A phase II study of bevacizumab and everolimus as treatment for refractory metastatic renal cell carcinoma

Clinical Genitourinary Cancer

Volumn 11, Issue 2, 2013, Pages 100-106

  Harshman, Lauren C ^a   Barbeau, Sarah ^a   McMillian, Alex ^b   Srinivas, Sandy ^a  

^a STANFORD CANCER INSTITUTE   (United States)

^b STANFORD UNIVERSITY   (United States)

Author keywords

Bevacizumab; Everolimus; Horizontal blockade; Metastatic renal cell carcinoma; Treatment refractory

Indexed keywords

BEVACIZUMAB; EVEROLIMUS; VASCULOTROPIN A;

ABSCESS; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLEEDING; BLOOD LEVEL; CHILL; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CREATININE PHOSPHOKINASE BLOOD LEVEL; DISEASE COURSE; DRUG WITHDRAWAL; DRY SKIN; EDEMA; EPISTAXIS; FATIGUE; FEMALE; GLOMERULUS FILTRATION RATE; HEMATURIA; HUMAN; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPERTRIGLYCERIDEMIA; HYPOALBUMINEMIA; HYPOMAGNESEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; KIDNEY CARCINOMA; KIDNEY METASTASIS; MALE; MICROCYTOSIS; MONOTHERAPY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MYALGIA; NOSE SEPTUM PERFORATION; OVERALL SURVIVAL; PATHOLOGIC FRACTURE; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; PRURITUS; RASH; RIGOR; SIDE EFFECT; SINUS CONGESTION; STOMATITIS; THROMBOCYTOPENIA; THROMBOTIC THROMBOCYTOPENIC PURPURA; URINARY TRACT INFECTION; WEAKNESS; WEIGHT REDUCTION;

ADULT; AGED; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, RENAL CELL; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; SIROLIMUS; TOR SERINE-THREONINE KINASES; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84876965794     PISSN: 15587673     EISSN: 19380682     Source Type: Journal    
DOI: 10.1016/j.clgc.2012.12.002     Document Type: Article

References (32)

1. B. Escudier, J. Bellmunt, S. Négrier Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival J Clin Oncol 28 2010 2144 2150
2. B. Escudier, T. Eisen, W.M. Stadler Sorafenib in advanced clear-cell renal-cell carcinoma N Engl J Med 356 2007 125 134
3. B. Escudier, T. Eisen, W.M. Stadler Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial J Clin Oncol 27 2009 3312 3318
4. B. Escudier, A. Pluzanska, P. Koralewski Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial Lancet 370 2007 2103 2111
5. G. Hudes, M. Carducci, P. Tomczak Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma N Engl J Med 356 2007 2271 2281
6. R.J. Motzer, B. Escudier, S. Oudard Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors Cancer 116 2010 4256 4265
7. R.J. Motzer, B. Escudier, S. Oudard Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial Lancet 372 2008 449 456
8. R.J. Motzer, T.E. Hutson, P. Tomczak Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma J Clin Oncol 27 2009 3584 3590
9. R.J. Motzer, T.E. Hutson, P. Tomczak Sunitinib versus interferon alfa in metastatic renal-cell carcinoma N Engl J Med 356 2007 115 124
10. B.I. Rini, S. Halabi, J.E. Rosenberg Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206 J Clin Oncol 28 2010 2137 2143
11. B.I. Rini, S. Halabi, J.E. Rosenberg Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206 J Clin Oncol 26 2008 5422 5428
12. C.N. Sternberg, I.D. Davis, J. Mardiak Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial J Clin Oncol 28 2010 1061 1068
13. D.Y. Heng, W. Xie, M.M. Regan Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: results from a large, multicenter study J Clin Oncol 27 2009 5794 5799
14. R.J. Motzer, M. Mazumdar, J. Bacik Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma J Clin Oncol 17 1999 2530 2540
15. R.J. Motzer, T. Eisen, I.N. Bondarenko Tivozanib versus sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma: results from a phase III randomized, open-label, multicenter trial J Clin Oncol 30 suppl 2012 abstract 4501
16. J.C. Yang, L. Haworth, R.M. Sherry A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer N Engl J Med 349 2003 427 434
17. M.S. Gordon, K. Margolin, M. Talpaz Phase I safety and pharmacokinetic study of recombinant human anti-vascular endothelial growth factor in patients with advanced cancer J Clin Oncol 19 2001 843 850
18. K.E. Bullock, W.P. Petros, I. Younis A phase I study of bevacizumab (B) in combination with everolimus (E) and erlotinib (E) in advanced cancer (BEE) Cancer Chemother Pharmacol 67 2011 465 474
19. Zafar Y, Bendel J, Lager J, et al. Preliminary results of a phase I study of bevacizumab (BV) in combination with everolimus (E) in patients with advanced solid tumors. Proceedings of the American Society of Clinical Oncology Annual Meeting 2006, Atlanta, GA. Abstract #3097.
20. R.M. Bukowski, F.F. Kabbinavar, R.A. Figlin Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer J Clin Oncol 25 2007 4536 4541
21. Flaherty K, Manola J, Pins M, et al. A randomized phase II study of VEGF, RAF kinase and mTOR combination targeted therapy with bevacizumab, sorafenib and temsirolimus in advanced renal cell carcinoma, in The BeST trial; E204. Presented at the 2012 Kidney Cancer Association Meeting, Chicago, IL, October 5-6, 2012.
22. N.S. Azad, E.M. Posadas, V.E. Kwitkowski Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity J Clin Oncol 26 2008 3709 3714
23. D.R. Feldman, M.S. Baum, M.S. Ginsberg Phase I trial of bevacizumab plus escalated doses of sunitinib in patients with metastatic renal cell carcinoma J Clin Oncol 27 2009 1432 1439
24. S. Négrier, G. Gravis, D. Pérol Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): a randomised phase 2 trial Lancet Oncol 12 2011 673 680
25. Ravaud A, Anak O, Gogov S, et al. Randomized phase II study of first-line everolimus (EVE) + bevacizumab (BEV) versus interferon alfa-2a (IFN) + BEV in patients (pts) with metastatic renal cell carcinoma (mRCC): record-2. Presented at the 37th Congress of the European Society for Medical Oncology (ESMO). Vienna, Austria, September 28-October 2, 2012.
26. B.I. Rini, J.A. Garcia, M.M. Cooney A phase I study of sunitinib plus bevacizumab in advanced solid tumors Clin Cancer Res Off J Am Assoc Cancer Res 15 2009 6277 6283
27. Rini Bi BJ, Alyzasova AV, Clancy J, et al. Randomized phase IIIb trial of temsirolimus and bevacizumab versus interferon and bevacizumab in metastatic renal cell carcinoma: results from INTORACT. Presented at the 37th Congress of the European Society for Medical Oncology (ESMO), Vienna, Austria, September 28-October 2, 2012. abstract LBA21.
28. J.D. Hainsworth, D.R. Spigel, H.A. Burris III Phase II trial of bevacizumab and everolimus in patients with advanced renal cell carcinoma J Clin Oncol 28 2010 2131 2136
29. B. Escudier How to interpret phase II data for everolimus plus bevacizumab in renal cell carcinoma J Clin Oncol 28 2010 2125 2126
30. B.I. Rini, J.H. Schiller, J.P. Fruehauf Diastolic blood pressure as a biomarker of axitinib efficacy in solid tumors Clin Cancer Res 17 2011 3841 3849
31. D.A. Chan, P.D. Sutphin, P. Nguyen Targeting GLUT1 and the Warburg effect in renal cell carcinoma by chemical synthetic lethality Sci Transl Med 3 2011 94ra70
32. S.L. Topalian, F.S. Hodi, J.R. Brahmer Safety, activity, and immune correlates of anti-PD-1 antibody in cancer N Engl J Med 366 2012 2443 2454