Artikel
Neoadjuvant Therapy with Temozolomide and 13-cis-Retinoic Acid in High Grade Glioma – a Phase II-Study
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Autoren
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Peter Hau
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg, Deutschland
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Birgit Hirschmann
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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Tanja Jauch
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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Ulrike Baumgart
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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Christoph Beier
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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Dagmar Beier
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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Susanne Gänßbauer
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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Martin Glas
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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Horst Koch
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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C. Wismeth
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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A. Steinbrecher
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
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Ulrich Bogdahn
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Regensburg
| Veröffentlicht: | 20. März 2006 |
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Gliederung
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Purpose: A number of studies have evaluated the benefit of neoadjuvant chemotherapy after resection in anaplastic glioma and glioblastoma (WHO grade III/IV). For example, Friedman et al. (1998) demonstrated a 54% progression free survival at 6 months under neoadjuvant chemotherapy with Temozolomide alone. Other studies have shown similar results. Nevertheless, a clear benefit concerning median time to progression or median overall survival could not be shown yet. Besides that, a phase II-study in recurrent high grade glioma published recently has shown significant benefit under combined treatment with temozolomide and 13-cis-retinoic acid (Jaeckle et al., 2000).
Patients and Methods: Therefore, we initiated a phase II-protocol with a neoadjuvant combined therapy consisting of Temozolomide 200 mg/m2 BS day 1-5 in 28 days and 13-cis-retinoic acid 60 mg/m2 BS day 1-21 in 28 days until tumor progression. Patients were followed closely with clinical and imaging (MRI) follow up every 4 weeks. Primary end point was tumor progression. In the case of clinical or radiological relapse, a second surgery was performed, if possible, and radiotherapy was initiated.
Results: Twenty patients with high grade glioma (n=5, glioblastoma; n=1, gliosarcoma, n=5, anaplastic astrocytoma; n=6, anaplastic oligoastrocytoma; n=3, anaplastic oligodendroglioma) have been included at this point. Three patients progressed after 1 cycle, all other patients had tumor stabilizations ranging from 12 to 127 weeks with 10 of the included patients being progression free at this point. Median time to progression is 34 weeks for all patients and 60 weeks for patients with grade III-tumors. Of the patients with glioblastoma treated so far, the major part progressed rapidly during the first 3 cycles of therapy (mTTP, 8 weeks).
Conclusion: At this point, it is to early to draw definite conclusions about efficacy in this phase II-trial with neoadjuvant combined chemotherapy in patients with high-grade glioma. Nevertheless, patients with grade III-tumors may benefit significantly from this combined approach.
