Temozolomide for recurrent high-grade glioma.

Despite aggressive treatment, the high-grade malignant glioma (specifically, anaplastic astrocytoma and glioblastoma multiforme) have a poor prognosis with current methods. Relapse is nearly universal, responses in recurrent disease are not enduring, and quality of life because of tumor growth is poor. New treatment strategies that address symptom control and quality of life as well as progression-free and overall survival are urgently needed. Temozolomide (Temodar in the United States, Temodal globally; Schering Corporation, Kenilworth, NJ), a novel, oral, antineoplastic agent, has shown efficacy against high-grade glioma with a favorable safety profile, while maintaining or improving quality of life. In a pivotal randomized, international phase II trial comparing temozolomide (n = 112) with procarbazine (n = 113) in patients with glioblastoma multiforme, temozolomide significantly improved median and 6-month progression-free survival and 6-month overall survival. Additionally, patients receiving temozolomide had superior responses in all seven quality-of-life domains tested, which included the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire functions and brain-cancer-specific symptoms. A large, multicenter, single-arm trial (N = 162) showed an impressive response rate for patients with relapsed anaplastic astrocytoma receiving temozolomide, and patients maintained or improved their quality of life compared with baseline values. For patients with recurrent malignant glioma, temozolomide provides a therapeutic option with a predictable safety profile, clinical efficacy, and convenient dosing that can provide important quality-of-life benefits. Copyright 2001 by W.B. Saunders Company.