Bevacizumab and breast cancer: Current therapeutic progress and future perspectives

Expert Review of Anticancer Therapy

Volumn 9, Issue 12, 2009, Pages 1715-1725

  Yang, Sherry X ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

Author keywords

Bevacizumab; Breast cancer; Chemotherapy; Clinical trials; First line therapy; VEGF

Indexed keywords

ANTHRACYCLINE; BEVACIZUMAB; BIOLOGICAL MARKER; CAPECITABINE; CARBOPLATIN; CISPLATIN; DOCETAXEL; DOXORUBICIN; ENDOTHELIAL LEUKOCYTE ADHESION MOLECULE 1; EPIRUBICIN; EVEROLIMUS; FLUOROURACIL; FOLINIC ACID; INTERCELLULAR ADHESION MOLECULE 1; INTERFERON; IRINOTECAN; IXABEPILONE; LAPATINIB; LETROZOLE; OXALIPLATIN; PACLITAXEL; PLACEBO; TAMOXIFEN; TAXANE DERIVATIVE; TRASTUZUMAB; VASCULAR CELL ADHESION MOLECULE 1; VASCULOTROPIN A;

ADVANCED CANCER; ARTERY THROMBOSIS; BLEEDING; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER STAGING; CARDIOMYOPATHY; CARDIOTOXICITY; CLINICAL TRIAL; COLORECTAL CANCER; CONGESTIVE HEART FAILURE; DIET THERAPY; DIGESTIVE SYSTEM PERFORATION; DISEASE FREE SURVIVAL; DRUG APPROVAL; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG PROTEIN BINDING; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; EARLY CANCER; FATIGUE; FEBRILE NEUTROPENIA; GLIOBLASTOMA; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERTENSION; KIDNEY CARCINOMA; LOW DRUG DOSE; LUNG NON SMALL CELL CANCER; MULTIPLE CYCLE TREATMENT; NAUSEA; NAUSEA AND VOMITING; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHARMACOGENOMICS; PROTEIN ANALYSIS; PROTEIN FUNCTION; PROTEINURIA; REVIEW; SIDE EFFECT; THROMBOEMBOLISM; THROMBOSIS; WOUND HEALING IMPAIRMENT;

ANGIOGENESIS INHIBITORS; ANIMALS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS AS TOPIC; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; NEOVASCULARIZATION, PATHOLOGIC; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 73349123799     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/ERA.09.153     Document Type: Review

References (72)

1. Folkman J. Tumor angiogenesis: therapeutic implications. N. Engl. J. Med. 285(21), 1182-1186 (1971).
2. Kaelin WG Jr. The von Hippel - Lindau protein, HIF hydroxylation, and oxygen sensing. Biochem. Biophys. Res. Commun. 338(1), 627-638 (2005).
3. Ruohola JK, Valve EM, Karkkainen MJ et al. Vascular endothelial growth factors are differentially regulated by steroid hormones and antiestrogens in breast cancer cells. Mol. Cell. Endocrinol. 149(1-2), 29-40 (1999).
4. Mueller MD, Vigne JL, Minchenko A et al. Regulation of vascular endothelial growth factor (VEGF) gene transcription by estrogen receptors a and b. Proc. Natl Acad. Sci. USA 97(20), 10972-10977 (2000).
5. Klos KS, Wyszomierski SL, Sun M et al. ErbB2 increases vascular endothelial growth factor protein synthesis via activation of mammalian target of rapamycin/p70S6K leading to increased angiogenesis and spontaneous metastasis of human breast cancer cells. Cancer Res. 66(4), 2028-2037 (2006).
6. Senger DR, Galli SJ, Dvorak AM et al. Tumor cells secrete a vascular permeability factor that promotes accumulation of ascites fluid. Science 219(4587), 983-985 (1983).
7. Ferrara N, Chen H, Davis-Smyth T et al. Vascular endothelial growth factor is essential for corpus luteum angiogenesis. Nat. Med. 4(3), 336-340 (1998).
8. Bloch W, Huggel K, Sasaki T et al. The angiogenesis inhibitor endostatin impairs blood vessel maturation during wound healing. FASEB J. 14(15), 2373-2376 (2000).
9. Park JE, Keller GA, Ferrara N. The vascular endothelial growth factor (VEGF) isoforms: differential deposition into the subepithelial extracellular matrix and bioactivity of extracellular matrix-bound VEGF. Mol. Biol. Cell 4(12), 1317-1326 (1993).
10. Houck KA, Ferrara N, Winer J et al. The vascular endothelial growth factor family: identification of a fourth molecular species and characterization of alternative splicing of RNA. Mol. Endocrinol. 5(12), 1806-1814 (1991).
11. Ferrara N. Vascular endothelial growth factor as a target for anticancer therapy. Oncologist 9(Suppl.), 12-10 (2004). Comprehensive review of VEGF as a target for anticancer therapy.
12. de Vries C, Escobedo JA, Ueno H et al. The fms-like tyrosine kinase, a receptor for vascular endothelial growth factor. Science 255(5047), 989-991 (1992).
13. Lohela M, Bry M, Tammela T Alitalo K. VEGFs and receptors involved in angiogenesis versus lymphangiogenesis. Curr. Opin. Cell. Biol. 21(2), 154-165 (2009).
14. Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nat. Med. 9(6), 669-676 (2003). Comprehensive review of VEGF biology and its receptors.
15. Folkman J. Antiangiogenesis agents. In: Cancer Principles and Practice of Oncology (7th Edition). DeVita VT, Helmann S, Rosenberg SA (Eds). Lippincott Williams and Wilkins, PA, USA 2865-2882 (2005).
16. Jubb AM, Pham TQ, Hanby AM et al. Expression of vascular endothelial growth factor, hypoxia inducible factor 1a, and carbonic anhydrase IX in human tumours. J. Clin. Pathol. 57(5), 504-512 (2004).
17. Toi M, Inada K, Hoshina S et al. Vascular endothelial growth factor and plateletderived endothelial cell growth factor are frequently coexpressed in highly vascularized human breast cancer. Clin. Cancer Res. 1(9), 961-964 (1995).
18. Foekens JA, Peters HA, Grebenchtchikov N et al. High tumor levels of vascular endothelial growth factor predict poor response to systemic therapy in advanced breast cancer. Cancer Res. 61(14), 5407-5414 (2001).
19. Gasparini G, Toi M, Gion M et al. Prognostic significance of vascular endothelial growth factor protein in node-negative breast carcinoma. J. Natl Cancer Inst. 89(2), 139-147 (1997).
20. Linderholm B, Grankvist K, Wilking N et al. Correlation of vascular endothelial growth factor content with recurrences, survival, and first relapse site in primary node-positive breast carcinoma after adjuvant treatment. J. Clin. Oncol. 18(7), 1423-1431 (2000).
21. Gasparini G, Toi M, Miceli R et al. Clinical relevance of vascular endothelial growth factor and thymidine phosphorylase in patients with node-positive breast cancer treated with either adjuvant chemotherapy or hormone therapy. Cancer J. Sci. Am. 5(2), 101-111 (1999).
22. Hu Z, Fan C, Livasy C et al. A compact VEGF signature associated with distant metastases and poor outcomes. BMC Med. 79 (2009).
23. Ferrara N, Hillan KJ, Gerber HP, Novotny W. Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer. Nat. Rev. Drug Discov. 3(5), 391-400 (2004). Comprehensive review on the discovery and development of bevacizumab.
24. Presta LG, Chen H, O'Connor SJ et al. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res. 57(20), 4593-4599 (1997).
25. Willett CG, Boucher Y, di Tomaso E et al. Direct evidence that the VEGF-specific antibody bevacizumab has antivascular effects in human rectal cancer. Nat. Med. 10(2), 145-147 (2004).
26. Mancuso MR, Davis R, Norberg SM et al. Rapid vascular regrowth in tumors after reversal of VEGF inhibition. J. Clin. Invest. 116(10), 2610-2621 (2006).
27. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N. Engl. J. Med. 350(23), 2335-2342 (2004). First Phase III clinical trial of an antiangiogenic agent in metastatic colorectal cancer.
28. Giantonio BJ, Catalano PJ, Meropol NJ et al. 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(12), 1539-1544 (2007).
29. Sandler A, Gray R, Perry MC et al. Paclitaxel - carboplatin alone or with bevacizumab for non-small-cell lung cancer. N. Engl. J. Med. 355(24), 2542-2550 (2006).
30. Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N. Engl. J. Med. 357(26), 2666-2676 (2007). First Phase III clinical trial of bevacizumab in combination with chemotherapy as first-line therapy in metastatic breast cancer, which demonstrated a progression-free survival (PFS) benefit.
31. Cloughesy TF, Prados MD, Wen PY et al. A Phase II, randomized, non-comparative clinical trial of the effect of bevacizumab (BV) alone or in combination with irinotecan (CPT) on 6-month progression free survival (PFS6) in recurrent, treatment-refractory glioblastoma (GBM). J. Clin. Oncol. 26(Suppl.), (2008) (Abstract 2010b).
32. Kreisl TN, Kim L, Moore K et al. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J. Clin. Oncol. 27(5), 740-745 (2009).
33. Miller KD, Chap LI, Holmes FA et al. Randomized Phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J. Clin. Oncol. 23(4), 792-799 (2005).
34. Relf M, LeJeune S, Scott PA et al. Expression of the angiogenic factors vascular endothelial cell growth factor, acidic and basic fibroblast growth factor, tumor growth factor β-1, platelet-derived endothelial cell growth factor, placenta growth factor, and pleiotrophin in human primary breast cancer and its relation to angiogenesis. Cancer Res. 57(5), 963-969 (1997).
35. Sweeney CJ, Miller KD, Sissons SE et al. The antiangiogenic property of docetaxel is synergistic with a recombinant humanized monoclonal antibody against vascular endothelial growth factor or 2-methoxyestradiol but antagonized by endothelial growth factors. Cancer Res. 61(8), 3369-3372 (2001).
36. Muta M, Yanagawa T, Sai Y et al. Effect of low-dose paclitaxel and docetaxel on endothelial progenitor cells. Oncology 77(3-4), 182-191 (2009).
37. Steeg PS. Tumor metastasis: mechanistic insights and clinical challenges. Nat. Med. 12(8), 895-904 (2006).
38. Gray R, Bhattacharya S, Bowden C, Miller K, Comis RL. Independent review of E2100: a Phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer. J. Clin. Oncol. 27(30), 4966-4972 (2009).
39. Miles D, Chan A, Romieu G et al. Randomized, double-blind, placebocontrolled, Phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. J. Clin. Oncol. 26(Suppl.), (2008) (Abstract LBA1011). Second Phase III clinical trial of bevacizumab as first-line therapy in metastatic breast cancer, which demonstrated a PFS benefit.
40. Robert NJ, Dieras V, Glaspy J et al. RIBBON-1: randomized, double-blind, placebo-controlled, Phase III trial of chemotherapy with or without bevacizumab (B) for first-line treatment of HER2-negative locally recurrent or metastatic breast cancer (MBC). J. Clin. Oncol. 27(Suppl.), (2009) (Abstract 1005). Third Phase III clinical trial of bevacizumab as first-line therapy in metastatic breast cancer, which demonstrated a PFS benefit.
41. Kumar R, Yarmand-Bagheri R. The role of HER2 in angiogenesis. Semin. Oncol. 28(5 Suppl. 16), 27-32 (2001).
42. 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. 24(5), 769-777 (2006). First neoadjuvant clinical trial of bevacizumab in previously untreated breast cancer, which demonstrated several biomarkers of bevacizumab activity.
43. Balduzzi A, Montagna E, Bagnardi V et al. Infusional fluorouracil, epirubicin, and cisplatin followed by weekly paclitaxel plus bevacizumab in locally advanced breast cancer with unfavorable prognostic features. Anticancer Drugs 20(3), 197-203 (2009).
44. Greil R, Moik M, Reitsamer R et al. Neoadjuvant bevacizumab, docetaxel and capecitabine combination therapy for HER2/neu-negative invasive breast cancer: efficacy and safety in a Phase II pilot study. Eur. J. Surg. Oncol. 35(10), 1048-1054 (2009).
45. Cobleigh MA, Langmuir VK, Sledge GW et al. A Phase I/II dose-escalation trial of bevacizumab in previously treated metastatic breast cancer. Semin Oncol 30(5 Suppl. 16), 117-124 (2003). First Phase I/II clinical trial of bevacizumab in previously treated metastatic breast cancer, which established the bevacizumab safety profile and dose for use in metastatic breast cancer.
46. Smith IE, Biganzoli L, Cortes-Funes H et al. Primary analysis of study MO19391, an open-label safety study of bevacizumab (B) plus taxane-based therapy as 1st-line treatment of patients (pts) with locally recurrent (LR) or metastatic breast cancer (mBC). Cancer Res. 69(Suppl.2), (2009) (Abstract 4118).
47. Jain RK, Duda DG, Willett CG et al. Biomarkers of response and resistance to antiangiogenic therapy. Nat. Rev. Clin. Oncol. 6(6), 327-338 (2009). Important comprehensive review on biomarkers of anti-angiogenesis therapy.
48. Yang SX, Simon RM, Tan AR, Nguyen D Swain SM. Gene expression patterns and profile changes pre- and post-erlotinib treatment in patients with metastatic breast cancer. Clin. Cancer Res. 11(17), 6226-6232 (2005).
49. Denduluri N, Yang SX, Berman AW et al. Circulating biomarkers of bevacizumab activity in patients with breast cancer. Cancer Biol. Ther. 7(1), 15-20 (2008).
50. Baar J, Silverman P, Lyons J et al. A vasculature-targeting regimen of preoperative docetaxel with or without bevacizumab for locally advanced breast cancer: impact on angiogenic biomarkers. Clin. Cancer Res. 15(10), 3583-3590 (2009).
51. Torrisi R, Bagnardi V, Cardillo A et al. Preoperative bevacizumab combined with letrozole and chemotherapy in locally advanced ER- and/or PgR-positive breast cancer: clinical and biological activity. Br. J. Cancer 99(10), 1564-1571 (2008).
52. Gao D, Nolan D, McDonnell K et al. Bone marrow-derived endothelial progenitor cells contribute to the angiogenic switch in tumor growth and metastatic progression. Biochim. Biophys. Acta 1796(1), 33-40 (2009).
53. Schneider BP, Wang M, Radovich M et al. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J. Clin. Oncol. 26(28), 4672-4678 (2008). First translational study that demonstrated biomarkers of overall survival benefit in metastatic breast cancer.
54. Burstein HJ, Chen YH, Parker LM et al. VEGF as a marker for outcome among advanced breast cancer patients receiving anti-VEGF therapy with bevacizumab and vinorelbine chemotherapy. Clin. Cancer Res. 14(23), 7871-7877 (2008).
55. 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. 12(10), 3124-3129 (2006).
56. Bevacizumb full prescribing information www.accessdata.fda.gov/ drugsatfda-docs/label/2009/125085s0168lbl.pdf
57. Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery http://clinicaltrials.gov/ct2/show/NCT00408408?term=NCT00408408&rank=1
58. A Phase III Trials Program Exploring the Integration of Bevacizumab, Everolimus (RAD001), and Lapatinib Into Current Neoadjuvant Chemotherapy Regimes for Primary Breast Cancer (GeparQuinto) http://clinicaltrials.gov/ct2/show/ NCT00567554?term=NCT00567554&rank=1
59. Avastin Plus Commonly Used Chemotherapies Improved Progression-Free Survival in Advanced Breast Cancer www.medicineandbiotech.com/clinical.html
60. A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2) http://clinicaltrials.gov/ct2/show/NCT00281697?term=NCT00281697&rank=1
61. Bevacizumab and Paclitaxel, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, or Ixabepilone in Treating Patients With Locally Recurrent, Stage IIIB, or Stage IV Breast Cancer http://clinicaltrials.gov/ct2/show/NCT00785291? term=NCT00785291&rank=1
62. First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU http://clinicaltrials.gov/ct2/show/NCT00520975?term=NCT00520975&rank=1
63. Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer http://clinicaltrials.gov/ct2/show/ NCT00601900?term=NCT00601900&rank=1
64. Two-Arm Trial of Paclitaxel Plus Bevacizumab vs Capecitabine Plus Bevacizumab http://clinicaltrials.gov/ct2/show/NCT00600340?term= NCT00600340&rank=1
65. A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer http://clinicaltrials.gov/ct2/show/NCT00929240?term=NCT00929240&rank=1
66. A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer http://clinicaltrials.gov/ct2/show/NCT003 91092?term=NCT00391092&rank=1
67. Bevacizumab + Letrozol vs Letrozol as First Line Treatment in Postmenopausal Patients With Advanced or Metastatic Breast Cancer http://clinicaltrials.gov/ct2/show/NCT00545077?term=NCT00545077&rank=1
68. Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer http://clinicaltrials.gov/ct2/show/NCT00433511?term= NCT00433511&rank=1
69. BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab http://clinicaltrials.gov/ct2/show/NCT00625898?term=NCT00625898&rank=1
70. A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer http://clinicaltrials.gov/ct2/show/NCT00887536?term= NCT00887536&rank=1
71. BEATRICE Study: A Study of Avastin (Bevacizumab) Adjuvant Therapy in Triple Negative Breast Cancer http://clinicaltrials.gov/ct2/show/NCT00528567? term=NCT00528567&rank=1
72. Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer (ABCDE) http://clinicaltrials.gov/ ct2/show/NCT00925652?term=NCT00925652&rank=1