Dose-finding and pharmacokinetic study to optimize the dosing of irinotecan according to the UGT1A1 genotype of patients with cancer

Journal of Clinical Oncology

Volumn 32, Issue 22, 2014, Pages 2328-2334

  Innocenti, Federico ^a   Schilsky, Richard L ^a   Ramiŕez, Jacqueline ^a   Janisch, Linda ^a   Undevia, Samir ^a   House, Larry K ^a   Das, Soma ^a   Wu, Kehua ^a   Turcich, Michelle ^a   Marsh, Robert ^b   Karrison, Theodore ^a   Maitland, Michael L ^a   Salgia, Ravi ^a   Ratain, Mark J ^a  

^a UNIVERSITY OF CHICAGO   (United States)

^b NORTHSHORE UNIVERSITY HEALTHSYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FIRTECAN; FIRTECAN GLUCURONIDE; GLUCURONOSYLTRANSFERASE 1A1; IRINOTECAN;

ADULT; ADVANCED CANCER; AGED; AREA UNDER THE CURVE; ARTICLE; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; DIARRHEA; DOSE CALCULATION; DRUG CLEARANCE; DRUG EFFICACY; DRUG GLUCURONIDATION; DRUG SAFETY; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; FEMALE; GENE; GENOTYPE; GLUCURONOSYLTRANSFERASE 1A1 GENE; HUMAN; INFECTION; LUNG CANCER; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAUSEA; NAUSEA AND VOMITING; NEUTROPENIA; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PNEUMONIA; PRIORITY JOURNAL; SMALL INTESTINE CANCER; SOLID TUMOR; STOMACH CANCER; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, PHYTOGENIC; CAMPTOTHECIN; DOSE-RESPONSE RELATIONSHIP, DRUG; GENOTYPE; GLUCURONOSYLTRANSFERASE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS;

EID: 84905817082     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.55.2307     Document Type: Article

References (23)

1. Meyerhardt JA, Mayer RJ: Systemic therapy for colorectal cancer. N Engl J Med 352:476-487, 2005
2. Innocenti F, Ratain MJ: Pharmacogenetics of irinotecan: Clinical perspectives on the utility of genotyping. Pharmacogenomics 7:1211-1221, 2006 (Pubitemid 46024184)
3. Ramchandani RP, Wang Y, Booth BP, et al: The role of SN-38 exposure, UGT1A1*28 polymorphism, and baseline bilirubin level in predicting severe irinotecan toxicity. J Clin Pharmacol 47:78-86, 2007 (Pubitemid 44974001)
4. Innocenti F, Undevia SD, Iyer L, et al: Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol 22:1382-1388, 2004 (Pubitemid 41103619)
5. Minami H, Sai K, Saeki M, et al: Irinotecan pharmacokinetics/ pharmacodynamics and UGT1A genetic polymorphisms in Japanese: Roles of UGT1A1*6 and *28. Pharmacogenet Genomics 17:497-504, 2007 (Pubitemid 46905216)
6. Han JY, Lim HS, Shin ES, et al: Comprehensive analysis of UGT1A polymorphisms predictive for pharmacokinetics and treatment outcome in patients with non-small-cell lung cancer treated with irinotecan and cisplatin. J Clin Oncol 24:2237-2244, 2006
7. Toffoli G, Cecchin E, Corona G, et al: The role of UGT1A1*28 polymorphism in the pharmacodynamics and pharmacokinetics of irinotecan in patients with metastatic colorectal cancer. J Clin Oncol 24:3061-3068, 2006 (Pubitemid 46638941)
8. Hoskins JM, Goldberg RM, Qu P, et al: UGT1A1*28 genotype and irinotecan-induced neutropenia: Dose matters. J Natl Cancer Inst 99:1290-1295, 2007 (Pubitemid 47394168)
9. Pfizer: Camptosar Package Insert. New York, NY, Pfizer, 2012
10. Egorin MJ: Horseshoes, hand grenades, and body-surface area-based dosing: Aiming for a target. J Clin Oncol 21:182-183, 2003
11. Mathijssen RH, Verweij J, de Jonge MJ, et al: Impact of body-size measures on irinotecan clearance: Alternative dosing recommendations. J Clin Oncol 20:81-87, 2002 (Pubitemid 34032599)
12. Iyer L, Das S, Janisch L, et al: UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J 2:43-47, 2002 (Pubitemid 34982202)
13. Iyer L, Hall D, Das S, et al: Phenotypegenotype correlation of in vitro SN-38 (active metabolite of irinotecan) and bilirubin glucuronidation in human liver tissue with UGT1A1 promoter polymorphism. Clin Pharmacol Ther 65:576-582, 1999 (Pubitemid 29237332)
14. Therasse P, Eisenhauer EA, Verweij J: RECIST revisited: A review of validation studies on tumour assessment. Eur J Cancer 42:1031-1039, 2006
15. Gillis NK, Patel JN, Innocenti F: Clinical implementation of germ line cancer pharmacogenetic variants during the next-generation sequencing era. Clin Pharmacol Ther 95:269-280, 2014
16. Cancer Genome Atlas Research Network, Weinstein JN, Collisson EA, et al: The Cancer Genome Atlas Pan-Cancer analysis project. Nat Genet 45:1113-1120, 2013
17. Sleijfer S, Bogaerts J, Siu LL: Designing transformative clinical trials in the cancer genome era. J Clin Oncol 31:1834-1841, 2013
18. Innocenti F, Schilsky RL: Translating the cancer genome into clinically useful tools and strategies. Dis Model Mech 2:426-429, 2009
19. Marcuello E, Páez D, Paré L, et al: A genotype-directed phase I-IV dose-finding study of irinotecan in combination with fluorouracil/leucovorin as first-line treatment in advanced colorectal cancer. Br J Cancer 105:53-57, 2011
20. Hall D, Ybazeta G, Destro-Bisol G, et al: Variability at the uridine diphosphate glucuronosyltransferase 1A1 promoter in human populations and primates. Pharmacogenetics 9:591-599, 1999
21. Merrouche Y, Extra JM, Abigerges D, et al: High dose-intensity of irinotecan administered every 3 weeks in advanced cancer patients: A feasibility study. J Clin Oncol 15:1080-1086, 1997 (Pubitemid 27106292)
22. Toffoli G, Cecchin E, Gasparini G, et al: Genotype-driven phase I study of irinotecan administered in combination with fluorouracil/leucovorin in patients with metastatic colorectal cancer. J Clin Oncol 28:866-871, 2010
23. Zhang D, Zhang D, Cui D, et al: Characterization of the UDP glucuronosyltransferase activity of human liver microsomes genotyped for the UGT1A1*28 polymorphism. Drug Metab Dispos 35:2270-2280, 2007 (Pubitemid 350146214)