NCIC-CTG phase II study of gemcitabine in patients with malignant glioma (IND.94)

Citation
Sz. Gertler et al., NCIC-CTG phase II study of gemcitabine in patients with malignant glioma (IND.94), ANN ONCOL, 11(3), 2000, pp. 315-318
Citations number
30
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Oncology,"Onconogenesis & Cancer Research
Journal title
ANNALS OF ONCOLOGY
ISSN journal
0923-7534 → ACNP
Volume
11
Issue
3
Year of publication
2000
Pages
315 - 318
Database
ISI
SICI code
0923-7534(200003)11:3<315:NPISOG>2.0.ZU;2-K
Abstract
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.