Population pharmacokinetic analysis of free and bound aflibercept in patients with advanced solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 72, Issue 1, 2013, Pages 167-180

  Thai, Hoai Thu ^a,b,c   Veyrat Follet, Christine ^a   Mentré, France ^b,c   Comets, Emmanuelle ^b,c  

^a SANOFI   (France)

^b INSERM   (France)

^c UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

Aflibercept; Covariate effect; Dosing schedule; Population pharmacokinetics; Target mediated drug disposition; VEGF

Indexed keywords

AFLIBERCEPT; ALBUMIN; ALKALINE PHOSPHATASE; DOCETAXEL; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; IRINOTECAN; VASCULOTROPIN;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BODY WEIGHT; CANCER COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DISEASE ASSOCIATION; DOSE RESPONSE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG PROTEIN BINDING; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; PANCREAS CANCER; PRIORITY JOURNAL; SOLID TUMOR;

ADULT; AGED; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BODY WEIGHT; CARCINOMA, NON-SMALL-CELL LUNG; COHORT STUDIES; COLORECTAL NEOPLASMS; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MODELS, BIOLOGICAL; NEOPLASMS; PANCREATIC NEOPLASMS; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; RECOMBINANT FUSION PROTEINS; SEX CHARACTERISTICS; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84879793440     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2182-1     Document Type: Article

References (41)

1. Folkman J (1997) Addressing tumor blood vessels. Nat Biotechnol 15(6):510
2. Takahashi Y, Kitadai Y, Bucana CD, Cleary KR, Ellis LM (1995) Expression of vascular endothelial growth factor and its receptor, KDR, correlates with vascularity, metastasis, and proliferation of human colon cancer. Cancer Res 55(18):3964-3968
3. Takebayashi Y, Aklyama S, Yamada K, Akiba S, Aikou T (1996) Angiogenesis as an unfavorable prognostic factor in human colorectal carcinoma. Cancer 78(2):226-231
4. Radinsky R, Ellis LM (1996) Molecular determinants in the biology of liver metastasis. Surg Oncol Clin North Am 5(2):215-229
5. Ferrara N, Davis-Smyth T (1997) The biology of vascular endothelial growth factor. Endocr Rev 18(1):4-25
6. Gaya A, Tse V (2012) A preclinical and clinical review of aflibercept for the management of cancer. Cancer Treat Rev 38(5):484-493
7. Sternberg CN (2008) Systemic chemotherapy and new experimental approaches in the treatment of metastatic prostate cancer. Ann Oncol 19(Suppl 7):vii91-vii95
8. Chu QS (2009) Aflibercept (AVE0005): an alternative strategy for inhibiting tumour angiogenesis by vascular endothelial growth factors. Exp Opin Biol Ther 9(2):263-271
9. Lockhart AC, Rothenberg ML, Dupont J, Cooper W, Chevalier P, Sternas L, Buzenet G, Koehler E, Sosman JA, Schwartz LH, Gultekin DH, Koutcher JA, Donnelly EF, Andal R, Dancy I, Spriggs DR, Tew WP (2009) Phase I study of intravenous vascular endothelial growth factor trap, aflibercept, in patients with advanced solid tumors. J Clin Oncol 28(2):207-214
10. Baffert F, Le T, Sennino B, Thurston G, Kuo CJ, Hu-Lowe D, McDonald DM (2006) Cellular changes in normal blood capillaries undergoing regression after inhibition of VEGF signaling. Am J Physiol 290(2):H547-H559
11. Holash J, Davis S, Papadopoulos N, Croll SD, Ho L, Russell M, Boland P, Leidich R, Hylton D, Burova E, Ioffe E, Huang T, Radziejewski C, Bailey K, Fandl JP, Daly T, Wiegand SJ, Yancopoulos GD, Rudge JS (2002) VEGF-Trap: a VEGF blocker with potent antitumor effects. Proc Nat Acad Sci USA 99(17):11393-11398
12. Eichten A, Adler A, Cooper B, Griffith J, Wei Y, Yancopoulos G, Lin H, Thurston G (2012) Rapid decrease in tumor perfusion following VEGF blockade predicts long-term tumor growth inhibition in preclinical tumor models. Angiogenesis 16(2):429-441
13. Freyer G, Isambert N, You B, Zanetta S, Falandry C, Favier L, Trillet-Lenoir V, Assadourian S, Soussan-Lazard K, Ziti-Ljajic S, Fumoleau P (2012) Phase I dose-escalation study of aflibercept in combination with docetaxel and cisplatin in patients with advanced solid tumours. British J Cancer 107(4):598-603
14. Coleman RL, Duska LR, Ramirez PT, Heymach JV, Kamat AA, Modesitt SC, Schmeler KM, Iyer RB, Garcia ME, Miller DL, Jackson EF, Ng CS, Kundra V, Jaffe R, Sood AK (2011) Phase 1-2 study of docetaxel plus aflibercept in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Lancet Oncol 12(12):1109-1117
15. Colombo N, Mangili G, Mammoliti S, Kalling M, Tholander B, Sternas L, Buzenet G, Chamberlain D (2012) A phase II study of aflibercept in patients with advanced epithelial ovarian cancer and symptomatic malignant ascites. Gynecol Oncol 125(1):42-47
16. Ramlau R, Gorbunova V, Ciuleanu TE, Novello S, Ozguroglu M, Goksel T, Baldotto C, Bennouna J, Shepherd FA, Le-Guennec S, Rey A, Miller V, Thatcher N, Scagliotti G (2012) Aflibercept and docetaxel versus docetaxel alone after platinum failure in patients with advanced or metastatic non-small-cell lung cancer: a randomized, controlled phase III trial. J Clin Oncol 30(29):3640-3647
17. He K, Cui B, Li G, Wang H, Jin K, Teng L (2012) The effect of anti-VEGF drugs (bevacizumab and aflibercept) on the survival of patients with metastatic colorectal cancer (mCRC). OncoTargets Ther 5:59-65
18. Wang TF, Lockhart AC (2012) Aflibercept in the treatment of metastatic colorectal cancer. Clin Med Insights 6:19-30
19. Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausova J, Macarulla T, Ruff P, van Hazel GA, Moiseyenko V, Ferry D, McKendrick J, Polikoff J, Tellier A, Castan R, Allegra C (2012) Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol 30(28):3499-3506
20. Thai HT, Veyrat-Follet C, Vivier N, Dubruc C, Sanderink G, Mentre F, Comets E (2011) A mechanism-based model for the population pharmacokinetics of free and bound aflibercept in healthy subjects. British J Clin Pharmacol 72(3):402-414
21. Lavielle M (2008) MONOLIX (MOdèles NOn LInéaires à effets miXtes). MONOLIX group, Orsay, France
22. Kuhn E, Lavielle M (2005) Maximum likelihood estimation in nonlinear mixed effects models. Comput Stat Data Anal 49(4):1020-1038
23. Samson A, Lavielle M, Mentre F (2007) The SAEM algorithm for group comparison tests in longitudinal data analysis based on non-linear mixed-effects model. Stat Med 26(27):4860-4875
24. Wald A (1943) Tests of statistical hypotheses concerning several parameters when the number of observations is large. Trans Am Math Soc 54(3):426-482
25. Brendel K, Comets E, Laffont C, Laveille C, Mentre F (2006) Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res 23(9):2036-2049
26. Comets E, Brendel K, Mentre F (2008) Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the npde add-on package for R. Comput Methods Programs Biomed 90(2):154-166
27. Comets E, Brendel K, Mentré F (2010) Model evaluation in nonlinear mixed effect models, with applications to pharmacokinetics. J Soc Fr Stat 151:106-128
28. Savic RM, Karlsson MO (2009) Importance of shrinkage in empirical Bayes estimates for diagnostics: problems and solutions. AAPS Journal 11(3):558-569
29. Mager DE, Jusko WJ (2001) General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn 28(6):507-532
30. Mager DE (2006) Target-mediated drug disposition and dynamics. Biochem Pharmacol 72(1):1-10
31. Mager DE, Krzyzanski W (2005) Quasi-equilibrium pharmacokinetic model for drugs exhibiting target-mediated drug disposition. Pharm Res 22(10):1589-1596
32. Gibiansky L, Gibiansky E, Kakkar T, Ma P (2008) Approximations of the target-mediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn 35(5):573-591
33. Gibiansky L, Gibiansky E (2010) Target-mediated drug disposition: new derivation of the michaelis-menten model, and why it is often sufficient for description of drugs with TMDD. Population Approach Group in Europe. p 19, Abstr 1728. [ www.page-meeting.org/?abstract=1728 ]
34. Kut C, Mac Gabhann F, Popel AS (2007) Where is VEGF in the body? A meta-analysis of VEGF distribution in cancer. British J Cancer 97(7):978-985
35. Stefanini MO, Wu FT, Mac Gabhann F, Popel AS (2008) A compartment model of VEGF distribution in blood, healthy and diseased tissues. BMC Syst Biol 2:77
36. Lu JF, Bruno R, Eppler S, Novotny W, Lum B, Gaudreault J (2008) Clinical pharmacokinetics of bevacizumab in patients with solid tumors. Cancer Chemother Pharmacol 62(5):779-786
37. Fasanmade AA, Adedokun OJ, Ford J, Hernandez D, Johanns J, Hu C, Davis HM, Zhou H (2009) Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol 65(12):1211-1228
38. Kerbel R, Folkman J (2002) Clinical translation of angiogenesis inhibitors. Nat Rev Cancer 2(10):727-739
39. Li J, Wientjes MG, Au JL (2010) Pancreatic cancer: pathobiology, treatment options, and drug delivery. AAPS J 12(2):223-232
40. Kindler HL, Niedzwiecki D, Hollis D, Sutherland S, Schrag D, Hurwitz H, Innocenti F, Mulcahy MF, O'Reilly E, Wozniak TF, Picus J, Bhargava P, Mayer RJ, Schilsky RL, Goldberg RM (2010) Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the cancer and Leukemia Group B (CALGB 80303). J Clin Oncol 28(22):3617-3622
41. Rudge JS, Holash J, Hylton D, Russell M, Jiang S, Leidich R, Papadopoulos N, Pyles EA, Torri A, Wiegand SJ, Thurston G, Stahl N, Yancopoulos GD (2007) VEGF Trap complex formation measures production rates of VEGF, providing a biomarker for predicting efficacious angiogenic blockade. Proc Nat Acad Sci USA 104(47):18363-18370