Pharmacokinetics and pharmacodynamics of irinotecan and its metabolites from plasma and saliva data in patients with metastatic digestive cancer receiving Folfiri regimen

Cancer Chemotherapy and Pharmacology

Volumn 58, Issue 3, 2006, Pages 292-305

  Poujol, Sylvain ^a   Bressolle, Françoise ^a,b   Duffour, Jacqueline ^a   Abderrahim, Anissa Gauthey ^a   Astre, Cécile ^a   Ychou, Marc ^a   Pinguet, Frédéric ^a  

^a CENTRE VAL D AURELLE   (France)

^b UNIV MONTPELLIER   (France)

Author keywords

Irinotecan; Pharmacodynamics; Pharmacokinetics; Plasma; Saliva

Indexed keywords

7 ETHYL 10 (4 AMINO 1 PIPERIDINO)CARBONYLOXYCAMPTOTHECIN; 7 ETHYL 10 [4 N (5 AMINOPENTANOIC ACID) 1 PIPERIDINO]CARBONYLOXYCAMPTOTHECIN; 7 ETHYL 10 HYDROXYCAMPTOTHECIN; 7 ETHYL 10 HYDROXYCAMPTOTHECIN GLUCURONIDE; CAMPTOTHECIN DERIVATIVE; DRUG METABOLITE; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; UNCLASSIFIED DRUG;

ADULT; AGE; ANEMIA; ARTICLE; BLOOD TOXICITY; BODY WEIGHT; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CONSTIPATION; DIARRHEA; DIGESTIVE SYSTEM CANCER; DISTRIBUTION VOLUME; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG HALF LIFE; DRUG METABOLISM; DRUG SALIVA LEVEL; FEBRILE NEUTROPENIA; FEMALE; FLUORESCENCE SPECTROSCOPY; GASTROINTESTINAL SYMPTOM; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; METASTASIS; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SAFETY; SAMPLING; STEADY STATE;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CAMPTOTHECIN; DIGESTIVE SYSTEM NEOPLASMS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; SALIVA; TISSUE DISTRIBUTION;

EID: 33744474829     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-005-0166-5     Document Type: Article

References (32)

1. Abigerges D, Chabot GG, Armand JP, Herait P, Gouyette A, Gandia D (1995) Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol 13:210-221
2. Beal SL, Sheiner LB (1992) NONMEM user's guide. University of California at San Francisco, San Francisco
3. Canal P, Gay C, Dezeuze A, Douillard JY, Bugat R, Brunet R, Adenis A, Herait P, Lokiec F, Mathieu-Boue A (1996) Pharmacokinetics and pharmacodynamics of irinotecan during a phase II clinical trial in colorectal cancer. Pharmacology and molecular mechanisms group of the European Organization for research and treatment of cancer. J Clin Oncol 14:2688-2695
4. Catimel G, Chabot GG, Guastalla JP, Dumortier A, Cote C, Engel C, Gouyette A, Mathieu-Boue A, Mahjoubi M, Clavel M (1995) Phase I and pharmacokinetic study of irinotecan (CPT-11) administered daily for three consecutive days every three weeks in patients with advanced solid tumors. Ann Oncol 6:133-140
5. Chabot GG, Abigerges D, Catimel G, Culine S, de Forni M, Extra JM, Mahjoubi M, Herait P, Armand JP, Bugat R, (1995) Population pharmacokinetics and pharmacodynamics of irinotecan (CPT-11) and active metabolite SN-38 during phase I trials. Ann Oncol 6:141-151
6. Cunningham D, Pyrhonen S, James RD, Punt CJ, Hickish TF, Heikkila R, Johannesen TB, Starkhammar H, Topham CA, Awad L, Jacques C, Herait P (1998) Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 352:1413-1418
7. de Forni M, Bugat R, Chabot GG, Culine S, Extra JM, Gouyette A, Madelaine I, Marty ME, Mathieu-Boue A (1994) Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res 54:4347-4354
8. de Jonge MJ, Verweij J, de Bruijn P, Brouwer E, Mathijssen RH, van Alphen RJ, Boer-Dennert MM, Vernillet L, Jacques C, Sparreboom A (2000) Pharmacokinetic, metabolic, and pharmacodynamic profiles in a dose-escalating study of irinotecan and cisplatin. J Clin Oncol 18:195-203
9. Dodds HM, Clarke SJ, Findlay M, Bishop JF, Robert J, Rivory LP (2000) Clinical pharmacokinetics of the irinotecan metabolite 4-piperidinopiperidine and its possible clinical importance. Cancer Chemother Pharmacol 45:9-14
10. Douillard JY, Cunningham D, Roth AD, Germa JR, James R, Karasek P, Jandik P, Iveson T, Carmichael J, Gruia G, Dembak M, Sibaud D, Rougier P (1999) A randomized phase III trial comparing irinotecan +5-FU/folinic acid to the same schedule of 5-FU/FA in patients with metastatic colorectal as front line chemotherapy. In: Proceedings of the American society of clinical oncology 18:233
11. Ducreux M, Ychou M, Seitz JF, Bonnay M, Bexon A, Armand JP, Mahjoubi M, Mery-Mignard D, Rougier P (1999) Irinotecan combined with bolus fluorouracil, continuous infusion fluorouracil, and high-dose leucovorin every two weeks (LV5FU2 regimen): a clinical dose-finding and pharmacokinetic study in patients with pretreated metastatic colorectal cancer. J Clin Oncol 17:2901-2908
12. Farenc C, Fabreguette JR, Bressolle F (2000) Pk fit: a pharmacokinetic/pharmacodynamic and statistical data analysis software. Comput Biomed Res 33:315
13. Gupta E, Lestingi TM, Mick R, Ramirez J, Vokes EE, Ratain MJ (1994) Metabolic fate of irinotecan in humans: correlation of glucuronidation with diarrhea. Cancer Res 54:3723-3725
14. Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ (2004) Cancer statistics, 2004. CA Cancer J Clin 54:8-29
15. Klein CE, Gupta E, Reid JM, Atherton PJ, Sloan JA, Pilot HC, Ratain MJ, Kastrissios H (2002) Population pharmacokinetic model for irinotecan and two of its metabolites, SN-38 and SN-38 glucuronide. Clin Pharmacol Ther 72:638-647
16. Mathijssen RH, van Alphen RJ, Verweij J, Loos WJ, Nooter K, Stoter G, Sparreboom A (2001) Clinical pharmacokinetics and metabolism of irinotecan (CPT-11). Clin Cancer Res 7:2182-2194
17. Mathijssen RH, Verweij J, de Jonge MJ, Nooter K, Stoter G, Sparreboom A (2002) Impact of body-size measures on irinotecan clearance: alternative dosing recommendations. J Clin Oncol 20:81-87
18. Mathijssen RH, Verweij J, Loos WJ, de Bruijn P, Nooter K, Sparreboom A (2002) Irinotecan pharmacokinetics-pharmacodynamics: the clinical relevance of prolonged exposure to SN-38. Br J Cancer 87:144-150
19. Poujol S, Pinguet F, Malosse F, Astre C, Ychou M, Culine S, Bressolle F (2003) Sensitive HPLC-fluorescence method for irinotecan and four major metabolites in human plasma and saliva: application to pharmacokinetic studies. Clin Chem 49:1900-1908
20. Rivory LP, Bowles MR, Robert J, Pond SM (1996) Conversion of irinotecan (CPT-11) to its active metabolite, 7-ethyl-10-hydroxycamptothecin (SN-38), by human liver carboxylesterase. Biochem Pharmacol 52:1103-1111
21. Rivory LP, Chatelut E, Canal P, Mathieu-Boue A, Robert J (1994) Kinetics of the in vivo interconversion of the carboxylate and lactone forms of irinotecan (CPT-11) and of its metabolite SN-38 in patients. Cancer Res 54:6330-6333
22. Rougier P, Van Cutsem E, Bajetta E, Niederle N, Possinger K, Labianca R, Navarro M, Morant R, Bleiberg H, Wils J, Awad L, Herait P, Jacques C (1998) Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 352:1407-1412
23. Rowinsky EK, Grochow LB, Ettinger DS, Sartorius SE, Lubejko BG, Chen TL, Rock MK, Donehower RC (1994) Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-[4-(1-piperidino)-1-piperidino] carbonyloxycamptothecin (CPT-11) administered as a ninety-minute infusion every 3 weeks. Cancer Res 54:427-436
24. Saltz LB, Kanowitz J, Kemeny NE, Schaaf L, Spriggs D, Staton BA, Berkery R, Steger C, Eng M, Dietz A, Locker P, Kelsen DP (1996) Phase I clinical and pharmacokinetic study of irinotecan, fluorouracil, and leucovorin in patients with advanced solid tumors. J Clin Oncol 14:2959-2967
25. Sasaki Y, Hakusui H, Mizuno S, Morita M, Miya T, Eguchi K, Shinkai T, Tamura T, Ohe Y, Saijo N (1995) A pharmacokinetic and pharmacodynamic analysis of CPT-11 and its active metabolite SN-38. Jpn J Cancer Res 86:101-110
26. Sheiner BL, Beal SL (1981) Evaluation of methods for estimating population pharmacokinetic parameters. II. Biexponential model and experimental pharmacokinetic data. J Pharmacokinet Biopharm 9:635-651
27. Sheiner LB, Beal SL (1981) Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 9:503-512
28. Slatter JG, Schaaf LJ, Sams JP, Feenstra KL, Johnson MG, Bombardt PA, Cathcart KS, Verburg MT, Pearson LK, Compton LD, Miller LL, Baker DS, Pesheck CV, Lord RS III (2000) Pharmacokinetics, metabolism, and excretion of irinotecan (CPT-11) following I.V. infusion of [(14)C]CPT-11 in cancer patients. Drug Metab Dispos 28:423-433
29. Sparreboom A, de Jonge MJ, de Bruijn P, Brouwer E, Nooter K, Loos WJ, van Alphen RJ, Mathijssen RH, Stoter G, Verweij J (1998) Irinotecan (CPT-11) metabolism and disposition in cancer patients. Clin Cancer Res 4:2747-2754
30. Takahashi T, Fujiwara Y, Sumiyoshi H, Isobe T, Yamaoka N, Yamakido M (1997) Salivary drug monitoring of irinotecan and its active metabolite in cancer patients. Cancer Chemother Pharmacol 40:449-452
31. Visual NM program (1998) Visual NM User's Manual, version 5.1. Montpellier, France: Research Development Population Pharmacokinetics
32. Xie R, Mathijssen RH, Sparreboom A, Verweij J, Karlsson MO (2002) Clinical pharmacokinetics of irinotecan and its metabolites: a population analysis. J Clin Oncol 20:3293-3301