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Treatment > Carmustine
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Acta Neurochirurgica, Volume 148, Number
3, March 2006.
(Clinical Study)
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Abstract |
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Gliadel® wafer in initial
surgery for malignant glioma: long-term follow-up of a multicenter
controlled trial
M. Westphal1,
Z. Ram2, V. Riddle3, D. Hilt4,
E. Bortey5 and On behalf of the Executive
Committee of the Gliadel® Study Group
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(1) Department
of Neurosurgery, University Hospital Eppendorf, Hamburg, Germany. (2)
Department of Neurosurgery, Tel Aviv Sourasky Medical Center, Tel
Aviv, Turkey. (3) Pharm Athene, Inc., Maryland, USA. (4) Ascend
Therapeutics, VA, USA. (5) Athero Genics, Inc., Georgia, USA.
Received: 3 December 2004. Accepted:
3 November 2005. Published online: 17 February 2006.
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Objective. Adjuvant systemic
chemotherapy increases survival of primary malignant glioma patients
beyond 12–18 months.
The only interstitial chemotherapy treatment approved for malignant
glioma is Gliadel® wafer containing carmustine (BCNU)
placed in the resection cavity at surgery.
Analysis of a large trial by Westphal and colleagues (n = 240) showed
a 29% risk reduction (P = 0.03) in the BCNU wafer-treated group
over the course of the 30-month trial.
Long-term follow-up of these patients was undertaken to determine the
survival benefit at 2 and 3 years.
Methods. Survival
proportions for the placebo and treatment groups over the 56-month
study were estimated by the Kaplan-Meier method. Multiple-regression
analyses using the Cox proportional hazards model included prognostic
factors of age, KPS, and tumor type.
A secondary analysis was conducted for 207 GBM patients.
Results. Of the 59
patients available for long-term follow-up, 11 were alive at 56
months: 9 had received BCNU wafers and 2 had received placebo
wafers.
Median survival of patients treated with BCNU wafers was 13.8 months vs
11.6 months in placebo-treated patients (P = 0.017) with a
hazard ratio of 0.73 (P = 0.018), representing a 27%
significant risk reduction.
This survival advantage was maintained at 1, 2, and 3 years and was
statistically significant (P = 0.01) at 3 years.
Two of 207 GBM patients remained alive at the end of the follow-up
period, both in the BCNU wafer-treated group.
Conclusion.
Malignant glioma patients treated with BCNU wafers at the time of
initial surgery in combination with radiation therapy demonstrated a
survival advantage at 2 and 3 years follow-up compared with placebo.
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© Springer
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DOI: 10.1007/s00701-005-0707-z
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Abstract
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Source: http://www.springerlink.com/(0dxez3553mprubmmmlkava45)/app/home/contribution.asp?referrer=parent&backto=issue,3,23;journal,4,426;linkingpublicationresults,1:102025,1
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