Table 2.

BCNU-impregnated wafers as monochemotherapy for newly diagnosed high-grade glioma

Study	Year	Study Phase	Description	Design	Results	Conclusion/Comments/Complications
Brem et al73	1995	Phase I	22 patients with newly diagnosed HGG treated with surgery and BCNU wafers	Multicenter, single-arm designed to evaluate safety of wafers and XRT	Median overall survival: 40 weeks	BCNU wafers and XRT safe in combination No increase in neurotoxicity when compared with historical controls. No wound infection or systemic toxicity.
Valtonen et al45	1997	Phase III	32 patients with newly diagnosed HGG treated with surgery and BCNU wafers or placebo wafers	Multicenter, placebo-controlled, double-blind	Median overall survival: BCNU 58.1 weeks Placebo 39.9 weeks P = .012	BCNU wafers effective for prolonging survival Infection noted in treatment group; frequency not reported
Westphal et al40,74	2003/ 2006	Phase III	240 patients with newly diagnosed HGG treated with surgery and BCNU wafers or placebo wafers	Multicenter, placebo-controlled, double-blind	Median intent-to-treat overall survival: BCNU 13.9 months Placebo 11.6 months	BCNU wafers significantly effective for prolonging overall survival in intent-to-treat analysis BCNU wafers effective for prolonging overall survival in GBM group after applying Cox proportional hazards model CSF leak (5% vs 0.8%) and intracranial hypertension (9.1% vs 1.7%) were more common in the BCNU group

Abbreviations: BCNU, 1,3-bis(2-chloroethyl)-1-nitrosurea; CSF, cerebrospinal fluid; GBM, glioblastoma; HGG, high-grade glioma; XRT, external beam radiation therapy.