Safety and tolerability of vorinostat--Experience from the vorinostat clinical trial program

14580 Background: Vorinostat is a histone deacetylase inhibitor with anticancer properties when used alone or in combination. Here we present an overview of safety and tolerability data from patients who received vorinostat as monotherapy or in combination with other systemic therapies. Methods: Safety data from all patients who participated in the vorinostat clinical trial program were collated (cut-off date December 2007). Results: Data from 476 patients were included: 341 received vorinostat as monotherapy and 135 in combination with other systemic therapies. The most commonly reported adverse events (AEs) associated with monotherapy were fatigue (68.3%), nausea (60.1%), diarrhea (55.4%), and anorexia (49.9%). Grade 3–5 AEs included thrombocytopenia (15.2%), fatigue (13.5%), dehydration (8.5%), and anemia (7.9%). Of 156 patients who received vorinostat monotherapy at 400 mg q.d. (the current FDA approved dose in CTCL patients), 13 (8.3%) discontinued due to AEs (predominantly anorexia [1.3%], pulmonary...