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

Abstract

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.

• Authors: M Westphal, Z Ram, V Riddle, D Hilt, E Bortey, Executive Committee of the Gliadel Study Group
• Journal: Acta neurochirurgica (Acta Neurochir (Wien)) Vol. 148 Issue 3 Pg. 269-75; discussion 275 (Mar 2006) ISSN: 0001-6268 [Print] Austria
• PMID: 16482400 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Alkylating
• Decanoic Acids
• Drug Carriers
• Polyesters
• decanedioic acid-4,4'-(1,3-propanediylbis(oxy))bis(benzoic acid) copolymer
• Carmustine

Topics

• Adult
• Aged
• Antineoplastic Agents, Alkylating (administration & dosage)
• Brain (drug effects, pathology, physiopathology)
• Brain Neoplasms (drug therapy, surgery)
• Carmustine (administration & dosage)
• Decanoic Acids (administration & dosage)
• Drug Carriers (administration & dosage)
• Drug Therapy (methods, trends)
• Female
• Follow-Up Studies
• Glioblastoma (drug therapy, surgery)
• Glioma (drug therapy, surgery)
• Humans
• Male
• Middle Aged
• Neurosurgical Procedures (methods)
• Placebo Effect
• Polyesters (administration & dosage)
• Survival Rate (trends)
• Treatment Outcome