Staging and Prognosis | Treatment > Temozolomide Clinical Trials

Meeting Abstract

Temozolomide in glioblastoma: 4 years' experience with monthly or fortnigthly schedule

L. Butttolo, F. Giunta, V. D. Ferrari, G. Marini

Neurosurgery Unit - Spedali Civili, Brescia, Italy; Medical Oncology Unit - Beretta Foundation Spedali Civili, Brescia, Italy

Introduction. Temozolomide (TMZ) enhanced life expectancy in glioblastoma pts.
In our institution we valuated a new schedule to verify a low dose activity and the enhance in life expectancy.
In literature the efficacy of treatment is dose dependent.
The standard schedule (SS) of TMZ in glioblastoma patient was 200 mg/m2 for 5 days every 28 days.
We administered 150 mg/m2 of TMZ for 7 days every other week "extended schedule" (ES) to reduce toxicity.

Methods. In our Hospital from September 98 to December 02 215 pts had the diagnosis of glioblastoma.
In 4 years 157 (93 m/64 f) pts were valuated in our Unit, 143 pts had glioblastoma de novo and 14 pts had progression to prior tumor.
From September 1998 to 2000: 35 pts made the SS (200 mg/m2 for 5 days every 28 days) as adiuvant therapy after surgery (5 stereotactic biopsy-SBIO, 14 partial removal-PR, 15 total removal-TR, 1 not verified-NV) and radiotherapy (21 pts).
In the same period 46 pts underwent only surgery (14 SBIO, 13 PR, 16 TR, 3 NV) and radiotherapy (23 pts).
Pts who refused the chemotherapy for personal reason were the control group.
From 2000 to 2002: 34 pts made the "ES" (150 mg/m2 for 7 days every 14 days) as adiuvant therapy in combination of surgery (4 SBIO, 14 PR, 15 TR, 1 NV) and radiotherapy (22 pts).
In the same period 42 pts underwent only surgery (5 SBIO, 16 PR, 17 TR, 4 NV) and radiotherapy (26 pts).

Results. The "ES" was well tolerated by patients with a low gastric toxicity.
We administered 665 cycles and hematological toxicity was: thrombocytopenia grade 1-2 in 31cycles and grade 3-4 in 17 cycles; leukopenia grade 1-2 in 32 cycles and grade 3-4 in 8 cycles.
Median survival time (Kaplan-Mayer) of patients treated with the common schedule was 48 weeks (23 weeks of the control patients).
Median survival time of pts treated with the "ES" was 63 weeks (26 weeks of the control patients).
42% and 25% of the pts treated with common schedule were alive at 1 and 2 years (20% and 1% of the control pts).
55% and 21% of the pts treated with "ES" were alive at 1 and 2 years (21% and 1% of the control pts).

Conclusions. The expected median survival time is quite different: 63 weeks versus 48 weeks and the enhancement is evident.
Accrual is ongoing.

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