Long-term survivors in phase I clinical trials: Who are they and what predicts their survival?

9590 Background: Phase I trials (PhIT) participants are those who have exhausted standard treatment (tx) or for whom no standard tx exists; most patients (pts) are unlikely to benefit from new drugs. Response rate and median overall survival (OS) are ~ 5-10% and 10 months (m), respectively; however, we observe pts with improved outcomes. This study aims to characterize who these long-term survivors are and define factors predicting for this prolonged OS. Methods: Retrospective analysis of patients treated at the Drug Development Unit, RMH-ICR, UK, between 01/05-12/12 and who survived ≥12m within ≥1consecutive PhIT. Kaplan-Meier method was used to estimate OS. Cox-regression-model was applied for HR estimation and for MVA of prognostic (px) factors for OS. Results: Of 1424 pts, 86 pts (6%, 44M/42F) survived ≥12m. Median (range): age 56 (23-85), PS 0 (0-1) and no. of prior Tx 2 (0-7). Most common tumor types: 34% gynaecological (79% ovarian) & 24% genitourinary (GU) (86% prostate). RMHscore (0-1/2-3) 76/10....