Utility of pretreatment bilirubin level and UGT1A1 polymorphisms in multivariate predictive models of neutropenia associated with irinotecan treatment in previously untreated patients with colorectal cancer

Archives of Drug Information

Volumn 1, Issue 3, 2008, Pages 97-106

  Parodi, Luis ^a   Pickering, Eve ^a   Cisar, Laura A ^a   Lee, Doug ^a   Soufi Mahjoubi, Raoudha ^a  

^a PFIZER INC   (United States)

Author keywords

Bilirubin; Colorectal Cancer; Irinotecan; Neutropenia

Indexed keywords

BILIRUBIN; CAPECITABINE; CELECOXIB; DNA; FLUOROURACIL; FOLINIC ACID; GLUCURONOSYLTRANSFERASE 1A1; IRINOTECAN; PLACEBO; THALIDOMIDE;

ADULT; AGE; ARTICLE; BLOOD TOXICITY; CANCER PATIENT; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DISEASE SEVERITY; FEMALE; GENDER; GENETIC POLYMORPHISM; GENOTYPE; HUMAN; LINEAR REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; METASTASIS; NEUTROPENIA; NEUTROPHIL COUNT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; STATISTICAL MODEL;

EID: 77953459452     PISSN: None     EISSN: 17535174     Source Type: Journal    
DOI: 10.1111/j.1753-5174.2008.00014.x     Document Type: Article

References (49)

1. Tan BR, McLeod HL. Pharmacogenetic influences on treatment response and toxicity in colorectal cancer. Semin Oncol 2005; 32: 113-9.
2. Goldberg RM. Therapy for metastatic colorectal cancer. Oncologist 2006; 11: 981-7.
3. Venook A. Critical evaluation of current treatments in metastatic colorectal cancer. Oncologist 2005; 10: 250-61.
4. Tournigand C, AndréT, Achille E, Lledo G, Flesh M, Mery-Mignard D, etal. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: A randomized GERCOR study. J Clin Oncol 2004; 22: 229-37.
5. Grothey A, Sargent D, Goldberg RM, Schmoll HJ. Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 2004; 22: 1209-14.
6. Hurwitz HI, Fehrenbacher L, Hainsworth JD, Heim W, Berlin J, Holmgren E, et al. Bevacizumab in combination with fluorouracil and leucovorin: An active regimen for first-line metastatic colorectal cancer. J Clin Oncol 2005; 23: 3502-8.
7. Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: The addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol 2005; 23: 3706-12.
8. Kabbinavar F, Hurwitz HI, Fehrenbacher L, Meropol NJ, Novotny WF, Lieberman G, et al. Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol 2003; 21: 60-5.
9. Extermann M, Bonetti M, Sledge GW, O'Dwyer PJ, Bonomi P, Benson AB 3rd. MAX2-A convenient index to estimate the average per patient risk for chemotherapy toxicity; validation in ECOG trials. Eur J Cancer 2004; 40: 1193-8.
10. Extermann M, Chen H, Cantor AB, Corcoran MB, Meyer J, Grendys E, et al. Predictors of tolerance to chemotherapy in older cancer patients: A prospective pilot study. Eur J Cancer 2002; 38: 1466-73.
11. Rogatko A, Babb JS, Wang H, Slifker MJ, Hudes GR. Patient characteristics compete with dose as predictors of acute treatment toxicity in early phase clinical trials. Clin Cancer Res 2004; 10: 4645-51.
12. Park DJ, Stoehlmacher J, Lenz HJ. Tailoring chemotherapy in advanced colorectal cancer. Curr Opin Pharmacol 2003; 3: 378-85.
13. Robert J. Pharmacogenetics and pharmacogenomics as new tools to optimise cancer chemotherapy. J Chemother 2004;16(4 suppl): 22-4.
14. Toffoli G, Cecchin E, Corona G, Russo A, Buonadonna A, D'Andrea M, et al. The role of UGT1A1*28 polymorphism in the pharmacodynamics and pharmacokinetics of irinotecan in patients with metastatic colorectal cancer. J Clin Oncol 2006; 24: 3061-8.
15. Iyer L, King CD, Whitington PF, Green MD, Roy SK, Tephly TR, et al. Genetic predisposition to the metabolism of irinotecan (CPT-11). Role of uridine diphosphate glucuronosyltransferase isoform 1A1 in the glucuronidation of its active metabolite (SN-38) in human liver microsomes. J Clin Invest 1998; 101: 847-54.
16. Iyer L, Hall D, Das S, Mortell MA, Ramírez J, Kim S, et al. Phenotype-genotype correlation of in vitro SN-38 (active metabolite of irinotecan) and bilirubin glucuronidation in human liver tissue with UGT1A1 promoter polymorphism. Clin Pharmacol Ther 1999; 65: 576-82.
17. Bosma PJ, Chowdhury JR, Bakker C, Gantla S, de Boer A, Oostra BA, et al. The genetic basis of the reduced expression of bilirubin UDP-glucuronosyltransferase 1 in Gilbert's syndrome. N Engl J Med 1995; 333: 1171-5.
18. Monaghan G, Ryan M, Seddon R, Hume R, Burchell B. Genetic variation in bilirubin UPD-glucuronosyltransferase gene promoter and Gilbert's syndrome. Lancet 1996; 347: 578-81.
19. Raijmakers MT, Jansen PL, Steegers EA, Peters WH. Association of human liver bilirubin UDP-glucuronyltransferase activity with a polymorphism in the promoter region of the UGT1A1 gene. J Hepatol 2000; 33: 348-51.
20. Iyer L, Das S, Janisch L, Wen M, Ramírez J, Karrison T, et al. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J 2002; 2: 43-7.
21. Innocenti F, Undevia SD, Iyer L, Chen PX, Das S, Kocherginsky M, et al. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol 2004; 22: 1382-8.
22. Innocenti F, Iyer L, Ratain MJ. Pharmacogenetics of anticancer agents: Lessons from amonafide and irinotecan. Drug Metab Dispos 2001; 29: 596-600.
23. Innocenti F. UGT1A1 genotyping in patients undergoing treatment with irinotecan. Clin Adv Hematol Oncol 2005; 3: 843-4.
24. Ando Y, Saka H, Ando M, Sawa T, Muro K, Ueoka H, et al. Polymorphisms of UDP-glucuronosyltransferase gene and irinotecan toxicity: A pharmacogenetic analysis. Cancer Res 2000; 60: 6921-6.
25. Fuchs CS, Marshall J, Mitchell E, Wierzbicki R, Ganju V, Jeffery M, et al. Randomized controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: Results from the BICC-C study. J Clin Oncol 2007; 25: 4779-86.
26. Cisar LA, Pickering E, Lee DS, Soufi-Mahjoubi R, Fuchs CS, Parodi LA. Multivariate predictive models of neutropenia associated with irinotecan treatment in previously untreated patients with colorectal cancer: A comparison of infusional and bolus regimens. Poster presented at: Gastrointestinal Cancers Symposium; January 19-21, 2007; Orlando, Florida (abstract 423).
27. Peterkin VC, Bauman JN, Goosen TC, Menning L, Man MZ, Paulauskis JD, et al. Limited influence of UGT1A1*28 and no effect of UGT2B7*2 polymorphisms on UGT1A1 or UGT2B7 activities and protein expression in human liver microsomes. Br J Clin Pharmacol 2007; 64: 458-68.
28. McLeod HL, Parodi L, Sargent DJ, Sargent DJ, Marsh S, Green E, et al. UGT1A1*28, toxicity and outcome in advanced colorectal cancer: Results from Trial N9741. J Clin Oncol 2006; 24(suppl): 18s. (abstract 3520).
29. Hoskins JM, Goldberg RM, McLeod HL. Irinotecan-induced neutropenia and UGT1A1*28: Does dose matter? J Clin Oncol 2007;25(suppl): 18s. (abstract 4023).
30. Lenz HJ. Pharmacogenomics in colorectal cancer. Semin Oncol 2003; 30(15 suppl): 47-53.
31. Rouits E, Boisdron-Celle M, Dumont A, Guérin O, Morel A, Gamelin E. Relevance of different UGT1A1 polymorphisms in irinotecan-induced toxicity: A molecular and clinical study of 75 patients. Clin Cancer Res 2004; 10: 5151-9.
32. Marcuello E, Altés A, Menoyo A, Del Rio E, Gómez-Pardo M, Baiget M. UGT1A1 gene variations and irinotecan treatment in patients with metastatic colorectal cancer. Br J Cancer 2004; 91: 678-82.
33. Massacesi C, Terrazzino S, Marcucci F, Rocchi MB, Lippe P, Bisonni R, et al. Uridine diphosphate glucoronosyl transferase 1A1 promoter polymorphism predicts the risk of gastrointestinal toxicity and fatigue induced by irinotecan-based chemotherapy. Cancer 2006; 106: 1007-16.
34. Carlini LE, Meropol NJ, Bever J, Andria ML, Hill T, Gold P, et al. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res 2005; 11: 226-36.
35. Chiara S, Serra M, Marrón P, Lastraioli P, Ponzanelli A, Tomasello L, et al. UGT1A1 promoter genotype and toxicity in patients with advanced colorectal cancer treated with irinotecan-containing chemotherapy. J Clin Oncol 2005; 23(suppl): 16s. (abstract 2016).
36. Ramchandani RP, Wang Y, Booth BP, Ibrahim A, Johnson JR, Rahman A, et al. The role of SN-38 exposure, UGT1A1*28 polymorphism, and baseline bilirubin level in predicting severe irinotecan toxicity. J Clin Pharmacol 2007; 47: 78-86.
37. Scripture CD, Sparreboom A, Figg WD. Modulation of cytochrome P450 activity: Implications for cancer therapy. Lancet Oncol 2005; 6: 780-9.
38. Haaz MC, Rivory L, RichéC, Vernillet L, Robert J. Metabolism of irinotecan (CPT-11) by human hepatic microsomes: Participation of cytochrome P-450 3A and drug interactions. Cancer Res 1998; 58: 468-72.
39. Santos A, Zanetta S, Cresteil T, Deroussent A, Pein F, Raymond E, et al. Metabolism of irinotecan (CPT-11) by CYP3A4 and CYP3A5 in humans. Clin Cancer Res 2000; 6: 2012-20.
40. Gupta E, Mick R, Ramirez J, Wang X, Lestingi TM, Vokes EE, et al. Pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan in cancer patients. J Clin Oncol 1997; 15: 1502-10.
41. Marsh S, McLeod HL. Cancer pharmacogenetics. Br J Cancer 2004; 90: 8-11.
42. Raida M, Schwabe W, Häusler P, Van Kuilenburg AB, Van Gennip AH, Behnke D, et al. Prevalence of a common point mutation in the dihydropyrimidine dehydrogenase (DPD) gene within the 5′-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.
43. Eichelbaum M, Ingelman-Sundberg M, Evans WE. Pharmacogenomics and individualized drug therapy. Annu Rev Med 2006; 57: 119-37.
44. Roden DM, Altman RB, Benowitz NL, Flockhart DA, Giacomini KM, Johnson JA, et al. Pharmacogenetics research network. Pharmacogenomics: Challenges and opportunities. Ann Intern Med 2006; 145: 749-57.
45. Bosch TM, Meijerman I, Beijnen JH, Schellens JH. Genetic polymorphisms of drug-metabolising enzymes and drug transporters in the chemotherapeutic treatment of cancer. Clin Pharmacokinet 2006; 45: 253-85.
46. Del Rio M, Molina F, Bascoul-Mollevi C, Copois V, Bibeau F, Chalbos P, et al. Gene expression signature in advanced colorectal cancer patients select drugs and response for the use of leucovorin, fluorouracil, and irinotecan. J Clin Oncol 2007; 125: 773-80.
47. Ginsburg GS, Konstance RP, Allsbrook JS, Schulman KA. Implications of pharmacogenomics for drug development and clinical practice. Arch Intern Med 2005; 165: 2331-6.
48. Willard HF, Angrist M, Ginsburg GS. Genomic medicine: Genetic variation and its impact on the future of health care. Philos Trans R Soc Lond B Biol Sci 2005; 360: 1543-50.
49. Maitland ML, Vasisht K, Ratain MJ. TPMT, UGT1A1 and DPYD: Genotyping to ensure safer cancer therapy? Trends Pharmacol Sci 2006; 27: 432-7.