|
|
Temozolomide for the
treatment of recurrent glioma: Results of a compassionate use program in Belgium
B. Neyns, E. Everaert, E. Joosens, T. Strauven, F. Branle, J. Menten
AZ-VUB, Brussels, Belgium; UZ KUL, Leuven, Belgium; AZ
Middelheim, Antwerpen, Belgium; AZ Sint-Augustinus, Wilrijk, Belgium; Hôpital
Erasme ULB, Brussels, Belgium
Background.
Temozolomide (TMZ) is an oral alkylating agent that has
demonstrated objective activity and an acceptable toxicity profile for the
treatment of recurrent high-grade gliomas in phase II trials.
Only limited information is available on the activity and
toxicity of TMZ when prescribed outside a clinical trial.
Methods.
We conducted a retrospective study to evaluate the activity and
safety of TMZ that was prescribed for the treatment of recurrent glioma in the
context of a compassionate use program in Belgium.
Data were obtained on 117 adult patients (from 5
hospitals) who received TMZ as first or second line chemotherapy.
The recommended starting dose of TMZ was 200 mg/m2
x5d q28d for chemonaïve patients and 150 mg/m2 x5d q28d for
pretreated patients.
Results.
Toxicity was generally mild although grade 3/4 toxicity was
observed in 22 % of patients.
Thrombocytopenia was the most frequent encountered
toxicity (grade 3/4 in 17% of patients) and its occurrence was correlated with a
starting dose of 200 mg/m²/d.
The overall RR (CR + PR) was 29% and 34 % of patients
achieved a SD.
The median PFS was 104 days (95% CI 85-123) and the median
OS was 215 days (95% CI 161-269).
In multivariate analysis a “deep localization” of the
glioma (as opposed to a cortico-subcortical localization) and the preceding
history of a low-grade glioma were identified as independent prognostic
variables with regard to TTP & OS.
Administration of TMZ as first line chemotherapy was an
independent prognostic variable for TTP only.
Absence of disease progression at the end of TMZ cycle 3
was significantly correlated with a superior overall survival (landmark
analysis, P<0.0001).
Conclusions.
This retrospective study indicates that the reported
activity and toxicity profile of TMZ for the treatment of patients with
recurrent glioma is reproducible outside the setting of a prospective clinical
trial.
Copyright 2004 American Society of Clinical Oncology All rights
reserved worldwide.
Source: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-001048,00.asp
|
