Safety of bevacizumab in patients with advanced cancer: A meta-analysis of randomized controlled trials

Oncologist

Volumn 15, Issue 11, 2010, Pages 1179-1191

  Geiger Gritsch, Sabine ^a,b   Stollenwerk, Bjoern ^a,d   Miksad, Rebecca ^c   Guba, Beate ^b   Wild, Claudia ^b   Siebert, Uwe ^a,c,e,f  

^a UNIVERSITY FOR HEALTH SCIENCES   (Austria)

^b LUDWIG BOLTZMANN INSTITUTE FOR LUNG VASCULAR RESEARCH   (Austria)

^c HARVARD MEDICAL SCHOOL   (United States)

^d INSTITUTE OF EPIDEMIOLOGY   (Germany)

^e HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^f ONCOTYROL Center for Personalized Cancer Medicine   (Austria)

Author keywords

Adverse events; Anti VEGF antibody; Bevacizumab; Cancer; Meta analysis; Safety; Vascular endothelial growth factor; VEGF

Indexed keywords

ALPHA2A INTERFERON; BEVACIZUMAB; CAPECITABINE; CARBOPLATIN; DOCETAXEL; ERLOTINIB; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN; PACLITAXEL; PEMETREXED; PLACEBO;

ADVANCED CANCER; ARTERY THROMBOSIS; ARTICLE; ASTHENIA; BLEEDING; BREAST CANCER; CLINICAL TRIAL; COLORECTAL CANCER; COLORECTAL CARCINOMA; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DISEASE SEVERITY; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; EPISTAXIS; GASTROINTESTINAL HEMORRHAGE; HEART DISEASE; HEMOPTYSIS; HUMAN; HYPERTENSION; KIDNEY CARCINOMA; LEUKOPENIA; LOW DRUG DOSE; LUNG NON SMALL CELL CANCER; META ANALYSIS; METASTASIS POTENTIAL; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; SYSTEMATIC REVIEW; THROMBOCYTOPENIA; VEIN THROMBOSIS; WOUND HEALING IMPAIRMENT;

ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; DISEASE PROGRESSION; HUMANS; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; RISK FACTORS; SURVIVAL RATE;

EID: 78649978359     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2009-0155     Document Type: Article

References (45)

1. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinote-can, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004;350:2335-2342.
2. Kabbinavar F, Hurwitz HI, Fehrenbacher L et al. Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol 2003;21:60-65.
3. Kabbinavar FF, Schulz J, McCleod M et al. Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: Results of a randomized phase II trial. J Clin Oncol 2005;23:3697-3705.
4. 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;355:2542-2550.
5. Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab versus pac-litaxel alone for metastatic breast cancer. N Engl J Med 2007;357:2666-2676.
6. 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;370:2103-2111.
7. Cohn DE, Valmadre S, Resnick KE et al. Bevacizumab and weekly taxane chemotherapy demonstrates activity in refractory ovarian cancer. Gynecol Oncol 2006;102:134-139.
8. D'Adamo DR, Anderson SE, Albritton K et al. Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas. Journal of Clinical Oncology Oct 23(28):7135-7142, 2005.
9. Karp JE, Gojo I, Pili R et al. Targeting vascular endothelial growth factor for relapsed and refractory adult acute myelogenous leukemias: Therapy with sequential 1-beta-D-arabinofuranosylcytosine, mitoxantrone, and bevacizumab. Clin Cancer Res 2004;10:3577-3585.
10. 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.
11. Rini BI, Weinberg V, Fong L et al. Combination immunotherapy with prostatic acid phosphatase pulsed antigen-presenting cells (Provenge) plus bevacizumab in patients with serologic progression of prostate cancer after definitive local therapy. Cancer 2006;107:67-74.
12. Varker KA, Biber JE, Kefauver C et al. A randomized phase 2 trial of bevacizumab with or without daily low-dose interferon alfa-2b in metastatic malignant melanoma. Ann Surg Oncol 2007;14:2367-2376.
13. Zhu AX, Blaszkowsky LS, Ryan DP et al. Phase II study of gemcitabine and oxaliplatin in combination with bevacizumab in patients with advanced hepatocellular carcinoma. J Clin Oncol 2006;24:1898-1903.
14. National Cancer Institute. Common Terminology Criteria for Adverse Events. Available at http://ctep.info.nih.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf, accessed October 22, 2010.
15. ® (Bevacizumab) - FDA Drug Label (2008). Available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125085s145lbl.pdf, accessed October 22, 2010.
16. Zhu X, Wu S, Dahut WL et al. Risks of proteinuria and hypertension with bevacizumab, an antibody against vascular endothelial growth factor: Systematic review and meta-analysis. Am J Kidney Dis Feb 2007;49:186-193.
17. Scappaticci FA, Skillings JR, Holden SN et al. Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst 2007;99:1232-1239.
18. Nalluri SR, Chu D, Keresztes R et al. Risk of venous thromboembolism with the angiogenesis inhibitor bevacizumab in cancer patients: A metaanalysis. JAMA 2008;300:2277-2285.
19. Moher D, Cook DJ, Eastwood S et al. Improving the quality of reports of meta-analyses of randomised controlled trials: The QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 1999;354:1896-1900.
20. ® (Bevacizumab) - Summary of Product Characteristics. Available at http://www.emea.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000582/WC500029271.pdf, accessed October 22, 2010.
21. Jadad AR, Moore RA, Carroll D et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials 1996; 17:1-12.
22. Laird NM, Mosteller F. Some statistical methods for combining experimental results. Int J Technol Assess Health Care 1990;6:5-30.
23. Higgins JP, Thompson SG, Deeks JJ et al. Measuring inconsistency in meta-analyses. BMJ 2003;327:557-560.
24. Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions, Version 5.0.2 [updated September 2009] - The Cochrane Collaboration. Available at http://www.cochrane-handbook.org, accessed April 18, 2008.
25. Review Manager (RevMan) [Computer program]. Version 5.0. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration. Available at http://ims.cochrane.org/revman/download, accessed October 22, 2010.
26. Hurwitz HI, Fehrenbacher L, Hainsworth JD et al. Bevacizumab in combination with fluorouracil and leucovorin: An active regimen for first-line metastatic colorectal cancer. J Clin Oncol 2005;23:3502-3508.
27. Hurwitz H, Saini S. Bevacizumab in the treatment of metastatic colorectal cancer: Safety profile and management of adverse events. Semin Oncol 2006;33(suppl 10):S26-S34.
28. Lyseng-Williamson KA, Robinson DM. Bevacizumab: A review of its use in advanced colorectal cancer, breast cancer, and NSCLC. Am J Cancer 2006;5:43-60.
29. Saif MW, Mehra R. Incidence and management of bevacizumab-related toxicities in colorectal cancer. Expert Opin Drug Saf 2006;5:553-566.
30. Motl S. Bevacizumab in combination chemotherapy for colorectal and other cancers. Am J Health Syst Pharm 2005;62:1021-1032.
31. Saif MW, Elfiky A, Salem RR. Gastrointestinal perforation due to bevacizumab in colorectal cancer. Ann Surg Oncol Jun 14(6):1860-1869, 2007.
32. Kabbinavar FF, Hambleton J, Mass RD et al. Combined analysis of efficacy: The addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol 2005; 23:3706-3712.
33. Scappaticci FA, Fehrenbacher L, Cartwright T et al. Surgical wound healing complications in metastatic colorectal cancer patients treated with bevacizumab. J Surg Oncol 2005;91:173-180.
34. ® (Bevacizumab) - European Public Assessment Report (EPAR). Available at http://www.emea.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000582/WC500029260.pdf, accessed October 22, 2010.
35. Tappenden P, Jones R, Paisley S et al. Systematic review and economic evaluation of bevacizumab and cetuximab for the treatment of metastatic colorectal cancer. Health Technol Assess 2007;11:1-128, iii-iv.
36. Drummond MF, Mason AR. European perspective on the costs and cost-effectiveness of cancer therapies. J Clin Oncol 2007;25:191-195.
37. Earle CC, Chapman RH, Baker CS et al. Systematic overview of cost-utility assessments in oncology. J Clin Oncol 2000;18:3302-3317.
38. Earle CC, Coyle D, Evans WK. Cost-effectiveness analysis in oncology. Ann Oncol 1998;9:475-482.
39. Siebert U. When should decision-analytic modeling be used in the economic evaluation of health care [editorial]? Eur J Health Econ 2003;4:143-150.
40. Yang JC, Haworth L, Sherry RM et al. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med 2003;349:427-434.
41. Johnson DH, Fehrenbacher L, Novotny WF., et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2004;22:2184-2191.
42. Miller KD, Chap LI, Holmes FA et al. Randomized phase III trial of cape-citabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005;23:792-799.
43. 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 2007;25:1539-1544.
44. Herbst RS, O'Neill VJ, Fehrenbacher L et al. Phase II study of efficacy and safety of bevacizumab in combination with chemotherapy or erlo-tinib compared with chemotherapy alone for treatment of recurrent or refractory non small-cell lung cancer. J Clin Oncol 2007;25:4743-4750.
45. Saltz LB, Clarke S, Diaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorec-tal cancer:Arandomized phase III study.J Clin Oncol 2008;26:2013-2019.