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Clinical Trial
. 2011 Apr;13(4):410-6.
doi: 10.1093/neuonc/noq205. Epub 2011 Feb 22.

Temozolomide in the treatment of children with newly diagnosed diffuse intrinsic pontine gliomas: a report from the Children's Oncology Group

Kenneth J Cohen  1 , Richard L Heideman, Tianni Zhou, Emiko J Holmes, Robert S Lavey, Eric Bouffet, Ian F Pollack
Affiliations
Clinical Trial

Temozolomide in the treatment of children with newly diagnosed diffuse intrinsic pontine gliomas: a report from the Children's Oncology Group

Kenneth J Cohen et al. Neuro Oncol. 2011 Apr.

Abstract

An open-label phase II study (ACNS0126) testing the efficacy of chemoradiotherapy with temozolomide (TMZ) followed by adjuvant TMZ was conducted by the Children's Oncology Group. During the period from July 6, 2004 through September 6, 2005, 63 children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) were enrolled in the study. All patients received TMZ at a dosage of 90 mg/m(2)/day for 42 days to a dose of 59.4 Gy. Four weeks following irradiation, TMZ was given at a dosage of 200 mg/m(2)/day for 5 days every 28 days, for a total of 10 cycles. The primary objective of the statistical analysis was to determine whether the current treatment produced a 1-year event-free survival (EFS) rate higher than the historical baseline of 21.9% observed in CCG-9941. The mean 1-year EFS (± standard deviation) was 14% ± 4.5%, compared with 21.9% ± 5% for CCG-9941. The P value of the test of comparison of 1-year EFS, based on a 1-sided, 1-sample test of proportions, was .96. There was no evidence that temozolomide produced a 1-year EFS rate higher than 21.9%. The mean 1-year OS (± standard deviation) was 40% ± 6.5%, compared with 32% ± 6% for CCG-9941. The median time to death was 9.6 months. Chemoradiotherapy with TMZ followed by adjuvant TMZ is not more effective than previously reported regimens for the treatment of children with DIPG.

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Figures

Fig. 1.
Fig. 1.
ACNS0126 DIPG Event-Free and Overall Survival.
Fig. 2.
Fig. 2.
Event-Free Survival Comparison of ACNS0126 and CCG-9941.
See this image and copyright information in PMC

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