COMPARISONS OF CARMUSTINE, PROCARBAZINE, AND HIGH-DOSE METHYLPREDNISOLONE AS ADDITIONS TO SURGERY AND RADIOTHERAPY FOR THE TREATMENT OF MALIGNANT GLIOMA

Abstract

Within 3 wk of definitive surgery, 609 patients with histologically demonstrated, supratentorial malignant glioma were randomized to receive, in addition to 6000 rad of radiotherapy, 1 of the following 4 treatment regimens: carmustine (BCNU [1,3-bis-(2-chloroethyl)-1-nitrosourea]), high-dose methylprednisolone, procarbazine, or BCNU plus high-dose methylprednisolone. The data were analyzed for the total randomized population and for the 527 patients (87% with glioblastoma multiforme) in whom the initial protocol specifications were met (the valid study group). Significantly longer survival was experienced by patients receiving procarbazine or BCNU alone compared to those receiving only high-dose methylprednisolone. No other pairwise comparisons demonstrated differences significant at the 0.05 level. However, the combination of BCNU plus high-dose methylprednisolone tended to be less effective than BCNU alone in patients with poor prognosis. BCNU and procarbazine apparently are moderately useful agents in conjunction with radiotherapy for patients with malignant glioma. Future protocols may allow use of corticosteroids in conventional dosages for treating cerebral edema and controlling symptoms; conclusions based on survival as the endpoint are unlikely to be affected by administering steroids at somewhat greater than the usual sought.