Table 1.

BCNU-impregnated wafers as monochemotherapy for recurrent high-grade glioma

Study	Year	Study Phase	Description	Design	Results	Conclusion/Comments/Complications
Brem et al72	1991	Phase I/II	21 patients with recurrent HGG treated with surgery and 1 of 3 concentrations of BCNU wafers	Dose escalation, single-arm, multicenter	Mean postimplant survival: 65 weeks (1.93% BCNU) 64 weeks (3.85% BCNU) 32 weeks (6.35% BCNU)	Mid-concentration dose (3.85% BCNU) chosen for further study No complications More GBMs in 6.35% group
Brem et al44	1995	Phase III	222 patients with recurrent HGG treated with surgery and either BCNU wafers or placebo wafers	Multicenter, placebo-controlled, double-blind	Median postimplant survival (P = .006): 31 weeks (BCNU wafers) 23 weeks (placebo wafers)	Safe and effective for recurrent HGG Similar postop seizure rates for each group Nonsignificant increase in intracranial infection in BCNU group (3.6% vs 0.89%
Olivi et al114	2003	Phase I	44 patients with recurrent HGG treated with surgery and escalating BCNU wafer doses	Multicenter, dose-escalation trial measuring 5 BCNU doses (6.5%, 10%, 14.5%, 20%, and 28%)	Median overall survival: 251 days Maximum tolerated dose: 20% BCNU	Seizures, infections, CSF leak, and brain edema common in 28% BCNU concentration (3/4 participants), less common in 20% BCNU concentration (13.6%), 1 participant had wound infection in 6.5%, 10%, and 14.5% groups combined (5.6%)

Abbreviations: BCNU, 1,3-bis(2-chloroethyl)-1-nitrosurea; HGG, high-grade glioma.