Open Access Research article

RNOP-09: Pegylated liposomal doxorubicine and prolonged temozolomide in addition to radiotherapy in newly diagnosed glioblastoma - a phase II study

Christoph P Beier1, Christina Schmid1, Thierry Gorlia2, Christine Kleinletzenberger1, Dagmar Beier1, Oliver Grauer1, Andreas Steinbrecher1, Birgit Hirschmann1, Alexander Brawanski3, Christopher Dietmaier4, Tanja Jauch-Worley1, Oliver Kölbl5, Torsten Pietsch6, Martin Proescholdt3, Petra Rümmele7, Armin Muigg8, Günther Stockhammer8, Monika Hegi9, Ulrich Bogdahn1 and Peter Hau1*

Author Affiliations

1 Department of Neurology, University of Regensburg, Universitätsstrasse 84, 93053 Regensburg, Germany

2 EORTC Data Center, Avenue Mounierlaan 83/11, 1200, Brussels, Belgium

3 Department of Neurosurgery, University of Regensburg, Franz-Josef-Strauss Allee 11, 93053 Regensburg, Germany

4 University of Applied Sciences Amberg Weiden, Hetzenrichter Weg 15, 92224 Weiden, Germany

5 Department of Radiooncology, University of Regensburg, Franz-Josef-Strauss Allee 11, 93053 Regensburg, Germany

6 Department of Neuropathology, University of Bonn, Sigmund-Freud-Strasse 3, 53015 Bonn, Germany

7 Department of Pathology, Franz-Josef-Strauss Allee 11, 93053 Regensburg, Germany

8 Department of Neurology, University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria

9 Laboratory of Brain Tumor Biology and Genetics, Centre Universitaire Romands de Neurochirurgie and University of Lausanne, Rue du Bugnon 46, 1011 Lausanne, Switzerland

For all author emails, please log on.

BMC Cancer 2009, 9:308  doi:10.1186/1471-2407-9-308

Published: 2 September 2009



Although Temozolomide is effective against glioblastoma, the prognosis remains dismal and new regimens with synergistic activity are sought for.


In this phase-I/II trial, pegylated liposomal doxorubicin (Caelyx™, 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/m2 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/m2 daily during radiotherapy (60 Gy) and 150-200 mg/m2 on days 1-5 of each 28-day cycle for 12 cycles or until disease progression.


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.


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

Trial registration NCT00944801.