Phase 2 study of BCNU and temozolomide for recurrent glioblastoma multiforme: North American brain tumor consortium study

Michael D. Prados, W. K.Alfred Yung, Howard A. Fine, Harry S. Greenberg, Larry Junck, Susan M. Chang, M. Kelly Nicholas, H. Ian Robins, Minesh P. Mehta, Karen L. Fink, Kurt A. Jaeckle, John Kuhn, Kenneth R. Hess, S. Clifford Schold

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60 Scopus citations

Abstract

The purpose of this study was to evaluate the activity, measured in terms of progression-free survival (PFS) and response rates, of 1,3-bis(chloro-ethyl)-1-nitrosourea (BCNU) plus temozolomide in adult patients with recurrent glioblastoma multiforme. The phase 2 dose and schedule for this trial was BCNU 150 mg/m2 i.v. followed in 2 h by temozolomide 550 mg/m2 as a single oral dose. Treatment was repeated every 6 weeks for up to 8 cycles unless tumor progression was documented. The primary end point was PFS at 6 months (PFS-6). Response was a secondary end point, measured by MR imaging, neurological status, and steroid requirements prior to each 6-week cycle. The median age of eligible patients was 53, and 89.5% had no prior chemotherapy. All patients were evaluable for toxicity and time to progression. The PFS-6 was 21%. Overall survival was 68% at 6 months and 26% at 1 year. The MRI response for 36 patients was 2 partial responses, 2 minor responses, 19 cases of stable disease, and 13 immediate progressions. Median survival was 34 weeks, and median PFS was 11 weeks. Toxicity was primarily myelosuppression; no toxic deaths occurred. Historical phase 2 study data in this patient population show a PFS-6 of 15%. Recent data for use of temozolomide alone have shown a PFS-6 of 21%. We conclude that BCNU plus temozolomide when used in these doses and schedule has only modest activity, with significant toxicity, and appears to be no more effective than single-agent temozolomide.

Original languageEnglish (US)
Pages (from-to)33-37
Number of pages5
JournalNeuro-oncology
Volume6
Issue number1
DOIs
StatePublished - Jan 2004

ASJC Scopus subject areas

  • Oncology
  • Clinical Neurology
  • Cancer Research

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    Prados, M. D., Yung, W. K. A., Fine, H. A., Greenberg, H. S., Junck, L., Chang, S. M., Nicholas, M. K., Robins, H. I., Mehta, M. P., Fink, K. L., Jaeckle, K. A., Kuhn, J., Hess, K. R., & Schold, S. C. (2004). Phase 2 study of BCNU and temozolomide for recurrent glioblastoma multiforme: North American brain tumor consortium study. Neuro-oncology, 6(1), 33-37. https://doi.org/10.1215/S1152851703000309