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Phase II study of neoadjuvant BCNU and temozolomide for newly diagnosed anaplastic glioma


Posted on: 06/14/2003

39th ASCO Annual Meeting • Chicago, IL • May 31-June 3, 2003 (Abstract No. 413)

Phase II study of neoadjuvant BCNU and temozolomide for newly diagnosed anaplastic glioma

S. M. Chang, W. K. A. Yung, J. Kuhn, D. Schiff, H. Fine, M. Mehta, I. Robins, L. Junck, K. Hess, M. Prados

Neuro-Onc Svc UCSF, San Francisco, CA, Albania; MD Anderson Cancer Center, Houston, TX; University of Texas Health Science Center, San Antonio, TX; University of Virginia Health Science Center, Charlottesville, VA; National Cancer Institute, Bethesda, MD; University of Wisconsin, Madison, WI; University of Michigan, Ann Arbor, MI; UCSF, SF, CA

Temozolomide (TMZ) and the nitrosourea BCNU are active agents in anaplastic glioma (AG).

TMZ has also been shown to deplete alkyltransferase, a DNA repair enzyme contributing to nitrosourea resistance. The objective of this study was to determine the efficacy and toxicity profile of a combination of these agents prior to radiation therapy (RT) in newly diagnosed AG.

Eligibility criteria included histologically confirmed newly diagnosed, previously untreated AG with measurable disease, KPS at least 60, DLCO at least 80%, normal laboratory parameters and informed consent. TMZ was administered at a dose of 550 mg/m2 orally and BCNU 150 mg/m2 intravenously on day 1 of a 42-day cycle to a maximum of 4 cycles, unless there was tumor progression or unacceptable toxicity.

Dose reductions were specified for toxicities.

Patients were assessed for response clinically and with neuro-imaging (including steroid requirements) before every cycle.

41 eligible and evaluable patients were accrued to assess the response rate of this strategy before RT.

Median age was 40 yrs (range 18-71yrs).

54% were male.

KPS characteristics were 5% at 60, 19% 70-80 and 76% 90-100.

There were 81% anaplastic astrocytoma, 12% anaplastic oligodendroglioma and the remaining 7% had mixed anaplastic tumors.

The median number of cycles was 3 (range 1- 4).

22% could not complete the 4 cycles of therapy because of toxicity, mainly hematological.

46% of patients experienced grade 3 or 4 thrombocytopenia.

20% had grade 4 granulocytopenia.

2 patients died while on therapy- one from progressive disease and the other from pneumocystis carinii pneumonia.

Complete and partial response rates were 2% and 27% respectively.

An additional 54% had stable disease.

17% had progressive disease- 10% after the 1st cycle and 7% after the 2nd cycle.

This neoadjuvant strategy appears to be associated with significant myelosuppression and modest response rate in newly diagnosed AG.

© Copyright 2003 American Society of Clinical Oncology All rights reserved worldwide

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