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 Journal

Volumn 16, Issue 5, 2014, Pages 1056-1063

  Han, Kelong ^a   Jin, Jin ^a   Maia, Mauricio ^a   Lowe, John ^a   Sersch, Martina A ^a   Allison, David E ^a  

^a GENENTECH INC   (United States)

Author keywords

advanced gastric cancer; bevacizumab; ethnicity; NONMEM; pharmacokinetics

Indexed keywords

ALBUMIN; BEVACIZUMAB; CISPLATIN; PLACEBO; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; CAPECITABINE; DEOXYCYTIDINE; FLUOROURACIL; MONOCLONAL ANTIBODY;

ADULT; AGED; ALBUMIN BLOOD LEVEL; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; DISEASE COURSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EXPOSURE; FEMALE; GASTRECTOMY; HUMAN; LIMIT OF QUANTITATION; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; PHASE 3 CLINICAL TRIAL; PREDICTOR VARIABLE; STOMACH CANCER; ADENOCARCINOMA; ANALOGS AND DERIVATIVES; BAYES THEOREM; BIOAVAILABILITY; BIOLOGICAL MODEL; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG MONITORING; METABOLIC CLEARANCE RATE; MIDDLE AGED; PATHOLOGY; SECONDARY; STOMACH NEOPLASMS; TREATMENT OUTCOME; VERY ELDERLY;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BAYES THEOREM; BIOLOGICAL AVAILABILITY; CISPLATIN; DEOXYCYTIDINE; DISEASE PROGRESSION; DRUG MONITORING; FEMALE; FLUOROURACIL; GASTRECTOMY; HUMANS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MODELS, BIOLOGICAL; STOMACH NEOPLASMS; TREATMENT OUTCOME;

EID: 84908357093     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9631-6     Document Type: Article

References (28)

1. Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nat Med. 2003;9:669-76. (Pubitemid 36749215)
2. Koukourakis GV, Sotiropoulou-Lontou A. Targeted therapy with bevacizumab (Avastin) for metastatic colorectal cancer. Clin Transl Oncol. 2011;13(10):710-4.
3. Planchard D. Bevacizumab in non-small-cell lung cancer: a review. Expert Rev Anticancer Ther. 2011;11(8):1163-79.
4. Chamberlain MC. Bevacizumab for the treatment of recurrent glioblastoma. Clin Med Insights Oncol. 2011;5:117-29.
5. Escudier B, Albiges L. Vascular endothelial growth factor-targeted therapy for the treatment of renal cell carcinoma. Drugs. 2011;71(9):1179-91.
6. Van Meter ME, Kim ES. Bevacizumab: current updates in treatment. Curr Opin Oncol. 2010;22(6):586-91.
7. Summary of product characteristics (http://www.ema.europa.eu/docs/en-GB/ document-library/EPAR---Product-Information/human/000582/WC500029271.pdf).
8. Rivera F, López-Tarruella S, Vega-Villegas ME, Salcedo M. Treatment of advanced pancreatic cancer: from gemcitabine single agent to combinations and targeted therapy. Cancer Treat Rev. 2009;35(4):335-9.
9. Mulder K, Scarfe A, Chua N, Spratlin J. The role of bevacizumab in colorectal cancer: understanding its benefits and limitations. Expert Opin Biol Ther. 2011;11(3):405-13.
10. Ulahannan SV, Brahmer JR. Antiangiogenic agents in combination with chemotherapy in patients with advanced non-small cell lung cancer. Cancer Invest. 2011;29(4):325-37.
11. Jakobsen JN, Hasselbalch B, Stockhausen MT, Lassen U, Poulsen HS. Irinotecan and bevacizumab in recurrent glioblastoma multiforme. Expert Opin Pharmacother. 2011;12(5):825-33.
12. Park MS, Ravi V, Araujo DM. Inhibiting the VEGF-VEGFR pathway in angiosarcoma, epithelioid hemangioendothelioma, and hemangiopericytoma/solitary fibrous tumor. Curr Opin Oncol. 2010;22(4):351-5.
13. Ohtsu A, Shah MA, Van Cutsem E, et al. Bevacizumab in combination with chemotherapy as fi rst-line therapy in advanced gastric cancer: a randomized double-blind placebo-controlled phase III study. J Clin Oncol. 2011;29:3968-76.
14. Gordon MS, Margolin K, Talpaz M, Sledge Jr GW, Holmgren E, Benjamin R, et al. Phase I safety and pharmacokinetic study of recombinant human anti-vascular endothelial growth factor in patients with advanced cancer. J Clin Oncol. 2001;19(3):843-50. (Pubitemid 32119100)
15. Lu JF, Bruno R, Eppler S, Novotny W, Lum B, Gaudreault J. Clinical pharmacokinetics of bevacizumab in patients with solid tumors. Cancer Chemother Pharmacol. 2008;62(5):779-86.
16. Zhi J, Chen E, Major P, Burns I, Robinson B, McKendrick J, et al. A multicenter, randomized, open-label study to assess the steady state pharmacokinetics of bevacizumab given with either XELOX or FOLFOX-4 in patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 2011;68(5):1199- 206.
17. Li J, Gupta M, Jin D, Xin Y, Visich J, Allison DE. 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. 2013;71(3):575-80.
18. Page 4-5, EMEA (European Medicines Agency) Assessment report for herceptin, Procedure No. EMEA/H/C/278/II/0047, London, 19 January 2010, Doc. Ref No.: EMA/842364/2009, URL: http://www.ema.europa.eu/docs/en-GB/document- library/EPAR---Assessment-Report---Variation/human/000278/WC500074921.pdf.
19. Australian public assessment report for trastuzumab, page 7-9, February 2011, URL: http://www.tga.gov.au/pdf/auspar/ausparherceptin.pdf.
20. Yang J, Zhao H, Garnett C, Rahman A, Gobburu JV, Pierce W, et al. The combination of exposure-response and case-control analyses in regulatory decision making. J Clin Pharmacol. 2013;53(2):160-6.
21. Kang Y, Rha SY, Tassone P, Barriuso J, Yu R, Szado T, Garg A, Bang Y.: Pertuzumab pharmacokinetics and safety in combination with trastuzumab and chemotherapy in patients with HER2-positive advanced gastric cancer (AGC). Ann Oncol 24 (suppl 4) 2013 :iv19-iv19. Abstract No.: O-0021.
22. Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomized controlled trial. Lancet. 2010;376:687-97.
23. J. Randolph Hecht, Yung-Jue Bang, Shukui Qin, et al.: Lapatinib in combination with capecitabine plus oxaliplatin (CapeOx) in HER2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma (AC): The TRIO-013/LOGiC Trial. J Clin Oncol 31, 2013 (suppl; abstr LBA4001).
24. Avastin Biological License Application (BLA) (2003) Data on file Genentech, Inc. South San Francisco.
25. R Development Core Team (2008). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, URL http://www.R-project.org.
26. Fasanmade AA, Adedokun OJ, Olson A, Strauss R, Davis HM. Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int J Clin Pharmacol Ther. 2010;48(5):297-308.
27. Kim J, Bronson CL, Hayton WL, Radmacher MD, Roopenian DC, Robinson JM, et al. Albumin turnover: FcRn-mediated recycling saves as much albumin from degradation as the liver produces. Am J Physiol Gastrointest Liver Physiol. 2006;290:G352-60.
28. Kim J, Hayton WL, Robinson JM, Anderson CL. Kinetics of FcRn-mediated recycling of IgG and albumin in human: pathophysiology and therapeutic implications using a simplified mechanism-based model. Clin Immunol. 2007;122:146-55. (Pubitemid 46073892)