Journal article
CODEL: Phase III study of RT, RT + Temozolomide (TMZ), or TMZ for newly-diagnosed 1p/19q Codeleted Oligodendroglioma. Analysis from the initial study design.
- Jaeckle KA Department of Neurology, Mayo Clinic Florida, Jacksonville FL.
- Ballman KV Alliance Statistics and Data Center, Weill Cornell Medicine, New York, NY.
- van den Bent M Brain Tumor Center, Erasmus MC Cancer Center, Erasmus University Medical Center, Rotterdam, The Netherlands.
- Giannini C Department of Radiation Oncology, Mayo Clinic, Rochester MN.
- Galanis E Department of Radiation Oncology, Mayo Clinic, Rochester MN.
- Brown PD Department of Radiation Oncology, Mayo Clinic, Rochester MN.
- Jenkins RB Department of Radiation Oncology, Mayo Clinic, Rochester MN.
- Cairncross JG Department of Clinical Neurosciences, Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, Alberta, Canada.
- Wick W Neurologische Klinik, University of Heidelberg, Heidelberg Germany.
- Weller M Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.
- Aldape KD Department of Neuropathology, University of Texas MD Anderson Cancer Center, Houston, TX.
- Dixon JG Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
- Anderson SK Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
- Cerhan JH Departments of Psychiatry and Psychology. , University of Texas MD Anderson Cancer Center, Houston, TX.
- Wefel JS Departments of Neuro-Oncology and Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX.
- Klein M Department of Medical Psychology, VU University Medical Center, Amsterdam, The Netherlands.
- Grossman SA Department of Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore MD.
- Schiff D Department of Neurology, University of Virginia, Charlottesville, VA.
- Raizer JJ Department of Neurology, Northwestern University, Chicago, IL.
- Dhermain F Department of Radiation Therapy, Institut de Cancerologie Gustave Roussy, Villejuif France.
- Nordstrom DG Medical Oncology, France Abben Cancer Center, Spencer, IA.
- Flynn PJ Medical Oncology, Minnesota Oncology, Northfield MN.
- Vogelbaum MA Dept. of Neurosurgery, Cleveland Clinic, Cleveland OH.
- 2020-07-18
Published in:
- Neuro-oncology. - 2020
English
BACKGROUND
We report the analysis involving patients treated on the initial CODEL design.
METHODS
Adults (>18) with newly-diagnosed 1p/19q WHO grade III oligodendroglioma were randomized to RT (5940 cGy) 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 to RT-treated patients (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 IDH status (mutated/wildtype) in a Cox regression model utilizing IDH and RT treatment status as co-variables (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.
We report the analysis involving patients treated on the initial CODEL design.
METHODS
Adults (>18) with newly-diagnosed 1p/19q WHO grade III oligodendroglioma were randomized to RT (5940 cGy) 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 to RT-treated patients (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 IDH status (mutated/wildtype) in a Cox regression model utilizing IDH and RT treatment status as co-variables (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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1093/neuonc/noaa168
- PMID 32678879
- Persistent URL
- https://folia.unifr.ch/global/documents/50370
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