A phase II study of preradiation chemotherapy followed by external beam radiotherapy for the treatment of patients with newly diagnosed glioblastoma multiforme: an Eastern Cooperative Oncology Group Study (E2393)

Recent publications support the use of preradiation chemotherapy in the tre atment of selected primary brain tumors. In the pediatric population, this treatment strategy often delays radiotherapy and may improve the outcome in patients. This manuscript describes the use of a preradiation chemotherapy approach for adult patients with newly diagnosed glioblastoma multiforme. The main objective of this trial was to determine the feasibility of delive ring up to 3 monthly cycles of a 72 h continuous simultaneous intravenous i nfusion of BCNU (40 mg/m(2)/day) and cisplatin (40 mg/m(2)/day). Patients w ere evaluated for tumor response or progression after each cycle. Following the completion of the chemotherapy treatments or evidence of tumor progres sion, patients underwent external beam radiotherapy. A dose of 45 Gy was de livered to the pretreatment tumor volume plus surrounding edema and a margi n of 3.0 cm. An additional 14.4 Gy was delivered to the preoperative volume plus a 2 cm margin. Fifty patients were enrolled, 47 were eligible and ana lyzable. Overall, 79% of patients were able to complete at least 2 cycles o f treatment, exceeding the predefined measure of feasibility. One patient a chieved a complete response, 10 patients a partial response and 18 patients had stable disease at completion of the chemotherapy treatments. Twenty-fo ur patients experienced grade 4 toxicity, mostly hematologic. All patients were able to undergo radiotherapy following chemotherapy. These results ind icate that a preradiation strategy is feasible. Although responses to the c hemotherapy were seen, a phase III trial is needed to determine whether thi s approach provides an advantage over standard treatment; such a phase III trial has been undertaken by ECOG.