Schadendorf, D. and Hauschild, A. and Ugurel, S. and Thoelke, A. and Egberts, F. and Kreissig, M. and Linse, R. and Trefzer, U. and Vogt, T. and Tilgen, W. and Mohr, P. and Garbe, C. (2006) Dose-intensified bi-weekly temozolomide in patients with asymptomatic brain metastases from malignant melanoma: a phase II DeCOG/ADO study. ANNALS OF ONCOLOGY, 17 (10). pp. 1592-1597. ISSN 0923-7534, 1569-8041
Full text not available from this repository. (Request a copy)Abstract
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/m(2)/day (arm A) or 125 mg/m(2)/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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CEREBRAL METASTASES; AGGRESSIVE TREATMENT; CLINICAL-TRIALS; RADIOTHERAPY; MULTICENTER; IRRADIATION; FOTEMUSTINE; THERAPY; TUMORS; temozolomide; brain metastases; metastatic melanoma |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Dermatologie und Venerologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 20 Jan 2021 16:42 |
| Last Modified: | 20 Jan 2021 16:42 |
| URI: | https://pred.uni-regensburg.de/id/eprint/33905 |
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