MP44-01 A PROGNOSTIC MODEL FOR OVERALL SURVIVAL IN PATIENTS WITH METASTATIC CLEAR CELL RENAL CARCINOMA: RESULTS FROM CALGB 90206 (ALLIANCE)

randomization codes were decoded at study completion. Appropriate statistical tests were applied. RESULTS: Of 96 patients, 89 were randomized, and 82 completed the study, 41 in each group. Demographic profile, baseline IIEF-5 score and FMD % were comparable. Post-treatment there were significant improvements in IIEF-5 score (Pre vs Post treatment; Tadalafil: 11.4 3.2vs 15.9 3.7, p <0.001 and placebo: 11.2 3.2 vs 14.9 3.5, p <0.001, respectively ) and FMD % (Pre vs Post treatment; Tadalafil: 11.2 2.2 vs 13.8 2.7, p <0.001 and placebo: 11.6 1.7vs 14.0 2.7, p <0.001, respectively) and this change was significant in all the sub-groups (based on IIEF-5 severity categorization). Inter-group comparison did not show any significant difference in IIEF scores (Mean change in IIEF-5 scores, Tadalafil vs Placebo: 3.7 1.9 vs 4.4 3.3, p1⁄40.223) and FMD % (Mean change in FMD%, Tadalafil vs Placebo: 2.4 2.6 and 2.8 2.9, p1⁄40.528) This was true across all the subgroups except in patients with severe ED, where tadalafil group showed a significant improvement in FMD %.( Mean change in FMD%, Tadalafil vs Placebo: 4.6 1.9 vs 1.6 1.4, p1⁄40.020 ). The adverse events were significantly more in Tadalafil group (Tadalafil vs placebo 14 ADR vs 5 ADR, p<0.001) CONCLUSIONS: The response of low dose tadalafil (10mg per day) on IIEF and FMD is largely similar to placebo especially in young patients, however to draw meaningful conclusions, utility of FMD % in young patients and placebo effect a longer study need to be seen.