Pharmacokinetic analysis of irinotecan plus bevacizumab in patients with advanced solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 65, Issue 1, 2009, Pages 97-105

  Denlinger, Crystal S ^a   Blanchard, Rebecca ^a,e   Xu, Lu ^d   Bernaards, Coen ^d   Litwin, Samuel ^a   Spittle, Cynthia ^a   Berg, Daniel J ^c   McLaughlin, Susan ^a   Redlinger, Maryann ^b   Dorr, Andrew ^d   Hambleton, Julie ^d   Holden, Scott ^d   Kearns, Anne ^d   Kenkare Mitra, Sara ^d   Lum, Bert ^d   Meropol, Neal J ^a   O'Dwyer, Peter J ^b  

^a FOX CHASE CANCER CENTER   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY OF IOWA   (United States)

^d GENENTECH INC   (United States)

^e Merck   (United States)

Author keywords

Bevacizumab; Irinotecan; Pharmacokinetics; UGT 1A

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; 7 ETHYL 10 HYDROXYCAMPTOTHECIN GLUCURONIDE; APC; BEVACIZUMAB; DRUG METABOLITE; FLUOROURACIL; FOLINIC ACID; GLUCURONOSYLTRANSFERASE 1A1; GLUCURONOSYLTRANSFERASE 1A6; IRINOTECAN;

ADULT; ADVANCED CANCER; AGED; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BOLUS INJECTION; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DNA POLYMORPHISM; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG HALF LIFE; DRUG METABOLISM; FEMALE; GASTROINTESTINAL TOXICITY; GENETIC LINKAGE; GENOTYPE; HUMAN; LEUKOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SOLID TUMOR; SWEATING; SYSTEMIC THERAPY; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; VOMITING;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CAMPTOTHECIN; DRUG INTERACTIONS; FEMALE; FLUOROURACIL; GASTROINTESTINAL TRACT; GENOTYPE; GLUCURONOSYLTRANSFERASE; HUMANS; LEUCOVORIN; LEUKOPENIA; MALE; MIDDLE AGED; NEOPLASMS; PHARMACOGENETICS; POLYMORPHISM, GENETIC; PRODRUGS;

EID: 70349632629     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-009-1008-7     Document Type: Article

References (34)

1. Y Ando H Saka M Ando T Sawa H Ueoka A Yokoyama S Saitoh K Shimokata Y Hasegawa 2000 Polymorphisms of UDP-glucuronosyltransferase gene and irinotecan toxicity: a pharmacogenetic analysis Can Res 60 6921 6926 1:CAS:528: DC%2BD3MXjsVOjsA%3D%3D
2. LE Carlini NJ Meropol YM Chen C McGarry T Hill P Gold RL Blanchard 2004 Pharmacogenetic analysis of UGT1A1, UGT1A6, UGT1A7 and thymidylate synthase in a phase II study of capecitabine plus irinotecan in patients with metastatic colorectal cancer J Clin Oncol (meeting abstracts) 22 3623
3. LE Carlini NJ Meropol J Bever ML Andria T Hill P Gold A Rogatko H Wang RL Blanchard 2005 UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan Clin Can Res 11 1226 1236 1:CAS:528:DC%2BD2MXht1yntLk%3D
4. GG Chabot D Abigerges G Catimel S Culine M de Forni JM Extra M Mahjoubi P Herait JP Armand R Bugat M Clavel ME Marty 1995 Population pharmacokinetics and pharmacodynamics of irinotecan (CPT-11) and active metabolite SN-38 during phase I trials Ann Oncol 6 141 151 7786822 1:STN:280:DyaK2Mzgs1Cjuw%3D%3D
5. Common terminology criteria for adverse events version 3.0, US Department of Health and Human Services, National Institutes of Health
6. MJ de Jonge J Verweij P de Bruijn E Brouwer RH Mathijssen RJ van Alphen MM de Boer-Dennert L Vernillet C Jacques A Sparreboom 2000 Pharmacokinetic, metabolic, and pharmacodynamic profiles in a dose escalating study of irinotecan and cisplatin J Clin Oncol 18 195 203 10623710
7. J Gagne V Montminy P Belanger K Journault G Gaucher C Guillemette 2002 Common human UGT1A polymorphisms and the altered metabolism of irinotecan active metabolite 7-ethyl-10-hydroxycamptothecin (SN-38) Mol Pharmacol 62 608 617 12181437 10.1124/mol.62.3.608 1:CAS:528:DC%2BD38XmsVKmuro%3D (Pubitemid 36329379)
8. Genentech (2007) Avastin Package Insert
9. SW Guo EA Thompson 1992 Performing the exact test of Hardy-Weinberg proportion for multiple alleles Biometrics 48 361 372 1637966 10.2307/2532296 1:STN:280:DyaK38zksFGgsA%3D%3D
10. J Han H Lim ES Sin Y Yoo YH Park J Lee I Jang DO Lee JS Lee 2006 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 16636344 10.1200/JCO.2005.03. 0239 1:CAS:528:DC%2BD28XlvV2ksLg%3D (Pubitemid 46630652)
11. H Hurwitz L Fehrenbacher W Novotny T Cartwright J Hainsworth W Heim J Berlin A Baron S Griffing E Holmgren N Ferrara G Fyfe B Rogers R Ross F Kabbinavar 2004 Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer New Engl J Med 350 2335 2342 15175435 10.1056/NEJMoa032691 1:CAS:528:DC%2BD2cXks1Gjt74%3D (Pubitemid 38702844)
12. F Innocenti SD Undevia L Iyer PX Chen S Das M Kocherginsky T Karrison L Janisch J Ramirez CM Rudin EE Vokes MJ Ratain 2004 Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan J Clin Oncol 22 1382 1388 15007088 10.1200/JCO.2004.07.173 1:CAS:528:DC%2BD2cXpt1yjtbk%3D (Pubitemid 41103619)
13. F Innocenti EE Vokes MJ Ratain 2006 Irinogenetics: what is the right star? J Clin Oncol 24 2221 2224 16636339 10.1200/JCO.2005.05.2464 1:CAS:528:DC%2BD28XlvV2ksLw%3D (Pubitemid 46630647)
14. L Iyer CD King PF Whitington MD Green SK Roy TR Thephly BL Coffman MJ Ratain 1998 Genetic predisposition to the metabolism of irinotecan (CPT-11): role of uridine diphosphate glucuronosyltransferase isoform 1A1 in the glucuronidation of its active metabolite (SN38) in human liver microsomes J Clin Invest 101 847 854 9466980 10.1172/JCI915 1:CAS:528:DyaK1cXht1Wrtrc%3D
15. L Iyer S Das L Janisch M Wen J Ramirez T Karrison GF Fleming EE Vokes RL Schilsky MJ Ratain 2002 UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity Pharmacogenomics J 2 43 47 11990381 10.1038/sj.tpj.6500072 1:CAS:528:DC%2BD38Xitl2ju7k%3D (Pubitemid 34982202)
16. DFS Kehrer A Sparreboom J Verweij P de Bruijn CA Nierop J van de Schraaf EJ Ruijgrok MJA de Jonge 2001 Modulation of Irinotecan-induced diarrhea by cotreatment with neomycin in cancer patients Clin Cancer Res 7 1136 1141 11350876 1:CAS:528:DC%2BD3MXktlemurY%3D
17. Lu JF, Gaudreault J, Novotny W, Lum BL, Bruno R (2005) A population pharmacokinetic (PK) model for bevacizumab (Avastin). ASCPT meeting, Miami, Florida
18. RH Mathijssen RJ van Alphen J Verweij WJ Loos K Nooter G Stoter A Sparreboom 2001 Clinical pharmacokinetics and metabolism of irinotecan (CPT-11) Clin Can Res 7 2182 2194 1:CAS:528:DC%2BD3MXmsVOmsbg%3D
19. HL McLeod L Parodi DJ Sargent S Marsh E Green P Abreu LA Cisar RM Goldberg 2006 UGT1A1*28, toxicity and outcome in advanced colorectal cancer: results from trial N9741 J Clin Oncol (Meeting Abstracts) 24 3520
20. S Nagar JJ Zalatoris RL Blanchard 2004 Human UGT1A6 pharmacogenetics: identification of a novel SNP, characterization of allele frequencies and functional analysis of recombinant allozymes in human liver tissue and in cultured cells Pharmacogenetics 14 487 499 15284531 10.1097/01.fpc.0000114771. 78957.cb 1:CAS:528:DC%2BD2cXmtVGgtb8%3D (Pubitemid 39100001)
21. PJ O'Dwyer RB Catalano 2006 Uridine diphosphate glucuronosyltransferase (UGT) 1A1 and irinotecan: practical pharmacogenomics arrives in cancer therapy J Clin Oncol 24 4534 4538 17008691 10.1200/JCO.2006.07.3031 (Pubitemid 46630947)
22. Pfizer (2007) Camptosar Package Insert
23. HC Pitot RM Goldberg JM Reid JA Sloan PA Skaff C Erlichman J Rubin PA Burch AA Adjei SA Alberts LJ Schaaf G Elfring LL Miller 2000 Phase I dose-finding and pharmacokinetic trial of irinotecan hydrochloride (CPT-11) using a once-every-three-week dosing schedule for patients with advanced solid tumor malignancy Clin Cancer Res 6 2236 2244 10873073 1:CAS:528: DC%2BD3cXksVGhsrY%3D
24. S Poujol F Bressolle J Duffour AG Abderrahim C Astre M Yehou F Pinguet 2006 Pharmacokinetics and pharmacodynamics of irinotecan and its metabolites from plasma and saliva data in patients with metastatic digestive cancer receiving folfiri regimen Cancer Chemother Pharmacol 58 292 305 16369821 10.1007/s00280-005-0166-5 1:CAS:528:DC%2BD28XkvFOisr8%3D (Pubitemid 43800732)
25. MJ Ratain 2002 Irinotecan dosing: does the CPT in CPT-11 stand for "can't predict toxicity J Clin Oncol 20 7 8 11773147
26. ML Rothenberg JG Kuhn LJ Schaaf GI Rodriguez SG Eckhardt MA Villalona-Calero DA Rinaldi LA Hammond S Hodges A Sharma GL Elfring RG Petit PK Locker LL Miller DD von Hoff 2001 Phase I dose-finding and pharmacokinetic trial of irinotecan (CPT-11) administered every two weeks Ann Oncol 12 1631 1641 11822765 10.1023/A:1013157727506 1:STN:280:DC%2BD38%2FptlGhtA%3D%3D (Pubitemid 34065894)
27. M Saeki Y Saito H Jinno M Tohkin K Kurose N Kaniwa K Komamura K Ueno S Kamakura M Kitakaze S Ozawa J Sawada 2003 Comprehensive UGT1A1 genotyping in a Japonese population by pyrosequencing Clin Chem 49 1182 1185 12816917 10.1373/49.7.1182 1:CAS:528:DC%2BD3sXltFeitro%3D (Pubitemid 36751107)
28. Siegel S, Castellan NJ (1988) Non-parametric statistics for the behavior sciences. McGraw-Hill
29. CF Stewart JC Panetta MA O'Shaughnessy SL Throm CH Fraga T Owens T Lui C Billups C Rodriguez-Galindo A Gajjar WL Furman LM McGregor 2007 UGT1A1 promoter genotype correlates with SN-38 pharmacokinetics, but no severe toxicity in patients receiving low-dose irinotecan J Clin Oncol 25 2594 2600 17577039 10.1200/JCO.2006.10.2301 1:CAS:528:DC%2BD2sXotV2mtL8%3D (Pubitemid 47041233)
30. G Toffoli E Cecchin G Corona A Russo A Buonadonna M D'Andrea LM Pasetto S Pessa D Errante V De Pangher M Giusto M Medici F Gaion P Sandri E Galligioni S Bonura M Boccalon P Biason S Frustaci 2006 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 16809730 10.1200/JCO.2005.05.5400 1:CAS:528:DC%2BD28XnslKhs7w%3D (Pubitemid 46638941)
31. C Tournigand T Andre E Achille G Lledo M Flesh D Mery-Mignard E Quinaux C Couteau M Buyse G Ganem B Landi P Colin C Louvet A de Gramont 2004 FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study J Clin Oncol 22 229 237 14657227 10.1200/JCO.2004.05.113 1:CAS:528:DC%2BD2cXpsVKit7w%3D (Pubitemid 41095086)
32. U.S. Department of Health and Human Services FaDA, CDER, CBER (1999) In vivo drug metabolism/drug interaction studies-study design, data analysis and recommendations for dosing and labeling. Guidance for industry, Rockville, MD
33. JM van der Bol RH Mathijssen WJ Loos LE Friberg RHN van Schaik MJ de Jonge AS Planting J Verweij A Sparreboom FA de jonge 2007 Cigarette smoking and irinotecan treatment: pharmacokinetic interaction and effects on neutropenia J Clin Oncol 25 1 8 10.1200/JCO.2006.07.7677 (Pubitemid 350002979)
34. L Villeneuve H Girard L Fortier J Gagne C Guillemette 2003 Novel functional polymorphisms in the UGT1A7 and UGT1A9 glucuronidating enzymes in Caucasian and African-American subjects and their impact on the metabolism of 7-ethyl-10-hydroxycamptothecin and flavopiridol anticancer drugs JPET 307 117 128 10.1124/jpet.103.054072 1:CAS:528:DC%2BD3sXnslGktb8%3D (Pubitemid 37151897)