A Randomized Trial of Bevacizumab for Newly Diagnosed Glioblastoma
Open accessAbstract
BACKGROUND: Concurrent treatment with temozolomide and radiotherapy followed by maintenance temozolomide is the standard of care for patients with newly diagnosed glioblastoma. Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor A, is currently approved for recurrent glioblastoma. Whether the addition of bevacizumab would improve survival among patients with newly diagnosed glioblastoma is not known. METHODS: In this randomized, double-blind, placebo-controlled trial, we treated adults who had centrally confirmed glioblastoma with radiotherapy (60 Gy) and daily temozolomide. Treatment with bevacizumab or placebo began during week 4 of radiotherapy and was continued for up to 12 cycles of maintenance chemotherapy. At disease progression, the assigned treatment was revealed, and bevacizumab therapy could be initiated or continued. The trial was designed to detect a 25% reduction in the risk of death and a 30% reduction in the risk of progression or death, the two coprimary end points, with the addition of bevacizumab. RESULTS: A total of 978 patients were registered, and 637 underwent randomization. There was no significant difference in the duration of overall survival between the bevacizumab group and the placebo group (median, 15.7 and 16.1 months, respectively; hazard ratio for death in the bevacizumab group, 1.13). Progression-free survival was longer in the bevacizumab group (10.7 months vs. 7.3 months; hazard ratio for progression or death, 0.79). There were modest increases in rates of hypertension, thromboembolic events, intestinal perforation, and neutropenia in the bevacizumab group. Over time, an increased symptom burden, a worse quality of life, and a decline in neurocognitive function were more frequent in the bevacizumab group. CONCLUSIONS: First-line use of bevacizumab did not improve overall survival in patients with newly diagnosed glioblastoma. Progression-free survival was prolonged but did not reach the prespecified improvement target. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00884741.).
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One of the 6 out-of-sample sites (Site 11) contributed aggregated a priori data from a multi-site randomized clinical trial for newly diagnosed glioblastoma.
“One of these 6 out-of-sample sites (Site 11) contributed aggregated a priori data from a multi-site randomized clinical trial for newly diagnosed glioblastoma (ClinicalTrials.gov Identifier: NCT00884741, RTOG082572,73, ACRIN668674,75), with inherent diversity benefiting the intended generalizability validation purpose.”
From Federated learning enables big data for rare cancer boundary detection (2022) · cites this paper as [73]
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“The disease prognosis is poor, with an estimated five-year overall survival (OS) rate of 6.9% [1] and a median OS of 12–16 months after diagnosis [2, 3].”
Influential
- Authors
- Gilbert, M. R., Dignam, J. J., Armstrong, T. S., Wefel, J. S., Blumenthal, D. T., Vogelbaum, M. A., Colman, H., Chakravarti, A., Pugh, S., Won, M., Jeraj, R., Brown, P. D., Jaeckle, K. A., Schiff, D., Stieber, V. W., Brachman, D. G., Werner-Wasik, M., Tremont-Lukats, I. W., Sulman, E. P., Aldape, K. D., Curran, W. J., & Mehta, M. P.
- Affiliations
- University of Maryland, Baltimore (US)
- American College of Radiology (US)
- The University of Texas MD Anderson Cancer Center (US)
- Tel Aviv Sourasky Medical Center (IL)
- Cleveland Clinic (US)
- University of Utah (US)
- The Ohio State University (US)
- University of Wisconsin–Madison (US)
- Mayo Clinic in Florida (US)
- University of Virginia (US)
- Barrow Neurological Institute (US)
- ORCID
- Gilbert, Mark R.
- Dignam, James J.
- Armstrong, Terri S.
- Wefel, Jeffrey S.
- Blumenthal, Deborah T.
- Vogelbaum, Michael A.
- Colman, Howard
- Chakravarti, Arnab
- Pugh, Stephanie
- Won, Minhee
- Jeraj, Robert
- Brown, Paul D.
- Jaeckle, Kurt A.
- Schiff, David
- Stieber, Volker W.
- Sulman, Erik P.
- Aldape, Kenneth D.
- Curran, Walter J.
- Mehta, Minesh P.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-02-20
- Volume
- 370
- Issue
- 8
- Pages
- 699-708
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4201043
- OpenAlex
- W2124736921
- Cited by
- 2,834
- References
- 33
- Citations by year
- 2026: 124 · 2025: 151 · 2024: 189 · 2023: 208 · 2022: 225 · 2021: 265 · 2020: 266 · 2019: 247 · 2018: 247 · 2017: 251 · 2016: 242 · 2015: 246 · 2014: 166 · 2013: 1
- FWCI
- 151.36
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- The Medicine Forum (submittedVersion)
- Funders
- National Institutes of Health (UL1TR000427)
- National Cancer Institute (U10-CA-21661, U10CA037422, U10CA37422, U10CA021661, P30CA016672, P30CA056036)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Genetics › Glioma Diagnosis and Treatment
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Angiogenesis and VEGF in Cancer
- Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
- Keywords
- bevacizumab, glioblastoma, newly diagnosed glioblastoma, temozolomide, radiotherapy, maintenance chemotherapy, VEGF-A, first-line therapy, overall survival, progression-free survival, adverse events, quality of life, neurocognitive decline
- MeSH terms
- Bevacizumab, Temozolomide, Adult, Brain Neoplasms, Combined Modality Therapy, Dacarbazine, Double-Blind Method, Glioblastoma, Humans, Proportional Hazards Models, Survival Analysis, Disease-Free Survival, Angiogenesis Inhibitors, Antibodies, Monoclonal, Humanized
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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