Sorafenib plus daily low-dose temozolomide for relapsed glioblastoma: a phase II study

Bevacizumab has provided encouraging results in relapsed glioblastoma multiforme (GBM). Pre-clinical and clinical investigations also showed that continuous low-dose temozolomide has some antiangiogenic activity. Based on this evidence, a phase II trial was designed to investigate an oral regimen of...

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Bibliographic Details
Published in:Anticancer research 2013-08, Vol.33 (8), p.3487
Main Authors: Zustovich, Fable, Landi, Lorenza, Lombardi, Giuseppe, Porta, Camillo, Galli, Luca, Fontana, Andrea, Amoroso, Domenico, Galli, Costanza, Andreuccetti, Michele, Falcone, Alfredo, Zagonel, Vittorina
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - therapeutic use
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Brain Neoplasms - drug therapy
Dacarbazine - administration & dosage
Dacarbazine - adverse effects
Dacarbazine - analogs & derivatives
Dacarbazine - therapeutic use
Disease Progression
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Glioblastoma - drug therapy
Humans
Magnetic Resonance Imaging
Male
Middle Aged
Niacinamide - administration & dosage
Niacinamide - adverse effects
Niacinamide - analogs & derivatives
Niacinamide - therapeutic use
Phenylurea Compounds - administration & dosage
Phenylurea Compounds - adverse effects
Phenylurea Compounds - therapeutic use
Recurrence
Survival Analysis
Time Factors
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Summary:Bevacizumab has provided encouraging results in relapsed glioblastoma multiforme (GBM). Pre-clinical and clinical investigations also showed that continuous low-dose temozolomide has some antiangiogenic activity. Based on this evidence, a phase II trial was designed to investigate an oral regimen of sorafenib, an oral multikinase inhibitor, and metronomic temozolomide for relapsed GBM. Forty-three patients (median age=60.0 years) naive for antiangiogenic agents received 400 mg sorafenib twice daily plus TMZ 40 mg/m(2)/day until disease progression. Toxicity, mostly grade 1-2, was manageable. Grade 3-4 toxicities were hand-foot syndrome (n=4), hypertension (n=2), and fatigue (n=3). Five patients (12%) achieved partial response, 18 (43%) stable disease, 20 (48%) showed progression. The median time-to-progression was 3.2 months, 6-month progression-free survival was 26%, and median overall survival was 7.4 months. This combination of sorafenib and temozolomide was feasible and safe, showing some activity in patients with relapsed GBM.
ISSN:1791-7530