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

Christoph P Beier, Christina Schmid, Thierry Gorlia, Christine Kleinletzenberger, Dagmar Beier, Oliver Grauer, Andreas Steinbrecher, Birgit Hirschmann, Alexander Brawanski, Christopher Dietmaier, Tanja Jauch-Worley, Oliver Kölbl, Torsten Pietsch, Martin Proescholdt, Petra Rümmele, Armin Muigg, Günther Stockhammer, Monika Hegi, Ulrich Bogdahn, Peter Hau

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Abstrakt

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, 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.

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.

OriginalsprogEngelsk
TidsskriftBMC Cancer
Vol/bind9
Sider (fra-til)308
ISSN1471-2407
DOI
StatusUdgivet - 2. sep. 2009
Udgivet eksterntJa

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