Evaluation of 5-fluorouracil pharmacokinetics in cancer patients with a c.19051G>A Mutation in DPYD by means of a bayesian limited sampling strategy

Clinical Pharmacokinetics

Volumn 51, Issue 3, 2012, Pages 163-174

  Van Kuilenburg, André B P ^a   Häusler, Peter ^b   Schalhorn, Andreas ^c   Tanck, Michael W T ^a   Proost, Johannes H ^d   Terborg, Christoph ^e   Behnke, Detlev ^f   Schwabe, Wolfgang ^f   Jabschinsky, Kati ^f   Maring, Jan Gerard ^g  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b CLONDIAG GmbH   (Germany)

^c LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^d UNIVERSITY OF GRONINGEN   (Netherlands)

^e DEPARTMENT OF CARDIOLOGY   (Germany)

^f Oncoscreen GmbH   (Germany)

^g Bethesda Hospital   (Netherlands)

Author keywords

Cancer; Fluorouracil; Genetic polymorphism; Pharmacokinetic modelling; Pharmacokinetics; Pharmacology.

Indexed keywords

DIHYDROPYRIMIDINE DEHYDROGENASE; FLUOROURACIL;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER PATIENT; CECUM CANCER; CLINICAL ARTICLE; COLORECTAL CANCER; CONTROLLED STUDY; DIHYDROPYRIMIDINE DEHYDROGENASE DEFICIENCY; DRUG BLOOD LEVEL; DRUG ELIMINATION; ESOPHAGUS CANCER; FEMALE; GALLBLADDER CANCER; GENE MUTATION; GENOTYPE; HUMAN; MALE; METASTASIS; PANCREAS CANCER; PRIORITY JOURNAL; STOMACH CANCER; TONGUE CANCER; UNSPECIFIED SIDE EFFECT;

EID: 84857074749     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/bf03257473     Document Type: Article

References (45)

1. Meyerhardt JA, Mayer RJ. Systemic therapy for colorectal cancer. N Engl J Med 2005; 352: 476-87
2. Twelves C, Wong A, Nowacki MP, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 2005; 352: 2696-704 (Pubitemid 41007824)
3. Heggie GD, Sommadossi JP, Cross DS, et al. Clinical pharmacokinetics of 5-fluorouracil and its metabolites in plasma, urine, and bile. Cancer Res 1987; 47: 2203-6 (Pubitemid 17074634)
4. Mattison LK, Soong R, Diasio RB. Implications of dihydropyrimidine dehydrogenase on 5-fluorouracil pharmacogenetics and pharmacogenomics. Pharmacogenomics 2002; 3: 485-92 (Pubitemid 34814677)
5. van Kuilenburg ABP. Dihydropyrimidine dehydrogenase and the efficacy and toxicity of 5-fluorouracil. Eur J Cancer 2004; 40: 939-50 (Pubitemid 38496249)
6. van Kuilenburg ABP, Haasjes J, Richel DJ, et al. Clinical implications of dihydropyrimidine dehydrogenase (DPD) deficiency in patients with severe 5-fluorouracil-associated toxicity: identification of new mutations in theDPD gene. Clin Cancer Res 2000; 6: 4705-12 (Pubitemid 32110408)
7. Milano GA, Etienne MC, Pierrefite V, et al. Dihydropyrimidine dehydrogenase deficiency and fluorouracil-related toxicity. Br J Cancer 1999; 79: 627-30 (Pubitemid 29046246)
8. Ciccolini J, Mercier C, Evrard A, et al. A rapid and inexpensive method for anticipating severe toxicity to fluorouracil and fluorouracil-based chemotherapy. Ther Drug Monit 2006; 28: 678-85 (Pubitemid 44564069)
9. Morel A, Boisdron-Celle M, Fey L, et al. Clinical relevance of different dihydropyrimidine dehydrogenase gene single nucleotide polymorphisms on 5-fluorouracil tolerance. Mol Cancer Ther 2006; 5: 2895-904 (Pubitemid 44849017)
10. Schwab M, Zanger UM, Marx C, et al. Role of genetic and nongenetic factors for fluorouracil treatment-related severe toxicity: a prospective clinical trial by the German 5-FU Toxicity Study Group. J Clin Oncol 2008; 26: 2131-8
11. Etienne MC, Lagrange JL, Dassonville O, et al. Population study of dihydropyrimidine dehydrogenase in cancer patients. J Clin Oncol 1994; 12: 2248-53 (Pubitemid 24346691)
12. Deenen MJ, Tol J, Burylo AM, et al. Relationship between single nucleotide polymorphisms and haplotypes in DPYD and toxicity and efficacy of capecitabine in advanced colorectal cancer. Clin Cancer Res 2011 May 15; 17 (10): 3455-68
13. Diasio RB, Beavers TL, Carpenter JT. Familial deficiency of dihydropyrimidine dehydrogenase: biochemical basis for familial pyrimidinemia and severe 5-fluorouracil-induced toxicity. J Clin Invest 1988; 81: 47-51 (Pubitemid 18092231)
14. Codacci-Pisanelli G, Pinedo HM, Lankelma J, et al. Pharmacokinetics of bolus 5-fluorouracil: relationship between dose, plasma concentrations, areaunder-the-curve and toxicity. J Chemother 2005; 17: 315-20 (Pubitemid 40992271)
15. van Kuilenburg ABP, Maring JG, Schalhorn A, et al. Pharmacokinetics of 5-fluorouracil in patients heterozygous for the IVS14+1G>A mutation in the dihydropyrimidine dehydrogenase gene. Nucleos Nucleot Nucleic Acids 2008; 27: 692-8 (Pubitemid 351948568)
16. Maring JG, van Kuilenburg ABP, Haasjes J, et al. Reduced 5-FU clearance in a patient with low DPD activity due to heterozygosity for a mutant allele of the DPYD gene. Br J Cancer 2002; 86: 1028-33 (Pubitemid 34438069)
17. Terret C, Erdociain E, Guimbaud R, et al. Dose and time dependencies of 5-fluorouracil pharmacokinetics. Clin Pharmacol Ther 2000; 68: 270-9
18. Raida M, Schwabe W, Häusler P, et al. Prevalence of a common point mutation in the dihydropyrimidine dehydrogenase (DPD) gene within the 50-splice donor site of intron 14 in patients with severe 5-fluorouracil (5-FU)-related toxicity compared with controls. Clin Cancer Res 2001; 7: 2832-9 (Pubitemid 32911393)
19. Schalhorn A, Peyerl G, Denecke H. Pharmacokinetics of 5-fluorouracil during isolated liver perfusion. Regional Cancer Treatment 1988; 1: 21-7
20. Proost JH, Meijer DK. MW/Pharm, an integrated software package for drug dosage regimen calculation and therapeutic drug monitoring. Comput Biol Med 1992; 22: 155-63
21. Proost JH, Eleveld DJ. Performance of an iterative two-stage Bayesian technique for population pharmacokinetic analysis of rich data sets. Pharm Res 2006; 23: 2748-59 (Pubitemid 44885363)
22. Maring JG, Schouten L, Greijdanus B, et al. A simple and sensitive fully validated HPLC-UV method for the determination of 5-fluorouracil and its metabolite 5,6-dihydrofluorouracil in plasma. Ther Drug Monit 2005; 27: 25-30 (Pubitemid 40189969)
23. Maring JG, Piersma H, van Dalen A, et al. Extensive hepatic replacement due to liver metastases has no effect on 5-fluorouracil pharmacokinetics. Cancer Chemother Pharmacol 2003; 51: 167-73 (Pubitemid 36259478)
24. Akobeng AK. Understanding diagnostic tests 3: receiver operating characteristic curves. Acta Paediatr 2007; 96: 644-7 (Pubitemid 46653167)
25. Wei X, McLeod HL, McMurrough J, et al. Molecular basis of the human dihydropyrimidine dehydrogenase deficiency and 5-fluorouracil toxicity. J Clin Invest 1996; 98: 610-5 (Pubitemid 26349163)
26. Vreken P, van Kuilenburg ABP, Meinsma JR, et al. A point mutation in an invariant splice donor site leads to exon skipping in two unrelated Dutch patients with dihydropyrimidine dehydrogenase deficiency. J Inherit Metab Dis 1996; 19: 645-54 (Pubitemid 26315916)
27. van Kuilenburg ABP, Vreken P, Abeling NGGM, et al. Genotype and phenotype in patients with dihydropyrimidine dehydrogenase deficiency. Hum Genet 1999; 104: 1-9 (Pubitemid 29134634)
28. van Kuilenburg ABP, Meinsma JR, Zoetekouw L, et al. Increased risk of grade IV neutropenia after administration of 5-fluorouracil due to a dihydropyrimidine dehydrogenase deficiency: high prevalence of the IVS14+1G>A mutation. Int J Cancer 2002; 101: 253-8 (Pubitemid 34970893)
29. Gusella M, Ferrazzi E, Ferrari M, et al. New limited sampling strategy for determining 5-fluorouracil area under the concentration-time curve after rapid intravenous bolus. Ther Drug Monit 2002; 24: 425-31 (Pubitemid 34553210)
30. Di Paolo A, Danesi R, Vannozzi F, et al. Limited sampling model for the analysis of 5-fluorouracil pharmacokinetics in adjuvant chemotherapy for colorectal cancer. Clin Pharmacol Ther 2002; 72: 627-37 (Pubitemid 36021002)
31. Bocci G, Danesi R, Di Paolo AD, et al. Comparative pharmacokinetic analysis of 5-fluorouracil and its major metabolite 5-fluoro-5,6-dihydrouracil after conventional and reduced test dose in cancer patients. Clin Cancer Res 2000; 6: 3032-7 (Pubitemid 30637725)
32. Bocci G, Barbara C, Vannozzi F, et al. A pharmacokinetic-based test to prevent severe 5-fluorouracil toxicity. Clin Pharmacol Ther 2006; 80: 384-95 (Pubitemid 44479748)
33. Boisdron-Celle M, Remaud G, Traore S, et al. 5-Fluorouracil-related severe toxicity: a comparison of different methods for the pretherapeutic detection of dihydropyrimidine dehydrogenase deficiency. Cancer Lett 2007; 249: 271-82 (Pubitemid 46452935)
34. Mattison LK, Ezzeldin H, Carpenter M, et al. Rapid identification of dihydropyrimidine dehydrogenase deficiency by using a novel 2-13C-uracil breath test. Clin Cancer Res 2004; 10: 2652-8 (Pubitemid 38509138)
35. van Kuilenburg ABP. Screening for dihydropyrimidine dehydrogenase deficiency: to do or not to do, that's the question. Cancer Invest 2006; 24: 215-7
36. Ciccolini J, Gross E, Dahan L, et al. Routine dihydropyrimidine dehydrogenase testing for anticipating 5-fluorouracil-related severe toxicities: hype or hope? Clin Colorectal Cancer 2010; 9: 224-8
37. van Staveren MC, Theeuwes-Oonk B, Guchelaar HJ, et al. Pharmacokinetics of orally administered uracil in healthy volunteers and in DPD-deficient patients, a possible tool for screening of DPD deficiency. Cancer Chemother Pharmacol 2011; 68: 1611-7
38. Collie-Duguid ESR, Etienne MC, Milano GA, et al. Known variant DPYD alleles do not explain DPD deficiency in cancer patients. Pharmacogenetics 2000; 10: 217-23 (Pubitemid 30242737)
39. van Kuilenburg ABP, Meijer J, Mul ANPM, et al. Intragenic deletions and a deep intronic mutation affecting pre-mRNA splicing in the dihydropyrimidine dehydrogenase gene as novel mechanisms causing 5-fluorouracil toxicity. Hum Genet 2010; 128: 529-38
40. Yen JL, McLeod HL. Should DPD analysis be required prior to prescribing fluoropyrimidines? Eur J Cancer 2007; 43: 1011-2
41. Di Paolo A, Danesi R, Falcone A, et al. Relationship between 5-fluorouracil disposition, toxicity and dihydropyrimidine dehydrogenase activity in cancer patients. Ann Oncol 2001; 12: 1301-6 (Pubitemid 32994761)
42. Gamelin E, Boisdron-Celle M. Dose monitoring of 5-fluorouracil in patients with colorectal or head and neck cancer: status of the art. Crit Rev Oncol Hematol 1999; 30: 71-9 (Pubitemid 29294713)
43. Gusella M, Crepaldi G, Barile C, et al. Pharmacokinetic and demographic markers of 5-fluorouracil toxicity in 181 patients on adjuvant therapy for colorectal cancer. Ann Oncol 2006; 17: 1656-60 (Pubitemid 44680886)
44. 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: 2099-105
45. Swen JJ, Nijenhuis M, de Boer A, et al. Pharmacogenetics: from bench to byte: an update of guidelines. Clin Pharmacol Ther 2011; 89: 662-73