CODEL: Phase III study of RT, RT + TMZ, or TMZ for newly diagnosed 1p/19q codeleted oligodendroglioma. Analysis from the initial study design
Open accessAbstract
Background: We report the analysis involving patients treated on the initial CODEL design. Methods: Adults (>18) with newly diagnosed 1p/19q World Health Organization (WHO) grade III oligodendroglioma were randomized to radiotherapy (RT; 5940 centigray ) alone (arm A); RT with concomitant and adjuvant temozolomide (TMZ) (arm B); or TMZ alone (arm C). Primary endpoint was overall survival (OS), arm A versus B. Secondary comparisons were performed for OS and progression-free survival (PFS), comparing pooled RT arms versus TMZ-alone arm. Results: Thirty-six patients were randomized equally. At median follow-up of 7.5 years, 83.3% (10/12) TMZ-alone patients progressed, versus 37.5% (9/24) on the RT arms. PFS was significantly shorter in TMZ-alone patients compared with RT patients (hazard ratio [HR] = 3.12; 95% CI: 1.26, 7.69; P = 0.014). Death from disease progression occurred in 3/12 (25%) of TMZ-alone patients and 4/24 (16.7%) on the RT arms. OS did not statistically differ between arms (comparison underpowered). After adjustment for isocitrate dehydrogenase (IDH) status (mutated/wildtype) in a Cox regression model utilizing IDH and RT treatment status as covariables (arm C vs pooled arms A + B), PFS remained shorter for patients not receiving RT (HR = 3.33; 95% CI: 1.31, 8.45; P = 0.011), but not OS ((HR = 2.78; 95% CI: 0.58, 13.22, P = 0.20). Grade 3+ adverse events occurred in 25%, 42%, and 33% of patients (arms A, B, and C). There were no differences between arms in neurocognitive decline comparing baseline to 3 months. Conclusions: TMZ-alone patients experienced significantly shorter PFS than patients treated on the RT arms. The ongoing CODEL trial has been redesigned to compare RT + PCV versus RT + TMZ.
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Anaplastic oligodendrogliomas (AOs) are central nervous system (CNS) World Health Organization (WHO) grade 3 gliomas characterized by isocitrate dehydrogenase (IDH) mutation and 1p/19q codeletion.
“Anaplastic oligodendrogliomas (AOs) are central nervous system (CNS) World Health Organization (WHO) grade 3 gliomas characterized by isocitrate dehydrogenase (IDH) mutation (m)IDH and 1p/19q codeletion.”
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“Anaplastic oligodendrogliomas (AOs) are central nervous system (CNS) World Health Organization (WHO) grade 3 gliomas characterized by isocitrate dehydrogenase mutations (mIDHs) and 1p/19q codeletion [1,2].”
- Authors
- Jaeckle, K. A., Ballman, K. V., van den Bent, M., Giannini, C., Galanis, E., Brown, P. D., Jenkins, R. B., Cairncross, J. G., Wick, W., Weller, M., Aldape, K. D., Dixon, J. G., Anderson, S. K., Cerhan, J. H., Wefel, J. S., Klein, M., Grossman, S. A., Schiff, D., Raizer, J. J., Dhermain, F., Nordstrom, D. G., Flynn, P. J., & Vogelbaum, M. A.
- Affiliations
- Mayo Clinic in Florida (US)
- Weill Cornell Medicine (US)
- Brain Tumor Center, Erasmus MC Cancer Center, Erasmus University Medical Center, Rotterdam, Netherlands
- Mayo Clinic (US)
- University of Calgary (CA)
- Heidelberg University (DE)
- University of Zurich (CH)
- The University of Texas MD Anderson Cancer Center (US)
- Departments of Psychiatry and Psychology, Houston, Texas, USA
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- Johns Hopkins University (US)
- University of Virginia (US)
- Northwestern University (US)
- Institut Gustave Roussy (FR)
- Medical Oncology, France Abben Cancer Center, Spencer, Iowa, USA
- Minnesota Oncology (US)
- Cleveland Clinic (US)
- Corresponding author
- Jaeckle, Kurt A
- ORCID
- Jaeckle, Kurt A
- Ballman, Karla V
- Giannini, Caterina
- Galanis, Evanthia
- Brown, Paul D
- Jenkins, Robert B
- Cairncross, J Gregory
- Wick, Wolfgang
- Weller, Michael
- Aldape, Kenneth D
- Dixon, Jesse G
- Anderson, S Keith
- Cerhan, Jane H
- Wefel, Jeffrey S
- Klein, Martin
- Grossman, Stuart A
- Schiff, David
- Raizer, Jeffrey J
- Flynn, Patrick J
- Vogelbaum, Michael A
- Venue
- Neuro-Oncology
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-07-17
- Volume
- 23
- Issue
- 3
- Pages
- 457-467
- ISSN
- 1522-8517 (ISSN-L)
- 1523-5866
- PMC
- PMC7992874
- OpenAlex
- W3043701315
- Cited by
- 119
- References
- 24
- Citations by year
- 2026: 14 · 2025: 18 · 2024: 27 · 2023: 16 · 2022: 25 · 2021: 17 · 2020: 2
- FWCI
- 7.76
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Neuro-Oncology (publishedVersion, public-domain)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion, other-oa)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
- Pure Amsterdam UMC (acceptedVersion, public-domain)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, public-domain)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- National Cancer Institute
- National Institutes of Health (U10CA180821, U10CA180882)
- Alliance for Clinical Trials in Oncology (UG1CA233320, UG1CA233329, UG1CA232760, U10CA180820, U10CA180863, U10CA180868)
- Topics
- Health Sciences › Medicine › Genetics › Glioma Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
- Keywords
- newly diagnosed glioma, radiotherapy, temozolomide, progression-free survival, overall survival, IDH mutation, treatment toxicity, neurocognitive decline, WHO grade III
- MeSH terms
- Temozolomide, Progression-Free Survival, Adult, Brain Neoplasms, Humans, Isocitrate Dehydrogenase, Oligodendroglioma
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