RTOG 0825: Phase III double-blind placebo-controlled trial evaluating bevacizumab (Bev) in patients (Pts) with newly diagnosed glioblastoma (GBM).
Abstract
1 Background: Chemoradiation (CRT) with temozolomide (TMZ/RT→TMZ) is the standard of care for newly diagnosed GBM. This trial determined if the addition of Bev to standard CRT improves survival (OS) or progression-free survival (PFS) in newly diagnosed GBM. Methods: This phase III trial was conducted by the RTOG, NCCTG, and ECOG. Neurologically stable pts > 18 yrs with KPS ≥ 60, and > 1cm 3 tumor tissue block, were randomized to Arm 1: standard CRT + placebo or Arm 2: standard CRT plus Bev (10 mg/kg iv q 2wks). Experimental treatment began at wk 4 of radiation then thru 6-12 cycles of maintenance chemotherapy. Protocol specified co-primary endpoints were OS and PFS, with significance levels of .023 and .002, respectively. At progression, treatment was unblinded and pts allowed to crossover or continue Bev. Symptom, QOL and neurocognitive (NCF) testing was performed in the majority of pts. Secondary analyses evaluated impact of MGMT methylation (meth) and prognostic 9 gene signature status. Results: From 978 registered pts, 637 were randomized. Inadequate tissue (n=105) and blood on imaging (n=40) were key reasons for non-randomization. No difference was found between arms for OS (median 16.1 vs. 15.7 mo, p = 0.11). PFS was extended for Arm 2 (7.3 vs. 10.7 mo, p = 0.004). Pts with MGMT meth had superior OS (23.2 vs. 14.3 mo, p < 0.001) and PFS (14.1 vs. 8.2 mo, p < 0.001). Neither the 9 gene signature nor MGMT predicted selective benefit for Bev treatment, but best prognosis pts (MGMT meth, favorable 9-gene), had a worse survival trend with Bev (15.7 vs 25 mo p = 0.08). To date, 128 pts were unblinded on Arm 1 (salvage Bev in 86) and 87 pts on Arm 2 (continued Bev in 39). Increased grade ≥ 3 toxicity was seen with Bev, mostly neutropenia, hypertension, and DVT/PE. Conclusions: The addition of Bev for newly diagnosed GBM did not improve OS, did improve PFS but did not reach the significance criterion. MGMT and 9 gene profile did not identify selective benefit, but risk subset results suggested strongly against the upfront use of Bev in the best prognosis pts. Full interpretation of the PFS results incorporating symptom burden, QOL, and NCF is ongoing. Support: NCI U10 CA 21661, U10 CA37422, and Genentech. Clinical trial information: 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.”
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- Authors
- Gilbert, M. R., Dignam, J., Won, M., Blumenthal, D. T., Vogelbaum, M. A., Aldape, K. D., Colman, H., Chakravarti, A., Jeraj, R., Armstrong, T. S., Wefel, J. S., Brown, P. D., Jaeckle, K. A., Schiff, D., Atkins, J. N., Brachman, D., Werner-Wasik, M., Komaki, R., Sulman, E. P., & Mehta, M. P.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- RTOG Foundation (US)
- Tel Aviv Sourasky Medical Center (IL)
- Cleveland Clinic (US)
- University of Utah (US)
- The Ohio State University (US)
- University of Wisconsin–Madison (US)
- The University of Texas Health Science Center at Houston (US)
- Mayo Clinic in Florida (US)
- University of Virginia Medical Center (US)
- NSABP Foundation (US)
- Arizona Oncology Services Foundation, Phoenix, AZ
- Thomas Jefferson University Hospital, Philadelphia, PA
- University of Maryland, Baltimore (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2013-06-20
- Volume
- 31
- Issue
- 18_suppl
- Pages
- 1-1
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W4251989766
- Cited by
- 70
- References
- 0
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 1 · 2023: 7 · 2022: 6 · 2021: 1 · 2020: 2 · 2019: 5 · 2018: 1 · 2017: 2 · 2016: 3 · 2015: 6 · 2014: 20 · 2013: 11
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- 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
- glioblastoma, bevacizumab, chemoradiotherapy, temozolomide, overall survival, progression-free survival, MGMT promoter methylation, predictive biomarkers, salvage therapy, neurocognitive function, quality of life, treatment toxicity, newly diagnosed glioblastoma, maintenance chemotherapy
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