Sunitinib as a paradigm for tyrosine kinase inhibitor development for renal cell carcinoma

Urologic Oncology: Seminars and Original Investigations

Volumn 33, Issue 6, 2015, Pages 275-279

  Lee, Chung Han ^a   Motzer, Robert J ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Renal cell carcinoma; Sunitinib; Targeted agents

Indexed keywords

SUNITINIB; ANTINEOPLASTIC AGENT; INDOLE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRROLE DERIVATIVE;

CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; DRUG APPROVAL; DRUG DEVELOPMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; KIDNEY CARCINOMA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STANDARDIZATION; CARCINOMA, RENAL CELL; PATHOLOGY;

ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; HUMANS; INDOLES; PROTEIN KINASE INHIBITORS; PYRROLES;

EID: 84929882306     PISSN: 10781439     EISSN: 18732496     Source Type: Journal    
DOI: 10.1016/j.urolonc.2014.10.012     Document Type: Review

References (33)

1. Siegel R., Naishadham D., Jemal A. Cancer statistics, 2013. CA Cancer J Clin 2013, 63:11-30.
2. Karumanchi S.A., Merchan J., Sukhatme V.P. Renal cancer: molecular mechanisms and newer therapeutic options. Curr Opin Nephrol Hypertens 2002, 11:37-42.
3. Maxwell P.H., Wiesener M.S., Chang G.W., et al. The tumour suppressor protein VHL targets hypoxia-inducible factors for oxygen-dependent proteolysis. Nature 1999, 399:271-275.
4. Young A.P., Schlisio S., Minamishima Y.A., et al. VHL loss actuates a HIF-independent senescence programme mediated by Rb and p400. Nat Cell Biol 2008, 10:361-369.
5. Kondo K., Kim W.Y., Lechpammer M., Kaelin W.G. Inhibition of HIF2alpha is sufficient to suppress pVHL-defective tumor growth. PLoS Biol 2003, 1:E83.
6. Dalgliesh G.L., Furge K., Greenman C., et al. Systematic sequencing of renal carcinoma reveals inactivation of histone modifying genes. Nature 2010, 463:360-363.
7. Voss M.H., Hsieh J.J., Motzer R.J. Novel approaches targeting the vascular endothelial growth factor axis in renal cell carcinoma. Cancer J 2013, 19:299-306.
8. Johnson J.R., Williams G., Pazdur R. End points and united states food and drug administration approval of oncology drugs. J Clin Oncol 2003, 21:1404-1411.
9. Mendel D.B., Laird A.D., 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 2003, 9:327-337.
10. Faivre S., Delbaldo C., Vera K., et al. Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. J Clin Oncol 2006, 24:25-35.
11. Motzer R.J., Michaelson M.D., Redman B.G., et al. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol 2006, 24:16-24.
12. Motzer R.J., Rini B.I., Bukowski R.M., et al. Sunitinib in patients with metastatic renal cell carcinoma. J Am Med Assoc 2006, 295:2516-2524.
13. Motzer R.J., Hutson T.E., Tomczak P., et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007, 356:115-124.
14. Motzer R.J., Hutson T.E., Olsen M.R., 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 2012, 30:1371-1377.
15. O'Farrell A.M., Foran J.M., Fiedler W., et al. An innovative phase I clinical study demonstrates inhibition of FLT3 phosphorylation by SU11248 in acute myeloid leukemia patients. Clin Cancer Res 2003, 9:5465-5476.
16. Motzer R.J., Michaelson M.D., Rosenberg J., et al. Sunitinib efficacy against advanced renal cell carcinoma. J Urol 2007, 178:1883-1887.
17. Escudier B., Roigas J., Gillessen S., et al. Phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol 2009, 27:4068-4075.
18. Barrios C.H., Hernandez-Barajas D., Brown M.P., et al. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer 2012, 118:1252-1259.
19. Sternberg C.N., Hawkins R.E., Wagstaff J., et al. A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: final overall survival results and safety update. Eur J Cancer 2013, 49:1287-1296.
20. Sternberg C.N., Davis I.D., 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.
21. Escudier B., Szczylik C., Hutson T.E., 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 2009, 27:1280-1289.
22. Motzer R.J., Hutson T.E., Cella D., et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med 2013, 369:722-731.
23. Motzer R.J., Porta C., Vogelzang N.J., et al. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol 2014, 15:286-296.
24. Motzer R.J., 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.
25. Awada A., Hendlisz A., Gil T., et al. Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours. Br J Cancer 2005, 92:1855-1861.
26. Ratain M.J., Eisen T., Stadler W.M., et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 2006, 24:2505-2512.
27. Escudier B., Eisen T., Stadler W.M., et al. Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol 2009, 27:3312-3318.
28. Di Lorenzo G., Carteni G., Autorino R., et al. Phase II study of sorafenib in patients with sunitinib-refractory metastatic renal cell cancer. J Clin Oncol 2009, 27:4469-4474.
29. Hutson T.E., Davis I.D., Machiels J.P., et al. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J Clin Oncol 2010, 28:475-480.
30. Rixe O., Bukowski R.M., Michaelson M.D., et al. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol 2007, 8:975-984.
31. Rini B.I., Wilding G., Hudes G., et al. Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma. J Clin Oncol 2009, 27:4462-4468.
32. Rini B.I., Escudier B., Tomczak P., et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet 2011, 378:1931-1939.
33. Hutson T.E., 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.