Influence of the American ODAC statement on Austrian bevacizumab prescribing practice for metastatic breast cancer

Oncologist

Volumn 17, Issue 7, 2012, Pages

  Preusser, Matthias ^a   Fülöp, Gerhard ^c   Berghoff, Anna Sophie ^a,b   Heinzl, Harald ^a   Steger, Guenther G ^a   Greil, Richard ^d   Zielinski, Christoph C ^a   Bartsch, Rupert ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b MEDICAL UNIVERSITY OF VIENNA   (Austria)

^c GESUNDHEIT ÖSTERREICH GMBH   (Austria)

^d PARACELSUS MEDICAL UNIVERSITY   (Austria)

Author keywords

Bevacizumab; Breast cancer; EMA; FDA; Oncologic Drugs Advisory Committee; Prescription Practice

Indexed keywords

BEVACIZUMAB; CAPECITABINE; DOCETAXEL; PACLITAXEL; PAZOPANIB;

ADVISORY COMMITTEE; ARTICLE; AUSTRIA; BREAST CANCER; COLORECTAL CANCER; CONTROLLED STUDY; FOOD AND DRUG ADMINISTRATION; GLIOBLASTOMA; HUMAN; KIDNEY CARCINOMA; LICENCE; LUNG ADENOCARCINOMA; METASTASIS; OVARY CANCER; PRESCRIPTION; PRIORITY JOURNAL; UNITED STATES;

ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL, HUMANIZED; AUSTRIA; BREAST NEOPLASMS; DRUG APPROVAL; DRUG PRESCRIPTIONS; EUROPEAN UNION; FEMALE; HUMANS; NEOPLASM METASTASIS; UNITED STATES;

EID: 84864056138     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2012-0115     Document Type: Article

References (19)

1. Folkman J, Klagsbrun M. Angiogenic factors. Science 1987;235:442-447.
2. Kim KJ, Li B, Winer J et al. Inhibition of vascular endothelial growth factor-induced angiogenesis suppresses tumour growth in vivo. Nature 1993;362:841-844.
3. 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: 792-799.
4. Casanovas O, Hicklin DJ, Bergers G et al. Drug resistance by evasion of antiangiogenic targeting of VEGF signaling in late-stage pancreatic islet tumors. Cancer Cell 2005;8:299-309.
5. Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007;357:2666-2676.
6. National Cancer Institute. FDA Approval for Bevacizumab. Available at http://www.cancer.gov/ cancertopics/druginfo/fda-bevacizumab, accessed December 11, 2011.
7. 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;28:3239-3247.
8. 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;29:1252-1260.
9. Roche Global. Media Release: European Commission Continues to Support Avastin in Combination with Paclitaxel as an Effective Treatment Option for Women with Metastatic Breast Cancer. Available at http://www. roche.com/media/media_releases/med-cor-2011-03-02. htm, accessed December 10, 2011.
10. U.S. Food and Drug Administration. Food and Drug Administration Oncologic Drugs Advisory Committee: Avastin (Bevacizumab)/Genentech, Inc. Available at http:// www.fda.gov/downloads/AdvisoryCommittees/Committees MeetingMaterials/Drugs/OncologicDrugsAdvisory Committee/UCM221998.pdf, accessed December 11, 2011.
11. Wilking N, Jönsson, B. A Pan-European Comparison Regarding Patient Access to Cancer Drugs. Stockholm, Sweden: Karolinska Institutet, 2005. Available at http://ki.se/content/1/c4/33/52/Cancer_Report.pdf, accessed January 10, 2012.
12. Gesundheit Österreich GmbH. Available at http:// www.goeg.at, accessed December 10, 2011.
13. O'Shaughnessy J, Miles D, Gray R et al. A metaanalysis 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 1005]. J Clin Oncol 2010;28(suppl 15): 115S.
14. Saad ED, Katz A, Hoff PM et al. Progression-free survival as surrogate and as true end point: Insights from the breast and colorectal cancer literature. Ann Oncol 2010;21:7-12.
15. Sternberg CN, Davis ID, Mardiak J et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: Results of a randomized phase III trial. J Clin Oncol 2010;28:1061-1068.
16. Bear HD, Tang G, Rastogi P et al. Bevacizumab added to neoadjuvant chemotherapy for breast cancer. N Engl J Med 2012;366:310-320.
17. von Minckwitz G, Eidtmann H, Rezai M et al. Neoadjuvant chemotherapy and bevacizumab for HER2-negative breast cancer. N Engl J Med 2012;366:299-309.
18. D'Agostino RB Sr. Changing end points in breastcancer drug approval-the Avastin story. N Engl J Med 2011;365:e2.
19. Bonifazi M, Rossi M, Moja L et al. Bevacizumab in clinical practice: Prescribing appropriateness relative to national indications and safety. The Oncologist 2012; 17:117-124.