Preliminary results of a phase III comparison study of BCNU, hydroxyurea and radiation to BCNU and radiation

Patients were randomized to receive BCNU, radiation, and hydroxyurea (HU) on alternate days during radiation (BHR), or BCNU and radiation (BR). Within the two groups, patients were stratified almost equally by tumor type (glioblastoma multiforme [GM] or non-glioblastoma multiforme [NGM] malignant gliomas). On study entry, patients were rated by the Karnofsky performance scale and the extent of surgical resection of tumor. Time to tumor progression was the end point for the study. While NGM patients with Karnofsky ratings of ⩾60 did better on both arms of the study (median time to tumor progression [MTP] of 50 and 72 wks for BHR and BR, respectively), GM patients showed statistically significant differences ( p = 0.4) between the two arms (MTPs of 41 and 31 wks for BHR and BR, respectively). GM patients with subtotal tumor resection did slightly better on BHR (49 wks, p = 0.03) than BR (31 wks).