ADJUVANT THERAPY WITH DIBROMODULCITOL AND BCNU INCREASES SURVIVAL OF ADULTS WITH MALIGNANT GLIOMAS

Objective: We tested adjuvant chemotherapy combining dibromodulcitol (DBD) and bischloroethylnitrosourea (BCNU) given postoperatively to adults with newly diagnosed supratentorial malignant gliomas. Methods: We enrolled 269 patients, 255 of whom were eligible. Alter surgery, we treated all patients with radiation therapy, using a median dose of 60 Gy given in 30 fractions. After randomization, patients in the chemotherapy group also received (1) six weekly courses, administered during irradiation, of DBD 700 mg/m(2) and (2) one to nine (median, four) courses, administered during the first year following radiation therapy, of DBD 1,000 mg/m(2) on day 1 and BCNU 150 mg/m(2) on day 2, with the course being repeated every 6 weeks. Results: Patients treated with radiation therapy along with DBD plus BCNU (group 2) had significantly longer survival time (p=0.044) and time to progression (p=0.003) than did those treated with radiation therapy alone (group I), The median survival time was 13.0 months for group 2 and 10.4 months for group 1; the median time to progression was 8.1 months for group 2 and 6.7 months for group 1. The percentage of patients alive at 18 and 24 months was 34% and 21% in group 2 compared with 21% and 12% in group 1. Conclusion: DBD plus BCNU is an effective adjuvant therapy for malignant glioma.