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Temozolomide combined with
radiation as first-line treatment in primary glioblastoma multiforme: Phase
I/II-study
S. E. Combs, S. Gutwein, D. Schulz-Ertner, M. Van Kampen, C. Thilmann, M. M.
Wannenmacher, J. Debus
University of Heidelberg, Dept of Radiation Oncology, Heidelberg,
Germany; Nordwestkrankenhaus Frankfurt, Frankfurt, Germany; German Cancer
Research Center (DKFZ), Heidelberg, Germany
Background.
The role of chemotherapy in combination with radiation
therapy is still discussed controversially in the treatment of primary
glioblastoma multiforme.
To evaluate the feasibility and toxicity of radiation and concomitant
administration of temozolomide in patients with primary malignant glioma, this
phase I/II study was conducted.
Methods.
53 Patients with histologically confirmed WHO ºIV malignant
glioma were enrolled in the study.
All patients were treated with radiation therapy with a total dose of 60Gy using
conventional fractionation of 5x2.0Gy/week.
Temozolomide was administered orally each therapy day at a dose of 50mg/m2.
Results.
Prior to radio-chemotherapy, complete resection of the tumor was
performed in 14 patients, 22 patients received a subtotal resection, and in 17
patients only a biopsy could be performed.
The median time interval between surgery and initiation of radio-chemotherapy
was 21 days.
Treatment related toxicity was very mild.
Acute toxicity > ºII was observed in one patient who developed ºIV
hemotoxicity.
Minor side effects of chemotherapy included nausea and vomiting which could be
managed with odansetron medication.
No severe late effects were observed.
The median progression-free survival and the median overall survival were 8
months and 19 months, respectively.
Actuarial overall survival was 72% at 1 year and 29% at 2 years.
Age < 40 vs. > 40 and extent of surgery significantly influenced
survival.
Conclusion.
The combination of temozolomide plus radiation therapy is
feasible and safe by means of toxicity.
Overall survival times were relatively high compared to the survival times
reported for radiotherapy alone.
By applying a dosage of 50mg/m2 of temozolomide, application can be
performed throughout the whole time course without interruption due to side
effects and might contribute in a large manner to the prolonged overall
survival.
A clinical phase III trial is warranted to prove the superiority of combined
radiotherapy with temozolomide compared to radiotherapy alone.
Copyright 2004 American Society of Clinical Oncology All rights
reserved worldwide.
Source: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-001836,00.asp
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