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, 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.
journal_name
BMC Cancerjournal_title
BMC cancerauthors
Beier CP,Schmid C,Gorlia T,Kleinletzenberger C,Beier D,Grauer O,Steinbrecher A,Hirschmann B,Brawanski A,Dietmaier C,Jauch-Worley T,Kölbl O,Pietsch T,Proescholdt M,Rümmele P,Muigg A,Stockhammer G,Hegi M,Bogdahn U,Haudoi
10.1186/1471-2407-9-308subject
Has Abstractpub_date
2009-09-02 00:00:00pages
308issn
1471-2407pii
1471-2407-9-308journal_volume
9pub_type
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