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Section of Hematology/Oncology, Department of Medicine [E. G., T. M. L., R. M., J. R., E. E. V., M. J. R.], Committee on Clinical Pharmacology [R. M., M. J. R.], Cancer Research Center [R. M., E. E. V., M. J. R.]. and Department of Radiation and Cellular Oncology [E. E. V.], University of Chicago Pritzker School of Medicine, Chicago, Illinois 60637
Irinotecan (7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxy-camptothecin (CPT-11) is hydrolyzed by the enzyme carboxyl esterase to 7-ethyl-10-hydroxycamptothecin (SN-38), which further undergoes glucuronic acid conjugation to form the corresponding SN-38 glucuronide (SN-38G). SN-38 is believed to be the cause of treatment-related diarrhea, a dose-limiting toxicity of CPT-11 observed in phase I clinical trials. This study investigated the effect of glucuronidation on the concentrations of SN-38 following CPT-11 infusion in 21 patients undergoing a phase I trial. To assess the relationship between gastrointestinal toxicity and pharmacokinetics of CPT-11 and its metabolites, we defined a "biliary index" of SN-38 which was the product of the relative area ratio of SN-38 to SN-38G and the total CPT-11 area under the plasma concentration-time curve. Nine patients with grade 3–4 diarrhea had higher biliary indexes than 12 patients with grade 0–2 diarrhea (median 2228 versus 5499, P = 0.0004). The relatively higher index values, suggestive of higher biliary concentrations of SN-38, were possibly due to low glucuronidation rates. Hence, modulation of glucuronidation may be effective in increasing the therapeutic index of CPT-11.
1 Supported in part by Grants N01-CM-07301 and CA-14599.
2 To whom requests for reprints should be addressed, at University of Chicago, 5841 S. Maryland Ave., MC2115, Chicago, IL 60637.
Received 5/31/94. Accepted 6/15/94.
Commentary
Clin. Cancer Res. 2006 12: 1658-1660.
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J. G. Slatter, L. J. Schaaf, J. P. Sams, K. L. Feenstra, M. G. Johnson, P. A. Bombardt, K. S. Cathcart, M. T. Verburg, L. K. Pearson, L. D. Compton, et al. Pharmacokinetics, Metabolism, and Excretion of Irinotecan (CPT-11) Following I.V. Infusion of [14C]CPT-11 in Cancer Patients Drug Metab. Dispos., April 1, 2000; 28(4): 423 - 433. [Abstract] [Full Text]
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C. J. van Groeningen, W. J. F. Van der Vijgh, J. J. Baars, H. Stieltjes, K. Huibregtse, and H. M. Pinedo Altered Pharmacokinetics and Metabolism of CPT-11 in Liver Dysfunction: A Need for Guidelines Clin. Cancer Res., April 1, 2000; 6(4): 1342 - 1346. [Abstract] [Full Text]
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R. Humerickhouse, K. Lohrbach, L. Li, W. F. Bosron, and M. E. Dolan Characterization of CPT-11 Hydrolysis by Human Liver Carboxylesterase Isoforms hCE-1 and hCE-2 Cancer Res., March 1, 2000; 60(5): 1189 - 1192. [Abstract] [Full Text]
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M. K. Ma, W. C. Zamboni, K. M. Radomski, W. L. Furman, V. M. Santana, P. J. Houghton, S. K. Hanna, A. K. Smith, and C. F. Stewart Pharmacokinetics of Irinotecan and Its Metabolites SN-38 and APC in Children with Recurrent Solid Tumors after Protracted Low-Dose Irinotecan Clin. Cancer Res., March 1, 2000; 6(3): 813 - 819. [Abstract] [Full Text]
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C. H. Takimoto, G. Morrison, N. Harold, M. Quinn, B. P. Monahan, R. A. Band, J. Cottrell, A. Guemei, V. Llorens, H. Hehman, et al. Phase I and Pharmacologic Study of Irinotecan Administered as a 96-Hour Infusion Weekly to Adult Cancer Patients J. Clin. Oncol., February 1, 2000; 18(3): 659 - 659. [Abstract] [Full Text] [PDF]
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M. J. A. de Jonge, A. Sparreboom, A. S. T. Planting, M. E. L. van der Burg, M. M. de Boer-Dennert, J. t. Steeg, C. Jacques, and J. Verweij Phase I Study of 3-Week Schedule of Irinotecan Combined With Cisplatin in Patients With Advanced Solid Tumors J. Clin. Oncol., January 5, 2000; 18(1): 187 - 187. [Abstract] [Full Text] [PDF]
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M. J. A. de Jonge, J. Verweij, P. de Bruijn, E. Brouwer, R. H. J. Mathijssen, R. J. van Alphen, M. M. de Boer-Dennert, L. Vernillet, C. Jacques, and A. Sparreboom Pharmacokinetic, Metabolic, and Pharmacodynamic Profiles in a Dose-Escalating Study of Irinotecan and Cisplatin J. Clin. Oncol., January 5, 2000; 18(1): 195 - 195. [Abstract] [Full Text] [PDF]
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M. Brangi, T. Litman, M. Ciotti, K. Nishiyama, G. Kohlhagen, C. Takimoto, R. Robey, Y. Pommier, T. Fojo, and S. E. Bates Camptothecin Resistance: Role of the ATP-binding Cassette (ABC), Mitoxantrone-resistance Half-Transporter (MXR), and Potential for Glucuronidation in MXR-expressing Cells Cancer Res., December 1, 1999; 59(23): 5938 - 5946. [Abstract] [Full Text] [PDF]
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R. F. DeVore, D. H. Johnson, J. Crawford, J. Garst, I. W. Dimery, J. Eckardt, S. G. Eckhardt, G. L. Elfring, L. J. Schaaf, C. K. Hanover, et al. Phase II Study of Irinotecan Plus Cisplatin in Patients With Advanced Non-Small-Cell Lung Cancer J. Clin. Oncol., September 1, 1999; 17(9): 2710 - 2710. [Abstract] [Full Text] [PDF]
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E. Wasserman, C. Cuvier, F. Lokiec, F. Goldwasser, S. Kalla, D. Mery-Mignard, M. Ouldkaci, A. Besmaine, G. Dupont-Andre, M. Mahjoubi, et al. Combination of Oxaliplatin Plus Irinotecan in Patients With Gastrointestinal Tumors: Results of Two Independent Phase I Studies With Pharmacokinetics J. Clin. Oncol., June 1, 1999; 17(6): 1751 - 1751. [Abstract] [Full Text] [PDF]
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V. M.M. Herben, J. H.M. Schellens, M. Swart, G. Gruia, L. Vernillet, J. H. Beijnen, and W. W. ten Bokkel Huinink Phase I and Pharmacokinetic Study of Irinotecan Administered as a Low-Dose, Continuous Intravenous Infusion Over 14 Days in Patients With Malignant Solid Tumors J. Clin. Oncol., June 1, 1999; 17(6): 1897 - 1897. [Abstract] [Full Text] [PDF]
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 J. A. Skirvin and V. Relias Review : Topoisomerase I inhibitors: 2. Irinotecan Journal of Oncology Pharmacy Practice, June 1, 1998; 4(2): 103 - 116. [Abstract] [PDF]
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J. G. Slatter, P. Su, J. P. Sams, L. J. Schaaf, and L. C. Wienkers Bioactivation of the Anticancer Agent CPT-11 to SN-38 by Human Hepatic Microsomal Carboxylesterases and the in Vitro Assessment of Potential Drug Interactions Drug Metab. Dispos., October 1, 1997; 25(10): 1157 - 1164. [Abstract] [Full Text]
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X.-Y. Chu, Y. Kato, K. Niinuma, K.-I. Sudo, H. Hakusui, and Y. Sugiyama Multispecific Organic Anion Transporter Is Responsible for the Biliary Excretion of the Camptothecin Derivative Irinotecan and its Metabolites in Rats J. Pharmacol. Exp. Ther., April 1, 1997; 281(1): 304 - 314. [Abstract] [Full Text]
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