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

Détails

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Etat: Serval
Version: de l'auteur
ID Serval
serval:BIB_852C93962248
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
RNOP-09: pegylated liposomal doxorubicine and prolonged temozolomide in addition to radiotherapy in newly diagnosed glioblastoma--a phase II study.
Périodique
BMC Cancer
Auteur(s)
Beier C.P., 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., Hau P.
ISSN
1471-2407[electronic]
Statut éditorial
Publié
Date de publication
2009
Peer-reviewed
Oui
Volume
9
Numéro
1
Pages
308
Langue
anglais
Résumé
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.
Pubmed
Web of science
Open Access
Oui
Création de la notice
24/09/2009 15:31
Dernière modification de la notice
08/05/2019 21:22
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