A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse

Abstract

A randomized, multicentre, open-label, phase II study compared temozolomide (TMZ), an oral second-generation alkylating agent, and procarbazine (PCB) in 225 patients with glioblastoma multiforme at first relapse. Primary objectives were to determine progression-free survival (PFS) at 6 months and safety for TMZ and PCB in adult patients who failed conventional treatment. Secondary objectives were to assess overall survival and health-related quality of life (HRQL). TMZ was given orally at 200 mg/m2/day or 150 mg/m2/day (prior chemotherapy) for 5 days, repeated every 28 days. PCB was given orally at 150 mg/m2/day or 125 mg/m2/day (prior chemotherapy) for 28 days, repeated every 56 days. HRQL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 [+3]) and the Brain Cancer Module 20 (BCM20). The 6-month PFS rate for patients who received TMZ was 21%, which met the protocol objective. The 6-month PFS rate for those who received PCB was 8% (P = 0.008, for the comparison). Overall PFS significantly improved with TMZ, with a median PFS of 12.4 weeks in the TMZ group and 8.32 weeks in the PCB group (P = 0.0063). The 6-month overall survival rate for TMZ patients was 60% vs. 44% for PCB patients (P = 0.019). Freedom from disease progression was associated with maintenance of HRQL, regardless of treatment received. TMZ had an acceptable safety profile; most adverse events were mild or moderate in severity. © 2000 Cancer Research Campaign

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Affiliated Institutions

• Merck (Japan) JP
• Western Pennsylvania Hospital US
• University of Michigan US
• St. Joseph Medical Center US
• Emory University US
• Memorial Hospital of Rhode Island US
• The University of Texas Southwestern Medical Center US
• Beatson West of Scotland Cancer Centre GB
• The University of Texas MD Anderson Cancer Center US
• University of British Columbia CA
• University of Washington US
• University of Pennsylvania US
• University of Mississippi US
• University of Iowa Hospitals and Clinics US
• NorthShore University HealthSystem US
• University of California, San Francisco US
• Duke University US
• Royal Marsden NHS Foundation Trust GB
• Ann Arbor VA Medical Center US
• St. Joseph's Hospital and Medical Center US

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