Issues on fit-for-purpose validation of a panel of ELISAs for application as biomarkers in clinical trials of anti-Angiogenic drugs

British Journal of Cancer

Volumn 102, Issue 10, 2010, Pages 1524-1532

  Brookes, K ^a   Cummings, J ^a   Backen, A ^a   Greystoke, A ^a   Ward, T ^a   Jayson, G C ^a   Dive, C ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

Angiogenesis; Biomarkers; ELISA; Method validation; Platelets; Stability

Indexed keywords

ANGIOGENESIS INHIBITOR; ANGIOPOIETIN RECEPTOR; BIOLOGICAL MARKER; ENDOGLIN; INTERLEUKIN 8; OSTEOPONTIN; PLATELET DERIVED GROWTH FACTOR BB; RECOMBINANT PROTEIN; STROMAL CELL DERIVED FACTOR 1ALPHA; VASCULOTROPIN A; VASCULOTROPIN C; VASCULOTROPIN D; VASCULOTROPIN RECEPTOR 1; VASCULOTROPIN RECEPTOR 2;

ANGIOGENESIS; ARTICLE; CANCER PATIENT; CENTRIFUGATION; COLORECTAL CANCER; DISEASE MARKER; ENZYME LINKED IMMUNOSORBENT ASSAY; FREEZING; HUMAN; PRIORITY JOURNAL; THROMBOCYTE; THROMBOCYTE RICH PLASMA; VALIDATION STUDY;

ANGIOGENESIS INHIBITORS; CLINICAL TRIALS AS TOPIC; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; NEOPLASMS; PROTEIN STABILITY; QUALITY CONTROL; REAGENT KITS, DIAGNOSTIC; SPECIMEN HANDLING; TUMOR MARKERS, BIOLOGICAL; VALIDATION STUDIES AS TOPIC;

EID: 77952242853     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6605661     Document Type: Article

References (48)

1. Aziz N, Nishanian P, Mitsuyasu R, Detels R, Fahey JL (1999) Variables that affect assays for plasma cytokines and soluble activation markers. Clin Diagn Lab Immunol 6: 89-95
2. Backen AC, Cummings J, Mitchell C, Jayson G, Ward TH, Dive C (2009) Fit-for-purpose' validation of SearchLight multiplex ELISAs of angiogenesis for clinical trial use. J Immunol Methods 342: 106-114
3. Bast Jr RC, Lilja H, Urban N, Rimm DL, Fritsche H, Gray J, Veltri R, Klee G, Allen A, Kim N, Gutman S, Rubin MA, Hruszkewycz A (2005) Translational crossroads for biomarkers. Clin Cancer Res 11: 6103-6108
4. Bergers G, Benjamin LE (2003) Tumorigenesis and the angiogenic switch. Nat Rev Cancer 3: 401-410
5. Brill A, Elinav H, Varon D (2004) Differential role of platelet granular mediators in angiogenesis. Cardiovasc Res 63: 226-235
6. Chowdhury F, Williams A, Johnson P (2009) Validation and comparison of two multiplex technologies, Luminex and Mesoscale Discovery, for human cytokine profiling. J Immunol Methods 340: 55-64
7. Cummings J, Ranson M, Butt F, Moore D, Dive C (2007) Qualification of M30 and M65 ELISAs as surrogate biomarkers of cell death: long term antigen stability in cancer patient plasma. Cancer Chemother Pharmacol 60: 921-924
8. Cummings J, Ranson M, Lacasse E, Ganganagari JR, St-Jean M, Jayson G, Durkin J, Dive C (2006) Method validation and preliminary qualification of pharmacodynamic biomarkers employed to evaluate the clinical efficacy of an antisense compound (AEG35156) targeted to the X-linked inhibitor of apoptosis protein XIAP. Br J Cancer 95: 42-48
9. Cummings J, Ward TH, Greystoke A, Ranson M, Dive C (2008) Biomarker method validation in anticancer drug development. Br J Pharmacol 153: 646-656
10. Cummings J, Ward TH, Lacasse E, Lefebvre C, St-Jean M, Durkin J, Ranson M, Dive C (2005) Validation of pharmacodynamic assays to evaluate the clinical efficacy of an antisense compound (AEG 35156) targeted to the X-linked inhibitor of apoptosis protein XIAP. Br J Cancer 92: 532-538
11. Deligezer U, Erten N, Akisik EE, Dalay N (2006) Circulating fragmented nucleosomal DNA and caspase-3 mRNA in patients with lymphoma and myeloma. Exp Mol Pathol 80: 72-76
12. DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, Khan M, Tacey R, Hill H, Celniker A (2003) Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res 20: 1885-1900
13. Findlay JW (2009) Some important considerations for validation of ligand-binding assays. J Chromatogr B Analyt Technol Biomed Life Sci 877: 2191-2197
14. Findlay JW, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, Khan MN, Bowsher RR (2000) Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal 21: 1249-1273
15. Folkman J (1971) Tumor angiogenesis: therapeutic implications. N Engl J Med 285: 1182-1186
16. Folkman J (1990) What is the evidence that tumors are angiogenesis dependent? J Natl Cancer Inst 82: 4-6
17. Hanrahan EO, Lin HY, Kim ES, Yan S, Du DZ, McKee KS, Tran HT, Lee JJ, Ryan AJ, Langmuir P, Johnson BE, Heymach JV (2009) Distinct patterns of cytokine and angiogenic factor modulation and markers of benefit for vandetanib and/or chemotherapy in patients with non-small-cell lung cancer. J Clin Oncol 28(2): 193-201
18. Heath VL, Bicknell R (2009) Anticancer strategies involving the vasculature. Nat Rev Clin Oncol 6: 395-404
19. Hsu E, Osslund T, Nybo R, Chen BL, Kenney WC, Morris CF, Arakawa T, Narhi LO (2006) Enhanced stability of recombinant keratinocyte growth factor by mutagenesis. Protein Eng Des Sel 19: 147-153
20. Jain RK, Duda DG, Willett CG, Sahani DV, Zhu AX, Loeffler JS, Batchelor TT, Sorensen AG (2009) Biomarkers of response and resistance to antiangiogenic therapy. Nat Rev Clin Oncol 6: 327-338
21. James CA, Hill HM (2007) Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices and regulated clinical studies. AAPS J 9: E123-E127
22. Kerbel R, Folkman J (2002) Clinical translation of angiogenesis inhibitors. Nat Rev Cancer 2: 727-739
23. Klement GL, Yip TT, Cassiola F, Kikuchi L, Cervi D, Podust V, Italiano JE, Wheatley E, Abou-Slaybi A, Bender E, Almog N, Kieran MW, Folkman J (2009) Platelets actively sequester angiogenesis regulators. Blood 113: 2835-2842
24. Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O'Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA (2006) Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 23: 312-328
25. Lee JW, Weiner RS, Sailstad JM, Bowsher RR, Knuth DW, O'Brien PJ, Fourcroy JL, Dixit R, Pandite L, Pietrusko RG, Soares HD, Quarmby V, Vesterqvist OL, Potter DM, Witliff JL, Fritche HA, O'Leary T, Perlee L, Kadam S, Wagner JA (2005) Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm Res 22: 499-511
26. Ling MM, Ricks C, Lea P (2007) Multiplexing molecular diagnostics and immunoassays using emerging microarray technologies. Expert Rev Mol Diagn 7: 87-98
27. Mahler HC, Friess W, Grauschopf U, Kiese S (2009) Protein aggregation: pathways, induction factors and analysis. J Pharm Sci 98: 2909-2934
28. Maity H, Karkaria C, Davagnino J (2009) Effects of pH and arginine on the solubility and stability of a therapeutic protein (fibroblast growth factor 20): relationship between solubility and stability. Curr Pharm Biotechnol 10: 609-625
29. Maruvada P, Srivastava S (2006) Joint National Cancer Institute-Food and Drug Administration workshop on research strategies, study designs, and statistical approaches to biomarker validation for cancer diagnosis and detection. Cancer Epidemiol Biomarkers Prev 15: 1078-1082
30. Nash GF, Turner LF, Scully MF, Kakkar AK (2002) Platelets and cancer. Lancet Oncol 3: 425-430
31. Nayeri F, Brudin L, Nilsson I, Forsberg P (2002) Sample handling and stability of hepatocyte growth factor in blood samples. Cytokine 19: 201-205
32. Nowatzke W, Wood E (2007) Best practices during bioanalytical method validation for the characterisation of assay reagents and the evaluation of analyte stability in assay standards, quality controls and study samples. AAPS J 9: E117-E122
33. O'Connor JP, Carano RA, Clamp AR, Ross J, Ho CC, Jackson A, Parker GJ, Rose CJ, Peale FV, Friesenhahn M, Mitchell CL, Watson Y, Roberts C, Hope L, Cheung S, Reslan HB, Go MA, Pacheco GJ, Wu X, Cao TC, Ross S, Buonaccorsi GA, Davies K, Hasan J, Thornton P, del Puerto O, Ferrara N, van Bruggen N, Jayson GC (2009) Quantifying antivascular effects of monoclonal antibodies to vascular endothelial growth factor: insights from imaging. Clin Cancer Res 15: 6674-6682
34. Ostman A, Andersson M, Backstrom G, Heldin CH (1993) Assignment of intrachain disulfide bonds in platelet-derived growth factor B-chain. J Biol Chem 268: 13372-13377
35. Pepe MS, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M, Winget M, Yasui Y (2001) Phases of biomarker development for early detection of cancer. J Natl Cancer Inst 93: 1054-1061
36. Sessa C, Guibal A, Del Conte G, Ruegg C (2008) Biomarkers of angiogenesis for the development of antiangiogenic therapies in oncology: tools or decorations? Nat Clin Pract Oncol 5: 378-391
37. Shah VP (2007) The history of bioanalytical method validation and regulation: evloution of a guidance document on bioanalytical methods valdiation. AAPS J 9: E43-E47
38. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD (1991) Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report. Eur J Drug Metab Pharmacokinet 16: 249-255
39. Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A (2000) Bioanalytical method validation-a revisit with a decade of progress. Pharm Res 17: 1551-1557
40. Solanilla A, Villeneuve J, Auguste P, Hugues M, Alioum A, Lepreux S, Ducroix JP, Duhaut P, Conri C, Viallard JF, Nurden AT, Constans J, Ripoche J (2009) The transport of high amounts of vascular endothelial growth factor by blood platelets underlines their potential contribution in systemic sclerosis angiogenesis. Rheumatology (Oxford) 48: 1036-1044
41. Toedter G, Hayden K, Wagner C, Brodmerkel C (2008) Simultaneous detection of eight analytes in human serum by two commercially available platforms for multiplex cytokine analysis. Clin Vaccine Immunol 15: 42-48
42. Treiber G, Wex T, Malfertheiner P (2009) Impact of different anticancer regimens on biomarkers of angiogenesis in patients with advanced hepatocellular cancer. J Cancer Res Clin Oncol 135: 271-281
43. Twardowski PW, Smith-Powell L, Carroll M, VanBalgooy J, Ruel C, Frankel P, Synold TW (2008) Biologic markers of angiogenesis: circulating endothelial cells in patients with advanced malignancies treated on phase I protocol with metronomic chemotherapy and celecoxib. Cancer Invest 26: 53-59
44. Urbanowska T, Mangialaio S, Zickler C, Cheevapruk S, Hasler P, Regenass S, Legay F (2006) Protein microarray platform for the multiplex analysis of biomarkers in human sera. J Immunol Methods 316: 1-7
45. Wagner JA, Williams SA, Webster CJ (2007) Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin Pharmacol Ther 81: 104-107
46. Westgard JO, Quam EF, Barry PL (1994) Establishing and evaluating QC acceptability criteria. MLO Med Lab Obs 26: 22-26
47. Wu FT, Stefanini MO, Mac Gabhann F, Popel AS (2009) A compartment model of VEGF distribution in humans in the presence of soluble VEGF receptor-1 acting as a ligand trap. PLoS One 4: e5108
48. Zakrzewska M, Wiedlocha A, Szlachcic A, Krowarsch D, Otlewski J, Olsnes S (2009) Increased protein stability of FGF1 can compensate for its reduced affinity for heparin. J Biol Chem 284: 25388-25403