Dose-intensified bi-weekly temozolomide in patients with asymptomatic brain metastases from malignant melanoma: a phase II DeCOG/ADO study
Background: Temozolomide has shown some efficacy in metastatic melanoma and recently received extended approval to treat brain tumours. The purpose of this study was to test a dose-intensified regimen of temozolomide in melanoma patients with brain metastases in a prospective, open-label, multicentr...
Gespeichert in:
| Hauptverfasser: | , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2006
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| In: |
Annals of oncology
Year: 2006, Jahrgang: 17, Heft: 10, Pages: 1592-1597 |
| ISSN: | 1569-8041 |
| DOI: | 10.1093/annonc/mdl148 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/annonc/mdl148 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753419473195 
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| Verfasserangaben: | D. Schadendorf, A. Hauschild, S. Ugurel, A. Thoelke, F. Egberts, M. Kreissig, R. Linse, U. Trefzer, T. Vogt, W. Tilgen, P. Mohr & C. Garbe |
MARC
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| 245 | 1 | 0 | |a Dose-intensified bi-weekly temozolomide in patients with asymptomatic brain metastases from malignant melanoma |b a phase II DeCOG/ADO study |c D. Schadendorf, A. Hauschild, S. Ugurel, A. Thoelke, F. Egberts, M. Kreissig, R. Linse, U. Trefzer, T. Vogt, W. Tilgen, P. Mohr & C. Garbe |
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| 520 | |a Background: Temozolomide has shown some efficacy in metastatic melanoma and recently received extended approval to treat brain tumours. The purpose of this study was to test a dose-intensified regimen of temozolomide in melanoma patients with brain metastases in a prospective, open-label, multicentre phase II trial. Patients and methods: Forty-five patients with asymptomatic brain metastases from melanoma were stratified into arm A (no prior chemotherapy; n = 21) and arm B (previous chemotherapy; n = 24). Patients received oral temozolomide either 150 mg/m2/day (arm A) or 125 mg/m2/day (arm B), days 1-7 and 15-21, every 28 days. The primary study end point was objective response, and secondary end points were overall survival and safety. Results: Two patients (4.4%) achieved a partial response (PR) in brain metastases (one in each arm), one of them (2.2%) also showing a PR in extracerebral disease. An additional five patients (11.1%; two in arm A, three in arm B) showed disease stabilisation (SD) in brain and other sites. However, 82% revealed progressive disease (PD) already evident 8 weeks after therapy initiation. Median survival time from therapy onset was 3.5 months (range 0.7-8.3; arm B) and 4.3 months (range 1.6-11.8; arm A), P = 0.43. Dose modifications and prolongations of therapy cycles due to toxicity were required in 20% of patients. Grade 3/4 toxicity was observed in one patient only (2.2%). Conclusions: Oral administration of temozolomide given bi-weekly is well-tolerated in melanoma patients with cerebral involvement. However, the efficacy is limited, with lower than 5% objective responses observed in brain and extracerebral metastases. | ||
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