A randomized trial of bevacizumab for newly diagnosed glioblastoma

New England Journal of Medicine

Volumn 370, Issue 8, 2014, Pages 699-708

  Gilbert, Mark R ^a   Dignam, James J ^c,e   Armstrong, Terri S ^a,b   Wefel, Jeffrey S ^a   Blumenthal, Deborah T ^f   Vogelbaum, Michael A ^g   Colman, Howard ^h   Chakravarti, Arnab ⁱ   Pugh, Stephanie ^c   Won, Minhee ^c   Jeraj, Robert ^j   Brown, Paul D ^a   Jaeckle, Kurt A ^k   Schiff, David ^l   Stieber, Volker W ^m   Brachman, David G ⁿ   Werner Wasik, Maria ^d   Tremont Lukats, Ivo W ^a   Sulman, Erik P ^a   Aldape, Kenneth D ^a   Curran Jr , Walter J ^o   Mehta, Minesh P ^p   more..

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON   (United States)

^c AMERICAN COLLEGE OF RADIOLOGY   (United States)

^d THOMAS JEFFERSON UNIVERSITY   (United States)

^e UNIVERSITY OF CHICAGO   (United States)

^f TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^g LERNER RESEARCH INSTITUTE   (United States)

^h UNIVERSITY OF UTAH   (United States)

ⁱ OHIO STATE UNIVERSITY   (United States)

^j UNIVERSITY OF WISCONSIN MADISON   (United States)

^k MAYO CLINIC   (United States)

^l UNIVERSITY OF VIRGINIA   (United States)

^m Southeast Cancer Control Consortium   (United States)

ⁿ BARROW NEUROLOGICAL INSTITUTE   (United States)

^o EMORY UNIVERSITY   (United States)

^p UNIVERSITY OF MARYLAND   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; PLACEBO; TEMOZOLOMIDE;

ADULT; ADVERSE OUTCOME; ANEMIA; ARTICLE; BLEEDING; CANCER RADIOTHERAPY; CANCER RISK; CANCER SURVIVAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; FATIGUE; GLIOBLASTOMA; HUMAN; HYPERTENSION; INTESTINE PERFORATION; LEUKOPENIA; LYMPHOCYTOPENIA; MAINTENANCE CHEMOTHERAPY; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; RISK REDUCTION; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT DURATION; TREATMENT RESPONSE; WOUND DEHISCENCE;

EID: 84894114159     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1308573     Document Type: Article

References (30)

1. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 2005;352:987-96. (Pubitemid 40349501)
2. Lacroix M, Abi-Said D, Fourney DR, et al. A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extent of resection, and survival. J Neurosurg 2001;95:190-8. (Pubitemid 32799739)
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;10:459-66.
4. Lund EL, Spang-Thomsen M, Skovgaard-Poulsen H, Kristjansen PE. Tumor angiogenesis - a new therapeutic target in gliomas. Acta Neurol Scand 1998;97:52-62. (Pubitemid 28057388)
5. 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)
6. Batchelor TT, Mulholland P, Neyns B, et al. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol 2013;31:3212-8.
7. Lee EQ, Kuhn J, Lamborn KR, et al. Phase I/II study of sorafenib in combination with temsirolimus for recurrent glioblastoma or gliosarcoma: North American Brain Tumor Consortium study 05-02. Neuro Oncol 2012;14:1511-8.
8. Ferrara N, Hillan KJ, Novotny W. Bevacizumab (Avastin), a humanized anti-VEGF monoclonal antibody for cancer therapy. Biochem Biophys Res Commun 2005;333:328-35. (Pubitemid 40848295)
9. Friedman HS, Prados MD, Wen PY, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol 2009;27:4733-40.
10. 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;27:740-5.
11. Jain RK. Normalization of tumor vasculature: an emerging concept in antiangiogenic therapy. Science 2005;307:58-62. (Pubitemid 40093472)
12. Zelen M. The randomization and stratification of patients to clinical trials. J Chronic Dis 1974;27:365-75.
13. Colman H, Zhang L, Sulman EP, et al. A multigene predictor of outcome in glioblastoma. Neuro Oncol 2010;12:49-57.
14. Vlassenbroeck I, Califice S, Diserens AC, et al. Validation of real-time methylation-specific PCR to determine O6-methylguanine-DNA methyltransferase gene promoter methylation in glioma. J Mol Diagn 2008;10:332-7. (Pubitemid 352019119)
15. Armstrong TS, Mendoza T, Gning I, et al. Validation of the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT). J Neurooncol 2006;80:27-35. (Pubitemid 44473259)
16. Osoba D, Aaronson NK, Muller M, et al. The development and psychometric validation of a brain cancer quality-of-life questionnaire for use in combination with general cancer-specific questionnaires. Qual Life Res 1996;5:139-50. (Pubitemid 26100512)
17. Wefel JS, Cloughesy T, Zazzali JL, et al. Neurocognitive function in patients with recurrent glioblastoma treated with bevacizumab. Neuro Oncol 2011;13:660-8.
18. Armstrong TS, Wefel JS, Wang M, et al. Net clinical benefit analysis of Radiation Therapy Oncology Group 0525: a phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma. J Clin Oncol 2013; 31:4076-84.
19. Macdonald DR, Cascino TL, Schold SC Jr, Cairncross JG. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 1990;8:1277-80. (Pubitemid 20195640)
20. Sanghera P, Perry J, Sahgal A, et al. Pseudoprogression following chemoradio-therapy for glioblastoma multiforme. Can J Neurol Sci 2010;37:36-42.
21. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966;50:163-70.
22. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
23. Cox DR. Regression models and life-tables. J R Stat Soc B 1972;34:187-202.
24. Grambsch P, Louis TA, Bostick RM, et al. Statistical analysis of proliferative index data in clinical trials. Stat Med 1994;13:1619-34. (Pubitemid 24275841)
25. Müller HG, Wang JL. Hazard rate estimation under random censoring with varying kernels and bandwidths. Biometrics 1994;50:61-76.
26. Vredenburgh JJ, Desjardins A, Reardon DA, et al. The addition of bevacizumab to standard radiation therapy and temozolomide followed by bevacizumab, temozolomide, and irinotecan for newly diagnosed glioblastoma. Clin Cancer Res 2011;17:4119-24.
27. Lai A, Tran A, Nghiemphu PL, et al. Phase II study of bevacizumab plus temozolomide during and after radiation therapy for patients with newly diagnosed glioblastoma multiforme. J Clin Oncol 2011;29:142-8.
28. Chinot OL, Wick W, Mason W, et al. Bevacizumab plus radiotherapy- temozolomide for newly diagnosed glioblastoma. N Engl J Med 2014;370:709-22.
29. Sorensen AG, Batchelor TT, Wen PY, Zhang WT, Jain RK. Response criteria for glioma. Nat Clin Pract Oncol 2008;5:634-44.
30. Mackenzie F, Ruhrberg C. Diverse roles for VEGF-A in the nervous system. Development 2012;139:1371-80.