Reducing irinotecan-associated diarrhea in children

Pediatric Blood and Cancer

Volumn 50, Issue 2, 2008, Pages 201-207

  Wagner, Lars M ^a,f   Crews, Kristine R ^b   Stewart, Clinton F ^b   Rodriguez Galindo, Carlos ^b   McNall Knapp, Rene Y ^c   Albritton, Karen ^d   Pappo, Alberto S ^e   Furman, Wayne L ^b  

^a UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^b ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^c UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE   (United States)

^d PRIMARY CHILDREN'S MEDICAL CENTER   (United States)

^e TEXAS CHILDREN S HOSPITAL   (United States)

^f CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

Author keywords

Cefixime; Cefpodoxime; Diarrhea; Irinotecan

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; ACETORPHAN; ACTIVATED CARBON; AMIFOSTINE; ANTIBIOTIC AGENT; AST 120; ATROPINE; BICARBONATE; CEFIXIME; CEFPODOXIME; CEFPODOXIME PROXETIL; CELECOXIB; CEPHALOSPORIN; CHRYSIN; CISPLATIN; CYCLOSPORIN; DEXTRO ARGINYL DEXTRO NORLEUCYL DEXTRO NORLEUCYL DEXTRO NORLEUCYL DEXTRO ARGINYL DEXTRO NORLEUCYL DEXTRO NORLEUCYL DEXTRO NORLEUCYLGLYCYL DEXTRO TYROSINAMIDE; HANGE SHASHIN TO; IRINOTECAN; JBT 3002; KAMPO; LOPERAMIDE; MAGNESIUM OXIDE; NEOMYCIN; OCTREOTIDE; PROBENECID; TEMOZOLOMIDE; THALIDOMIDE; TIORFAN VANTIN; UNCLASSIFIED DRUG; UNINDEXED DRUG; URSODEOXYCHOLIC ACID; VINCRISTINE;

ABDOMINAL PAIN; ALLELE; ANTIBIOTIC PROPHYLAXIS; BRAIN TUMOR; CONTINUOUS INFUSION; DIAPHORESIS; DIARRHEA; DISEASE PREDISPOSITION; DRUG TOLERANCE; FLUSHING; GENOTYPE; HEREDITY; HUMAN; MUSCLE CRAMP; NEUROBLASTOMA; PATHOGENESIS; PRIORITY JOURNAL; REVIEW; SARCOMA; SOLID TUMOR; UNSPECIFIED SIDE EFFECT;

ANTINEOPLASTIC AGENTS, PHYTOGENIC; CAMPTOTHECIN; CEPHALOSPORINS; CHILD; DIARRHEA; GENETIC PREDISPOSITION TO DISEASE; HUMANS;

EID: 37549056239     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.21280     Document Type: Review

References (88)

1. Garcia-Carbonero R, Supko JG. Current perspectives on the clinical experience, pharmacology, and continued development of the camptothecins. Clin Cancer Res 2002;8:641-661.
2. Masuda N, Kudoh S, Fukuoka M. Irinotecan (CPT-11): Pharmacology and clinical applications. Crit Rev Oncol Hematol 1996;24:3-26.
3. Rodriguez-Galindo C, Radomski K, Stewart CF, et al. Clinical use of topoisomerase I inhibitors in anticancer treatment. Med Pediatr Oncol 2000;35:385-402.
4. Houghton PJ, Cheshire PJ, Hallman JC, et al. Therapeutic efficacy of the topoisomerase I inhibitor 7-ethyl-10-(4-[1-piperidino]-1-piperidino)- carbonyloxy-camptothecin against human tumor xenografts: Lack of cross-resistance in vivo in tumors with acquired resistance to the topoisomerase I inhibitor 9-dimethylaminomethyl-10-hydroxycamptothecin. Cancer Res 1993;53:2823-2829.
5. Houghton PJ, Cheshire PJ, Hallman JD II, et al. Efficacy of topoisomerase I inhibitors, topotecan and irinotecan, administered at low dose levels in protracted schedules to mice bearing xenografts of human tumors. Cancer Chemother Pharmacol 1995;36:393-403.
6. Vassal G, Terrier-Lacombe MJ, Bissery MC, et al. Therapeutic activity of CPT-11, a DNA-topoisomerase I inhibitor, against peripheral primitive neuroectodermal tumour and neuroblastoma xenografts. Br J Cancer 1996;74:537-545.
7. Furman WL, Stewart CF, Poquette CA, et al. Direct translation of a protracted irinotecan schedule from a xenograft model to a phase I trial in children. J Clin Oncol 1999;17:1815-1824.
8. Cosetti M, Wexler LH, Calleja E, et al. Irinotecan for pediatric solid tumors: The Memorial Sloan-Kettering experience. J Pediatr Hematol Oncol 2002;24:101-105.
9. Bisogno G, Riccardi R, Ruggiero A, et al. Phase II study of a protracted irinotecan schedule in children with refractory or recurrent soft tissue sarcoma. Cancer 2006;106:703-707.
10. Kushner BH, Kramer K, Modak S, et al. Five-day courses of irinotecan as palliative therapy for patients with neuroblastoma. Cancer 2005;103:858-862.
11. Wagner LM, McAllister N, Goldsby RE, et al. Temozolomide and intravenous irinotecan for treatment of advanced Ewing sarcoma. Pediatr Blood Cancer 2007;48:132-139.
12. Wagner LM, Crews KR, Iacono LC, et al. Phase I trial of temozolomide and protracted irinotecan in pediatric patients with refractory solid tumors. Clin Cancer Res 2004;10:840-848.
13. Pappo AS, Lyden E, Breitfeld P, et al. Two consecutive phase II window trials of irinotecan alone or in combination with vincristine for the treatment of metastatic rhabdomyosarcoma: The Children's Oncology Group. J Clin Oncol 2007;25:362-369.
14. Schoemaker NE, Kuppens IE, Moiseyenko V, et al. A randomised phase II multicentre trial of irinotecan (CPT-11) using four different schedules in patients with metastatic colorectal cancer. Br J Cancer 2004;91:1434-1441.
15. Kawato Y, Sekiguchi M, Akahane K, et al. Inhibitory activity of camptothecin derivatives against acetylcholinesterase in dogs and their binding activity to acetylcholine receptors in rats. J Pharm Pharmacol 1993;45:444-448.
16. Vassal G, Doz F, Frappaz D, et al. A phase I study of irinotecan as a 3-week schedule in children with refractory or recurrent solid tumors. J Clin Oncol 2003;21:3844-3852.
17. Vassal G, Couanet D, Stockdale E, et al. Phase II trial of irinotecan in children with relapsed or refractory rhabdomyosarcoma: A joint study of the French society of pediatric oncology and the United Kingdom Children's Cancer Study Group. J Clin Oncol 2007;25:356-361.
18. Bomgaars L, Kerr J, Berg S, et al. A phase I study of irinotecan administered on a weekly schedule in pediatric patients. Pediatr Blood Cancer 2006;46:50-55.
19. Harel M, Hyatt JL, Brumshtein B, et al. The crystal structure of the complex of the anticancer prodrug 7-ethyl-10-[4-(1-piperidino)-1-piperidino]- carbonyloxycamptothecin (CPT-11) with torpedo californica acetylcholinesterase provides a molecular explanation for its cholinergic action. Mol Pharmacol 2005;67:1874-1881.
20. Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan study group. N Engl J Med 2000;343:905-914.
21. Saliba F, Hagipantelli R, Misset JL, et al. Pathophysiology and therapy of irinotecan-induced delayed-onset diarrhea in patients with advanced colorectal cancer: A prospective assessment. J Clin Oncol 1998;16:2745-2751.
22. Hecht JR. Gastrointestinal toxicity or irinotecan. Oncology (Williston Park) 1998;12:72-78.
23. Ikuno N, Soda H, Watanabe M, et al. Irinotecan (CPT-11) and characteristic mucosal changes in the mouse ileum and cecum. J Natl Cancer Inst 1995;87:1876-1883.
24. Sandmeier D, Chaubert P, Bouzourene H. Irinotecan-induced colitis. Int J Surg Pathol 2005;13:215-218.
25. Takasuna K, Hagiwara T, Hirohashi M, et al. Involvement of beta-glucuronidase in intestinal microflora in the intestinal toxicity of the antitumor camptothecin derivative irinotecan hydrochloride (CPT-11) in rats. Cancer Res 1996;56:3752-3757.
26. Alimonti A, Gelibter A, Pavese I, et al. New approaches to prevent intestinal toxicity of irinotecan-based regimens. Cancer Treat Rev 2004;30:555-562.
27. Iyer L, King CD, Whitington PF, 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;101:847-854.
28. Chu XY, Kato Y, Ueda K, et al. Biliary excretion mechanism of CPT-11 and its metabolites in humans: Involvement of primary active transporters. Cancer Res 1998;58:5137-5143.
29. Khanna R, Morton CL, Danks MK, et al. Proficient metabolism of irinotecan by a human intestinal carboxylesterase. Cancer Res 2000;60:4725-4728.
30. Brandi G, Dabard J, Raibaud P, et al. Intestinal microflora and digestive toxicity of irinotecan in mice. Clin Cancer Res 2006;12:1299-1307.
31. Takasuna K, Hagiwara T, Watanabe K, et al. Optimal antidiarrhea treatment for antitumor agent irinotecan hydrochloride (CPT-11)-induced delayed diarrhea. Cancer Chemother Pharmacol 2006;58:494-503.
32. Kobayashi K, Bouscarel B, Matsuzaki Y, et al. Ph-dependent uptake of irinotecan and its active metabolite, SN-38, by intestinal cells. Int J Cancer 1999;83:491-496.
33. Kase Y, Hayakawa T, Togashi Y, et al. Relevance of irinotecan hydrochloride-induced diarrhea to the level of prostaglandin E2 and water absorption of large intestine in rats. Jpn J Pharmacol 1997;75:399-405.
34. Sakai H, Sato T, Hamada N, et al. Thromboxane A2, released by the anti-tumour drug irinotecan, is a novel stimulator of Cl- secretion in isolated rat colon. J Physiol 1997;505:133-144.
35. Ciotti M, Basu N, Brangi M, et al. Glucuronidation of 7-ethyl-10-hydroxycamptothecin (SN-38) by the human UDP-glucuronosyltransferases encoded at the UGT1 locus. Biochem Biophys Res Commun 1999;260:199-202.
36. Hanioka N, Ozawa S, Jinno H, et al. Human liver UDP- glucuronosyltransferase isoforms involved in the glucuronidation of 7-ethyl-10-hydroxycamptothecin. Xenobiotica 2001;31:687-699.
37. Iyer L, Hall D, Das 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;65:576-582.
38. 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 2004;22:1382-1388.
39. Iyer L, Das S, Janisch L, et al. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J 2002;2:43-47.
40. Ando Y, Saka H, Ando M, et al. Polymorphisms of UDP- glucuronosyltransferase gene and irinotecan toxicity: A pharmacogenetic analysis. Cancer Res 2000;60:6921-6926.
41. Marcuello E, Altes A, Menoyo A, et al. UGT1A1 gene variations and irinotecan treatment in patients with metastatic colorectal cancer. Br J Cancer 2004;91:678-682.
42. Massacesi C, Terrazzino S, Marcucci F, et al. Uridine diphosphate glucuronosyl transferase 1A1 promoter polymorphism predicts the risk of gastrointestinal toxicity and fatigue induced by irinotecan-based chemotherapy. Cancer 2006;106:1007-1016.
43. United States Food and Drug Administration. Camptosar label http://wwwfdagov/cder/foi/label/2005/020571s024,027,028lblpdf.
44. Gagne JF, Montminy V, Belanger P, et al. Common human UGT1A polymorphisms and the altered metabolism of irinotecan active metabolite 7-ethyl-10- hydroxycamptothecin (SN-38). Mol Pharmacol 2002;62:608-617.
45. Carlini LE, Meropol NJ, Bever J, et al. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res 2005;11:1226-1236.
46. 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 2006;24:2237-2244.
47. Stewart CF, Panetta JC, O'Shaughnessy M, et al. UGT1A1 promoter genotype correlates with pharmacokinetics but not toxicity in patients receiving protracted irinotecan. J Clin Oncol 2006;24:3078 abstract.
48. Bomgaars L, Kuttesch N, Bernstein M, et al. Correlation of UGT1A1 promoter genotype with pharmacokinetics and toxicity in pediatric patients receiving irinotecan. Proc Am Soc Clin Oncol 2003;22:551 abstract.
49. Benson AB III, Ajani JA, Catalano RB, et al. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol 2004;22:2918-2926.
50. Abigerges D, Armand JP, Chabot GG, et al. Irinotecan (CPT-11) high-dose escalation using intensive high-dose loperamide to control diarrhea. J Natl Cancer Inst 1994;86:446-449.
51. Baumer P, Danquechin Dorval E, Bertrand J, et al. Effects of acetorphan, an enkephalinase inhibitor, on experimental and acute diarrhoea. Gut 1992;33:753-758.
52. Barbounis V, Koumakis G, Vassilomanolakis M, et al. Control of irinotecan-induced diarrhea by octreotide after loperamide failure. Support Care Cancer 2001;9:258-260.
53. Michael M, Brittain M, Nagai J, et al. Phase II study of activated charcoal to prevent irinotecan-induced diarrhea. J Clin Oncol 2004;22:4410-4417.
54. Takeda Y, Tsuduki E, Izumi S, et al. A phase I/II trial of irinotecan-cisplatin combined with an anti-late-diarrhoeal programme to evaluate the safety and antitumour response of this combination therapy in patients with advanced non-small-cell lung cancer. Br J Cancer 2005;93:1341-1349.
55. Mori K, Kondo T, Kamiyama Y, et al. Preventive effect of kampo medicine (hangeshashin-to) against irinotecan-induced diarrhea in advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 2003;51:403-406.
56. Chester JD, Joel SP, Cheeseman SL, et al. Phase I and pharmacokinetic study of intravenous irinotecan plus oral ciclosporin in patients with fuorouracil-refractory metastatic colon cancer. J Clin Oncol 2003;21:1125-1132.
57. Vasudev NS, Jagdev S, Anthoney DA, et al. Intravenous irinotecan plus oral ciclosporin. Clin Oncol (R Coll Radiol) 2005;17:646-649.
58. Desai AA, Kindler HL, Taber D, et al. Modulation of irinotecan with cyclosporine: A phase II trial in advanced colorectal cancer. Cancer Chemother Pharmacol 2005;56:421-426.
59. Tobin PJ, Beale P, Noney L, et al. A pilot study on the safety of combining chrysin, a non-absorbable inducer of UGT1A1, and irinotecan (CPT-11) to treat metastatic colorectal cancer. Cancer Chemother Pharmacol 2006;57:309-316.
60. Walle T, Otake Y, Brubaker JA, et al. Disposition and metabolism of the flavonoid chrysin in normal volunteers. Br J Clin Pharmacol 2001;51:143-146.
61. Karthaus M, Ballo H, Abenhardt W, et al. Prospective, double-blind, placebo-controlled, multicenter, randomized phase III study with orally administered budesonide for prevention of irinotecan (CPT-11)-induced diarrhea in patients with advanced colorectal cancer. Oncology 2005;68:326-332.
62. Delioukina ML, Prager D, Parson M, et al. Phase II trial of irinotecan in combination with amifostine in patients with advanced colorectal carcinoma. Cancer 2002;94:2174-2179.
63. de Jong FA, Kehrer DF, Mathijssen RH, et al. Prophylaxis of irinotecan-induced diarrhea with neomycin and potential role for UGT1A1*28 genotype screening: A double-blind, randomized, placebo-controlled study. Oncologist 2006;11:944-954.
64. Ychou M, Douillard JY, Rougier P, et al. Randomized comparison of prophylactic antidiarrheal treatment versus no prophylactic antidiarrheal treatment in patients receiving CPT-11 (irinotecan) for advanced 5-fu-resistant colorectal cancer: An open-label multicenter phase II study. Am J Clin Oncol 2000;23:143-148.
65. Millar JL, McElwain TJ, Clutterbuck RD, et al. The modification of melphalan toxicity in tumor bearing mice by S-2-(3-aminopropylamino)- ethylphosphorothioic acid (WR 2721). Am J Clin Oncol 1982;5:321-328.
66. Lenfers BH, Loeffler TM, Droege CM, et al. Substantial activity of budesonide in patients with irinotecan (CPT-11) and 5-fluorouracil induced diarrhea and failure of loperamide treatment. Ann Oncol 1999;10:1251-1253.
67. Schmittel A, Jahnke K, Thiel E, et al. Neomycin as secondary prophylaxis for irinotecan-induced diarrhea. Ann Oncol 2004;15:1296.
68. Kehrer DF, Sparreboom A, Verweij J, et al. Modulation of irinotecan-induced diarrhea by cotreatment with neomycin in cancer patients. Clin Cancer Res 2001;7:1136-1141.
69. Alimonti A, Satta F, Pavese I, et al. Prevention of irinotecan plus 5-fluorouracil/leucovorin-induced diarrhoea by oral administration of neomycin plus bacitracin in first-line treatment of advanced colorectal cancer. Ann Oncol 2003;14:805-806.
70. Chowbay B, Sharma A, Zhou QY, et al. The modulation of irinotecan-induced diarrhoea and pharmacokinetics by three different classes of pharmacologic agents. Oncol Rep 2003;10:745-751.
71. Thompson J, Stewart CF, Houghton PJ. Animal models for studying the action of topoisomerase I targeted drugs. Biochim Biophys Acta 1998;1400:301-319.
72. Furman WL, Crews KR, Billups C, et al. Cefixime allows greater dose escalation of oral irinotecan: A phase I study in pediatric patients with refractory solid tumors. J Clin Oncol 2006;24:563-570.
73. McNall-Knapp R, Meyer W, Cain JP, et al. Phase I evaluation of vincristine, irinotecan, temozolomide, and oral antibiotic in solid tumors. Ped Blood Cancer 2006;47:421 abstract.
74. Cascinu S, Bichisao E, Amadori D, et al. High-dose loperamide in the treatment of 5-fluorouracil-induced diarrhea in colorectal cancer patients. Support Care Cancer 2000;8:65-67.
75. Horikawa M, Kato Y, Sugiyama Y. Reduced gastrointestinal toxicity following inhibition of the biliary excretion of irinotecan and its metabolites by probenecid in rats. Pharm Res 2002;19:1345-1353.
76. Gibson RJ, Bowen JM, Keefe DM. Palifermin reduces diarrhea and increases survival following irinotecan treatment in tumor-bearing da rats. Int J Cancer 2005;116:464-470.
77. Shinohara H, Killion JJ, Bucana CD, et al. Oral administration of the immunomodulator JBT-3002 induces endogenous interleukin 15 in intestinal macrophages for protection against irinotecan-mediated destruction of intestinal epithelium. Clin Cancer Res 1999;5:2148-2156.
78. Cao S, Black JD, Troutt AB, et al. Interleukin 15 offers selective protection from irinotecan-induced intestinal toxicity in a preclinical animal model. Cancer Res 1998;58:3270-3274.
79. Zhao J, Huang L, Belmar N, et al. Oral RDP58 allows CPT-11 dose intensification for enhanced tumor response by decreasing gastrointestinal toxicity. Clin Cancer Res 2004;10:2851-2859.
80. Hardman WE, Moyer MP, Cameron IL. Consumption of an omega-3 fatty acids product, in cell AAFA, reduced side-effects of CPT-11 (irinotecan) in mice. Br J Cancer 2002;86:983-988.
81. Filipski E, Lemaigre G, Liu XH, et al. Circadian rhythm of irinotecan tolerability in mice. Chronobiol Int 2004;21:613-630.
82. Ohdo S, Makinosumi T, Ishizaki T, et al. Cell cycle-dependent chronotoxicity of irinotecan hydrochloride in mice. J Pharmacol Exp Ther 1997;283:1383-1388.
83. Maeda Y, Ohune T, Nakamura M, et al. Prevention of irinotecan-induced diarrhoea by oral carbonaceous adsorbent (kremezin) in cancer patients. Oncol Rep 2004;12:581-585.
84. Reardon DA, Quinn JA, Vredenburgh J, et al. Phase II trial of irinotecan plus celecoxib in adults with recurrent malignant glioma. Cancer 2005;103:329-338.
85. Trifan OC, Durham WF, Salazar VS, et al. Cyclooxygenase-2 inhibition with celecoxib enhances antitumor efficacy and reduces diarrhea side effect of CPT-11. Cancer Res 2002;62:5778-5784.
86. Rosenoff SH. Octreotide LAR resolves severe chemotherapy-induced diarrhoea (CID) and allows continuation of full-dose therapy. Eur J Cancer Care (Engl) 2004;13:380-383.
87. Savarese D, Al-Zoubi A, Boucher J. Glutamine for irinotecan diarrhea. J Clin Oncol 2000;18:450-451.
88. Govindarajan R, Heaton KM, Broadwater R, et al. Effect of thalidomide on gastrointestinal toxic effects of irinotecan. Lancet 2000;356:566-567.