Exposure-response relationships in patients with metastatic renal cell carcinoma receiving sunitinib: Maintaining optimum efficacy in clinical practice

Anti-Cancer Drugs

Volumn 22, Issue 5, 2011, Pages 377-383

  Ravaud, Alain ^a,b,c   Bello, Carlo L ^d  

^a HÔPITAL SAINT ANDRÉ   (France)

^b UNIVERSITÉ DE BORDEAUX   (France)

^c INSERM   (France)

^d PFIZER INC   (United States)

Author keywords

Dose; exposure response; pharmacokinetics; sunitinib malate; therapy management

Indexed keywords

ALPHA INTERFERON; DRUG METABOLITE; SU 12662; SUNITINIB; TRIACYLGLYCEROL LIPASE; UNCLASSIFIED DRUG;

AREA UNDER THE CURVE; ASTHENIA; BLOOD TOXICITY; CANCER SURVIVAL; CARDIOVASCULAR DISEASE; CLINICAL PRACTICE; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG TOLERABILITY; FATIGUE; GASTROINTESTINAL TOXICITY; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; KIDNEY CARCINOMA; META ANALYSIS (TOPIC); METASTASIS; MOUTH DISEASE; MUCOSA INFLAMMATION; NEUTROPENIA; NEUTROPHIL COUNT; OPTIMAL DRUG DOSE; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK FACTOR; SIDE EFFECT; SKIN DISEASE; STOMATITIS; SURVIVAL TIME; THYROID DISEASE; TREATMENT DURATION; TREATMENT RESPONSE;

EID: 79955072210     PISSN: 09594973     EISSN: None     Source Type: Journal    
DOI: 10.1097/CAD.0b013e3283442039     Document Type: Review

References (30)

1. Abrams TJ, Lee LB, Murray LJ, Pryer NK, Cherrington JM. SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer. Mol Cancer Ther 2003; 2:471-478.
2. Kim DW, Jo YS, Jung HS, Chung HK, Song JH, Park KC, et al. An orally administered multitarget tyrosine kinase inhibitor, SU11248, is a novel potent inhibitor of thyroid oncogenic RET/papillary thyroid cancer kinases. J Clin Endocrinol Metab 2006; 91:4070-4076. (Pubitemid 44536887)
3. Mendel DB, Laird AD, Xin X, Louie SG, Christensen JG, Li G, 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. (Pubitemid 36109749)
4. Murray LJ, Abrams TJ, Long KR, Ngai TJ, Olson LM, HongW, et al. SU11248 inhibits tumor growth and CSF-1R-dependent osteolysis in an experimental breast cancer bone metastasis model. Clin Exp Metastasis 2003; 20:757-766. (Pubitemid 38019277)
5. O'Farrell AM, Abrams TJ, Yuen HA, Ngai TJ, Louie SG, Yee KW, et al. SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo. Blood 2003; 101:3597-3605. (Pubitemid 36857948)
6. Fong TA, Shawver LK, Sun L, Tang C, App H, Powell TJ, et al. SU5416 is a potent and selective inhibitor of the vascular endothelial growth factor receptor (Flk-1/KDR) that inhibits tyrosine kinase catalysis, tumor vascularization, and growth of multiple tumor types. Cancer Res 1999; 59:99-106. (Pubitemid 29062964)
7. Pfizer Inc. SUTENT, Summary of product characteristics, September 2009.
8. European Medicines Agency (EMEA). Committee for medicinal products for human use (CHMP)-Summary of opinion (post authorisation): SUTENT. .
9. Ljungberg B, Hanbury D, Kuczyk M. Renal cell carcinoma guideline. Eur Urol 2007; 51:1502-1510. (Pubitemid 46634775)
10. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer V.I. 2009. National Comprehensive Cancer Network: .
11. O'Farrell AM, Foran JM, Fiedler W, Serve H, Paquette RL, Cooper MA, 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. (Pubitemid 37499464)
12. Motzer RJ, Michaelson MD, Redman BG, Hudes GR,Wilding G, Figlin RA, 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. (Pubitemid 46630489)
13. Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, et al. Sunitinib in patients with metastatic renal cell carcinoma. JAMA 2006; 295:2516-2524. (Pubitemid 43854967)
14. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O,et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007; 356:115-124. (Pubitemid 46089672)
15. Motzer RJ, Hutson TE, Tomczak P, Dror Michaelson M, Bukowski RM, Oudard S, et al. Overall survival and updated results for sunitinib versus interferon alfa in first-line treatment of patients with metastatic renal cell carcinoma. J Clin Oncol 2009; 27:3584-3590.
16. Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, et al. Safety and efficacy of sunitinib with subpopulation analysis in an expandedaccess trial of metastatic renal cell carcinoma. Lancet Oncol 2009; 10:757-763.
17. Escudier B, Roigas J, Gillessen S, Harmenberg U, Srinivas S, Mulder SF, 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. Coppin C, Porzsolt F, Awa A, Kumpf J, Coldman A, Wilt T. Immunotherapy for advanced renal cell cancer. Cochrane Database Syst Rev 2005; 3:CD001425.
19. Gore ME, Griffin CL, Hancock B, Patel PM, Pyle L, Aitchison M, et al. Interferon alfa-2a versus combination therapy with interferon alfa-2a, interleukin-2, and fluorouracil in patients with untreated metastatic renal cell carcinoma (MRC RE04/EORTC GU 30012): an open-label randomized trial. Lancet 2010; 375:641-648.
20. Dutcher J. Current status of interleukin-2 therapy for metastatic renal cell carcinoma and metastatic melanoma. Oncology (Williston Park) 2002; 16:4-10.
21. Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol 1995; 13:688-696.
22. McDermott DF, Regan MM, Clark JI, Flaherty LE,Weiss GR, Logan TF, et al. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol 2005; 23:133-141. (Pubitemid 41702632)
23. Houk B, Bello C, Kang D, Amantea M. A population pharmacokinetic metaanalysis of sunitinib malate (SU11248) and its primary metabolite (SU12662) in healthy volunteers and oncology patients. Clin Cancer Res 2009; 5:2497-2506.
24. Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer RJ. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/ pharmacodynamic meta-analysis. Cancer Chemother Pharmacol 2010; 66:357-371.
25. Schmidinger M, Arnold D, Szczylik C,Wagstaff J, Ravaud A. Optimising the use of sunitinib in metastatic renal cell carcinoma: an update from clinical practice. Cancer Invest 2010; 28:856-864.
26. Porta C, Szczylik C, Bracarda S, Hawkins R, Bjarnason GA, Oudard S, et al. Short and long-term safety with sunitinib in an expanded access trial in metastatic renal cell carcinoma (Abstract 5114; poster presentation). J Clin Oncol 2008; 26:5114.
27. Negrier S, Ravaud A. Optimisation of sunitinib therapy in metastatic renal cell carcinoma: adverse-event management. Eur J Cancer Suppl 2007; 5:12-19. (Pubitemid 350017071)
28. Ravaud A. How to optimise treatment compliance in metastatic renal cell carcinoma with targeted agents. Ann Oncol 2009; 20:i7-i12.
29. Roigas J. Clinical management of patients receiving tyrosine kinase inhibitors for advanced renal cell carcinoma. Eur Urol Suppl 2008; 7:593-600.
30. Sunitinib malate schedule 4/2 vs. sunitinib malate continuous dosing as first-line therapy for metastatic renal cell cancer; 08/2010 update. .