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Clinical Trial
. 2017 Feb 1;19(2):252-258.
doi: 10.1093/neuonc/now236.

Phase III randomized study of radiation and temozolomide versus radiation and nitrosourea therapy for anaplastic astrocytoma: results of NRG Oncology RTOG 9813

Susan Chang  1 , Peixin Zhang  2 , J Gregory Cairncross  3 , Mark R Gilbert  4 , Jean-Paul Bahary  5 , Carol A Dolinskas  6 , Arnab Chakravarti  7 , Kenneth D Aldape  8 , Erica H Bell  9 , David Schiff  10 , Kurt Jaeckle  11 , Paul D Brown  4 , Geoffrey R Barger  12 , Maria Werner-Wasik  13 , Helen Shih  14 , David Brachman  15 , Marta Penas-Prado  4 , H Ian Robins  16 , Karl Belanger  5 , Christopher Schultz  17 , Grant Hunter  18 , Minesh Mehta  19
Affiliations
Clinical Trial

Phase III randomized study of radiation and temozolomide versus radiation and nitrosourea therapy for anaplastic astrocytoma: results of NRG Oncology RTOG 9813

Susan Chang et al. Neuro Oncol. .

Erratum in

  • Corrigendum.
    [No authors listed] [No authors listed] Neuro Oncol. 2017 Feb 1;19(2):e1. doi: 10.1093/neuonc/nox004. Neuro Oncol. 2017. PMID: 28391301 Free PMC article. No abstract available.

Abstract

Background: The primary objective of this study was to compare the overall survival (OS) of patients with anaplastic astrocytoma (AA) treated with radiotherapy (RT) and either temozolomide (TMZ) or a nitrosourea (NU). Secondary endpoints were time to tumor progression (TTP), toxicity, and the effect of IDH1 mutation status on clinical outcome.

Methods: Eligible patients with centrally reviewed, histologically confirmed, newly diagnosed AA were randomized to receive either RT+TMZ (n = 97) or RT+NU (n = 99). The study closed early because the target accrual rate was not met.

Results: Median follow-up time for patients still alive was 10.1 years (1.9-12.6 y); 66% of the patients died. Median survival time was 3.9 years in the RT/TMZ arm (95% CI, 3.0-7.0) and 3.8 years in the RT/NU arm (95% CI, 2.2-7.0), corresponding to a hazard ratio (HR) of 0.94 (P = .36; 95% CI, 0.67-1.32). The differences in progression-free survival (PFS) and TTP between the 2 arms were not statistically significant. Patients in the RT+NU arm experienced more grade ≥3 toxicity (75.8% vs 47.9%, P < .001), mainly related to myelosuppression. Of the 196 patients, 111 were tested for IDH1-R132H status (60 RT+TMZ and 51 RT+NU). Fifty-four patients were IDH negative and 49 were IDH positive with a better OS in IDH-positive patients (median survival time 7.9 vs 2.8 y; P = .004, HR = 0.50; 95% CI, 0.31-0.81).

Conclusions: RT+TMZ did not appear to significantly improve OS or TTP for AA compared with RT+ NU. RT+TMZ was better tolerated. IDH1-R132H mutation was associated with longer survival.

Keywords: anaplastic astrocytoma; nitrosourea; radiotherapy; temozolomide.

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Figures

Fig. 1
Fig. 1
Consort diagram of patient disposition
Fig. 2
Fig. 2
Clinical outcomes by treatment
Fig. 2
Fig. 2
Clinical outcomes by treatment
Fig. 3
Fig. 3
Overall survival by IDH1-R132H mutation status
See this image and copyright information in PMC

Comment in

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