Hau, Peter and Fabel, Klaus and Baumgart, Ulrike and Rümmele, Petra and Grauer, Oliver and Bock, Annekatrin and Dietmaier, Christopher and Dietmaier, Wolfgang and Dietrich, Joerg and Dudel, Christine and Huebner, Franz and Jauch, Tanya and Drechsel, Elisabeth and Kleiter, Ingo and Wismeth, Cäcile and Zellner, Anton and Brawanski, Alexander and Steinbrecher, Andreas and Marienhagen, Joerg and Bogdahn, Ulrich (2004) Pegylated liposomal doxorubicin-efficacy in patients with recurrent high-grade glioma. CANCER, 100 (6). pp. 1199-1207. ISSN 0008-543X
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND. Doxorubicin exhibits high efficacy in malignant glioma cell cultures. Nonetheless, as a standard formulation, doxorubicin has not been used clinically, due to poor penetration of the blood-brain barrier. Furthermore, doxorubicin is known to induce tumor resistance genes. To address both of these issues, the authors investigated the use of pegylated liposomal doxorubicin (Caelyx(TM); Essex Pharma, Munich, Germany) alone (Trial 1) and in combination with tamoxifen (Trial 2) in two sequentially performed nonrandomized prospective Phase 11 trials involving patients with recurrent high-grade glioma. METHODS. Twenty patients were included in each trial. Progression-free survival at 6 months (PFS-6) and toxicity were the primary endpoints. Expression of the tumor resistance proteins multidrug resistance protein 1 (MDR-1) and multiple resistance protein (MRP) was evaluated by immunohistochemical methods and by sestamibi-single-photon emission computed tomography (SPECT). RESULTS. The overall response rate (including cases of disease stabilization) was 40% in both Trial 1 and Trial 2. PFS-6 was 15%, and the median time to disease progression was 17 weeks. It is noteworthy that 40% of patients with Grade III tumors had long-term responses, which lasted for up to 3 years. There was no significant difference between Trial I and Trial 2 in terms of efficacy. Both regimens were well tolerated, with the main side effect being palmoplantar erythrodysesthesia. The authors found no correlation between clinical response and expression of tumor resistance genes or between clinical response and SPECT data. CONCLUSIONS. Pegylated liposomal doxorubicin administered alone or in combination with tamoxifen is safe and moderately effective in patients with recurrent high-grade glioma. None of the putative predictors for response that were evaluated proved to be significant in this setting. (C) 2004 American Cancer Society.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | HIGH-DOSE TAMOXIFEN; QUALITY-OF-LIFE; MALIGNANT GLIOMA; PHASE-II; GLIOBLASTOMA-MULTIFORME; RESPONSE CRITERIA; DRUG-RESISTANCE; BRAIN-TUMORS; CHEMOTHERAPY; TRIAL; anaplastic astrocytoma; glioblastoma; pegylated liposomal doxorubicin; Phase II trial; tamoxifen |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurochirurgie Medicine > Lehrstuhl für Neurologie Medicine > Lehrstuhl für Pathologie Medicine > Abteilung für Nuklearmedizin |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 26 Jul 2021 08:32 |
| Last Modified: | 26 Jul 2021 08:32 |
| URI: | https://pred.uni-regensburg.de/id/eprint/37873 |
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