PT  - JOURNAL ARTICLE
AU  - FABLE ZUSTOVICH
AU  - LORENZA LANDI
AU  - GIUSEPPE LOMBARDI
AU  - CAMILLO PORTA
AU  - LUCA GALLI
AU  - ANDREA FONTANA
AU  - DOMENICO AMOROSO
AU  - COSTANZA GALLI
AU  - MICHELE ANDREUCCETTI
AU  - ALFREDO FALCONE
AU  - VITTORINA ZAGONEL
TI  - Sorafenib plus Daily Low-dose Temozolomide for Relapsed Glioblastoma: A Phase II Study
DP  - 2013 Aug 01
TA  - Anticancer Research
PG  - 3487--3494
VI  - 33
IP  - 8
4099  - http://ar.iiarjournals.org/content/33/8/3487.short
4100  - http://ar.iiarjournals.org/content/33/8/3487.full
SO  - Anticancer Res2013 Aug 01; 33
AB  - Background: 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. Patients and Methods: Forty-three patients (median age=60.0 years) naive for antiangiogenic agents received 400 mg sorafenib twice daily plus TMZ 40 mg/m2/day until disease progression. Results: 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. Conclusion: This combination of sorafenib and temozolomide was feasible and safe, showing some activity in patients with relapsed GBM.