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Temozolomide in the treatment of recurrent malignant glioma Chang SM; Theodosopoulos P; Lamborn K; Malec M; Rabbitt J; Page M; Prados MDCancer 2004[Feb]; 100 (3): 605-11BACKGROUND: Options for chemotherapy at the time of recurrence in patients with malignant glioma are limited. The authors describe the efficacy and safety results of their institution's open-label, compassionate-use protocol of temozolomide for patients with recurrent malignant glioma. METHODS: Patients with recurrent malignant glioma at any time during recurrence were treated with oral temozolomide at a dose of 150 mg/m2 per day on a 5-day schedule every 28 days. If this dose was tolerated, then escalation to 200 mg/m2 was allowed. Clinical evaluations and assessments of tumor response were performed every 2 months. All patients or their surrogates signed approved Institutional Review Board consent forms. RESULTS: Among 213 patients who were treated, 33% had Grade 3 tumors, and 67% had Grade 4 tumors. The overall objective response rate was 16% in both of these patient groups; and an additional 51% and 30% of patients with Grade 3 and Grade 4 tumors, respectively, had stable disease as their best response. The 6-month progression-free survival rates were 41% and 18% for patients with Grade 3 and Grade 4 tumors, respectively. The median survival was 49 weeks for patients with Grade 3 tumors and 32 weeks for patients with Grade 4 tumors. The major toxicity was hematologic toxicity. In multivariate analysis, the Karnofsky performance score was a significant predictor of survival for patients with Grade 4 tumors. CONCLUSIONS: Temozolomide was well tolerated in patients with recurrent malignant glioma and had modest efficacy, even at the time of multiple recurrences.|Adolescent[MESH]|Adult[MESH]|Aged[MESH]|Antineoplastic Agents, Alkylating/*administration & dosage[MESH]|Biopsy, Needle[MESH]|Brain Neoplasms/*drug therapy/mortality/pathology[MESH]|Dacarbazine/*administration & dosage/*analogs & derivatives[MESH]|Dose-Response Relationship, Drug[MESH]|Drug Administration Schedule[MESH]|Female[MESH]|Follow-Up Studies[MESH]|Glioma/*drug therapy/mortality/pathology[MESH]|Humans[MESH]|Magnetic Resonance Imaging[MESH]|Male[MESH]|Middle Aged[MESH]|Multivariate Analysis[MESH]|Neoplasm Recurrence, Local/*drug therapy/mortality/pathology[MESH]|Neoplasm Staging[MESH]|Probability[MESH]|Proportional Hazards Models[MESH]|Risk Assessment[MESH]|Survival Analysis[MESH]|Temozolomide[MESH]|Treatment Outcome[MESH] |
