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

A randomized, multicentre, open-label, phase I) study compared temozolomide (TMZ), an oral second-generation alkylating agent, and procarbazine (PCB) in 225 patients with glioblastoma multiforme at first relapse. Primary obje ctives were to determine progression-free survival (PFS) at 6 months and sa fety for TMZ and PCB in adult patients who failed conventional treatment. S econdary objectives were to assess overall survival and health-related qual ity 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 da ys, repeated every 56 days. HRQL was assessed using the European Organizati on for Research and Treatment of Cancer Quality of Life Questionnaire (EORT C QLQ-C30 [+3]) and the Brain Cancer Module 20 (BCM20). The 6-month PFS rat e 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 P CB patients (P = 0.019). Freedom from disease progression was associated wi th maintenance of HRQL, regardless of treatment received. TMZ had an accept able safety profile; most adverse events were mild or moderate in severity. (C) 2000 Cancer Research Campaign.