For information about COVID-19, including symptoms and prevention, please read our COVID-19 patient guide. Please also consider supporting Weill Cornell Medicine’s efforts against the pandemic.

CODEL: Phase III study of RT, RT + Temozolomide (TMZ), or TMZ for newly-diagnosed 1p/19q Codeleted Oligodendroglioma. Analysis from the initial study design.

TitleCODEL: Phase III study of RT, RT + Temozolomide (TMZ), or TMZ for newly-diagnosed 1p/19q Codeleted Oligodendroglioma. Analysis from the initial study design.
Publication TypeJournal Article
Year of Publication2020
AuthorsJaeckle KA, Ballman KV, van den Bent M, Giannini C, Galanis E, Brown PD, Jenkins RB, J Cairncross G, Wick W, Weller M, Aldape KD, Dixon JG, S Anderson K, Cerhan JH, Wefel JS, Klein M, Grossman SA, Schiff D, Raizer JJ, Dhermain F, Nordstrom DG, Flynn PJ, Vogelbaum MA
JournalNeuro Oncol
Date Published2020 Jul 17
ISSN1523-5866
Abstract

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.

DOI10.1093/neuonc/noaa168
Alternate JournalNeuro-oncology
PubMed ID32678879
Division: 
Biostatistics
Category: 
Faculty Publication