PD31-03 IMPAIRMENT FREE SURVIVAL: A RELEVANT CLINICAL ENDPOINT FOR BLADDER CANCER PATIENTS UNDERGOING CYSTECTOMY

2015 
INTRODUCTION AND OBJECTIVES: Surgeons frequently struggle to determine patient suitability for radical cystectomy (RC) due to a paucity of comprehensive measures that predict postoperative recovery. We investigated a novel clinical endpoint, Impairment Free Survival (IFS), as an objective measure to inform patients and physicians about functional recovery from RC. METHODS: We performed a prospective cohort study of 59 bladder cancer patients ( 65 years of age) undergoing RC. IFS was defined as the time from RC to identification of: 1) a major complication (Clavien score 3); 2) loss of independent living status; 3) ECOG performance status 3 beyond 4 weeks from RC; or 4) death from any cause. In addition to standard clinical parameters, we explored outcome measures related to functional status, cognition, quality of life, wellbeing, and regret. ROC methods using logistic regression were utilized and AUC (area under the curve) is reported for the models. RESULTS: Baseline variables from 52 evaluable patients included a mean age of 74 years. Total psoas area was 2004 mm and mean psoas density was 50.8 Hounsfield units. ECOG status was 0 in 41(79%), 1 in 8(15%), 2 in 2(4%), and 3 in 1(2%). Vulnerable Elders-13 (VES-13) Score was 3 (at high risk for death and decline) in 7(13%) of patients. The Rosow-Breslau (RB) Score was 0 in 38(73%) patients, 1 in 8(15%), 2 in 3(6%), and 3 in 3(6%). Neoadjuvant chemotherapy was used in 16(31%) of patients. Robotic cystectomy was performed in 22(42%). Median length of stay was 7.5 days. Six months after RC, 38 (73%) patients were non-impaired; 14 (27%) were impaired: 11 (20%) had a major complication; 2 (4%) had a decline in living status; 5 (9%) were ECOG 3; and 5 (9%) were deceased. Baseline measures associated with 6-month IFS were psoas density (measure of body composition; p1⁄4.01), RB Score (measure of mobility; p1⁄4.01), VES-13 Score (measure of future decline; p<.01), and ECOG status (p1⁄4.03). Patients were classified as impaired using psoas density (AUC 1⁄4 0.73), VES-13 (AUC 1⁄4 0.70), RB (AUC 1⁄4 0.66) and ECOG (AUC 1⁄4 0.60). The most efficient model included psoas density and VES-13 (AUC 1⁄4 0.76). CONCLUSIONS: Impairment Free Survival is an important endpoint as it accounts for functional outcomes relevant to patients. We have identified validated pre-operative clinical measures of decline and body composition that identify patients at risk for impaired survival after RC. We believe that 6-month IFS can inform treatment decisions in vulnerable patients considering cystectomy and select patients for preoperative rehabilitation strategies.
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