Purpose: We conducted a phase II multicentre study of gemcitabine in patien
ts with anaplastic astrocytoma and glioblastoma multiforme at first relapse
.
Patients and methods: Patients with anaplastic astrocytoma or glioblastoma
multiforme receiving a stable dose of steroids and ECOG performance status
less than or equal to 3 were eligible for this study at the time of first r
elapse. One adjuvant chemotherapy regimen was permissible. Patients receive
d gemcitabine 1000 mg/m(2) i.v. weekly x 3, repeated on a four-weekly cycle
.
Results: Of 20 patients enrolled, 15 were evaluable for response, 19 for no
n-hematological toxicity and 18 for hematological toxicity. Seven patients
had anaplastic astrocytoma (AA) and twelve glioblastoma multiforme (GBM). A
ge ranged from 28-71 years (median 50). Fifteen patients discontinued thera
py due to disease progression. The median number of cycles administered was
1 (range 1-11); only two patients received more than three cycles. Hematol
ogic toxicity was acceptable and no grade 4 toxicity was seen. One patient
developed Pneumocystis pneumonia and eventual pulmonary embolism; one died
of gastric hemorrhage related to steroid therapy. No objective responses we
re seen. Nine patients had stable disease (median duration 2.7 months, rang
e 0.9-11.2).
Conclusions: Gemcitabine given in this dose and schedule seems well tolerat
ed but is not active in patients with recurrent high-grade gliomas.