Population pharmacokinetics of bevacizumab in cancer patients with external validation

Cancer Chemotherapy and Pharmacology

Volumn 78, Issue 2, 2016, Pages 341-351

  Han, Kelong ^a,d   Peyret, Thomas ^b   Marchand, Mathilde ^c   Quartino, Angelica ^a   Gosselin, Nathalie H ^b   Girish, Sandhya ^a   Allison, David E ^a   Jin, Jin ^a  

^a GENENTECH INC   (United States)

^b Pharsight A Certara Company   (Canada)

^c Pharsight Consulting Services   (France)

^d GLAXOSMITHKLINE   (United States)

Author keywords

Adult; Asian; Bevacizumab; Cancer; External validation; Japan; Population pharmacokinetics

Indexed keywords

ALBUMIN; ALKALINE PHOSPHATASE; BEVACIZUMAB; ANGIOGENESIS INHIBITOR;

ADULT; ARTICLE; BODY WEIGHT; BRAIN CANCER; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER PATIENT; CENTRAL VOLUME OF DISTRIBUTION; COLORECTAL CANCER; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; EARLY CANCER; FEMALE; HUMAN; JAPANESE (PEOPLE); KIDNEY CANCER; MAJOR CLINICAL STUDY; MALE; METASTASIS; NON SMALL CELL LUNG CANCER; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); POPULATION MODEL; PRIORITY JOURNAL; PROSTATE CANCER; SENSITIVITY ANALYSIS; SEX DIFFERENCE; ASIAN CONTINENTAL ANCESTRY GROUP; BIOLOGICAL MODEL; DOSE RESPONSE; DRUG ADMINISTRATION; HALF LIFE TIME; NEOPLASMS; PATHOLOGY; TISSUE DISTRIBUTION; VALIDATION STUDY;

ADULT; ANGIOGENESIS INHIBITORS; ASIAN CONTINENTAL ANCESTRY GROUP; BEVACIZUMAB; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; CLINICAL TRIALS, PHASE IV AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HALF-LIFE; HUMANS; MALE; MODELS, BIOLOGICAL; NEOPLASMS; SEX FACTORS; TISSUE DISTRIBUTION;

EID: 84975219820     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-016-3079-6     Document Type: Article

References (40)

1. Ferrara N, Gerber HP, LeCouter J (2003) The biology of VEGF and its receptors. Nat Med 9:669–676
2. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F (2004) Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350(23):2335–2342
3. Giantonio BJ, Catalano PJ, Meropol NJ, O’Dwyer PJ, Mitchell EP, Alberts SR, Schwartz MA, Benson AB 3rd (2007) Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 25(12):1539–1544
4. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH (2006) Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355(24):2542–2550
5. Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE (2007) Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 357(26):2666–2676
6. Escudier B, Bellmunt J, Négrier S, Bajetta E, Melichar B, Bracarda S, Ravaud A, Golding S, Jethwa S, Sneller V (2010) Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival. J Clin Oncol 28(13):2144–2150
7. Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ (2014) Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med 370(8):734–743
8. Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I (2014) Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: the AURELIA open-label randomized phase III trial. J Clin Oncol 32(13):1302–1308
9. 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
10. ®(bevacizumab). 22nd Version. November 2014
11. Han K, Jin J, Maia M, Lowe J, Sersch MA, Allison DE (2014) Lower exposure and faster clearance of bevacizumab in gastric cancer and the impact of patient variables: analysis of individual data from AVAGAST phase III trial. AAPS J 16(5):1056–1063
12. Van Cutsem E, de Haas S, Kang YK, Ohtsu A, Tebbutt NC, Ming Xu J, Peng Yong W, Langer B, Delmar P, Scherer SJ, Shah MA (2012) Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a biomarker evaluation from the AVAGAST randomized phase III trial. J Clin Oncol 30(17):2119–2127
13. Miles DW, de Haas SL, Dirix LY, Romieu G, Chan A, Pivot X, Tomczak P, Provencher L, Cortés J, Delmar PR, Scherer SJ (2013) Biomarker results from the AVADO phase 3 trial of first-line bevacizumab plus docetaxel for HER2-negative metastatic breast cancer. Br J Cancer 108(5):1052–1060
14. Beal S, Sheiner LB, Boeckmann A, Bauer RJ (2009) NONMEM user’s guides (1989–2009). Icon Development Solutions, Ellicott City, MD
15. Lindbom L, Ribbing J, Jonsson EN (2004) Perl-speaks-NONMEM (PsN)—a perl module for NONMEM related programming. Comput Methods Progr Biomed 75(2):85–94
16. Team RC (2014) R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. http://www.R-project.org/
17. Dong JQ, Salinger DH, Endres CJ, Gibbs JP, Hsu CP, Stouch BJ, Hurh E, Gibbs MA (2011) Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction. Clin Pharmacokinet 50(2):131–142
18. Gastonguay MR, French JL, Heitjan DF, Rogers JA, Ahn JE, Ravva P (2010) Missing data in model-based pharmacometric applications: points to consider. J Clin Pharmacol 50(9 Suppl):63S–74S
19. Karlsson MO, Savic RM (2007) Diagnosing model diagnostics. Clin Pharmacol Ther 82:17–20
20. Food and Drug Administration (1999) Guidance for industry-population pharmacokinetics. US department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072137.pdf
21. Committee for Medicinal Products for Human Use (CHMP) (2007) Guideline on reporting the results of population pharmacokinetic analyses, Doc. Ref. CHMP/EWP/185990/06. London, 21 June 2007. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003067.pdf
22. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO (2011) Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J 13(2):143–151
23. Ette EI (1997) Stability and performance of a population pharmacokinetic model. J Clin Pharmacol 37:486–495
24. Savic RM (2009) Karlsson MO importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J 11(3):558–569
25. Dostalek M, Gardner I, Gurbaxani BM, Rose RH, Chetty M (2013) Pharmacokinetics, pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies. Clin Pharmacokinet 52(2):83–124
26. Han K, Peyret T, Quartino A, Gosselin NH, Gururangan S, Casanova M, Merks JH, Massimino M, Grill J, Daw NC, Navid F, Jin J, Allison DE (2016) Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation. Br J Clin Pharmacol 81(1):148–160
27. Cobleigh MA et al (2003) A phase I/II dose-escalation trial of bevacizumab in previously treated metastatic breast cancer. Semin Oncol 30(5 Suppl 16):117–124
28. Kabbinavar F et al (2003) Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol 21(1):60–65
29. Hurwitz H et al (2004) Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350(23):2335–2342
30. Hillan KJ et al (2003) The role of VEGF expression in response to bevacizumab plus capecitabine in metastatic breast cancer (MBC). In ASCO annual meeting. Abstract No 766
31. Li J, Gupta M, Jin D, Xin Y, Visich J, Allison DE (2013) Characterization of the long-term pharmacokinetics of bevacizumab following last dose in patients with resected stage II and III carcinoma of the colon. Cancer Chemother Pharmacol 71(3):575–580
32. Clinical Study Report – BO17704 – A randomized, double-blind multicenter 2-stage phase III study of bevacizumab in combination with cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with advanced or recurrent non-squamous non-small cell lung cancer, who have not received prior chemotherapy. Roche Report No. 1023798. June 2007
33. Escudier B et al (2010) Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival. J Clin Oncol 28(13):2144–2150
34. Escudier B et al (2007) Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 370(9605):2103–2111
35. Van Cutsem E et al (2009) Phase III trial of bevacizumab in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. J Clin Oncol 27(13):2231–2237
36. Wu JY et al (2010) Phase I safety and pharmacokinetic study of bevacizumab in Chinese patients with advanced cancer. Chin Med J (Engl) 123(7):901–906
37. Mok T et al (2014) A correlative biomarker analysis of the combination of bevacizumab and carboplatin-based chemotherapy for advanced nonsquamous non-small-cell lung cancer: results of the phase II randomized ABIGAIL study (BO21015). J Thorac Oncol 9(6):848–855
38. Chinot O (2012) Phase III trial of bevacizumab added to standard radiotherapy and temozolomide for newly-diagnosed glioblastoma: mature progression-free survival and preliminary overall survival results in AVAglio. In 17th Annual meeting of the society for neuro-oncology. Washington, USA. Abstract No. OT-03
39. Ito Y et al (2011) Efficacy of first-line bevacizumab (Bev) combined with weekly paclitaxel (wPac) for HER2-negative metastatic breast cancer (MBC): results of a Japanese phase II study (n = 120). In ASCO annual meeting. Abstract No. 1119
40. Niho S et al (2012) Randomized phase II study of first-line carboplatin-paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer. Lung Cancer 76(3):362–367