RT Journal Article SR Electronic T1 Sorafenib plus Daily Low-dose Temozolomide for Relapsed Glioblastoma: A Phase II Study JF Anticancer Research JO Anticancer Res FD International Institute of Anticancer Research SP 3487 OP 3494 VO 33 IS 8 A1 ZUSTOVICH, FABLE A1 LANDI, LORENZA A1 LOMBARDI, GIUSEPPE A1 PORTA, CAMILLO A1 GALLI, LUCA A1 FONTANA, ANDREA A1 AMOROSO, DOMENICO A1 GALLI, COSTANZA A1 ANDREUCCETTI, MICHELE A1 FALCONE, ALFREDO A1 ZAGONEL, VITTORINA YR 2013 UL http://ar.iiarjournals.org/content/33/8/3487.abstract 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.