PD04-02 RENAL FUNCTION BEFORE AND AFTER CYTOREDUCTIVE NEPHRECTOMY IN A PHASE 3 RANDOMIZED CLINICAL TRIAL

Abstract

You have accessJournal of UrologyKidney Cancer: Advanced (including Drug Therapy) II1 Apr 2016PD04-02 RENAL FUNCTION BEFORE AND AFTER CYTOREDUCTIVE NEPHRECTOMY IN A PHASE 3 RANDOMIZED CLINICAL TRIAL Erik N. Mayer, BS William T. Lowrance, MD, MPH Robert Uzzo, MD Christopher Wood, MD, FACS Alexander Kutikov, MD, FACS Marc Smaldone, MD, MSHP Jason Gee, MD William Huang, MD Thomas Gardner, MD Gennady Bratslavsky, MD Jeff Holzbeierlein, MD, FACS Lawrence Karsh, MD Viraj Master, MD, PhD, FACS Neal Shore, andMD Brian LaneMD, PhD, FACS Erik N. MayerErik N. Mayer More articles by this author , William T. LowranceWilliam T. Lowrance More articles by this author , Robert UzzoRobert Uzzo More articles by this author , Christopher WoodChristopher Wood More articles by this author , Alexander KutikovAlexander Kutikov More articles by this author , Marc SmaldoneMarc Smaldone More articles by this author , Jason GeeJason Gee More articles by this author , William HuangWilliam Huang More articles by this author , Thomas GardnerThomas Gardner More articles by this author , Gennady BratslavskyGennady Bratslavsky More articles by this author , Jeff HolzbeierleinJeff Holzbeierlein More articles by this author , Lawrence KarshLawrence Karsh More articles by this author , Viraj MasterViraj Master More articles by this author , Neal ShoreNeal Shore More articles by this author , and Brian LaneBrian Lane More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2407AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Cytoreductive nephrectomy (CN) in the setting of metastatic renal cell carcinoma (mRCC) has shown improvement in overall survival for select patients when combined with systemic therapy, but its impact on renal function is not completely understood. Our objective was to assess renal function before and after CN in patients with mRCC participating in the ADAPT (The Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma) trial. METHODS We examined pre-/post-CN renal function from the ongoing phase 3 clinical trial involving administration of AGS-003 + Sunitinib vs. Sunitinib alone after CN in patients with mRCC. Records of patients at trial sites between January 2013 and July 2015 were reviewed for tumor characteristics, established CKD risk factors, and demographic information. A univariate and multivariate logistic regression analysis was used to evaluate the impact of patient and disease specific factors on pre-operative renal function. RESULTS The ADAPT trial has enrolled >1000 patients at 113 centers worldwide since April 2012. Trial accrual completed mid-2015. Pre-operative info was available for 1007 patients. Of those undergoing CN, 198 (19.7%) had stage 3 or greater CKD (GFR < 60ml/min/1.73 m2) at baseline. Factors independently associated with an increased risk of pre-operative stage 3 or greater CKD included age at diagnosis (OR: 1.064, 95% CI: 1.042-1.087, p < .0001), LDH above the upper limit of normal (OR: 1.851, 95% CI: 1.231-2.781, p<0.003), and advanced tumor stage. The likelihood of having at least stage 3 CKD at surgery was lower for T stage 1 (OR 0.432, 95% CI: 0.192-0.969, p<0.042) and T stage 2 disease (OR: 0.303, 95% CI: 0.117-0.788, p<0.014) than for T stage 3. Gender, race, low albumin, symptoms of metastasis, and adenopathy were not significantly associated with pre-operative CKD stage 3 or greater. Post-operative GFR data was limited to 426 patients; the median change after CN was -21.6 ml/min/1.73 m2. Of these patients, 160 (37.6%) developed CKD 3 or greater post CN in the setting of previously normal renal function. CONCLUSIONS The ADAPT trial is the largest randomized CN trial completed to date. Here we observed that one fifth of patients with mRCC in this trial had baseline stage 3 or worse CKD. Increasing tumor stage and age were associated with a greater risk for pre-operative CKD in patients undergoing CN. Moreover, 37.6% of patients with available data developed de novo CKD 3 or worse post-CN. Older patients with advanced disease may be at higher risk of significant renal insufficiency after CN. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e120-e121 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Erik N. Mayer More articles by this author William T. Lowrance More articles by this author Robert Uzzo More articles by this author Christopher Wood More articles by this author Alexander Kutikov More articles by this author Marc Smaldone More articles by this author Jason Gee More articles by this author William Huang More articles by this author Thomas Gardner More articles by this author Gennady Bratslavsky More articles by this author Jeff Holzbeierlein More articles by this author Lawrence Karsh More articles by this author Viraj Master More articles by this author Neal Shore More articles by this author Brian Lane More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...