AVAglio: Phase 3 trial of bevacizumab plus temozolomide and radiotherapy in newly diagnosed glioblastoma multiforme

Advances in Therapy

Volumn 28, Issue 4, 2011, Pages 334-340

  Chinot, O L ^a   De La Motte Rouge, T ^b   Moore, N ^c   Zeaiter, A ^c   Das, A ^d   Phillips, H ^d   Modrusan, Z ^d   Cloughesy, T ^e  

^a TIMONE HOSPITAL   (France)

^b PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

^d GENENTECH INC   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Bevacizumab; Clinical trial; Glioblastoma multiforme; Phase 3

Indexed keywords

BEVACIZUMAB; PLACEBO; TEMOZOLOMIDE;

ADJUVANT THERAPY; ARTICLE; CANCER RADIOTHERAPY; CLINICAL PROTOCOL; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; EUROPE; GLIOBLASTOMA; HUMAN; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGNOSIS; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RADIATION DOSE FRACTIONATION; TREATMENT OUTCOME; UNITED STATES;

ADULT; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS, ALKYLATING; BRAIN NEOPLASMS; CLINICAL PROTOCOLS; CLINICAL TRIALS, PHASE III AS TOPIC; COMBINED MODALITY THERAPY; DACARBAZINE; EUROPE; GLIOBLASTOMA; HUMANS; PROGNOSIS; RADIOTHERAPY; RECURRENCE; STANDARD OF CARE; TREATMENT OUTCOME;

EID: 79958210803     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-011-0007-3     Document Type: Article

References (27)

1. Adamson C, Kanu OO, Mehta AI, et al. Glioblastoma mutliforme: a review of where we have been and where we are going. Expert Opin Investig Drugs. 2009;18:1061-1083.
2. Ohgaki H. Epidemiology of brain tumors. Methods Mol Biol. 2009;472:323-342.
3. Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009;10:459-466.
4. 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. (Pubitemid 36910021)
5. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350:2335-2342. (Pubitemid 38702844)
6. 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. (Pubitemid 44917502)
7. 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.
8. Ferrara N. Vascular endothelial growth factor: basic science and clinical progress. Endocr Rev. 2004;25:581-611. (Pubitemid 39099316)
9. Hicklin DJ, Ellis LM. Role of the vascular endothelial growth factor pathway in tumor growth and angiogenesis. J Clin Oncol. 2005;23:1011-1127.
10. Gerber HP, Ferrara N. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or in combination with cytotoxic therapy in preclinical studies. Cancer Res. 2005;65:671-680. (Pubitemid 40216420)
11. Mathieu V, De Neve N, Le Mercier M, et al. Combining bevacizumab with temozolomide increases the antitumor efficacy of temozolomide in a human glioblastoma orthotopic xenograft model. Neoplasia. 2008;10:1383-1392.
12. Lee CG, Heijn M, di Tomaso E, et al. Anti-vascular endothelial growth factor treatment augments tumour radiation response under normoxic or hypoxic conditions. Cancer Res. 2000;60:5565-5570.
13. Vredenburgh JJ, Desjardins A, Herndon JE 2nd, et al. Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. J Clin Oncol. 2007;25:4722-4729. (Pubitemid 350086473)
14. Kreisl TN, Kim L, Moore K, et al. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol. 2009;27:740-745.
15. Friedman HS, Prados MD, Wen PY, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009;27:4733-4740.
16. Vredenburgh JJ, Wefel J, Coughesy T, et al. Clinical assessment of corticosteroid use and neurocognitive function in patients with glioblastoma at first or second relapse treated with bevacizumab in the BRAIN study. Eur J Cancer Suppl. 2009;7:495 (abstract O-8701).
17. Lai A, Filka E, McGibbon B, et al. Phase II pilot study of bevacizumab in combination with temozolomide and regional radiation therapy for up-front treatment of patients with newly diagnosed glioblastoma multiforme: interim analysis of safety and tolerability. Int J Radiat Oncol Biol Phys. 2008;71:1372-1380.
18. Narayana A, Golfinos JG, Fischer I, et al. Feasibility of using bevacizumab with radiation therapy and temozolomide in newly diagnosed high-grade glioma. Int J Radiat Oncol Biol Phys. 2008;72:383-389.
19. Lai A, Tran A Nghiemphu PL, et al. Phase II trial of bevacizumab plus temozolomide during and after radiation therapy for patients with newly diagnosed glioblastoma multiforme. J Clin Oncol. 2011;29:142-148.
20. Gruber ML, Raza S, Gruber D, Narayana A. Bevacizumab in combination with radiotherapy plus concomitant and adjuvant temozolomide for newly diagnosed glioblastoma: update progression-free survival, overall survival, and toxicity. J Clin Oncol. 2009;27(Suppl):15s (abstract 2017).
21. Anon. A study of Avastin (bevacizumab) in combination with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma. Available at: http://clinicaltrials.gov/ct2/show/ NCT00943826. Accessed July 14, 2010.
22. Chinot O, de La Motte Rouge T, Moore N, Zeaiter A. Addition of bevacizumab to the multi-modality standard care in patients with newly diagnosed glioblastoma: a phase III trial. Poster presented at: 34th ESMO Multidisciplinary Congress, September 20-24, 2009; Berlin, Germany.
23. Wen PY, Macdonald DR, Reardon DA, et al. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010;28:1963-1972.
24. Lucio-Eterovic AK, Piao Y, de Groot JF. Mediators of glioblastoma resistance and invasion during antivascular endothelial growth factor therapy. Clin Cancer Res. 2009;15:4589-4599.
25. Pope WB, Xia Q, Paton VE, et al. Patterns of progression in patients with recurrent glioblastoma treated with bevacizumab. Neurology. 2011;76:432-437.
26. Wick W, Wick A, Weiler M, Weller M. Patterns of progression in malignant glioma following anti-VEGF therapy: perceptions and evidence. Curr Neurol Neurosci Rep. In press.
27. Anon. Temozolomide and radiation therapy with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma. Available at: http://clinicaltrials.gov/ct2/show/ NCT00884741. Accessed July 14, 2010.