Phase II trial of preirradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas ...

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Neuro Oncol. 2009 Apr;11(2):167-75. Epub 2008 Sep 8.

Phase
II trial of preirradiation and concurrent temozolomide in patients with
newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic
oligoastrocytomas: RTOG BR0131.

Vogelbaum MA, Berkey B, Peereboom D, Macdonald D, Giannini C, Suh JH, Jenkins R, Herman J, Brown P, Blumenthal DT, Biggs C, Schultz C, Mehta M.
 
Cleveland Clinic, Brain Tumor and NeuroOncology Center, Cleveland, OH 44195, USA.

 
The
primary objectives of this phase II study were to evaluate the use of
preirradiation temozolomide followed by concurrent temozolomide and
radiotherapy (RT) in patients with newly diagnosed anaplastic
oligodendroglioma (AO) and mixed anaplastic oligoastrocytoma (MOA).
Preirradiation temozolomide (150 mg/m(2)/day) was given on a
7-day-on/7-day-off schedule for up to six cycles. The primary end point
was the response rate during the 6-month, pre-RT chemotherapy. Tumor
tissue was analyzed for the presence of chromosomal deletions on 1p and
19q and for MGMT-promoter methylation. Forty-two patients were
enrolled; 39 were eligible.
 
The objective response rate was 32% (6%
[complete response, CR], 26% [partial response PR]), and the rate of
progression during pre-RT chemotherapy was 10%. The worst
nonhematological toxicity was grade 4 in three patients (8%).
Twenty-two patients completed concurrent chemotherapy and RT. There
were no grade 4 nonhematological toxicities during the concurrent
chemotherapy and RT. Seventeen of 28 (60.7%) evaluable cases had
codeletion of 1p/19q; all 17 were free from progression at 6 months.
Sixteen of 20 (80%) evaluable cases had MGMT-promoter methylation; all
16 were free from progression at 6 months. In conclusion, the rate of
progression of 10% during pre-RT temozolomide chemotherapy for newly
diagnosed AO and MAO compared favorably with prior experience with
pre-RT PCV chemotherapy (20% in RTOG 9402).
 
The toxicity of the
dose-intense pre-RT regimen used in this study may warrant evaluation
of other, less intense dosing strategies. Future studies will need to
prospectively stratify patients according to the presence of deletions
of chromosomes 1p and 19q.