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 Gliadel® wafer in initial surgery for malignant glioma: long-term follow-up of a multicenter controlled trial

Posted on: 05/09/2006

Acta Neurochirurgica
Publisher: Springer Wien
ISSN: 0001-6268 (Paper) 0942-0940 (Online)
DOI: 10.1007/s00701-005-0707-z
Issue:  Volume 148, Number 3
Date:  March 2006
Pages: 269 - 275

Clinical Article

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
(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

Summary  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.

Keywords: BCNU; brain neoplasms; carmustine; chemotherapy; glioblastoma multiforme; Kaplan-Meier; malignant glioma; neurosurgery; survival analysis


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