Phase II study of bevacizumab in combination with sorafenib in recurrent glioblastoma (N0776): A North Central Cancer Treatment Group Trial

Clinical Cancer Research

Volumn 19, Issue 17, 2013, Pages 4816-4823

  Galanis, Evanthia ^a   Anderson, S Keith ^a   Lafky, Jackie M ^a   Uhm, Joon H ^a   Giannini, Caterina ^a   Kumar, Shaji K ^a   Kimlinger, Teresa K ^a   Northfelt, Donald W ^c   Flynn, Patrick J ^b   Jaeckle, Kurt A ^d   Kaufmann, Timothy J ^a   Buckner, Jan C ^a  

^a MAYO CLINIC   (United States)

^b Metro Minnesota Community Clinical Oncology Program   (United States)

^c MAYO CLINIC   (United States)

^d MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOPOIETIN 2; BEVACIZUMAB; FIBROBLAST GROWTH FACTOR 2; HYPOXIA INDUCIBLE FACTOR 1ALPHA; PLACENTAL GROWTH FACTOR; SCATTER FACTOR; SORAFENIB; STEM CELL FACTOR RECEPTOR; STROMAL CELL DERIVED FACTOR 1; VASCULOTROPIN; VASCULOTROPIN RECEPTOR 2;

ADULT; AGED; ANEMIA; ANGIOGENESIS; ANOREXIA; ARTICLE; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG POTENTIATION; DRUG RESPONSE; DRUG WITHDRAWAL; ENDOTHELIUM CELL; FATIGUE; GLIOBLASTOMA; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; HYPOPHOSPHATEMIA; LEUKOPENIA; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; NAUSEA; NEUTROPHIL COUNT; ORAL MUCOSITIS; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROMOTER REGION; QUALITY OF LIFE; RECURRENT CANCER; RECURRENT GLIOBLASTOMA; SIDE EFFECT; SINGLE NUCLEOTIDE POLYMORPHISM; THROMBOCYTE COUNT; WEIGHT REDUCTION;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRAIN NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; GLIOBLASTOMA; HUMANS; HYPOXIA-INDUCIBLE FACTOR 1, ALPHA SUBUNIT; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASTIC CELLS, CIRCULATING; NIACINAMIDE; PHENYLUREA COMPOUNDS; POLYMORPHISM, SINGLE NUCLEOTIDE; PROPORTIONAL HAZARDS MODELS; TUMOR MARKERS, BIOLOGICAL; VASCULAR ENDOTHELIAL GROWTH FACTOR A; VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR-2;

EID: 84883474833     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-0708     Document Type: Article

References (34)

1. Stupp R, Pavlidis N, Jelic S. ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of malignant glioma. Ann Oncol 2005;16 Suppl 1:i64-5. (Pubitemid 40872994)
2. Fischer I, Gagner JP, Law M, Newcomb EW, Zagzag D. Angiogenesis in gliomas: biology and molecular pathophysiology. Brain Pathol 2005;15:297-310. (Pubitemid 41677429)
3. Kargiotis O, Rao JS, Kyritsis AP. Mechanisms of angiogenesis in gliomas. J Neurooncol 2006;78:281-93. (Pubitemid 44018823)
4. Jain RK, di Tomaso E, Duda DG, Loeffler JS, Sorensen AG, Batchelor TT. Angiogenesis in brain tumours. Nat Rev Neurosci 2007;8:610-22. (Pubitemid 47093931)
5. Batchelor TT, Sorensen AG, di Tomaso E, Zhang WT, Duda DG, Cohen KS, et al. AZD2171, a pan-VEGF receptor tyrosine kinase inhibitor, normalizes tumor vasculature and alleviates edema in glioblastoma patients. Cancer Cell 2007;11:83-95. (Pubitemid 46075199)
6. Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol 2009;27:4733-40.
7. Kreisl TN, Kim L, Moore K, Duic P, Royce C, Stroud I, et al. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol 2009;27:740-5.
8. Knobbe CB, Reifenberger J, Reifenberger G. Mutation analysis of the Ras pathway genes NRAS, HRAS, KRAS and BRAF in glioblastomas. Acta Neuropathol 2004;108:467-70. (Pubitemid 39534587)
9. Siegelin MD, Raskett CM, Gilbert CA, Ross AH, Altieri DC. Sorafenib exerts anti-glioma activity in vitro and in vivo. Neurosci Lett 2010;478:165-70.
10. Azad NS, Posadas EM, Kwitkowski VE, Annunziata CM, Barrett T, Premkumar A, et al. Increased efficacy and toxicity with combination anti-VEGF therapy using sorafenib and bevacizumab (abstract). J Clin Oncol 24;18s, 2006 (suppl; abstr 3004).
11. Sosman JA, Flaherty KT, Atkins MB, Puzanov I, McDermott DF, Vermeulen W, et al. A phase I/II trial of sorafenib (S) with bevacizumab (B) in metastatic renal cell cancer (mRCC) patients (pts) (abstract). J Clin Oncol 24;18s, 2006 (suppl; abstr 3031).
12. Wen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol 2010;28:1963-72.
13. Pope WB, Kim HJ, Huo J, Alger J, Brown MS, Gjertson D, et al. Recurrent glioblastoma multiforme: ADC histogram analysis predicts response to bevacizumab treatment. Radiology 2009;252:182-9.
14. Mancuso P, Burlini A, Pruneri G, Goldhirsch A, Martinelli G, Bertolini F. Resting and activated endothelial cells are increased in the peripheral blood of cancer patients. Blood 2001;97:3658-61.
15. Khan SS, Solomon MA, McCoy JP Jr. Detection of circulating endothelial cells and endothelial progenitor cells by flow cytometry. Cytometry B Clin Cytom 2005;64:1-8. (Pubitemid 40960406)
16. Sargent DJ, Chan V, Goldberg RM. A three-outcome design for phase II clinical trials. Control Clin Trials 2001;22:117-25. (Pubitemid 32289448)
17. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Statist Soc B 1995;57:289-300.
18. Pope WB, Qiao XJ, Kim HJ, Lai A, Nghiemphu P, Xue X, et al. Apparent diffusion coefficient histogramanalysis stratifies progression-free and overall survival in patients with recurrent GBM treated with bevacizumab: a multi-center study. J Neurooncol 2012;108:491-8.
19. Ellingson BM, Cloughesy TF, Lai A, Mischel PS, Nghiemphu PL, Lalezari S, et al. Graded functional diffusion map-defined characteristics of apparent diffusion coefficients predict overall survival in recurrent glioblastoma treated with bevacizumab. Neuro Oncol 2011;13:1151-61.
20. Nghiemphu PL, Liu W, Lee Y, Than T, Graham C, Lai A, et al. Bevacizumab and chemotherapy for recurrent glioblastoma: a single-institution experience. Neurology 2009;72:1217-22.
21. Wu W, Lamborn KR, Buckner JC, Novotny PJ, Chang SM, O'Fallon JR, et al. Joint NCCTG and NABTC prognostic factors analysis for high-grade recurrent glioma. Neuro Oncol 2010;12:164-72.
22. Taal W, Oosterkamp HM, Walenkamp AME, Victor Beerepoot L, Hanse M, Buter J, et al. A randomized phase II study of bevacizumab versus bevacizumab plus lomustine versus lomustine single agent in recurrent glioblastoma: the Dutch BELOB study. J Clin Oncol 2013;31:114s.
23. Maree Field K, Simes J, Wheeler H, Hovey EJ, Nowak AK, Cher L, et al. A randomized phase II study of carboplatin and bevacizumab in recurrent glioblastoma multiforme (CABARET). J Clin Oncol 2013;31:118s.
24. Stark-Vance V. Bevacizumab and CPT-11 in the treatment of relapsed malignant glioma. Neuro Oncol 2005;7:369.
25. Lorgis V, Maura G, Coppa G, Hassani K, Taillandier L, Chauffert B, et al. Relation between bevacizumab dose intensity and high-grade glioma survival: a retrospective study in two large cohorts. J Neurooncol 2012;107:351-8.
26. Raval S, Hwang S, Dorsett L. Bevacizumab and irinotecan in patients (pts) with recurrent glioblastoma multiforme (GBM). J Clin Oncol 25;18s, 2007 (suppl; abstr 2078).
27. Kabbinavar F, Hurwitz HI, Fehrenbacher L, Meropol NJ, Novotny WF, Lieberman G, 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;21:60-5.
28. Nabors LB, Supko JG, Rosenfeld M, Chamberlain M, Phuphanich S, Batchelor T, et al. Phase I trial of sorafenib in patients with recurrent or progressive malignant glioma. Neuro Oncol 2011;13:1324-30.
29. Azad NS, Posadas EM, Kwitkowski VE, Steinberg SM, Jain L, Annunziata CM, et al. Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity. J Clin Oncol 2008;26:3709-14.
30. Lee JM, Sarosy GA, Annunziata CM, Azad N, Minasian L, Kotz H, et al. Combination therapy: intermittent sorafenib with bevacizumab yields activity and decreased toxicity. Br J Cancer 2010;102:495-9.
31. Feldman DR, Ginsberg MS, Baum M, Flombaum C, Hassoun H, Velasco S, et al. Phase I trial of bevacizumab plus sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol 26:15s, 2008 (suppl; abstr 5100).
32. Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, 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. J Clin Oncol 2008;26:4672-8.
33. Loupakis F, Ruzzo A, Salvatore L, Cremolini C, Masi G, Frumento P, et al. Retrospective exploratory analysis of VEGF polymorphismsin the prediction of benefit from first-line FOLFIRI plus bevacizumab in metastatic colorectal cancer. BMC Cancer 2011;11:247.
34. Jain L, Sissung TM, Danesi R, Kohn EC, Dahut WL, Kummar S, et al. Hypertension and hand-foot skin reactions related to VEGFR2 genotype and improved clinical outcome following bevacizumab and sorafenib. J Exp Clin Cancer Res 2010;29:95.