, 2011
4. Rini BI, Halabi S, Rosenberg JE, et al: Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: Final results of CALGB 90206. J Clin Oncol 28:2137-2143, 2010
5. Motzer RJ, Hutson TE, Tomczak P, et al: Sunitinib versus interferon alfa in metastatic renalcell carcinoma. N Engl J Med 356:115-124, 2007
6. Motzer RJ, Hutson TE, Tomczak P, et al: Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 27:3584-3590, 2009
7. 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 28:1061-1068, 2010
8. Mendel DB, Laird AD, Xin X, et al: In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: Determination of a pharmacokinetic/pharmacodynamic relationship. Clin Cancer Res 9:327-337, 2003
9. Wilhelm SM, Carter C, Tang L, et al: BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 64:7099-7109, 2004
10. Motzer RJ, Hutson TE, Olsen MR, et al: Randomized phase II trial of sunitinib on an intermittent versus continuous dosing schedule as first-line therapy for advanced renal cell carcinoma. J Clin Oncol 30:1371-1377, 2012
11. Kumar R, Crouthamel MC, Rominger DH, et al: Myelosuppression and kinase selectivity of multikinase angiogenesis inhibitors. Br J Cancer 101: 1717-1723, 2009
12. Eskens FA, de Jonge MJ, 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-weekoff schedule in patients with advanced solid tumors. Clin Cancer Res 17:7156-7163, 2011
13. Cotreau MM: Comparison of the pharmacokinetics of tivozanib in oncology subjects compared with healthy volunteers. Clin Pharmacol Ther 89: S49, 2011 (suppl 1; abstr PII-36)
14. 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 66:9134-9142, 2006
15. 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 30:1678-1685, 2012
16. Esteves B, Regan EM, Fischer PM, et al: Management of hypertension during tivozanib therapy: Results from a phase 2 randomized discontinuation trial. Oncol Nurs Forum 38:E153, 2011 (abstr 1052744)
17. Bayer Health Care Pharmaceuticals: Nexavar (sorafenib) full prescribing information, December 2012
18. US Department of Health and Human Services, Food and Drug Administration: Guidance for industry: Clinical trial endpoints for the approval of cancer drugs and biologics. May 2007. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm071590.pdf
19. Webster K, Cella D, Yost K: The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: Properties, applications, and interpretation. Health Qual Life Outcomes 1:79, 2003
20. Cella D, Yount S, Brucker PS, et al: Development and validation of a scale to measure diseaserelated symptoms of kidney cancer. Value Health 10:285-293, 2007
21. [No authors listed]: EuroQol: A new facility for the measurement of health-related quality of life-The EuroQol Group. Health Policy 16:199-208, 1990
22. Motzer RJ, Mazumdar M, Bacik J, et al: Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol 17:2530-2540, 1999
23. Fitzmaurice GM, Laird NM, Ware JH: Applied Longitudinal Analysis. Hoboken, NJ, Wiley-Interscience, 2004
24. Singer JD, Willett JB: Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York, NY, Oxford University Press, 2003
25. Pickard AS, Neary MP, Cella D: Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes 5:70, 2007
26. Yost KJ, Eton DT: Combining distribution- and anchor-based approaches to determine minimally important differences: The FACIT experience. Eval Health Prof 28:172-191, 2005
27. Rini BI: Metastatic renal cell carcinoma: Many treatment options, one patient. J Clin Oncol 27: 3225-3234, 2009
28. Schneider BP, Wang M, Radovich M, et al: Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol 26:4672-4678, 2008
29. Dahlberg SE, Sandler AB, Brahmer JR, et al: Clinical course of advanced non-small-cell lung cancer patients experiencing hypertension during treatment with bevacizumab in combination with carboplatin and paclitaxel on ECOG 4599. J Clin Oncol 28:949-954, 2010
30. Rini BI, Cohen DP, Lu DR, et al: Hypertension as a biomarker of efficacy in patients with metastatic renal cell carcinoma treated with sunitinib. J Natl Cancer Inst 103:763-773, 2011
31. Goodwin R, Seymour L, Ding K, et al: Hypertension (HTN) in National Cancer Institute of Canada Clinical Trials Group study BR.24: A randomized, double-blind phase II trial of carboplatin (C) and paclitaxel (P) with either daily oral cediranib (CED), an inhibitor of vascular endothelial growth factor receptors, or placebo, in patients with advanced non-small cell lung cancer. J Clin Oncol 27:152s, 2009 (suppl; abstr 3527)
32. Wong MKK, Mohamed AF, Hauber AB, et al: Selecting renal cell carcinoma therapy: Ranking of patient perspective on toxicities. J Clin Oncol 30: 303s, 2012 (suppl; abstr 4608)
33. Escudier B, Szczylik C, Hutson TE, et al: Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol 27: 1280-1289, 2009
34. Rini BI, Szczylik C, Tannir NM, et al: AMG 386 in combination with sorafenib in patients (pts) with metastatic renal cell cancer (mRCC): A randomized, double-blind, placebo-controlled, phase II study. Cancer 118:6152-6161, 2012
35. Stadler WM, Figlin RA, McDermott DF, et al: Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America. Cancer 116:1272-1280, 2010
36. Motzer RJ, Escudier B, Oudard S, et al: Efficacy of everolimus in advanced renal cell carcinoma: A double-blind, randomised, placebo-controlled phase III trial. Lancet 372:449-456, 2008
37. Hudes G, Carducci M, Tomczak P, et al: Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 356:2271-2281, 2007
38. Hutson T, Escudier B, Esteban E, et al: Temsirolimus vs sorafenib as second line therapy in metastatic renal cell carcinoma: Results from the INTORSECT trial. Ann Oncol 23:ixe14, 2012 (suppl 9; abstr LBA22-PR)
39. Motzer R, Hutson TE, Reeves J, et al: Randomized, open-label, phase III trial of pazopanib versus sunitinib in first-line treatment of patients with metastatic renal cell carcinoma (MRCC): Results of the COMPARZ trial. Ann Oncol 23, 2012 (suppl 9; abstr LBA8 PR)
40. Motzer RJ, Nosov D, Tomczak P, et al: Efficacy and safety data from patients with advanced renal cell cancer treated with tivozanib hydrochloride after progression on sorafenib. J Clin Oncol 31, 2013 (suppl; abstr 364)
41. Harrison MR, George DJ, Walker MS, et al: Beyond metastatic renal cell carcinoma (mRCC) clinical trials: Targeted therapy use and overall survival in community oncology clinics. J Clin Oncol 30, 2012 (suppl; abstr e15061)
42. Xie W, Choueiri TK, Lee J-L, et al: Characteristics of long-term and short-term survivors of metastatic renal cell carcinoma (mRCC) treated with targeted therapy: Results from the International mRCC Database Consortium. J Clin Oncol 30:286s, 2012 (suppl; abstr 4538)