Acta Neurochirurgica

, Volume 148, Issue 3, pp 269–275

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

Authors

  • M. Westphal
    • Department of NeurosurgeryUniversity Hospital Eppendorf
  • Z. Ram
    • Department of NeurosurgeryTel Aviv Sourasky Medical Center
  • V. Riddle
    • Pharm Athene, Inc.
  • D. Hilt
    • Ascend Therapeutics
  • E. Bortey
    • Athero Genics, Inc.
  • On behalf of the Executive Committee of the Gliadel® Study Group
Clinical Article

DOI: 10.1007/s00701-005-0707-z

Cite this article as:
Westphal, M., Ram, Z., Riddle, V. et al. Acta Neurochir (Wien) (2006) 148: 269. doi:10.1007/s00701-005-0707-z

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.

Copyright information

© Springer-Verlag/Wien 2006