• W K Yung, R E Albright, J Olson, R Fredericks, K Fink, M D Prados, M Brada, A Spence, R J Hohl, W Shapiro, M Glantz, H Greenberg, R G Selker, N A Vick, R Rampling, H Friedman, P Phillips, J Bruner, N Yue, D Osoba, S Zaknoen, and V A Levin.
• Department of Neuro-Oncology, UTMD Anderson Cancer Center, Box 100, 1515 Holcombe Boulevard, Houston, Texas, 77030, USA.
• Br. J. Cancer. 2000 Sep 1; 83 (5): 588-93.

AbstractA 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/m(2)/day or 150 mg/m(2)/day (prior chemotherapy) for 5 days, repeated every 28 days. PCB was given orally at 150 mg/m(2)/day or 125 mg/m(2)/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.Copyright 2000 Cancer Research Campaign.

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