A pharmacokinetic/pharmacodynamic model of tumor lysis syndrome in chronic lymphocytic leukemia patients treated with flavopiridol

Clinical Cancer Research

Volumn 19, Issue 5, 2013, Pages 1269-1280

  Ji, Jia ^a   Mould, Diane R ^b,d   Blum, Kristie A ^a,c   Ruppert, Amy S ^c   Poi, Ming ^a   Zhao, Yuan ^b   Johnson, Amy J ^a,c   Byrd, John C ^a,b,c   Grever, Michael R ^a,c   Phelps, Mitch A ^a,b  

^a OHIO STATE UNIVERSITY   (United States)

^b Nashville Clinical Education Center and Statewide   (United States)

^c OHIO STATE UNIVERSITY   (United States)

^d Projections Research Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLOPURINOL; CALCIUM; CYCLIN DEPENDENT KINASE INHIBITOR; FLAVOPIRIDOL; FUROSEMIDE; GLUCOSE; GLUCURONIDE; INSULIN; PHOSPHATE BINDING AGENT; RASBURICASE; SALBUTAMOL;

ADULT; AREA UNDER THE CURVE; ARTICLE; CHRONIC LYMPHATIC LEUKEMIA; DEMOGRAPHY; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG MECHANISM; FEMALE; HUMAN; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROBABILITY; RISK FACTOR; TUMOR LYSIS SYNDROME;

ANTINEOPLASTIC AGENTS; FEMALE; FLAVONOIDS; FOLLOW-UP STUDIES; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MAXIMUM TOLERATED DOSE; MODELS, BIOLOGICAL; NEOPLASM RECURRENCE, LOCAL; PIPERIDINES; PREVALENCE; PROGNOSIS; TISSUE DISTRIBUTION; TUMOR LYSIS SYNDROME; UNITED STATES;

EID: 84874825923     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-12-1092     Document Type: Article

References (50)

1. Sausville EA. Cell cycle regulatory kinase modulators: interim progress and issues. Curr Topics Med Chem 2005;5: 1109-17.
2. Senderowicz AM. Inhibitors of cyclin-dependent kinase modulators for cancer therapy. Prog Drug Res 2005;63: 183-206.
3. Kouroukis CT, Belch A, Crump M, Eisenhauer E, Gascoyne RD, Meyer R, et al. Flavopiridol in untreated or relapsed mantle-cell lymphoma: results of a phase II study of the National Cancer Institute of Canada clinical trials group. J Clin Oncol 2003;21: 1740-5.
4. Aklilu M, Kindler HL, Donehower RC, Mani S, Vokes EE. Phase II study of flavopiridol in patients with advanced colorectal cancer. Ann Oncol 2003;14: 1270-3.
5. Burdette-Radoux S, Tozer RG, Lohmann RC, Quirt I, Ernst DS, Walsh W, et al. Phase II trial of flavopiridol, a cyclin-dependent kinase inhibitor, in untreated metastatic malignant melanoma. Invest New Drugs 2004;22: 315-22.
6. Liu G, Gandara DR, Lara PN Jr, Raghavan D, Doroshow JH, Twardowski P, et al. A phase II trial of flavopiridol (NSC #649890) in patients with previously untreated metastatic androgen-independent prostate cancer. Clin Cancer Res 2004;10: 924-8.
7. Schwartz GK, Ilson D, Saltz L, O'Reilly E, Tong W, Maslak P, et al. Phase II study of the cyclin-dependent kinase inhibitor flavopiridol administered to patients with advanced gastric carcinoma. J Clin Oncol 2001;19: 1985-92.
8. Shapiro GI. Preclinical and clinical development of the cyclin-dependent kinase inhibitor flavopiridol. Clin Cancer Res 2004;10: 4270s-5s.
9. Byrd JC, Peterson BL, Gabrilove J, Odenike OM, Grever MR, Rai K, et al. Treatment of relapsed chronic lymphocytic leukemia by 72-hour continuous infusion or 1-hour bolus infusion of flavopiridol: results from Cancer and Leukemia Group B study 19805. Clin Cancer Res 2005;11: 4176-81.
10. Schwartz GK, O'Reilly E, Ilson D, Saltz L, Sharma S, Tong W, et al. Phase I study of the cyclin-dependent kinase inhibitor flavopiridol in combination with paclitaxel in patients with advanced solid tumors. J Clin Oncol 2002;20: 2157-70.
11. Stadler WM, Vogelzang NJ, Amato R, Sosman J, Taber D, Liebowitz D, et al. Flavopiridol, a novel cyclin-dependent kinase inhibitor, in metastatic renal cancer: a University of Chicago Phase II Consortium study. J Clin Oncol 2000;18: 371-5.
12. Flinn IW, Byrd JC, Bartlett N, Kipps T, Gribben J, Thomas D, et al. Flavopiridol administered as a 24-hour continuous infusion in chronic lymphocytic leukemia lacks clinical activity. Leuk Res 2005;29: 1253-7.
13. Lin TS, Howard OM, Neuberg DS, Kim HH, Shipp MA. Seventy-two hour continuous infusion flavopiridol in relapsed and refractory mantle cell lymphoma. Leuk Lymphoma 2002;43: 793-7.
14. Phelps MA, Lin TS, Johnson AJ, Hurh E, Rozewski DM, Farley KL, et al. Clinical response and pharmacokinetics from a phase 1 study of an active dosing schedule of flavopiridol in relapsed chronic lymphocytic leukemia. Blood 2009;113: 2637-45.
15. Widmer N, Decosterd LA, Csajka C, Leyvraz S, Duchosal MA, Rosselet A, et al. Population pharmacokinetics of imatinib and the role of alphaacid glycoprotein. Br J Clin Pharmacol 2006;62: 97-112.
16. Christian BA, Grever MR, Byrd JC, Lin TS. Flavopiridol in chronic lymphocytic leukemia: a concise review. Clin Lymphoma Myeloma 2009;9 Suppl 3:S179-85.
17. Blum KA, Ruppert AS, Woyach JA, et al. Risk factors for tumor lysis syndrome in patients with chronic lymphocytic leukemia treated with the cyclin-dependent kinase inhibitor, flavopiridol. Leukemia 2011;25: 1444-51.
18. Tiu RV, Mountantonakis SE, Dunbar AJ, Schreiber MJ Jr. Tumor lysis syndrome. Semin Thromb Hemost 2007;33: 397-407.
19. Tosi P, Barosi G, Lazzaro C, Liso V, Marchetti M, Morra E, et al. Consensus conference on the management of tumor lysis syndrome. Haematologica 2008;93: 1877-85.
20. Ramirez J, Iyer L, Journault K, Belanger P, Innocenti F, Ratain MJ, et al. In vitro characterization of hepatic flavopiridol metabolism using human liver microsomes and recombinant UGT enzymes. Pharm Res 2002;19: 588-94.
21. Hagenauer B, Salamon A, Thalhammer T, Kunert O, Haslinger E, Klingler P, et al. In vitro glucuronidation of the cyclin-dependent kinase inhibitor flavopiridol by rat and human liver microsomes: involvement of UDP-glucuronosyltransferases 1A1 and 1A9. Drug Metab Dispos 2001;29: 407-14.
22. Liston HL, Markowitz JS, DeVane CL. Drug glucuronidation in clinical psychopharmacology. J Clin Psychopharmacol 2001;21: 500-15.
23. Jager W, Gehring E, Hagenauer B, Aust S, Senderowicz A, Thalhammer T. Biliary excretion of flavopiridol and its glucuronides in the isolated perfused rat liver: role of multidrug resistance protein 2 (Mrp2). Life Sci 2003;73: 2841-54.
24. Rudek MA, Bauer KS Jr, Lush RM III, Stinson SF, Senderowicz AM, Headlee DJ, et al. Clinical pharmacology of flavopiridol following a 72-hour continuous infusion. Ann Pharmacother 2003;37: 1369-74.
25. Gertz MA. Managing tumor lysis syndrome in 2010. Leuk Lymphoma 2010;51: 179-80.
26. Cheson BD, Bennett JM, Grever M, Kay N, Keating MJ, O'Brien S, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996;87: 4990-7.
27. Cheson BD. Etiology and management of tumor lysis syndrome in patients with chronic lymphocytic leukemia. Clin Adv Hematol Oncol 2009;7: 263-71.
28. Flynn J, Jones J, Andritsos L, Blum K, Johnson A, Hessler J, et al. Update on the phase I study of the cyclin-dependent kinase inhibitor dinaciclib (SCH 727965) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL): confirmation of clinical activity and feasibility of long-term administration. ASH Ann Meeting Abstracts 2010;116: 1396.
29. Ni W, Ji J, Dai Z, Papp A, Johnson AJ, Ahn S, et al. Flavopiridol pharmacogenetics: clinical and functional evidence for the role of SLCO1B1/OATP1B1 in flavopiridol disposition. PLoS One 2010;5: e13792.
30. Blum W, Phelps MA, Klisovic RB, Rozewski DM, Ni W, Albanese KA, et al. Phase I clinical and pharmacokinetic study of a novel schedule of flavopiridol in relapsed or refractory acute leukemias. Haematologica 2010;95: 1098-105.
31. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16: 31-41.
32. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine (CVM). Bioequivalence Guidance. Docket No. 94D-0401. November 8, 2006.
33. Jain L, Woo S, Gardner ER, Dahut WL, Kohn EC, Kummar S, et al. Population pharmacokinetic analysis of sorafenib in patients with solid tumours. Br J Clin Pharmacol 2011;72: 294-305.
34. Souverein OW, Zwinderman AH, Tanck MW. Multiple imputation of missing genotype data for unrelated individuals. Ann Human Genet 2006;70: 372-81.
35. Foulkes AS, Yucel R, Reilly MP. Mixed modeling and multiple imputation for unobservable genotype clusters. Stat Med 2008;27: 2784-801.
36. Nothnagel M, Ellinghaus D, Schreiber S, Krawczak M, Franke A. A comprehensive evaluation of SNP genotype imputation. Hum Genet 2009;125: 163-71.
37. Howie B, Fuchsberger C, Stephens M, Marchini J, Abecasis GR. Fast and accurate genotype imputation in genome-wide association studies through pre-phasing. Nat Genet 2012;44: 955-9.
38. Jewett EM, Zawistowski M, Rosenberg NA, Zollner S. A coalescent model for genotype imputation. Genetics 2012;191: 1239-55.
39. Buckley DB, Klaassen CD. Tissue- and gender-specificmRNA expression of UDP-glucuronosyltransferases (UGTs) in mice. Drug Metab Dispos 2007;35: 121-7.
40. Catania VA, Dannenberg AJ, Luquita MG, Sanchez Pozzi EJ, Tucker JK, Yang EK, et al. Gender-related differences in the amount and functional state of rat liver UDP-glucuronosyltransferase. Biochem Pharmacol 1995;50: 509-14.
41. Anderson GD. Sex differences in drug metabolism: cytochrome P-450 and uridine diphosphate glucuronosyltransferase. J Gend Specif Med 2002;5: 25-33.
42. Gallagher CJ, Balliet RM, Sun D, Chen G, Lazarus P. Sex differences in UDP-glucuronosyltransferase 2B17 expression and activity. Drug Metab Dispos 2010;38: 2204-9.
43. Anderson GD. Sex and racial differences in pharmacological response: where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics. J Women's Health 2005;14: 19-29.
44. Court MH, Hao Q, Krishnaswamy S, Bekaii-Saab T, Al-Rohaimi A, von Moltke LL, et al. UDP-glucuronosyltransferase (UGT) 2B15 pharmacogenetics: UGT2B15 D85Y genotype and gender are major determinants of oxazepam glucuronidation by human liver. J Pharmacol Exp Ther 2004;310: 656-65.
45. Cheson BD, Bennett JM, Grever M, Kay N, Keating MJ, O'Brien S, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996;87: 4990-7.
46. Villeneuve L, Girard H, Fortier LC, Gagne JF, Guillemette C. Novel functional polymorphisms in the UGT1A7 and UGT1A9 glucuronidating enzymes in Caucasian and African-American subjects and their impact on the metabolism of 7-ethyl-10-hydroxycamptothecin and flavopiridol anticancer drugs. J Pharmacol Exp Ther 2003;307: 117-28.
47. Ramirez J, Liu W, Mirkov S, Desai AA, Chen P, Das S, et al. Lack of association between common polymorphisms in UGT1A9 and gene expression and activity. Drug Metab Dispos 2007;35: 2149-53.
48. Mato AR, Riccio BE, Qin L, Heitjan DF, Carroll M, Loren A, et al. A predictive model for the detection of tumor lysis syndrome during AML induction therapy. Leuk Lymphoma 2006;47: 877-83.
49. Wossmann W, Schrappe M, Meyer U, Zimmerman M, Reiter A. Incidence of tumor lysis syndrome in children with advanced stage Burkitt's lymphoma/leukemia before and after introduction of prophylactic use of urate oxidase. Ann Hematol 2003;82: 160-5.
50. Byrd JC, Lin TS, Dalton JT, Wu D, Phelps MA, Fischer B, et al. Flavopiridol administered using a pharmacologically derived schedule is associated with marked clinical efficacy in refractory, genetically high-risk chronic lymphocytic leukemia. Blood 2007;109: 399-404.