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A
phase II study of temozolomide vs. procarbazine in patients with glioblastoma
multiforme at first relapse
Yung WK, Albright RE, Olson J, Fredericks R, Fink K, Prados MD, Brada M, Spence
A, Hohl RJ, Shapiro W, Glantz M, Greenberg H, Selker RG, Vick NA, Rampling R,
Friedman H, Phillips P, Bruner J, Yue N, Osoba D, Zaknoen S, Levin VA.
Department of Neuro-Oncology, UTMD Anderson Cancer Center, Box 100, 1515
Holcombe Boulevard, Houston, Texas, 77030, USA
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/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.
PMID: 10944597
[PubMed - indexed for
MEDLINE]
Source: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10944597&dopt=Abstract
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