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Clinical Trial
. 2021 Mar 25;23(3):457-467.
doi: 10.1093/neuonc/noaa168.

CODEL: phase III study of RT, RT + TMZ, or TMZ for newly diagnosed 1p/19q codeleted oligodendroglioma. Analysis from the initial study design

Kurt A Jaeckle  1 , Karla V Ballman  2 , Martin van den Bent  3 , Caterina Giannini  4 , Evanthia Galanis  4 , Paul D Brown  4 , Robert B Jenkins  4 , J Gregory Cairncross  5 , Wolfgang Wick  6 , Michael Weller  7 , Kenneth D Aldape  8 , Jesse G Dixon  9 , S Keith Anderson  9 , Jane H Cerhan  10 , Jeffrey S Wefel  11 , Martin Klein  12 , Stuart A Grossman  13 , David Schiff  14 , Jeffrey J Raizer  15 , Frederick Dhermain  16 , Donald G Nordstrom  17 , Patrick J Flynn  18 , Michael A Vogelbaum  19
Affiliations
Clinical Trial

CODEL: phase III study of RT, RT + TMZ, or TMZ for newly diagnosed 1p/19q codeleted oligodendroglioma. Analysis from the initial study design

Kurt A Jaeckle et al. Neuro Oncol. .

Abstract

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.

Keywords: 1p/19q; CODEL; N0577; codeleted; oligodendroglioma.

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Figures

Fig. 1
Fig. 1
CONSORT diagram.
Fig. 2
Fig. 2
(A) Overall survival arm A vs arm B. (B) Overall survival arms A + B vs arm C.
Fig. 3
Fig. 3
Progression-free survival (arms A + B vs arm C).
See this image and copyright information in PMC

Comment in

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