Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): Final analysis of overall survival

Journal of Clinical Oncology

Volumn 28, Issue 13, 2010, Pages 2144-2150

  Escudier, Bernard ^a   Bellmunt, Joaquim ^a   Négrier, Sylvie ^a   Bajetta, Emilio ^a   Melichar, Bohuslav ^a   Bracarda, Sergio ^a   Ravaud, Alain ^a   Golding, Sophie ^a   Jethwa, Sangeeta ^a   Sneller, Vesna ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA2A INTERFERON; BEVACIZUMAB; PLACEBO; PROTEIN TYROSINE KINASE INHIBITOR; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ARTICLE; ASTHENIA; CANCER CHEMOTHERAPY; CLINICAL PROTOCOL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; FATIGUE; FEMALE; HAZARD RATIO; HUMAN; HYPERTENSION; KIDNEY CARCINOMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; EUROPE; KAPLAN MEIER METHOD; KIDNEY TUMOR; METASTASIS; MORTALITY; PATHOLOGY; PATIENT SELECTION; RISK ASSESSMENT; RISK FACTOR; TIME; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, RENAL CELL; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; EUROPE; FEMALE; HUMANS; INTERFERON ALFA-2A; KAPLAN-MEIERS ESTIMATE; KIDNEY NEOPLASMS; MALE; PATIENT SELECTION; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 77952300540     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.26.7849     Document Type: Article

References (25)

1. National Comprehensive Cancer Network: Clinical Practice Guidelines in Oncology, v. 1.2009: Kidney Cancer. http://www.nccn.org/professionals/physician- gls/f-guidelines.asp
2. US Food and Drug Administration: Food and Drug Administration approval of everolimus. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm149550.htm
3. 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 57:4593-4599, 1997 (Pubitemid 27441066)
4. 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 370:2103-2111, 2007 (Pubitemid 350296300)
5. Motzer RJ, Hutson TE, Tomczak P, et al: Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 356:115-124, 2007 (Pubitemid 46089672)
6. Escudier B, Bellmunt J, Negrier S, et al: Final results of the phase III, randomised, double-blind AVOREN trial of first-line bevacizumab (BEV) + interferon-α2a (IFN) in metastatic renal cell carcinoma (mRCC). J Clin Oncol 27:239s, 2009 (suppl; abstr 5020)
7. Melichar B, Koralewski P, Ravaud A, et al: First-line bevacizumab combined with reduced dose interferon-alpha2a is active in patients with metastatic renal cell carcinoma. Ann Oncol 19:1470-1476, 2008
8. Rini BI, Halabi S, Rosenberg J, et al: Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: Results of overall survival for CALGB 90206. J Clin Oncol 27:798s, 2009 (suppl; abstr LBA5019)
9. Rini BI, Halabi S, Rosenberg JE, et al: Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol 26:5422-5428, 2008
10. Bracarda S, Negrier S, Melichar B, et al: What is the impact of subsequent antineoplastic therapy on overall survival following first-line bevacizumab/interferon-a2a in metastatic renal cell carcinoma? Experience from AVOREN. Eur J Cancer 7:431, 2009 (suppl, abstr 7126)
11. Kent DM, Hayward RA: Limitations of applying summary results of clinical trials to individual patients: The need for risk stratification. JAMA 298:1209-1212, 2007 (Pubitemid 47403108)
12. Motzer RJ, Bacik J, Murphy BA, et al: Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol 20:289-296, 2002 (Pubitemid 34032623)
13. Escudier B, Goupil MG, Massard C, et al: Sequential therapy in renal cell carcinoma. Cancer 115:2321-2326, 2009
14. Dudek AZ, Zolnierek J, Dham A, et al: Sequential therapy with sorafenib and sunitinib in renal cell carcinoma. Cancer 115:61-67, 2009
15. Porta C, Procopio G, Sabbatini R, et al: Retrospective analysis of the sequential use of sorafenib and sunitinib in patients with advanced renal cell carcinoma (RCC). Eur Urol 8:183, 2009 (suppl, abstr 252)
16. Rini BI, Michaelson MD, Rosenberg JE, et al: Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab-refractory metastatic renal cell carcinoma. J Clin Oncol 26:3743-3748, 2008
17. Sablin MP, Negrier S, Ravaud A, et al: Sequential sorafenib and sunitinib for renal cell carcinoma. J Urol 182:29-34, 2009
18. Merchan JR, Pitot HC, Qin R, et al: Phase I/II trial of CCI 779 and bevacizumab in advanced renal cell carcinoma (RCC): Safety and activity in RTKI refractory RCC patients. J Clin Oncol 27:244s, 2009 (suppl; abstr 5039)
19. Sosman J, Flaherty K, Atkins M, et al: Updated results of phase I trial of sorafenib (S) and bevacizumab (B) in patients with metastatic renal cell cancer (mRCC). J Clin Oncol 26:252s, 2008 (suppl; abstr 5011)
20. Patnaik A, Ricart A, Cooper J, et al: A phase I, pharmacokinetic and pharmacodynamic study of sorafenib (S), a multi-targeted kinase inhibitor in combination with temsirolimus (T), an mTOR inhibitor in patients with advanced solid malignancies. J Clin Oncol 25:141s, 2007 (suppl; abstr 3512)
21. Yothers G: Toward progression-free survival as a primary end point in advanced colorectal cancer. J Clin Oncol 25:5153-5154, 2007
22. US Food and Drug Administration: Guidance for industry: Clinical trial endpoints for the approval of cancer drugs and biologics. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatory%20Information/Guidances/UCM071590. pdf
23. European Agency for the Evaluation of Medicinal Products: Guideline on the evaluation of anticancer medicinal products in man. http://www.rsihata.com/ updateguidance/emea/old/020595en.pdf
24. Motzer RJ, Hutson TE, Tomczak P, et al: Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 27:3584-3590, 2009
25. Schmidinger M, Zielinski C: Novel agents for renal cell carcinoma require novel selection paradigms to optimise first-line therapy. Cancer Treat Rev 35:289-296, 2009