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Originally published as JCO Early Release 10.1200/JCO.2004.07.173 on March 8 2004

Journal of Clinical Oncology, Vol 22, No 8 (April 15), 2004: pp. 1382-1388
© 2004 American Society of Clinical Oncology.
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Genetic Variants in the UDP-glucuronosyltransferase 1A1 Gene Predict the Risk of Severe Neutropenia of Irinotecan

Federico Innocenti, Samir D. Undevia, Lalitha Iyer, Pei Xian Chen, Soma Das, Masha Kocherginsky, Theodore Karrison, Linda Janisch, Jacqueline Ramírez, Charles M. Rudin, Everett E. Vokes, Mark J. Ratain

From the Departments of Medicine, Human Genetics, and Health Studies, University of Chicago, Chicago, IL

Address reprint requests to Mark J. Ratain, MD, 5841 S Maryland Ave, MC2115, Chicago, IL 60637; e-mail: mratain{at}medicine.bsd.uchicago.edu

PURPOSE: Severe toxicity is commonly observed in cancer patients receiving irinotecan. UDP-glucuronosyltransferase 1A1 (UGT1A1) catalyzes the glucuronidation of the active metabolite SN-38. This study prospectively evaluated the association between the prevalence of severe toxicity and UGT1A1 genetic variation.

PATIENTS AND METHODS: Sixty-six cancer patients with advanced disease refractory to other treatments received irinotecan 350 mg/m2 every 3 weeks. Toxicity and pharmacokinetic data were measured during cycle 1. UGT1A1 variants (–3279G>T, –3156G>A, promoter TA indel, 211G>A, 686C>A) were genotyped.

RESULTS: The prevalence of grade 4 neutropenia was 9.5%. Grade 4 neutropenia was much more common in patients with the TA indel 7/7 genotype (3 of 6 patients; 50%) compared with 6/7 (3 of 24 patients; 12.5%) and 6/6 (0 of 29 patients; 0%) (P = .001). The TA indel genotype was significantly associated with the absolute neutrophil count nadir (7/7 < 6/7 < 6/6, P = .02). The relative risk of grade 4 neutropenia was 9.3 (95% CI, 2.4 to 36.4) for the 7/7 patients versus the rest of the patients. Pretreatment total bilirubin levels (mean ± standard deviation) were significantly higher in patients with grade 4 neutropenia (0.83 ± 0.08 mg/dL) compared to those without grade 4 neutropenia (0.47 ± 0.03 mg/dL; P < .001). The –3156G>A variant seemed to distinguish different phenotypes of total bilirubin within the TA indel genotypes. The –3156 genotype and the SN-38 area under the concentration versus time curve were significant predictors of ln(absolute neutrophil count nadir; r2 = 0.51).

CONCLUSION: UGT1A1 genotype and total bilirubin levels are strongly associated with severe neutropenia, and could be used to identify cancer patients predisposed to the severe toxicity of irinotecan. The hypothesis that the –3156G>A variant is a better predictor of UGT1A1 status than the previously reported TA indel requires further testing.

Supported by the Pharmacogenetics of Anticancer Agents Research (PAAR) Group (http://pharmacogenetics.org; NIH/NIGMS grant U01 GM61393), the Phase I Clinical Trials of Anticancer Agents Grant (NIH/NCI U01 CA69852), the UCCRC Cancer Center Support Grant (P30 CA14599), and the University of Chicago General Clinical Research Center Grant (M01 RR00055). Data will be deposited into PharmGKB (supported by NIH/NIGMS U01 GM61374, http://pharmgkb.org/).

Preliminary data were presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.


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L. E. Carlini, N. J. Meropol, J. Bever, M. L. Andria, T. Hill, P. Gold, A. Rogatko, H. Wang, and R. L. Blanchard
UGT1A7 and UGT1A9 Polymorphisms Predict Response and Toxicity in Colorectal Cancer Patients Treated with Capecitabine/Irinotecan
Clin. Cancer Res., February 1, 2005; 11(3): 1226 - 1236.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
W. Lee, A. C. Lockhart, R. B. Kim, and M. L. Rothenberg
Cancer Pharmacogenomics: Powerful Tools in Cancer Chemotherapy and Drug Development
Oncologist, February 1, 2005; 10(2): 104 - 111.
[Abstract] [Full Text] [PDF]

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 JNCI J Natl Cancer InstHome page
R. H. J. Mathijssen, F. A. de Jong, R. H. N. van Schaik, E. R. Lepper, L. E. Friberg, T. Rietveld, P. de Bruijn, W. J. Graveland, W. D. Figg, J. Verweij, et al.
Prediction of Irinotecan Pharmacokinetics by Use of Cytochrome P450 3A4 Phenotyping Probes
J Natl Cancer Inst, November 3, 2004; 96(21): 1585 - 1592.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
F. A. de Jong, S. Marsh, R. H. J. Mathijssen, C. King, J. Verweij, A. Sparreboom, and H. L. McLeod
ABCG2 Pharmacogenetics: Ethnic Differences in Allele Frequency and Assessment of Influence on Irinotecan Disposition
Clin. Cancer Res., September 1, 2004; 10(17): 5889 - 5894.
[Abstract] [Full Text] [PDF]

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 J Clin PharmacolHome page
L. Paoluzzi, A. S. Singh, D. K. Price, R. Danesi, R. H. J. Mathijssen, J. Verweij, W. D. Figg, and A. Sparreboom
Influence of Genetic Variants in UGT1A1 and UGT1A9 on the In Vivo Glucuronidation of SN-38
J. Clin. Pharmacol., August 1, 2004; 44(8): 854 - 860.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
R. Chan and D. J. Kerr
Can we individualise chemotherapy for colorectal cancer?
Ann. Onc., July 1, 2004; 15(7): 996 - 999.
[Full Text] [PDF]


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