Beier, Christoph P. and Schmid, Christina and Gorlia, Thierry and Kleinletzenberger, Christine and Beier, Dagmar and Grauer, Oliver and Steinbrecher, Andreas and Hirschmann, Birgit and Brawanski, Alexander and Dietmaier, Christopher and Jauch-Worley, Tanja and Koelbl, Oliver and Pietsch, Torsten and Proescholdt, Martin and Ruemmele, Petra and Muigg, Armin and Stockhammer, Guenther and Hegi, Monika and Bogdahn, Ulrich and Hau, Peter (2009) RNOP-09: Pegylated liposomal doxorubicine and prolonged temozolomide in addition to radiotherapy in newly diagnosed glioblastoma - a phase II study. BMC CANCER, 9: 308. ISSN 1471-2407,
Full text not available from this repository. (Request a copy)Abstract
Background: Although Temozolomide is effective against glioblastoma, the prognosis remains dismal and new regimens with synergistic activity are sought for. Methods: In this phase-I/II trial, pegylated liposomal doxorubicin (Caelyx (TM), PEG-Dox) and prolonged administration of Temozolomide in addition to radiotherapy was investigated in 63 patients with newly diagnosed glioblastoma. In phase-I, PEG-Dox was administered in a 3-by-3 dose-escalation regimen. In phase-II, 20 mg/m(2) PEG-Dox was given once prior to radiotherapy and on days 1 and 15 of each 28-day cycle starting 4 weeks after radiotherapy. Temozolomide was given in a dose of 75 mg/m(2) daily during radiotherapy (60 Gy) and 150-200 mg/m(2) on days 1-5 of each 28-day cycle for 12 cycles or until disease progression. Results: The toxicity of the combination of PEG-Dox, prolonged administration of Temozolomide, and radiotherapy was tolerable. The progression free survival after 12 months (PFS-12) was 30.2%, the median overall survival was 17.6 months in all patients including the ones from Phase-I. None of the endpoints differed significantly from the EORTC26981/NCIC-CE.3 data in a post-hoc statistical comparison. Conclusion: Together, the investigated combination is tolerable and feasible. Neither the addition of PEG-Dox nor the prolonged administration of Temozolomide resulted in a meaningful improvement of the patient's outcome as compared to the EORTC26981/NCIC-CE.3 data
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | METASTATIC BREAST-CARCINOMA; HIGH-GRADE GLIOMA; MALIGNANT GLIOMA; O-6-METHYLGUANINE-DNA METHYLTRANSFERASE; RESPONSE CRITERIA; RECURRENT GLIOMA; EFFICACY; CHEMOTHERAPY; TOXICITY; MODEL; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurochirurgie Medicine > Lehrstuhl für Neurologie Medicine > Lehrstuhl für Pathologie Medicine > Lehrstuhl für Strahlentherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 07 Sep 2020 08:39 |
| Last Modified: | 07 Sep 2020 08:39 |
| URI: | https://pred.uni-regensburg.de/id/eprint/28420 |
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