• Anticancer research · Aug 2013

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

    • Fable Zustovich, Lorenza Landi, Giuseppe Lombardi, Camillo Porta, Luca Galli, Andrea Fontana, Domenico Amoroso, Costanza Galli, Michele Andreuccetti, Alfredo Falcone, and Vittorina Zagonel.
    • Istituto Oncologico Veneto-IRCCS, Medical Oncology 1 - Via Gattamelata, 64, 35128 Padova, Italy. fable.zustovich@ioveneto.it
    • Anticancer Res. 2013 Aug 1; 33 (8): 3487-94.

    BackgroundBevacizumab 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.Patients And MethodsForty-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.ResultsToxicity, 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.ConclusionThis combination of sorafenib and temozolomide was feasible and safe, showing some activity in patients with relapsed GBM.

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