1768 PROGRESSION-FREE AND OVERALL SURVIVAL OF PATIENTS TREATED WITH PRESURGICAL SUNITINIB PRIOR TO CYTOREDUCTIVE NEPHRECTOMY (CN) IN CLEAR CELL SYNCHRONOUS METASTATIC RENAL CELL CARCINOMA (MRCC)

Abstract

You have accessJournal of UrologyKidney Cancer: Advanced1 Apr 20111768 PROGRESSION-FREE AND OVERALL SURVIVAL OF PATIENTS TREATED WITH PRESURGICAL SUNITINIB PRIOR TO CYTOREDUCTIVE NEPHRECTOMY (CN) IN CLEAR CELL SYNCHRONOUS METASTATIC RENAL CELL CARCINOMA (MRCC) Axel Bex, Christian Blank, Simon Chowdhury, David Nichol, John Peters, Simon Horenblas, Tim O'Brien, Naveed Sarwar, John Haanen, and Thomas Powles Axel BexAxel Bex Amsterdam, Netherlands More articles by this author , Christian BlankChristian Blank Amsterdam, Netherlands More articles by this author , Simon ChowdhurySimon Chowdhury London, United Kingdom More articles by this author , David NicholDavid Nichol London, United Kingdom More articles by this author , John PetersJohn Peters London, United Kingdom More articles by this author , Simon HorenblasSimon Horenblas Amsterdam, Netherlands More articles by this author , Tim O'BrienTim O'Brien London, United Kingdom More articles by this author , Naveed SarwarNaveed Sarwar London, United Kingdom More articles by this author , John HaanenJohn Haanen Amsterdam, Netherlands More articles by this author , and Thomas PowlesThomas Powles London, United Kingdom More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.2096AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Presurgical sunitinib can be safely administered in clear cell mRCC. This upfront approach may have advantages over initial CN followed by sunitinib. Here we describe progression free survival (PFS) and overall survival (OS) results for this upfront approach. METHODS The study combined the data from 2 prospective phase II studies which assessed upfront sunitinib (12–16 weeks) prior to CN in previously untreated patients with clear cell mRCC. Patients had MSKCC intermediate and poor risk disease. The Kaplan Meier method was used to assess outcome. Radiological PFS was evaluated using RECIST v1.1. The amount of necrosis at the time of surgery was assessed pathologically. RESULTS Sixty five patients with clear cell mRCC were entered into these 2 studies between 2007 and 2010. The median age of the cohort was 61 (range: 44–78) year and 53 (81%) were male. Twenty patients (31%) had MSKCC poor risk disease; the remainder had intermediate risk disease. CN was performed in 46 (71%) patients. The commonest reason for not performing surgery was disease progression 13 (20%). The median PFS and OS for the cohort was 7 months (95% CI 6–11 months) and 15 months (95%CI: 10-NA). Fourteen (30%) patients had progression of disease during the treatment break for surgery, 9 of whom achieved further clincal benifit with further sunitinib. The OS for patients with intermediate and poor risk disease was 26 months (11-not reached(NR) months) and 8 months (4-NR months) respectively. The MSKCC poor risk patients fell into 2 groups, those with progressive metastasis who did not undergo surgery (55%) as opposed to a subgroup who obtained clinical benefit with therapy and went on to have CN (45%). These patients had an improved outcome compared to those with primary refractory disease (median OS 6 vs 12 months). Neither a reduction in the size of the primary tumour (above median: 14%) or increased necrosis at surgery (>50%) correlated with outcome (HR 1.8 [0.89–4.06] and HR 1.68 HR 0.64–4.39] respectively). CONCLUSIONS The outcome of patients with MSKCC intermediate risk treated with sunitinib prior to CN is encouraging and consistent with results seen in the phase III trial sunitinib versus interferon in which most patients had initial nephrectomy, most of them with metachronous mRCC. The role of surgery in the poor risk population remains unclear. It may be useful in those who have clinical benefit with upfront sunitinib. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e709-e710 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Axel Bex Amsterdam, Netherlands More articles by this author Christian Blank Amsterdam, Netherlands More articles by this author Simon Chowdhury London, United Kingdom More articles by this author David Nichol London, United Kingdom More articles by this author John Peters London, United Kingdom More articles by this author Simon Horenblas Amsterdam, Netherlands More articles by this author Tim O'Brien London, United Kingdom More articles by this author Naveed Sarwar London, United Kingdom More articles by this author John Haanen Amsterdam, Netherlands More articles by this author Thomas Powles London, United Kingdom More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...