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From the Departments of Medical Oncology (Drs. Brandes, Tosoni, and Nicolardi, D. Grosso), Neuroradiology (Dr. P. Amistà), Radiotherapy (Dr. Berti), and Neurological Sciences (Dr. Ermani), Azienda Ospedale-Università, Padova, Italy.
Address correspondence and reprint requests to Dr. Alba A. Brandes, Department of Medical Oncology, Azienda Ospedale-Università, Ospedale Busonera, Via Gattamelata 64, 35100 Padova, Italy; e-mail: aabrandes{at}unipd.it
Background: The initial studies on nitrosoureas were performed >30 years ago. These drugs remain the standard chemotherapy for glioblastoma. However, because the criteria used to evaluate the activity of nitrosoureas in a neuro-oncologic setting have changed, new data on their activity are needed.
Methods: The authors conducted a phase II study on 40 patients with recurrent glioblastoma following surgery and standard radiotherapy. They analyzed progression-free survival at 6 months (PFS-6), time to progression (TTP), response rate, and toxicity. Patients were treated with 80 mg/m2 carmustine on days 1 to 3, every 8 weeks for a maximum of six cycles.
Results: Median TTP was 13.3 weeks (95% CI, 10.26 to 16.86 weeks), and PFS-6 was 17.5% (95% CI, 8.9 to 34.3). Response to chemotherapy, age 
40 years, and performance status 
90 were significant prognostic factors for TTP; however, with multivariate analysis, only response to chemotherapy was significant. The major side effects were reversible hematologic and long-lasting hepatic and pulmonary toxicity.
Conclusion: The activity of this BCNU regimen is comparable with that reported in the past and with the newest therapies, such as temozolomide. However, BCNU toxicity is high and recovery is slow, thus compromising the administration of further drugs in patients with progressive disease.
Received March 30, 2004. Accepted in final form June 2, 2004.
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