A model of hypertension and proteinuria in cancer patients treated with the anti-angiogenic drug E7080

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 37, Issue 4, 2010, Pages 347-363

  Keizer, Ron J ^a,b,c   Gupta, Anubha ^d   Mac Gillavry, Melvin R ^a   Jansen, Mendel ^d   Wanders, Jantien ^d   Beijnen, Jos H ^a,b,e   Schellens, Jan H M ^b,e   Karlsson, Mats O ^c   Huitema, Alwin D R ^a,b  

^a SLOTERVAART HOSPITAL   (Netherlands)

^b ANTONI VAN LEEUWENHOEK HOSPITAL   (Netherlands)

^c UPPSALA UNIVERSITY   (Sweden)

^d EISAI CO LTD   (Japan)

^e UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Hypertension; Model; Pharmacodynamics; Proteinuria; VEGF

Indexed keywords

ANGIOGENESIS INHIBITOR; ANTIHYPERTENSIVE AGENT; E 7080; UNCLASSIFIED DRUG;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD PRESSURE; CANCER PATIENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EXPOSURE; DRUG WITHDRAWAL; FEMALE; HUMAN; HYPERTENSION; LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MATHEMATICAL MODEL; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROBABILITY; PROTEINURIA; SOLID TUMOR; URINALYSIS;

ANGIOGENESIS INHIBITORS; ANTIHYPERTENSIVE AGENTS; BLOOD PRESSURE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HUMANS; HYPERTENSION; MODELS, BIOLOGICAL; NEOPLASMS; PHENYLUREA COMPOUNDS; PROTEINURIA; QUINOLINES; URINALYSIS;

EID: 77956611236     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-010-9164-2     Document Type: Article

References (31)

1. FALM Eskens J Verweij 2006 The clinical toxicity profile of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors; a review Eur J Cancer 42 18 3127 3139 10.1016/j.ejca.2006.09.015 1:CAS:528:DC%2BD28Xht12rtrzJ 17098419 (Pubitemid 44869016)
2. HMW Verheul HM Pinedo 2007 Possible molecular mechanisms involved in the toxicity of angiogenesis inhibition Nat Rev Cancer 7 6 475 485 10.1038/nrc2152 1:CAS:528:DC%2BD2sXls1Kjsb4%3D 17522716 (Pubitemid 46809172)
3. Sleijfer S, Wiemer E (2008) Dose selection in phase I studies: why we should always go for the top. J Clin Oncol. doi: 10.1200/JCO.2007.15.5192
4. ML Maitland K Moshier J Imperial KE Kasza T Karrison W Elliott, et al. 2006 Blood pressure (BP) as a biomarker for sorafenib (S), an inhibitor of the vascular endothelial growth factor (VEGF) signaling pathway J Clin Oncol 24 18 suppl 2035 (Meeting Abstracts)
5. O Rixe B Billemont H Izzedine 2007 Hypertension as a predictive factor of Sunitinib activity Ann Oncol 18 6 1117 10.1093/annonc/mdm184 1:STN:280:DC%2BD2szntFGrtg%3D%3D 17586751 (Pubitemid 47050505)
6. J Spano C Chodkiewicz J Maurel R Wong H Wasan C Barone, et al. 2008 Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study Lancet 371 9630 2101 2108 10.1016/S0140-6736(08)60661-3 1:CAS:528:DC%2BD1cXnsFGjurs%3D 18514303
7. M Scartozzi E Galizia S Chiorrini R Giampieri R Berardi C Pierantoni, et al. 2009 Arterial hypertension correlates with clinical outcome in colorectal cancer patients treated with first-line bevacizumab Ann Oncol 20 2 227 230 10.1093/annonc/mdn637 1:STN:280:DC%2BD1M7jtlWltg%3D%3D 18842611
8. J Matsui Y Yamamoto Y Funahashi A Tsuruoka T Watanabe T Wakabayashi, et al. 2008 E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition Int J Cancer 122 3 664 671 10.1002/ijc.23131 1:CAS:528:DC%2BD1cXhsVeltg%3D%3D 17943726 (Pubitemid 350308963)
9. J Matsui Y Funahashi T Uenaka T Watanabe A Tsuruoka M Asada 2008 Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumor MDA-MB-231 via inhibition of vascular endothelial growth factor-receptor (VEGF-R) 2 and VEGF-R3 kinase Clin Cancer Res 14 17 5459 5465 10.1158/1078-0432.CCR-07-5270 1:CAS:528:DC%2BD1cXhtVKmsbjP 18765537
10. Yamada K, Hirata T, Fujiwara Y, Nokihara N, Yamamoto N, Yamada Y et al (2008) Phase I dose escalation study and biomarker analysis of E7080 in patients with advanced solid tumors. J Clin Oncol 26:3527 (Meeting Abstracts)
11. Nemunaitis J, Senzer N, Kurzrock R, Ng C, Das A, Atienza R et al (2008) Phase I dose-escalation study of E7080, a multikinase inhibitor, in patients with advanced solid tumors. J Clin Oncol 26:14583 (Meeting Abstracts)
12. Glen H, Boss D, Evans TR, Roelvink M, Saro JM, Bezodis P et al (2007) A phase I dose finding study of E7080 in patients (pts) with advanced malignancies. J Clin Oncol 25 (Meeting Abstracts). Available from: http://meeting.ascopubs.org/cgi/content/abstract/25/18-suppl/14073. Cited 22 Jan 2008 (Internet)
13. L Lindbom P Pihlgren EN Jonsson 2005 PsN-Toolkit-a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM Comput Methods Programs Biomed 79 3 241 257 10.1016/j.cmpb.2005.04.005 16023764 (Pubitemid 41196689)
14. Keizer RJ, Zandvliet AS, Huitema ADR (2008) A simple infrastructure and graphical user interface (GUI) for distributed NONMEM analysis on standard network environments. In: Abstracts of the annual meeting of the population approach group in Europe, Marseille
15. Holford N (2005) The visual predictive check-superiority to standard diagnostic (Rorschach) plots. In: Abstracts of the annual meeting of the population approach group in Europe. PAGE 14, Abstract 738
16. LB Sheiner DR Stanski S Vozeh RD Miller J Ham 1979 Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine Clin Pharmacol Ther 25 3 358 371 1:CAS:528:DyaE1MXhsl2qsro%3D 761446
17. NL Dayneka V Garg WJ Jusko 1993 Comparison of four basic models of indirect pharmacodynamic responses J Pharmacokinet Biopharm 21 4 457 478 10.1007/BF01061691 1:CAS:528:DyaK2cXitlGhsb0%3D 8133465 (Pubitemid 24025269)
18. C Dansirikul H Silber M Karlsson 2008 Approaches to handling pharmacodynamic baseline responses J Pharmacokinet Pharmacodyn 35 3 269 283 10.1007/s10928-008-9088-2 1:CAS:528:DC%2BD1cXosVGiu74%3D 18446428
19. KD Miller LI Chap FA Holmes MA Cobleigh PK Marcom L Fehrenbacher, et al. 2005 Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer J Clin Oncol 23 4 792 799 10.1200/JCO.2005.05.098 1:CAS:528:DC%2BD2MXitVKitrk%3D 15681523 (Pubitemid 46224178)
20. G Hempel MO Karlsson DP de Alwis N Toublanc J McNay HG Schaefer 1998 Population pharmacokinetic-pharmacodynamic modeling of moxonidine using 24-hour ambulatory blood pressure measurements Clin Pharmacol Ther 64 6 622 635 10.1016/S0009-9236(98)90053-4 1:CAS:528:DyaK1MXjslWhug%3D%3D 9871427 (Pubitemid 29011382)
21. X Zhu S Wu WL Dahut CR Parikh 2007 Risks of proteinuria and hypertension with bevacizumab, an antibody against vascular endothelial growth factor: systematic review and meta-analysis Am J Kidney Dis 49 2 186 193 10.1053/j.ajkd.2006.11.039 1:CAS:528:DC%2BD2sXis1Kgu78%3D 17261421 (Pubitemid 46178407)
22. S Wu JJ Chen A Kudelka J Lu X Zhu 2008 Incidence and risk of hypertension with sorafenib in patients with cancer: a systematic review and meta-analysis Lancet Oncol 9 2 117 123 10.1016/S1470-2045(08)70003-2 1:CAS:528: DC%2BD1cXhsVOnu7k%3D 18221915
23. X Zhu K Stergiopoulos S Wu 2009 Risk of hypertension and renal dysfunction with an angiogenesis inhibitor sunitinib: systematic review and meta-analysis Acta Oncol 48 1 9 17 10.1080/02841860802314720 1:CAS:528:DC%2BD1cXhsFagtbjI 18752081
24. N Steeghs H Gelderblom JO' Roodt O Christensen P Rajagopalan M Hovens, et al. 2008 Hypertension and rarefaction during treatment with telatinib, a small molecule angiogenesis inhibitor Clin Cancer Res 14 11 3470 3476 10.1158/1078-0432.CCR-07-5050 1:CAS:528:DC%2BD1cXmslygtr8%3D 18519779
25. ML Veronese A Mosenkis KT Flaherty M Gallagher JP Stevenson RR Townsend, et al. 2006 Mechanisms of hypertension associated with BAY 43-9006 J Clin Oncol 24 9 1363 1369 10.1200/JCO.2005.02.0503 1:CAS:528:DC%2BD28Xjs1Ogt74%3D 16446323 (Pubitemid 46621999)
26. National Kidney Foundation KDOQI (2004) K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis 43(5 Suppl1):S1-S290
27. Lindauer A, Kanefendt F, Krambeer C, di Gion P, Kinzig M, Soergel F et al Pharmacokinetic/pharmacodynamic modeling of sunitinib in healthy volunteers. In: Abstracts of the annual meeting of the population approach group in Europe. PAGE, St. Petersburg
28. M Azizi A Chedid S Oudard 2008 Home blood-pressure monitoring in patients receiving sunitinib N Engl J Med 358 1 95 97 10.1056/NEJMc072330 1:CAS:528:DC%2BD1cXisFaiuw%3D%3D 18172185
29. N Sawyer J Wadsworth M Wijnen R Gábriel 1988 Prevalence, concentration, and prognostic importance of proteinuria in patients with malignancies Br Med J (Clin Res Ed) 296 6632 1295 1298 10.1136/bmj.296.6632.1295 1:STN:280:DyaL1c3lt1KqtA%3D%3D
30. RT Gansevoort WJ Sluiter MH Hemmelder D de Zeeuw PE de Jong 1995 Antiproteinuric effect of blood-pressure-lowering agents: a meta-analysis of comparative trials Nephrol Dial Transplant 10 11 1963 1974 1:STN:280: DyaK283islehtw%3D%3D 8643149
31. ACE Inhibitors in Diabetic Nephropathy Trialist Group 2001 Should all patients with type 1 diabetes mellitus and microalbuminuria receive angiotensin-converting enzyme inhibitors? A meta-analysis of individual patient data Ann Intern Med 134 5 370 379