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How effective is BCNU in recurrent
glioblastoma in the modern era?
A phase II trial
A. A. Brandes, MD, A. Tosoni, MD, P.
Amistà, MD, L. Nicolardi, MD, D. Grosso, RN, F.
Berti, MD and M. Ermani, MD
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@unipd.it.
Received March 30, 2004. Accepted in final form June 2, 2004.
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.
© 2004 American Academy of Neurology
Source: http://www.neurology.org/cgi/content/abstract/63/7/1281
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