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Long-Term Data from a Landmark Phase III Trial Show Survival Benefit at Three- and Four-Years in Patients with Glioblastoma multiforme
Date:10/30/2007

July 2000 and March 2002. Patients between the ages of 18-70 years with newly diagnosed GBM were eligible. Patients received either focal radiotherapy plus temozolomide at 75mg/meters squared daily continuously for 42 (up to 49) days, followed by up to six cycles of adjuvant temozolomide (150-200 mg/meters squared daily for five days every 28 days) or focal radiotherapy alone. Primary endpoint of the study was overall survival, with secondary endpoints of progression-free survival and quality of life. Initial study results presented in 2004 at the annual meeting of the American Society of Clinical Oncology and fully published in the New England Journal of Medicine in March 2005, found a median overall survival of 14.6 months in patients treated with TEMODAR concomitantly with radiotherapy and then as maintenance treatment compared to a median survival of 12.1 months in those treated with radiotherapy alone. The hazard ration (HR) for overall survival was 0.63 (95 percent CI for HR equal to 0.52-0.75) with a log-rank p less than 0.0001 in favor of the TEMODAR arm.

About Glioblastoma multiforme

Glioblastoma multiforme is a rapidly growing tumor of the central nervous system, most often located in the brain. It is the most common and deadliest type of primary brain tumor. GBM is more common among males, particularly men between the ages of 40 and 60 years, and occurs more frequently in Caucasians. The overall annual incidence of primary malignant brain tumors is six to seven per 100,000 people. (1)

Important Information Regarding U.S. Labeling for TEMODAR

TEMODAR(R) (temozolomide) Capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

In newly diagnosed glioblastoma multiforme, during the concomitant phase (TEMODAR plus radiotherapy) side effects including thrombocytopenia, nausea, vomiting, anorexia and constipation, were m
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SOURCE Schering-Plough Corp.
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