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

摘要: 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) 6 months safety for TMZ PCB adult who failed conventional treatment. Secondary assess overall health-related quality of life (HRQL). was given orally 200 mg/m(2)/day or 150 (prior chemotherapy) 5 days, repeated every 28 days. 125 56 HRQL assessed using the European Organization Research Treatment Cancer Quality Life Questionnaire (EORTC QLQ-C30 [+3]) Brain Module 20 (BCM20). The 6-month PFS rate received 21%, which met protocol objective. those 8% (P = 0.008, comparison). Overall significantly improved TMZ, a median 12.4 weeks group 8.32 0.0063). 60% vs. 44% 0.019). Freedom from disease progression associated maintenance HRQL, regardless treatment received. had acceptable profile; most adverse events mild moderate severity.