The Effect of ABCG2 genotype on the population pharmacokinetics of sunitinib in patients with renal cell carcinoma

Therapeutic Drug Monitoring

Volumn 36, Issue 3, 2014, Pages 310-316

  Mizuno, Tomoyuki ^a,b   Fukudo, Masahide ^a   Fukuda, Tsuyoshi ^b,c   Terada, Tomohiro ^a,e   Dong, Min ^b   Kamba, Tomomi ^d   Yamasaki, Toshinari ^d   Ogawa, Osamu ^d   Katsura, Toshiya ^a,f   Inui, Ken Ichi ^a,g   Vinks, Alexander A ^a,b   Matsubara, Kazuo ^a  

^a KYOTO UNIVERSITY HOSPITAL   (Japan)

^b CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^c UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^d KYOTO UNIVERSITY   (Japan)

^e SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL   (Japan)

^f RITSUMEIKAN UNIVERSITY   (Japan)

^g KYOTO PHARMACEUTICAL UNIVERSITY   (Japan)

Author keywords

oncology; pharmacogenetics; Population pharmacokinetics; sunitinib; transporter

Indexed keywords

BREAST CANCER RESISTANCE PROTEIN; SUNITINIB; ABC TRANSPORTER; ABCG2 PROTEIN, HUMAN; ANTINEOPLASTIC AGENT; INDOLE DERIVATIVE; PYRROLE DERIVATIVE; TUMOR PROTEIN;

ADULT; AGED; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; FEMALE; GENE FREQUENCY; GENETIC POLYMORPHISM; GENOTYPE; HUMAN; JAPANESE (PEOPLE); KIDNEY CARCINOMA; MAJOR CLINICAL STUDY; MALE; PHARMACOGENETICS; PRIORITY JOURNAL; STEADY STATE; BIOLOGICAL MODEL; CARCINOMA, RENAL CELL; GENETICS; JAPAN; KIDNEY NEOPLASMS; METABOLIC CLEARANCE RATE; URINE;

ANTINEOPLASTIC AGENTS; ATP-BINDING CASSETTE TRANSPORTERS; CARCINOMA, RENAL CELL; FEMALE; GENOTYPE; HUMANS; INDOLES; JAPAN; KIDNEY NEOPLASMS; MALE; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL; NEOPLASM PROTEINS; PYRROLES;

EID: 84901330582     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0000000000000025     Document Type: Article

References (36)

1. Goodman VL, Rock EP, Dagher R, et al. Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. Clin Cancer Res. 2007; 13:1367-1373.
2. Blumenthal GM, Cortazar P, Zhang JJ, et al. FDA approval summary: sunitinib for the treatment of progressive well-differentiated locally advanced or metastatic pancreatic neuroendocrine tumors. Oncologist. 2012;17:1108-1113.
3. 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.
4. 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. 2009;27:3584-3590.
5. Yoo C, Kim JE, Lee JL, et al. The efficacy and safety of sunitinib in Korean patients with advanced renal cell carcinoma: high incidence of toxicity leads to frequent dose reduction. Jpn J Clin Oncol. 2010;40: 980-985.
6. Uemura H, Shinohara N, Yuasa T, et al. A phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma: insights into the treatment, efficacy and safety. Jpn J Clin Oncol. 2010;40:194-202.
7. Hong MH, Kim HS, Kim C, et al. Treatment outcomes of sunitinib treatment in advanced renal cell carcinoma patients: a single cancer center experience in Korea. Cancer Res Treat. 2009;41:67-72.
8. Gamelin E, Delva R, Jacob J, et al. Individual fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: results of a multicenter randomized trial of patients with metastatic colorectal cancer. J Clin Oncol. 2008;26:2099-2105.
9. Rousseau A, Marquet P, Debord J, et al. Adaptive control methods for the dose individualization of anticancer agents. Clin Pharmacokinet. 2000;38:315-353.
10. de Jonge ME, Huitema AD, Schellens JH, et al. Individualized cancer chemotherapy: strategies and performance of prospective studies on therapeutic drug monitoring with dose adaptation: a review. Clin Pharmacokinet. 2005;44:147-173.
11. Alnaim L. Therapeutic drug monitoring of cancer chemotherapy. J Oncol Pharm Pract. 2007;13:207-221.
12. Gao B, Yeap S, Clements A, et al. Evidence for therapeutic drug monitoring of targeted anticancer therapies. J Clin Oncol. 2012;30: 4017-4025.
13. Picard S, Titier K, Etienne G, et al. Trough imatinib plasma levels are associated with both cytogenetic and molecular responses to standarddose imatinib in chronic myeloid leukemia. Blood. 2007;109:3496-3499.
14. Larson RA, Druker BJ, Guilhot F, et al. Imatinib pharmacokinetics and its correlation with response and safety in chronic-phase chronic myeloid leukemia: a subanalysis of the IRIS study. Blood. 2008;111:4022-4028.
15. Takahashi N, Wakita H, Miura M, et al. Correlation between imatinib pharmacokinetics and clinical response in Japanese patients with chronic-phase chronic myeloid leukemia. Clin Pharmacol Ther. 2010;88:809-813.
16. Bouchet S, Titier K, Moore N, et al. Therapeutic drug monitoring of imatinib in chronic myeloid leukemia: experience from 1216 patients at a centralized laboratory. Fundam Clin Pharmacol. 2013;27:690-697.
17. Petain A, Kattygnarath D, Azard J, et al. Population pharmacokinetics and pharmacogenetics of imatinib in children and adults. Clin Cancer Res. 2008;14:7102-7109.
18. Widmer N, Decosterd LA, Csajka C, et al. Population pharmacokinetics of imatinib and the role of alpha-acid glycoprotein. Br J Clin Pharmacol. 2006;62:97-112.
19. Delbaldo C, Chatelut E, Re M, et al. Pharmacokinetic-pharmacodynamic relationships of imatinib and its main metabolite in patients with advanced gastrointestinal stromal tumors. Clin Cancer Res. 2006;12: 6073-6078.
20. Schmidli H, Peng B, Riviere GJ, et al. Population pharmacokinetics of imatinib mesylate in patients with chronic-phase chronic myeloid leukaemia: results of a phase III study. Br J Clin Pharmacol. 2005;60:35-44.
21. Gotta V, Widmer N, Montemurro M, et al. Therapeutic drug monitoring of imatinib: Bayesian and alternative methods to predict trough levels. Clin Pharmacokinet. 2012;51:187-201.
22. Yamakawa Y, Hamada A, Nakashima R, et al. Association of genetic polymorphisms in the influx transporter SLCO1B3 and the efflux transporter ABCB1 with imatinib pharmacokinetics in patients with chronic myeloid leukemia. Ther Drug Monit. 2011;33:244-250.
23. Houk BE, Bello CL, Poland B, et al. 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.
24. Mizuno T, Fukudo M, Terada T, et al. Impact of genetic variation in breast cancer resistance protein (BCRP/ABCG2) on sunitinib pharmacokinetics. Drug Metab Pharmacokinet. 2012;27:631-639.
25. Houk BE, Bello CL, Kang D, et al. A population pharmacokinetic metaanalysis of sunitinib malate (SU11248) and its primary metabolite (SU12662) in healthy volunteers and oncology patients. Clin Cancer Res. 2009;15:2497-2506.
26. Mizuno T, Terada T, Kamba T, et al. ABCG2 421C.A polymorphism and high exposure of sunitinib in a patient with renal cell carcinoma. Ann Oncol. 2010;21:1382-1383.
27. Ludden TM, Beal SL, Sheiner LB. Comparison of the Akaike information criterion, the Schwarz criterion and the F test as guides to model selection. J Pharmacokinet Biopharm. 1994;22:431-445.
28. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008; 48:303-332.
29. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm. 1993;21:735-750.
30. Savic RM. Importance of shrinkage in empirical Bayes estimates for diagnostics: problems and solutions. AAPS J. 2009;11:558-569.
31. Bergstrand M, Hooker AC, Wallin JE, et al. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 2011;13:143-151.
32. de Jong FA, Marsh S, Mathijssen RH, et al. ABCG2 pharmacogenetics: ethnic differences in allele frequency and assessment of influence on irinotecan disposition. Clin Cancer Res. 2004;10:5889-5894.
33. Imai Y, Nakane M, Kage K, et al. C421A polymorphism in the human breast cancer resistance protein gene is associated with low expression of Q141K protein and low-level drug resistance. Mol Cancer Ther. 2002;1: 611-616.
34. 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.
35. Sparreboom A, Loos WJ, Burger H, et al. Effect of ABCG2 genotype on the oral bioavailability of topotecan. Cancer Biol Ther. 2005;4:650-658.
36. Thomas F, Rochaix P, White-Koning M, et al. Population pharmacokinetics of erlotinib and its pharmacokinetic/pharmacodynamic relationships in head and neck squamous cell carcinoma. Eur J Cancer. 2009; 45:2316-2323.