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

  • M. Westphal
  • Z. Ram
  • V. Riddle
  • D. Hilt
  • E. Bortey
  • On behalf of the Executive Committee of the Gliadel® Study Group
Clinical Article

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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Copyright information

© Springer-Verlag/Wien 2006

Authors and Affiliations

  • M. Westphal
    • 1
  • Z. Ram
    • 2
  • V. Riddle
    • 3
  • D. Hilt
    • 4
  • E. Bortey
    • 5
  • On behalf of the Executive Committee of the Gliadel® Study Group
  1. 1.Department of NeurosurgeryUniversity Hospital EppendorfHamburgGermany
  2. 2.Department of NeurosurgeryTel Aviv Sourasky Medical CenterTel AvivTurkey
  3. 3.Pharm Athene, Inc.MarylandUSA
  4. 4.Ascend TherapeuticsUSA
  5. 5.Athero Genics, Inc.GeorgiaUSA

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