'Fit-for-purpose' validation of SearchLight multiplex ELISAs of angiogenesis for clinical trial use

Journal of Immunological Methods

Volumn 342, Issue 1-2, 2009, Pages 106-114

  Backen, A C ^a   Cummings, J ^a   Mitchell, C ^a   Jayson, G ^a   Ward, T H ^a   Dive, C ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

Angiogenesis; Biomarkers; Clinical Trials; ELISA; Multiplex; Validation

Indexed keywords

BASIC FIBROBLAST GROWTH FACTOR; BIOLOGICAL MARKER; FIBROBLAST GROWTH FACTOR; INTERLEUKIN 8; KERATINOCYTE GROWTH FACTOR; PLATELET DERIVED GROWTH FACTOR BB; SCATTER FACTOR; VASCULOTROPIN; VASCULOTROPIN RECEPTOR 1; VASCULOTROPIN RECEPTOR 2;

ACCURACY; ANGIOGENESIS; ARTICLE; BLOOD SAMPLING; CANCER PATIENT; CONTROLLED STUDY; CROSS REACTION; DEVICE; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMAN; OVARY CANCER; PRIORITY JOURNAL; REPRODUCIBILITY; VALIDATION PROCESS;

BIOLOGICAL MARKERS; CROSS REACTIONS; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; NEOVASCULARIZATION, PATHOLOGIC; OVARIAN NEOPLASMS; SENSITIVITY AND SPECIFICITY; SOFTWARE VALIDATION;

EID: 59749098453     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2009.01.003     Document Type: Article

References (59)

1. Artini P.G., Ruggiero M., Monteleone P., Carpi A., Cristello F., Cela V., and Genazzani A.R. Vascular endothelial growth factor and its soluble receptor in benign and malignant ovarian tumors. Biomed. Pharmacother. 62 (2008) 373
2. Bansal S.K., Layloff T., Bush E.D., Hamilton M., Hankinson E.A., Landy J.S., Lowes S., Nasr M.M., St Jean P.A., and Shah V.P. Qualification of analytical instruments for use in the pharmaceutical industry: a scientific approach. AAPS PharmSciTech 5 (2004) E22
3. Barton D.P., Cai A., Wendt K., Young M., Gamero A., and De Cesare S. Angiogenic protein expression in advanced epithelial ovarian cancer. Clin. Cancer Res. 3 (1997) 1579
4. Bhatt, R.S., Seth, P., Sukhatme, V.P., 2007. Biomarkers for monitoring antiangiogenic therapy. Clin. Cancer Res. 13 (2 Pt 2), 777.
5. Cummings J., Ward T.H., Lacasse E., Lefebvre C., St-Jean M., Durkin J., Ranson M., and Dive C. 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 (2005) 532
6. Cummings J., Ranson M., Lacasse E., Ganganagari J.R., St-Jean M., Jayson G., Durkin J., and Dive C. 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 (2006) 42
7. Cummings J., Ward T.H., Greystoke A., Ranson M., and Dive C. Biomarker method validation in anticancer drug development. Br. J. Pharmacol. 153 (2008) 646
8. de Jager W., Prakken B.J., Bijlsma J.W., Kuis W., and Rijkers G.T. Improved multiplex immunoassay performance in human plasma and synovial fluid following removal of interfering heterophilic antibodies. J. Immunol. Methods 300 (2005) 124
9. DeSilva B., Smith W., Weiner R., Kelley M., Smolec J., Lee B., Khan M., Tacey R., Hill H., and Celniker A. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20 (2003) 1885
10. Drevs J., Siegert P., Medinger M., Mross K., Strecker R., Zirrgiebel U., Harder J., Blum H., Robertson J., Jurgensmeier J.M., Puchalski T.A., Young H., Saunders O., and Unger C. Phase I clinical study of AZD2171, an oral vascular endothelial growth factor signaling inhibitor, in patients with advanced solid tumors. J. Clin. Oncol. 25 (2007) 3045
11. Eder J.P., Heath E., Appleman L., Shapiro G., Wang D., Malburg L., Zhu A.X., Leader T., Wolanski A., and LoRusso P. Phase I experience with c-MET inhibitor XL880 administered orally to patients (pts) with solid tumors. Amer Soc Clin Oncol vol. 25 (2007) 3526
12. FDA. Guidance for Industry: Bioanalytical Method Validation (2001)
13. Ferrara N., and Kerbel R.S. Angiogenesis as a therapeutic target. Nature 438 (2005) 967
14. Findlay J.W., Smith W.C., Lee J.W., Nordblom G.D., Das I., DeSilva B.S., Khan M.N., and Bowsher R.R. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 21 (2000) 1249
15. Findley C.M., Mitchell R.G., Duscha B.D., Annex B.H., and Kontos C.D. Plasma levels of soluble Tie2 and vascular endothelial growth factor distinguish critical limb ischemia from intermittent claudication in patients with peripheral arterial disease. J. Am. Coll. Cardiol. 52 (2008) 387
16. Flaherty K.T., Rosen M.A., Heitjan D.F., Gallagher M.L., Schwartz B., Schnall M.D., and O'Dwyer P.J. Pilot study of DCE-MRI to predict progression-free survival with sorafenib therapy in renal cell carcinoma. Cancer Biol. Ther. 7 (2008) 496
17. Folkman J. What is the evidence that tumors are angiogenesis dependent?. J. Natl. Cancer Inst. 82 (1990) 4
18. Fontaine N., and Rosengren B. Directive 2001/20/EC of the European Parliament and of the Council: on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off. J. Eur. Communities L121 (2001) 34
19. Garcia A., Rosen L., Cunningham C.C., Nemunaitis J., Li C., Rulewski N., Dovholuk A., Savage R., Chan T., Bukowksi R., and Mekhail T. Phase 1 study of ARQ 197, a selective inhibitor of the c-Met RTK in patients with metastatic solid tumors reaches recommended phase 2 dose. Amer Soc Clin Oncol vol. 25 (2007) 3525
20. Giantonio B.J., Catalano P.J., Meropol N.J., O'Dwyer P.J., Mitchell E.P., Alberts S.R., Schwartz M.A., and Benson III A.B. 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 (2007) 1539
21. Gonzalez R.M., Seurynck-Servoss S.L., Crowley S.A., Brown M., Omenn G.S., Hayes D.F., and Zangar R.C. Development and validation of sandwich ELISA microarrays with minimal assay interference. J. Proteome Res. 7 (2008) 2406
22. Greystoke A., Cummings J., Ward T., Simpson K., Renehan A., Butt F., Moore D., Gietema J., Blackhall F., Ranson M., Hughes A., and Dive C. Optimisation of circulating biomarkers of cell death for routine clinical use. Ann. Oncol. 19 (2008) 990
23. HMSO. UK Statutory Instrument 1031. The Medicines for Human Use (Clinical Trials) Regulations 2004 (2004)
24. HMSO. UK Statutory Instruments. 2006 No. 1928. The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (2006)
25. Hu Q., Dey A.L., Shen Y.Y.Y., Jilani I.B., Estey E.H., Kantarjian H.M., Giles F.J., and Albitar M. Soluble vascular endothelial growth factor receptor 1, and not receptor 2, is an independent prognostic factor in acute myeloid leukemia and myelodysplastic syndromes. Cancer 100 (2004) 1884
26. Hurwitz H., Fehrenbacher L., Novotny W., Cartwright T., Hainsworth J., Heim W., Berlin J., Baron A., Griffing S., Holmgren E., Fyfe G., Rogers B., Ross R., and Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil and leucovorin for metastatic colorectal cancer. N. Engl. J. Med. 350 (2004) 2335
27. Jayson G.C., Mulatero C., Ranson M., Zweit J., Jackson A., Broughton L., Wagstaff J., Hakansson L., Groenewegen G., Lawrance J., Tang M., Wauk L., Levitt D., Marreaud S., Lehmann F.F., Herold M., and Zwierzina H. Phase I investigation of recombinant anti-human vascular endothelial growth factor antibody in patients with advanced cancer. Eur. J. Cancer 41 (2005) 555
28. Jubb, A.M., Hurwitz, H.I., Bai, W., Holmgren, E.B., Tobin, P., Guerrero, A.S., Kabbinavar, F., Holden, S.N., Novotny, W.F., Frantz, G.D., Hillan, K.J. and Koeppen, H., 2006, Impact of Vascular Endothelial Growth Factor-A Expression, Thrombospondin-2 Expression, and Microvessel Density on the Treatment Effect of Bevacizumab in Metastatic Colorectal Cancer. J. Clin. Oncol. 24, 217.
29. Kavsak P.A., Lee A., Hirte H., Young E., and Gauldie J. Cytokine elevations in acute coronary syndrome and ovarian cancer: a mechanism for the up-regulation of the acute phase proteins in these different disease etiologies. Clin. Biochem. 41 (2008) 607
30. Lash G.E., Scaife P.J., Innes B.A., Otun H.A., Robson S.C., Searle R.F., and Bulmer J.N. Comparison of three multiplex cytokine analysis systems: Luminex, SearchLight and FAST Quant. J. Immunol. Methods 309 (2006) 205
31. Lee J.W., Weiner R.S., Sailstad J.M., Bowsher R.R., Knuth D.W., O'Brien P.J., Fourcroy J.L., Dixit R., Pandite L., Pietrusko R.G., Soares H.D., Quarmby V., Vesterqvist O.L., Potter D.M., Witliff J.L., Fritche H.A., O'Leary T., Perlee L., Kadam S., and Wagner J.A. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm. Res. 22 (2005) 499
32. Lee J.W., Devanarayan V., Barrett Y.C., Weiner R., Allinson J., Fountain S., Keller S., Weinryb I., Green M., Duan L., Rogers J.A., Millham R., O'Brien P.J., Sailstad J., Khan M., Ray C., and Wagner J.A. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23 (2006) 312
33. Lee J.W., Figeys D., and Vasilescu J. Biomarker assay translation from discovery to clinical studies in cancer drug development: quantification of emerging protein biomarkers. Adv. Cancer Res. 96 (2007) 269
34. Lewis N., Eder J.P., Guo F., Pierce K.J., and Olszanski A.J. Phase 1 study of CP-868,596 an oral, highly specific PDGFR inhibitor. Amer Soc Clin Oncol vol. 25 (2007) 3524
35. Liew M., Groll M.C., Thompson J.E., Call S.L., Moser J.E., Hoopes J.D., Voelkerding K., Wittwer C., and Spendlove R.S. Validating a custom multiplex ELISA against individual commercial immunoassays using clinical samples. BioTechniques 42 (2007) 327
36. Ling M.M., Ricks C., and Lea P. Multiplexing molecular diagnostics and immunoassays using emerging microarray technologies. Expert Rev. Mol. Diagn. 7 (2007) 87
37. Liu G., Rugo H.S., Wilding G., McShane T.M., Evelhoch J.L., Ng C., Jackson E., Kelcz F., Yeh B.M., Lee F.T.J., Charnsangavej C., Park J.W., Ashton E.A., Steinfeldt H.M., Pithavala Y.K., Reich S.D., and Herbst R.S. Dynamic contrast-enhanced magnetic resonance imaging as a pharmacodynamic measure of response after acute dosing of AG-013736, an oral angiogenesis inhibitor, in patients with advanced solid tumors: results from a phase I study. J. Clin. Oncol. 23 (2005) 5464
38. Llovet, Ricci, S., Mazzaferro, V., Hilgard, P., Raoul, J., Zeuzem, S., Poulin-Costello, M., Moscovici, M., Voliotis, D., Bruix, J., Group, F.T.S.I.S., 2007. Sorafenib improves survival in advanced hepatocellular carcinoma (HCC): results of a phase III randomized placebo-controlled trial (SHARP trial). ASCO Annual Meeting Proceedings Part I. J. Clin. Oncology, vol. 25, No. 18S LBA1.
39. Miller K.J., Bowsher R.R., Celniker A., Gibbons J., Gupta S., Lee J.W., Swanson S.J., Smith W.C., and Weiner R.S. Workshop on bioanalytical methods validation for macromolecules: summary report. Pharm. Res. 18 (2001) 1373
40. Miller K.D., Wang M., Gralow J., et al. A randomized phase III trial of paclitaxel versus paclitaxel plus bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer: a trial coordinated by the Eastern Cooperative Oncology Group (E2100). Breast Cancer Res. Treat. 94 (2005) S6 abstract 3
41. Moody M.D., Van Arsdell S.W., Murphy K.P., Orencole S.F., and Burns C. Array-based ELISAs for high-throughput analysis of human cytokines. Biotechniques 31 (2001) 186
42. Morgan B., Thomas A.L., Drevs J., Hennig J., Buchert M., Jivan A., Horsfield M.A., Mross K., Ball H.A., Lee L., Mietlowski W., Fuxius S., Unger C., O'Byrne K., Henry A., Cherryman G.R., Laurent D., Dugan M., Marmé D., and P. S.W. Dynamic contrast-enhanced magnetic resonance imaging as a biomarker for the pharmacological response of PTK787/ZK 222584, an inhibitor of the vascular endothelial growth factor receptor tyrosine kinases, in patients with advanced colorectal cancer and liver metastases: results from two phase I studies. J. Clin. Oncol. 21 (2003) 3955
43. Mullamitha S.A., Ton N.C., Parker G.J., Jackson A., Julyan P.J., Roberts C., Buonaccorsi G.A., Watson Y., Davies K., Cheung S., Hope L., Valle J.W., Radford J.A., Lawrance J., Saunders M.P., Munteanu M.C., Nakada M.T., Nemeth J.A., Davis H.M., Jiao Q., Prabhakar U., Lang Z., Corringham R.E., Beckman R.A., and Jayson G.C. Phase I evaluation of a fully human anti-alphav integrin monoclonal antibody (CNTO 95) in patients with advanced solid tumors. Clin. Cancer Res. 13 (2007) 2128
44. Nowatzke W., and Wood E. 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 (2007) E117
45. Rosen L.S., Hong D., Chap L., Kurzrock R., Garcia A., Rasmussen E., Nguyen L., Hwang Y., Storgard C., and Herbst R.S. First-in-human study of AMG 386, a selective angiopoietin1/2-neutralizing peptibody, in adult patients with advanced solid tumors. Amer Soc Clin Oncol vol. 25 (2007) 3522
46. Sandler A., Gray R., Perry M.C., Brahmer J., Schiller J.H., Dowlati A., Lilenbaum R., and Johnson D.H. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N. Engl. J. Med. 355 (2006) 2542
47. Schilder R.J., Sill M.W., Lee R.B., Shaw T.J., Senterman M.K., Klein-Szanto A.J., Miner Z., and Vanderhyden B.C. Phase II evaluation of imatinib mesylate in the treatment of recurrent or persistent epithelial ovarian or primary peritoneal carcinoma: a Gynecologic Oncology Group Study. J. Clin. Oncol. 26 (2008) 3418
48. Shah V.P., Midha K.K., Dighe S., McGilveray I.J., Skelly J.P., Yacobi A., Layloff T., Viswanathan C.T., Cook C.E., McDowall R.D., et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report. Eur. J. Drug Metab. Pharmacokinet 16 (1991) 249
49. Shah V.P., Midha K.K., Findlay J.W., Hill H.M., Hulse J.D., McGilveray I.J., McKay G., Miller K.J., Patnaik R.N., Powell M.L., Tonelli A., Viswanathan C.T., and Yacobi A. Bioanalytical method validation-a revisit with a decade of progress. Pharm. Res. 17 (2000) 1551
50. Sheen-Chen S.M., Liu Y.W., Eng H.L., and Chou F.F. Serum levels of hepatocyte growth factor in patients with breast cancer. Cancer Epidemiol. Biomark. Prev. 14 (2005) 715
51. Smolec J., DeSilva B., Smith W., Weiner R., Kelly M., Lee B., Khan M., Tacey R., Hill H., Celniker A., Shah V., Bowsher R., Mire-Sluis A., Findlay J.W., Saltarelli M., Quarmby V., Lansky D., Dillard R., Ullmann M., Keller S., and Karnes H.T. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm. Res. 22 (2005) 1425
52. Spannuth W.A., Sood A.K., and Coleman R.L. Angiogenesis as a strategic target for ovarian cancer therapy. Nat. Clin. Pract. Oncol. 5 (2008) 194
53. Suzumori N., Sugiura-Ogasawara M., Katano K., and Suzumori K. Women with endometriosis have increased levels of placental growth factor in the peritoneal fluid compared with women with cystadenomas. Hum. Reprod. 18 (2003) 2595
54. Toedter G., Hayden K., Wagner C., and Brodmerkel C. Simultaneous detection of eight analytes in human serum by two commercially available platforms for multiplex cytokine analysis. Clin. Vaccine Immunol. 15 (2008) 42
55. Ton N.C., Parker G.J., Jackson A., Mullamitha S., Buonaccorsi G.A., Roberts C., Watson Y., Davies K., Cheung S., Hope L., Power F., Lawrance J., Valle J., Saunders M., Felix R., Soranson J.A., Rolfe L., Zinkewich-Peotti K., and Jayson G.C. Phase I evaluation of CDP791, a PEGylated di-Fab' conjugate that binds vascular endothelial growth factor receptor 2. Clin. Cancer Res. 13 (2007) 7113
56. Urbanowska T., Mangialaio S., Zickler C., Cheevapruk S., Hasler P., Regenass S., and Legay F. Protein microarray platform for the multiplex analysis of biomarkers in human sera. J. Immunol. Methods 316 (2006) 1
57. Yang J.C., Haworth L., Sherry R.M., Hwu P., Schwartzentruber D.J., Topalian S.L., Steinberg S.M., Chen H.X., and A. R.S. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N. Engl. J. Med. 349 (2003)
58. Yeboah J., Sane D.C., Crouse J.R., Herrington D.M., and Bowden D.W. Low plasma levels of FGF-2 and PDGF-BB are associated with cardiovascular events in type II diabetes mellitus (diabetes heart study). Dis. Markers 23 (2007) 173
59. Zangar R.C., Daly D.S., and White A.M. ELISA microarray technology as a high-throughput system for cancer biomarker validation. Exp. Rev. Proteomics 3 (2006) 37