Evaluation of aflibercept in the treatment of metastatic colorectal cancer

Expert Opinion on Biological Therapy

Volumn 14, Issue 10, 2014, Pages 1493-1505

  Macarulla, Teresa ^a   Sauri, Tamara ^a   Tabernero, Josep ^a  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

Author keywords

Aflibercept; Angiogenesis; Colorectal cancer; VEGF

Indexed keywords

AFLIBERCEPT; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN; VASCULOTROPIN RECEPTOR 2; ANGIOGENESIS INHIBITOR; HYBRID PROTEIN; VASCULOTROPIN A; VASCULOTROPIN RECEPTOR; VEGFA PROTEIN, HUMAN;

ADD ON THERAPY; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER SURVIVAL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG POTENCY; DRUG SAFETY; ELIMINATION HALF-LIFE; EVALUATION STUDY; HUMAN; IN VIVO STUDY; MAXIMUM PLASMA CONCENTRATION; METASTATIC COLORECTAL CANCER; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); SOLID TUMOR; TIME TO MAXIMUM PLASMA CONCENTRATION; TUMOR GROWTH; ANTAGONISTS AND INHIBITORS; COLORECTAL NEOPLASMS; MORTALITY; SURVIVAL RATE; TREATMENT OUTCOME;

ANGIOGENESIS INHIBITORS; COLORECTAL NEOPLASMS; HUMANS; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; RECOMBINANT FUSION PROTEINS; SURVIVAL RATE; TREATMENT OUTCOME; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84907048239     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1517/14712598.2014.947956     Document Type: Article

References (51)

1. Folkman J. Fundamental concepts of the angiogenic process. Curr Mol Med 2003;3:643-51
2. Chung AS, Lee J, Ferrara N. Targeting the tumor vasculature:insights from physiological angiogenesis. Nat Rev Cancer 2010;10:505-14
3. Ferrara N, Alitalo K. Clinical implications of angiog-enesis growth factors and their inhibitors. Nat Med 1999;5:1359-64
4. Folkman J. A ngiogenesis in cancer, vascular, rheumatoid and other disease. Nat Med 1995;1:27-31
5. Holash J, Wiegand SJ, Yancopoulos GD. New model of tumor angiogenesis: dynamic balance between vessel regression and growth mediated by angiopoietins and VEGF. Oncogene 1999;18:5356-62
6. Ellis LM, Hicklin DJ. VEGF targeted therapy: mechanism of anti-tumour therapy. Nat Rev Cancer 2008;8:579-91
7. Baluk P, Hashizume H, McDonald DM. Cellular abnormalities of blood vessels as targets in cancer. Curr Opin Genet Dev 2005;15:102-11
8. Carmeliet P. Angiogenensis in life, disease and medicine. Nature 2005;438:932-6
9. Rosen LS. Clinical experience with angiog-enesis signaling inhibitors: focus on vascular endotelial growth factor (VEGF) blockers. Cancer Contr 2002;9(Suppl 2):36-44
10. Ferrara N. Vascular endotherlial grow th factor as target for anticancer therapy. Oncologist 2004;9(Suppl 1):2-10
11. Yancopoulos GD, Davis S, Gale N, et al. Vascular-specific growth factors and blood vessels formation. Nature 2000;407:242-8
12. Grothey A, Galanis E. Targeting angiogenesis: progress with anti-VEGF treatment with large molecules. Nat Rev Clin Oncol 2009;6:507-18
13. Ficher C, Mazzone M, Jonckx B, et al. FLT1 and its ligands VEGFB and PIGF: drug targets for anti-angiogenic therapy? Nat Rev Cancer 2008;8:942-56
14. Ferrara N. Vascular endotelial growth factor: basic science and clinical progress. Endocr Rev 2000;25:581-611
15. Folkman J. Tumor angiogenesis: therapeutic implications. N Engl J Med 1971;285:1182-6
16. Fukumura D, Ra kesh J, Kaid T, et al. Tumor induction of VEGF promoter activity in stromal cells. Cell 1998;94:715-25
17. Gasparini G, Toi M, Gion M, et al. Prognostic significance of vascular endo thelial growth factor protein in node-negative breast carcinoma. J Natl Cancer Inst 1997;89:139-47
18. Maeda K, Chung YS, Ogawa Y, et al. Prognostic value of vascular endothelial growth factor expression in gastric carcinoma. Cancer 1996;77:853-63
19. Salven P,Ruotsalainen T,Mattson K,Joensuu H, High pre-treatment serum level of vascular endothelial growth factor (VEGF) is associated with poor outcome in small-cell lung cancer, Int J Cancer, 1998, 79, 144-6.
20. Kim K, Li B, Winer J, et al. Inhibition of vascular endothelial growth factor induced angiogenesis suppresses tumour growth in vivo. Nature 1993;362:841-4
21. Prewett M, H uber J, Li Y, et al. Antivascular endothelial growth factor receptor (fetal liver kinase 1) monoclonal antibody inhibits tumor angiogenesis. Cancer Res 1999;59:5209-18
22. Wood JM, Bold G, Bu chdunger E, et al. PTK787/ZK 222584, a novel and potent inhibitor of vascular endothelial growth factor receptor tyrosine kinases, impairs vascular endothelial growth factorinduced responses and tumor growth after oral administration. Cancer Res 2000;60:2178-89
23. Gerber H, Kowalski J, Sherman D, et al. Complete inhibition of rhabdomyosarcoma xenograft growth and neovascularization requires blockade of both tumor and host vascular endoth elial growth factor. Cancer Res 2000;60:6253-8
24. Holash J, Daveis S, Papadopoulos N, et al. VEGF-Trap: a VEGF blocker with potent antitumor effects. Proc Natl Acad Sci USA 2002;99:11393-8
25. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004;350:2335-42
26. Van Cutsem E, Tabernero J, Lakomy R, et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously t reated with oxaliplatin-based regimen. J Clin Oncol 2012;30(28):3499-506
27. Aghajanian C, Blank SV, Goff BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of che motherapy with or without bevacizumab in patients with platinumsensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 2012;30:2039-45
28. Fuchs CS, Marshall J, Mitchell E, et al. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C study. J Clin Oncol 2007;25:477 9-86
29. Scharovsky O, Mainetti E, Rozados V, et al. Genetic heterogeneity of the vasculogenic phenotype parallels angiog-enesis: implications for cellular surrogate marker analysis og antiangiogenesis. Cancer Ce ll 2005;7:101-11
30. Willett C, Boucher Y, di Tomaso E, et al. Direct evidence that the VEGFspecific sntibody bevacizumab has antivascular effects in human rectal cancer. Nat Med 2004;10:145-7
31. Kuo C, Farnebo F, Yu E, et al. Comparative evaluation of the antitumor activity of anti-angiogenic proteins delivered by gene transfer. Proc Natl Acad Sci USA 2001;98:4605-10.
32. Holash J, Maisonpierre P, Compton D, et al. Vessel cooption, regression, and growth in tumors mediated by angiopoietins and VEGF. Science 1999;284:1994-8
33. Huang J, Frischer J, Serur A, et al. Regression of established tumours and metastasis by potent vascular endothelial growth factor blockade. Proc Natl Acad Sci USA 2003;100:7785-90
34. Kim E, Serur A, Huang J, et al. Potent VEGF blockade causes regression of coopted vessels in a model neuroblastoma. Proc Natl Acad Sci USA 2002;99:11399-404
35. Hu L, Hofm ann J, Holash J, et al. Vascular endothelial growth factor trap combined with paclitaxel strikingly inhibits tumor and ascitis, prolonging survival in ovarian cancer model. Cancer Res 2005;11(19):6966-71
36. Wachsberger PR, Burd R, Cardi C, et al. VEGF Trap in combination with radiotherapyimproves control in U87 Glioblastoma. Int J Radiat Oncol Biol Phys 2007;67(5):1526-37
37. Dupo nt S, Joseph ML, Rothenberg et al. Safety and pharmacokynetics of intravenous VEGFR trap in a phase I clinical trial of patients with advanced solid tumors [abstract]. Proc Am Soc Clin Oncol 2005;24
38. Loc kart A, Rothenberg M, Dupont J, et al. Phase I study of intravenous vascular endotelial growth factor trap, aflibercept, in patients with advanced solid tumours. J Clin Oncol 2010;28:207-14
39. Tew WP, Gordon M, Murren J, et al. Phase I study of aflibercept administered subcutaneously to patients with advanced solid tumours. Clin Cancer Res 2010;16:358-66
40. Van Cutsem E,Khayat D ,Verslype C,et al, Phase I dose-escalation study of intravenous aflibercept administered in combination with irinotecan, 5-fluorouracil and leucovorin in patients with advanced solit tumours, Eur J Cancer 2013, 49, 1, 17 -24.
41. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin 2012;62(1):10-29
42. American Cancer Society. Cancer facts and figures 2012. American Cancer Society, Atlanta; 2012. Available from: http://www.cancer. org/Research/CancerFacts figures/index
43. Song X, Zhao Z, Barber B, et al. Characterizing medical care by disease phase in metastatic colorectal cancer. J Oncol Pract 2011;7:25S-30S
44. Goldberg RM, Sargent DJ, Morton RF, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in pat ients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004;22:23-30
45. Saltz L, Cox J, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer: irinotecan Study Group. N Engl J Med 2000;343:905-14
46. Tournigand C, Andre T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a ran domized GERCOR study. J Clin Oncol 2004;22:229-37
47. Cunningham D, Humblet Y, Siena S, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecanrefractory metastatic colorectal ca ncer. N Engl J Med 2004;351:337-45
48. Van Cutsem E, Ko€hne CH, Lang I, et al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatm ent for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol 2011;29:2011-19
49. Douillard I, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME Study. J Cli n Oncol 2010;28:4697
50. Giantonio BJ, Catalano PJ, Meropol NJ, et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previoulsy treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007;25:1539-44
51. Van Cutsem E, Raymond D, Lakomy R, et al. Aflibercept/FOLFIRI vs placebo/FOLFIRI in meta static colorectal cancer: post-hoc analysis of survival by prior bevacizumab use subsequent to exclusion of patients who had recurrence during or within 6 months of completing adjuvant oxaliplatin-based therapy [Abstract 2260]. Presented at: European Cancer Congress 2013; 27 September-1 October 2013; Amsterdam, The Netherlands