Survival results with AP23573, a novel mTOR inhibitor, in patients (pts) with advanced soft tissue or bone sarcomas: Update of phase II trial

10076 Background: AP23573 is an mTOR inhibitor that has demonstrated single-agent activity in a broad range of sarcoma tumor types in phase I phase II trials. Overall survival (OS) was monitored to characterize OS in the treated population and in the subset of patients who achieved a clinical benefit response (CBR). Methods: Pts with advanced sarcomas, with no restrictions on prior therapies, were enrolled into 4 cohorts based on histologic subtype, in a phase 2, Simon's 2-stage trial. AP23573 (12.5 mg, i.v.) was administered daily × 5 every 2 wks. Efficacy was assessed using RECIST, with CBR defined as a complete or partial response or stable disease for at least 16 wks duration. OS was defined as the time from the first dose of AP23573 to the date of death from any cause. Kaplan-Meier estimates of the survival times of the population were calculated with OS time censored at the last date the pt was known to be alive when the confirmation of death is absent or unknown. Patients are continuing to be follo...