Bevacizumab: A review of its use in combination with paclitaxel or capecitabine as first-line therapy for HER2-negative metastatic breast cancer

Drugs

Volumn 71, Issue 16, 2011, Pages 2213-2229

  Croom, Katherine F ^a   Dhillon, Sohita ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Evaluations; Advanced breast cancer; Bevacizumab; Capecitabine; Paclitaxel

Indexed keywords

BEVACIZUMAB; CAPECITABINE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; NAVELBINE; PACLITAXEL; TRASTUZUMAB;

ADD ON THERAPY; ANTINEOPLASTIC ACTIVITY; ARTERY THROMBOSIS; ARTICLE; BLEEDING; BRAIN ISCHEMIA; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL PRACTICE; DIGESTIVE SYSTEM PERFORATION; DRUG CLEARANCE; DRUG EFFICACY; DRUG ELIMINATION; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FOLLOW UP; HEART LEFT VENTRICLE FAILURE; HUMAN; HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR TYPE 2 NEGATIVE METASTATIC BREAST CANCER; IN VITRO STUDY; INFECTION; META ANALYSIS (TOPIC); NEUTROPENIA; NONHUMAN; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; PROTEINURIA; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SENSORY NEUROPATHY; THROMBOEMBOLISM; TREATMENT RESPONSE; VENOUS THROMBOEMBOLISM;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DEOXYCYTIDINE; FEMALE; FLUOROURACIL; HUMANS; PACLITAXEL; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 80155159962     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11207720-000000000-00000     Document Type: Article

References (63)

1. Jemal A, Bray F, CenterMM, et al. Global cancer statistics. CA Cancer J Clin 2011; 61: 69-90
2. Cardoso F, Senkus-Konefka E, Fallowfield L, et al. Locally recurrent or metastatic breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010; 21 Suppl. 5: v15-19
3. Chan A. Antiangiogenic therapy for metastatic breast cancer: current status and future directions. Drugs 2009; 69 (2): 167-81
4. Lyseng-Williamson KA, Robinson DM. Bevacizumab: a review of its use in advanced colorectal cancer, breast cancer, and NSCLC. Am J Cancer 2006; 5 (1): 43-60
5. Scott LJ. Bevacizumab: in first-line treatment of metastatic breast cancer. Drugs 2007; 67 (12): 1793-9 (Pubitemid 47263182)
6. Presta LG, Chen H, O'Connor SJ, et al. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumours and other disorders. Cancer Res 1997 Oct 15; 57: 4593-9 (Pubitemid 27441066)
7. Wang Y, Fei D, Vanderlaan M, et al. Biological activity of bevacizumab, a humanized anti-VEGF antibody in vitro. Angiogenesis 2004; 7 (4): 335-45 (Pubitemid 40767935)
8. Gordon MS, Margolin K, Talpaz M, et al. Phase I safety and pharmacokinetic study of recombinant human antivascular endothelial growth factor in patients with advanced cancer. J Clin Oncol 2001; 19 (3): 843-50 (Pubitemid 32119100)
9. Margolin K, Gordon MS, Holmgren E, et al. Phase Ib trial of intravenous recombinant humanized monoclonal antibody to vascular endothelial growth factor in combination with chemotherapy in patients with advanced cancer: pharmacologic and long-term safety data. J Clin Oncol 2001; 19 (3): 851-6 (Pubitemid 32119101)
10. Hsei V, Deguzman GG, Nixon A, et al. Complexation of VEGF with bevacizumab decreases VEGF clearance in rats. Pharm Res 2002; 19 (11): 1753-6 (Pubitemid 35305529)
11. Wildiers H, Guetens G, De Boeck G, et al. Effect of antivascular endothelial growth factor treatment on the intratumoral uptake of CPT-11. Br J Cancer 2003; 88: 1979-86 (Pubitemid 36829677)
12. Wedam SB, Low JA, Yang SX, et al. Antiangiogenic and antitumour effects of bevacizumab in inflammatory and locally advanced breast cancer patients. J Clin Oncol 2006; 24 (5): 769-77 (Pubitemid 46622044)
13. Yanagisawa M, Yorozu K, Kurasawa M, et al. Bevacizumab improves the delivery and efficacy of paclitaxel. Anticancer Drugs 2010 Aug; 21 (7): 687-94
14. Kim KJ, Li B, Winer J, et al. Inhibition of vascular endothelial growth factor-induced angiogenesis suppresses tumour growth in vivo. Nature 1993; 362: 841-4 (Pubitemid 23132159)
15. Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007 Dec 27; 357 (26): 2666-76
16. 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 [published erratum appears in J Clin Oncol 2009; 27 (18): 3070]. J Clin Oncol 2008 Oct 1; 26 (28): 4672-8
17. Smith IE, Pierga JY, Biganzoli L, et al. First-line bevacizumab plus taxane-based chemotherapy for locally recurrent or metastatic breast cancer: safety and efficacy in an open-label study in 2251 patients. Ann Oncol 2011 Mar; 22: 595-602
18. Etienne-Grimaldi MC, Formento P, Degeorges A, et al. Prospective analysis of the impact of VEGF-A gene polymorphisms on pharmacodynamics of bevacizumab-based therapy in metastatic breast cancer patients. Br J Clin Pharmacol 2010 Dec 30; 71 (6): 921-8
19. Fountzilas G, Kourea HP, Bobos M, et al. Paclitaxel and bevacizumab as first line combined treatment in patients with metastatic breast cancer: the Hellenic Cooperative Oncology Group experience with biological marker evaluation. Anticancer Res 2011 Sep; 31 (9): 3007-18
20. Miles D, de Haas SL, Dirix L, et al. Plasma biomarker analyses in the AVADO phase III randomized study of first-line bevacizumab + docetaxel in patients with human epidermal growth factor receptor (HER) 2-negative metastatic breast cancer [abstract no. P2-16-04]. 33rd Annual San Antonio Breast Cancer Symposium; 2010 Dec 8-12; San Antonio (TX) [online]. Available from URL: http://www.abstracts2view.com [Accessed 2011 Apr 15]
21. Bidard FC, Mathiot C, Degeorges A, et al. Clinical value of circulating endothelial cells and circulating tumor cells in metastatic breast cancer patients treated first line with bevacizumab and chemotherapy. Ann Oncol 2010 Sep; 21 (9): 1765-71
22. 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 2005; 23 (4): 792-9 (Pubitemid 46224178)
23. Jubb AM, Miller KD, Rugo HS, et al. Impact of exploratory biomarkers on the treatment effect of bevacizumab in metastatic breast cancer. Clin Cancer Res 2011 Jan 15; 17 (2): 372-81
24. Wu J, Wu X, Zhao Y, et al. Phase I safety and pharmacokinetic study of bevacizumab in Chinese patients with advanced cancer. Chin Med J (Engl) 2010; 123 (7): 901-6
25. European Medicines Agency. Avastin: summary of product characteristics [online]. Available from URL: http://www. ema.europa.eu/docs/en-GB/document- library/EPAR-Product-Information/human/000582/WC500029271.pdf [Accessed 2011 Sep 29]
26. European Medicines Agency. Avastin: European public assessment report-scientific discussion [online].Available from URL: http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Scientific-Discussion/human/000582/WC 500029262.pdf [Accessed 2011 May 26]
27. Robert NJ, Dieras V, Glaspy J, et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol 2011 Apr 1; 29 (10): 1252-60
28. Forster F, Schneeweiss A, Geberth M, et al. Updated results from a large, multicentre study of 1st-line bevacizumab combined with paclitaxel for HER2-negative metastatic breast cancer in routine oncology practice [abstract no. 302P]. Ann Oncol 2010 Oct 8; 21 Suppl. 8: viii104
29. Kountourakis P, Doufexis D, Maliou S, et al. Bevacizumab combined with two-weekly paclitaxel as first-line therapy for metastatic breast cancer. Anticancer Res 2010 Jul; 30 (7): 2969-71
30. Danso MM, Blum JL, Robert NJ, et al. Phase II trial of weekly nab-paclitaxel in combination with bevacizumab as first-line treatment in metastatic breast cancer [abstract no. 1075]. J Clin Oncol 2008 May 20; 26 (15S Pt I): 59S
31. Martin M, Roche H, Pinter T, et al. Motesanib, or openlabel bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, doubleblind, placebo-controlled study. Lancet Oncol 2011 Apr; 12 (4): 369-76
32. Conlin AK, Hudis CA, Bach A, et al. Randomized phase II trial of nanoparticle albumin-bound paclitaxel in three dosing schedules with bevacizumab as first-line therapy for HER2-negative metastatic breast cancer (MBC) [abstract no. 1066]. 45th American Society of Clinical Oncology Annual Meeting; 2009 May 29-Jun 2; Orlando (FL) [online]. Available from URL: http://www.asco.org [Accessed 2010 Feb 16]
33. Traina TA, Theodoulou M, Dugan U, et al. A novel capecitabine dosing schedule combined with bevacizumab is safe and active in patients with metastatic breast cancer: a phase II study [abstract no. 6121]. Cancer Res 2009; 69 Suppl. 2: 384s
34. Aogi K,Masuda N, Ohno S, et al. First-line bevacizumab in combination with weekly paclitaxel for metastatic breast cancer: efficacy and safety results from a large, open-label, single-arm Japanese study. Breast Cancer Res Treat 2011 Oct; 129 (3): 829-38
35. European Medicines Agency. Assessment report for Avastin (bevacizumab): procedure no. EMEA/H/C/582/A-20/038 [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Assessment-Report- Variation/human/000582/WC500105601.pdf [Accessed 2011 May 3]
36. Gray R, Bhattacharya S, Bowden C, et al. Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer. J Clin Oncol 2009 Oct 20; 27 (30): 4966-72
37. Cella D, Wang M, Wagner L, et al. Survival-adjusted healthrelated quality of life (HRQL) among patients with metastatic breast cancer receiving paclitaxel plus bevacizumab versus paclitaxel alone: results from Eastern Cooperative Oncology Group Study 2100 (E2100). Breast Cancer Res Treat. Epub 2011 Aug 27
38. O'Shaughnessy J, Miles D, Gray RJ, et al. A meta-analysis of overall survival data from three randomized trials of bevacizumab (BV) and first-line chemotherapy as treatment for patients with metastatic breast cancer (MBC) [abstract no. 1005]. J Clin Oncol 2010; 28 Suppl.: 15s
39. Smith I, Pierga JY, Biganzoli L, et al. Final overall survival results and effect of prolonged (‡1 year) first-line bevacizumab-containing therapy for metastatic breast cancer in the ATHENA trial. Breast Cancer Res Treat 2011; 130 (1): 133-43
40. Biganzoli L, Di Vincenzo E, Jiang Z, et al. First-line bevacizumab-containing therapy for breast cancer: results in patients aged ‡70 years treated in the ATHENA study. Ann Oncol. Epub 2011 Mar 28
41. Prichard KI, Thomssen C, Pierga J-Y, et al. Final overall survival results, including analysis of patients with triplenegative disease and aged ‡70 years, from the ATHENA study evaluating first-line bevacizumab-containing therapy for locally recurrent/metastatic breast cancer [abstract no. P2-16-06 plus poster]. 33rd Annual San Antonio Breast Cancer Symposium (SABCS); 2010 Dec 8-12; San Antonio (TX)
42. Dedes KJ, Matter-Walstra K, Schwenkglenks M, et al. Bevacizumab in combination with paclitaxel for HER-2 negative metastatic breast cancer: an economic evaluation. Eur J Cancer 2009 May; 45 (8): 1397-406
43. Fortune-Greeley A, Cornell P. Bevacizumab for the treatment of metastatic breast cancer: a cost-effectiveness analysis [abstract no. PCN58]. 15th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research; 2010 May 15-19; Atlanta (GA) [online]. Available from URL: http://www.ispor.org [Accessed 2011 Jun 10]
44. Lang I, Inbar M, Greil R, et al. Safety subgroup analyses from the CECOG phase III TURANDOT trial: first-line bevacizumab in combination with capecitabine or paclitaxel for HER2-negative locally recurrent or metastatic breast cancer [abstract no 281PD]. Ann Oncol 2010 Oct; 21 Suppl. 8: viii98
45. European Medicines Agency. Assessment report for Avastin (bevacizumab): procedure no.: EMEA/H/C/000582/II/0033 [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Assessment-Report- Variation/human/000582/WC500108311.pdf [Accessed 2011 Jul 19]
46. Giordano SH, Buzdar AU, Smith TL, et al. Is breast cancer survival improving? Trends in survival for patients with recurrent breast cancer diagnosed from 1974 through 2000. Cancer 2004; 100: 44-52 (Pubitemid 37553538)
47. Andre F, Slimane K, Bachelot T, et al. Breast cancer with synchronous metastases: trends in survival during a 14-year period. J Clin Oncol 2004; 22 (16): 3302-8 (Pubitemid 41103686)
48. Dawood S, Broglio K, Gonzalez-Angulo AM, et al. Trends in survival over the past two decades among white and black patients with newly diagnosed stage IV breast cancer. J Clin Oncol 2008; 26 (30): 4891-8
49. National Cancer Institute. SEER cancer statistics review (1975-2008) [online]. Available from URL: http://www. seer.cancer.gov [Accessed 2011 Jun 2]
50. Beslija S, Bonneterre J, Burstein HJ, et al. Third consensus on medical treatment of metastatic breast cancer. Ann Oncol 2009; 20: 1771-85
51. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: breast cancer (version 2.2011) [online]. Available from URL: http://www.nccn. org/professionals/physician-gls/pdf/breast.pdf [Accessed 2011 Jul 13]
52. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350 (23): 2335-42 (Pubitemid 38702844)
53. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006; 355: 2542-50 (Pubitemid 44917502)
54. Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007; 370 (9605): 2103-11 (Pubitemid 350296300)
55. Zhuang SH, Xiu L, Elsayed YA. Overall survival: a gold standard in search of a surrogate: the value of progessionfree survival and time to progression as end points of drug efficacy. Cancer J 2009; 15 (5): 395-400
56. Dawood S. Triple-negative breast cancer: epidemiology and management options. Drugs 2010; 70 (17): 2247-58
57. Hoffmann-La Roche. BEATRICE study: a study of Avastin (bevacizumab) adjuvant therapy in triple negative breast cancer [ClinicalTrials.gov identifier NCT00528567]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2011 Jul 19]
58. Miles DW, Chan A, Dirix LY, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010 Jul 10; 28 (20): 3239-47
59. Brufsky A, Bondarenko IN, Smirnov V, et al. RIBBON-2: A randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of HER2-negative metastatic breast cancer [abstract no. 42]. 32nd Annual San Antonio Breast Cancer Symposium; 2009 Dec 9-13; San Antonio (TX) [online]. Available from URL: http://www.abstracts2view.com/sabcs09 [Accessed 2011 Apr 15]
60. FDA.Avastin (bevacizumab) information (update, 6/29/2011) [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm193900.htm#. Tgz4eex4RZ4.email [Accessed 2011 Jul 20]
61. FDA Center for Drug Evaluation and Research. Regulatory decision to withdraw Avastin (bevacizumab) first-line metastatic breast cancer indication [online]. Available from URL: http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/UCM237171.pdf [Accessed 2011 Jul 20]
62. Damasceno M. Bevacizumab for the first-line treatment of human epidermal growth factor receptor 2-negative advanced breast cancer. Curr Opin Oncol 2011; 23 Suppl. 1: S3-9
63. Marty M, Pivot X. The potential of anti-vascular endothelial growth factor therapy in metastatic breast cancer: clinical experience with anti-angiogenic agents, focusing on bevacizumab. Eur J Cancer 2008 May; 44 (7): 912-20