Phase II study of temozolomide in patients with relapsing high grade glioma and poor performance status.
Med Oncol
; 17(2): 106-10, 2000 May.
Article
en En
| MEDLINE
| ID: mdl-10871815
Temozolomide (SCHS2.365), an oral alkylating agent which penetrates the blood-brain barrier, evolved as an alternative to dacarbazine. The aim of this study was to evaluate the efficacy and safety of temozolomide in terms of overall survival, progression-free survival, clinical benefit and health related quality of life in symptomatic patients with relapsing malignant glioma and a poor performance status. Eleven patients were enrolled in the study. The median age was 44.6 years. Patients were treated with temozolomide per os at a dose of 150-200 mg/m2 daily for 5 consecutive days. Each cycle was repeated every 28 days. The median number of courses given per patient was 3.5. Nine patients were assessable for response. All patients were evaluable for toxicity. Based on radiographic findings 4 patients had stable disease (2 patients after a total of 16 cycles, and 2 patients after a total of 10 cycles). Four patients had progressive disease after 2 to 4 cycles. Of these 3 patients demonstrated a clinical benefit and one patient died after 3 cycles of treatment. Six patients had a significant clinical benefit even after 2 cycles of treatment with improvement of their neurological and performance status. Hematologic toxicity Gr II-III occurred in 3/9 patients. Nonhematologic toxicity consisted of Gr I nausea, and vomiting. In conclusion temozolomide appears to be a useful alternative for patients with relapsing malignant glioma after radiation and surgery and a poor performance status with little or no toxicity and considerable clinical benefit.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Antineoplásicos Alquilantes
/
Dacarbazina
/
Glioma
Aspecto:
Patient_preference
Límite:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Med Oncol
Asunto de la revista:
NEOPLASIAS
Año:
2000
Tipo del documento:
Article
País de afiliación:
Grecia
Pais de publicación:
Estados Unidos