Thirty-four adults with recurrent cerebral glioblastoma, including gli
oblastoma multiforme (10), anaplastic astrocytoma (7), transformed low
grade astrocytoma (7), persistent low grade astrocytoma (5) and recur
rent radiological low grade astrocytoma without histological data at r
elapse (5), were treated with fotemustine 100 mg/m(2) intravenously ev
ery week for 3 consecutive weeks followed by a 5-week rest period. Mai
ntenance treatment consisted of one infusion every 3 weeks. Twenty-fou
r partial responses and stabilizations with a median progression-free
survival of 56 weeks were observed in 70% of cases. Ten progressions (
30%) were observed. Median overall survival from the start of treatmen
t was 40 weeks, with a survival rate of 24% at 12 months and 16% at 18
months. Moreover, 3 patients had a prolonged survival, beyond 100 wee
ks. The partial response or stabilization achieved by fotemustine was
highly predictive of median survival duration: 40 weeks versus 24 week
s in case of progression (p = 0.008). Myelosuppression was the most fr
equent toxicity (17%) and was mild for all patients except one case of
lethal myelodysplasia. Fotemustine is a safe chemotherapy for outpati
ent management. It delays tumor progression for 2/3 of patients with r
ecurrent malignant gliomas. In the absence of randomized studies, it i
s not possible to compare fotemustine with older nitrosoureas. However
, the evaluation of response by computed tomographic or by magnetic re
sonance imaging, which have been used with new nitrosoureas such as fo
temustine, provides a more reliable objective result than the analysis
of clinical neurological improvement used for the evaluation of respo
nse with older nitrosoureas. Therefore, we can conclude that results a
re equivalent for the various nitrosoureas, but the median duration of
response is often more prolonged with new nitrosoureas such as fotemu
stine. Moreover, taking into consideration that fotemustine is a safe
chemotherapy for outpatient management, it appears to be a good treatm
ent of recurrent malignant brain tumors with an encouraging rate of ob
jective responses and stabilizations (70%).