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Clinical Trial
. 2015 Mar 1;91(3):497-504.
doi: 10.1016/j.ijrobp.2014.11.012. Epub 2015 Jan 30.

Phase 2 study of temozolomide-based chemoradiation therapy for high-risk low-grade gliomas: preliminary results of Radiation Therapy Oncology Group 0424

Barbara J Fisher  1 , Chen Hu  2 , David R Macdonald  3 , Glenn J Lesser  4 , Stephen W Coons  5 , David G Brachman  6 , Samuel Ryu  7 , Maria Werner-Wasik  8 , Jean-Paul Bahary  9 , Junfeng Liu  10 , Arnab Chakravarti  11 , Minesh Mehta  12
Affiliations
Clinical Trial

Phase 2 study of temozolomide-based chemoradiation therapy for high-risk low-grade gliomas: preliminary results of Radiation Therapy Oncology Group 0424

Barbara J Fisher et al. Int J Radiat Oncol Biol Phys. .

Abstract

Purpose: Radiation Therapy Oncology Group (RTOG) 0424 was a phase 2 study of a high-risk low-grade glioma (LGG) population who were treated with temozolomide (TMZ) and radiation therapy (RT), and outcomes were compared to those of historical controls. This study was designed to detect a 43% increase in median survival time (MST) from 40.5 to 57.9 months and a 20% improvement in 3-year overall survival (OS) rate from 54% to 65% at a 10% significance level (1-sided) and 96% power.

Methods and materials: Patients with LGGs with 3 or more risk factors for recurrence (age ≥40 years, astrocytoma histology, bihemispherical tumor, preoperative tumor diameter of ≥6 cm, or a preoperative neurological function status of >1) were treated with RT (54 Gy in 30 fractions) and concurrent and adjuvant TMZ.

Results: From 2005 to 2009, 129 evaluable patients (75 males and 54 females) were accrued. Median age was 49 years; 91% had a Zubrod score of 0 or 1; and 69%, 25%, and 6% of patients had 3, 4, and 5 risk factors, respectively. Patients had median and minimum follow-up examinations of 4.1 years and 3 years, respectively. The 3-year OS rate was 73.1% (95% confidence interval: 65.3%-80.8%), which was significantly improved compared to that of prespecified historical control values (P<.001). Median survival time has not yet been reached. Three-year progression-free survival was 59.2%. Grades 3 and 4 adverse events occurred in 43% and 10% of patients, respectively. One patient died of herpes encephalitis.

Conclusions: The 3-year OS rate of 73.1% for RTOG 0424 high-risk LGG patients is higher than that reported for historical controls (P<.001) and the study-hypothesized rate of 65%.

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Conflict of interest statement

Conflict of interest: none.

Figures

Fig. 1
Fig. 1
Overall and progression-free survival of RTOG 0424 patients.
Fig. 2
Fig. 2
Overall survival of RTOG 0424 patients reclassified according to the EORTC LGG prognostic model. LGG = low-grade glioma.
See this image and copyright information in PMC

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