Surrogate biomarkers in evaluating response to anti-angiogenic agents: Focus on sunitinib

Annals of Oncology

Volumn 18, Issue SUPPL. 10, 2007, Pages

  Deprimo, Sam E ^a   Bello, C ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Anti angiogenesis; Biomarkers; Sunitinib; Surrogate; VEGF

Indexed keywords

ALPHA INTERFERON; ANGIOGENESIS INHIBITOR; AXITINIB; BASIC FIBROBLAST GROWTH FACTOR; BAY 57 9352; BEVACIZUMAB; BIOLOGICAL MARKER; CARBOPLATIN; CEDIRANIB; CYTOTOXIC AGENT; DOCETAXEL; FLUOROURACIL; FOLINIC ACID; GADOLINIUM PENTETATE; GEMCITABINE; IMATINIB; INTERLEUKIN 8; IRINOTECAN; PACLITAXEL; PLACEBO; PLACENTAL GROWTH FACTOR; PLATELET DERIVED GROWTH FACTOR; SCATTER FACTOR; SUNITINIB; UNCLASSIFIED DRUG; VASCULOTROPIN; VATALANIB; INDOLE DERIVATIVE; PYRROLE DERIVATIVE; TUMOR MARKER;

ADVANCED CANCER; BREAST CANCER; CLINICAL TRIAL; COLORECTAL CANCER; COMPUTER ASSISTED TOMOGRAPHY; CONFERENCE PAPER; CONTRAST ENHANCEMENT; DISEASE FREE SURVIVAL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG RESPONSE; ENDOTHELIUM CELL; GASTROINTESTINAL STROMAL TUMOR; GLIOBLASTOMA; HUMAN; KIDNEY CARCINOMA; LUNG NON SMALL CELL CANCER; MICROBUBBLE; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NEUROENDOCRINE TUMOR; NONHUMAN; NUCLEAR MAGNETIC RESONANCE IMAGING; OVERALL SURVIVAL; PANCREAS CANCER; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROGNOSIS; PROTEIN BLOOD LEVEL; PROTEIN URINE LEVEL; TUMOR VASCULARIZATION; DRUG EFFECT; METABOLISM; NEOPLASM; NEOVASCULARIZATION (PATHOLOGY); PATHOLOGY; REVIEW; VASCULARIZATION;

ANGIOGENESIS INHIBITORS; ENDOTHELIAL CELLS; HUMANS; INDOLES; NEOPLASMS; NEOVASCULARIZATION, PATHOLOGIC; PYRROLES; TUMOR MARKERS, BIOLOGICAL;

EID: 45949086825     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdm409     Document Type: Conference Paper

References (48)

1. Fleming TR, DeMets DL. Surrogate end points in clinical trials: Are we being misled? Ann Intern Med 1996; 125: 605-613.
2. Carmeliet P, Jain RK. Angiogenesis in cancer and other diseases. Nature 2000; 407: 249-257.
3. Hicklin DJ, Ellis LM. Role of the vascular endothelial growth factor pathway in tumor growth and angiogenesis. J Clin Oncol 2005; 23: 1011-1027.
4. Brower V. Evidence of efficacy: Researchers investigating markers for angiogenesis inhibitors. J Natl Cancer Inst 2003; 95: 1425-1427.
5. Jubb AM, Oates AJ, Holden S et al. Predicting benefit from anti-angiogenic agents in malignancy. Nat Rev Cancer 2006; 6: 626-635.
6. Mass RD, Sarkar S, Holden S et al. Clinical benefit from bevacizumab in responding and non-responding patients with metastatic colorectal cancer. J Clin Oncol 2005; 23: 3514.
7. Willett CG, Boucher Y, Duda DG et al. Surrogate markers for antiangiogenic therapy and dose-limiting toxicities for bevacizumab with radiation and chemotherapy: Continued experience of a phase I trial in rectal cancer patients. J Clin Oncol 2005; 23: 8136-8139.
8. Park JW, Kerbel RS, Kelloff GJ et al. Rationale for biomarkers and surrogate end points in mechanism-driven oncology drug development. Clin Cancer Res 2004; 10: 3885-3896.
9. Bocci G, Man S, Green SK et al. Increased plasma vascular endothelial growth factor (VEGF) as a surrogate marker for optimal therapeutic dosing of VEGF receptor-2 monoclonal antibodies. Cancer Res 2004; 64: 6616-6625.
10. Drevs J. Soluble markers for the detection of hypoxia under antiangiogenic treatment. Anticancer Res 2003; 23: 1159-1161.
11. Blann AD, Woywodt A, Bertolini F et al. Circulating endothelial cells: biomarker of vascular disease. Thromb Haemost 2005; 93: 228-235.
12. Shaked Y, Bertolini F, Man S et al. Genetic heterogeneity of the vasculogenic phenotype parallels angiogenesis: Implications for cellular surrogate marker analysis of antiangiogenesis. Cancer Cell 2005; 7: 101-111.
13. Furstenberger G, von MR, Lucas R et al. Circulating endothelial cells and angiogenic serum factors during neoadjuvant chemotherapy of primary breast cancer. Br J Cancer 2006; 94: 524-531.
14. Shaked Y, Ciarrocchi A, Franco M et al. Therapy-induced acute recruitment of circulating endothelial progenitor cells to tumors. Science 2006; 313: 1785-1787.
15. Bertolini F, Shaked Y, Mancuso P et al. The multifaceted circulating endothelial cell in cancer: Towards marker and target identification. Nat Rev Cancer 2006; 6: 835-845.
16. Collins JM. Imaging and other biomarkers in early clinical studies: One step at a time or re-engineering drug development? J Clin Oncol 2005; 23: 5417-5419.
17. Morgan B, Thomas AL, Drevs J et al. 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 2003; 21: 3955-3964.
18. Miller JC, Pien HH, Sahani D et al. Imaging angiogenesis: Applications and potential for drug development. J Natl Cancer Inst 2005; 97: 172-187.
19. Liu G, Rugo HS, Wilding G et al. 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 2005; 23: 5464-73.
20. Scott AM, Mitchell P, O'Keefe G et al. Tumor perfusion as assessed by (oxygen-15)-water PET imaging during treatment with sunitinib malate (SU11248) in patients with advanced malignancies. Presented at the International Conference on Molecular Targets and Cancer Therapeutics. Philadelphia, PA, USA November 2005.
21. Korpanty G, Grayburn PA, Shohet RV et al. Targeting vascular endothelium with avidin microbubbles. Ultrasound Med Biol 2005; 31: 1279-1283.
22. Korpanty G, Carbon JG, Grayburn PA et al. Monitoring response to anticancer therapy by targeting microbubbles to tumor vasculature. Clin Cancer Res 2007; 13: 323-330.
23. Bertolotto M, Pozzato G, Croce LS et al. Blood flow changes in hepatocellular carcinoma after the administration of thalidomide assessed by reperfusion kinetics during microbubble infusion: preliminary results. Invest Radiol 2006; 41: 15-21.
24. Wedam SB, Low JA, Yang SX et al. Antiangiogenic and antitumor effects of bevacizumab in patients with inflammatory and locally advanced breast cancer. J Clin Oncol 2006; 24: 769-777.
25. Christensen O, Zuehlsdorf M, Strumberg D et al. Measurement of VEGF, sVEGFR-2, and DCE-MRI in a Phase I Study with BAY 57-9352, a VEGFR inhibitor. Eur J Clin Pharmacol 2005; 61: 704.
26. Motzer RJ, Hutson TE, Tomczak P et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007; 356: 115-124.
27. Motzer RJ, Michaelson MD, Redman BG et al. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol 2006; 24: 16-24.
28. Miller KD, Burstein HJ, Elias AD et al. Phase II study of SU11248, a multitargeted tyrosine kinase inhibitor (TKI) in patients (pts) with previously treated metastatic breast cancer (MBC). Breast Cancer Res Treat 2005: 94.
29. DePrimo SE, Friece C, Huang X et al. Effect of treatment with sunitinib malate, a multitargeted tyrosine kinase inhibitor, on circulating plasma levels of VEGF, soluble VEGF receptors 2 and 3 and soluble KIT in patients with metastatic breast cancer. Presented at the American Society of Clinical Oncology 42nd Annual Meeting, Atlanta, GA, USA, 2-6 June 2006.
30. Ramaswamy B, Elias AD, Kelbick NT et al. Phase II trial of bevacizumab in combination with weekly docetaxel in metastatic breast cancer patients. Clin Cancer Res 2006; 12: 3124-3129.
31. Hillan KJ, Koeppen HKW, Tobin P et al. The role of VEGF expression in response to bevacizumab plus capecitabine in metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2003: 22.
32. Bischoff J. Cell adhesion and angiogenesis. J Clin Invest 1997; 100: S37-S39.
33. Moss MA, Zimmer S, Anderson KW. Role of metastatic potential in the adhesion of human breast cancer cells to endothelial monolayers. Anticancer Res 2000; 20: 1425-1433.
34. Kulke M, Lenz H, Meropol N et al. Results of a phase II study with sunitinib malate (SU11248) in patients (pts) with advanced neuroendocrine tumours (NETS). Eur J Cancer 2005; (Suppl 3) 2: 204.
35. Bello CL, DePrimo SE, Friece C et al. Analysis of circulating biomarkers of sunitinib malate in patients with unresectable neuroendocrine tumors (NET): VEGF, IL-8, and soluble VEGF receptors 2 and 3. Presented at the American Society of Clinical Oncology 42nd Annual Meeting, Atlanta, GA, USA, 2-6 June 2006.
36. Norden-Zfoni A, Desai J, Manola J et al. Blood-based biomarkers of SU11248 activity and clinical outcome in patients with metastatic imatinib-resistant gastrointestinal stromal tumor. Clin Cancer Res 2007; 13: 2643-2650.
37. DePrimo SE, Manning WC, O'Farrell A et al. Decreases in circulating levels of soluble KIT in patients with imatinib-resistant GIST receiving inhibitor SU11248: Correlative analysis of blood and plasma biomarkers. Proc Am Assoc Cancer Res 2003; 44: 678-679.
38. Manning WC, Bello CL, DePrimo SE et al. Pharmacokinetic and pharmacodynamic evaluation of SU11248 in a phase I clinical trial of patients (pts) with imatinib-resistant gastrointestinal stromal tumor (GIST). Proc Am Soc Clin Oncol 2003: 22: (Abstr 768).
39. Davis DW, McConkey DJ, Heymach JV et al. Pharmacodynamic analysis of target receptor tyrosine kinase activity and apoptosis in GIST tumors responding to therapy with SU11248. J Clin Oncol 2005; 23: 16s (Abstr 3006).
40. Jain RK. Normalization of tumor vasculature: An emerging concept in antiangiogenic therapy. Science 2005; 307: 58-62.
41. Drevs J, Zirrgiebel U, Schmidt-Gersbach CI et al. Soluble markers for the assessment of biological activity with PTK787/ZK 222584 (PTK/ZK), a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor in patients with advanced colorectal cancer from two phase I trials. Ann Oncol 2005; 16: 558-565.
42. Jubb AM, Hurwitz HI, Bai W et al. 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 2006; 24: 217-227.
43. Kindler HL, Friberg G, Singh DA et al. Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol 2005; 23: 8033-8040.
44. Dowlati A, Gray R, Johnson DH et al. Prospective correlative assessment of biomarkers in E4599 randomized phase II/III trial of carboplatin and paclitaxel ± bevacizumab in advanced non-small cell lung cancer (NSCLC). J Clin Oncol 2006; 24: 18s (Abstr 7027).
45. Batchelor TT, Sorensen AG, di TE et al. AZD2171, a pan-VEGF receptor tyrosine kinase inhibitor, normalizes tumor vasculature and alleviates edema in glioblastoma patients. Cancer Cell 2007; 11: 83-95.
46. Duda DG, Cohen KS, di TE et al. Differential CD146 expression on circulating versus tissue endothelial cells in rectal cancer patients: implications for circulating endothelial and progenitor cells as biomarkers for antiangiogenic therapy. J Clin Oncol 2006; 24: 1449-1453.
47. Bergers G, Song S, Meyer-Morse N et al. Benefits of targeting both pericytes and endothelial cells in the tumor vasculature with kinase inhibitors. J Clin Invest 2003; 111: 1287-1295.
48. Joyce JA, Laakkonen P, Bernasconi M et al. Stage-specific vascular markers revealed by phage display in a mouse model of pancreatic islet tumorigenesis. Cancer Cell 2003; 4: 393-403.