Objective: To determine the risks and survival benefit associated with implantation of an absorbable, 1,3-bis(2chloroethyl)-1-nitrosourea-impregnated polymer wafer, we prospectively studied patients with recurrent glioblastoma multiforme and compared them with a demographically matched cohort group.
Methods: Over a 29-month period, 62 patients underwent operations. All had tumor growth despite standard treatment, a Karnofsky performance score of > or =70, and histopathological confirmation of glioblastoma. Seventeen patients underwent gross total resection with placement of 1,3-bis(2-chloroethyl)-1-nitrosourea wafers (wafer group) at a median 44 weeks from diagnosis (6 women, 11 men; median age, 56 years). A cohort group of 45 patients undergoing surgery for recurrent glioblastoma during the same time period, but not receiving wafers, was identified. Surgery was performed at a median 47 weeks from diagnosis (14 women, 31 men; median age, 54 years).
Results: Within 6 weeks of surgery, 13 complications were identified in 8 patients in the wafer group. In the cohort group, 6 patients sustained 8 complications. We were unable to identify any survival advantage using Kaplan-Meier analysis. In the wafer group, median survival was 58 weeks from diagnosis and 14 weeks from wafer implantation. In the cohort group, median survival was 97 weeks from diagnosis and 50 weeks from operation.
Conclusion: 1,3-bis(2-chloroethyl)-1-Nitrosourea wafer implantation for recurrent glioblastoma was associated with a higher risk of postoperative complications, particularly those related to infection and wound healing. No clear survival benefit associated with wafer implantation was identified.