MP72-19 PHASE II STUDY OF AXITINIB FOR DOWNSTAGING CT2A TO CT1 RENAL TUMORS FOR ALLOWING PARTIAL NEPHRECTOMY (AXIPAN)

You have accessJournal of UrologyKidney Cancer: Localized: Surgical Therapy V1 Apr 2017MP72-19 PHASE II STUDY OF AXITINIB FOR DOWNSTAGING CT2A TO CT1 RENAL TUMORS FOR ALLOWING PARTIAL NEPHRECTOMY (AXIPAN) Cedric Lebacle, Jean Christophe Bernhard, Karim Bensalah, Herve Baumert, Herve Lang, Didier Jacqmin, Brigitte Duclos, Alain Ravaud, Brigitte Laguerre, Laurence Albiges, Armelle Arnoux, Bernard Escudier, and Jean Jacques Patard Cedric LebacleCedric Lebacle More articles by this author , Jean Christophe BernhardJean Christophe Bernhard More articles by this author , Karim BensalahKarim Bensalah More articles by this author , Herve BaumertHerve Baumert More articles by this author , Herve LangHerve Lang More articles by this author , Didier JacqminDidier Jacqmin More articles by this author , Brigitte DuclosBrigitte Duclos More articles by this author , Alain RavaudAlain Ravaud More articles by this author , Brigitte LaguerreBrigitte Laguerre More articles by this author , Laurence AlbigesLaurence Albiges More articles by this author , Armelle ArnouxArmelle Arnoux More articles by this author , Bernard EscudierBernard Escudier More articles by this author , and Jean Jacques PatardJean Jacques Patard More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2255AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Laparoscopic Radical Nephrectomy (RN) is the current standard of care for large organ confined renal tumors while Partial Nephrectomy (PN) is recommanded for tumor sizes up to 7 cm. PN preserves long term renal function with possible effect on overall survival. Axitinib, a potent VEGFR TKI can reduce the size of primary tumor in metastatic setting. Our primary objective was to test the ability of axitinib to reduce the size of large tumors for shifting from a RN to a PN indication. METHODS Patients with localized (cT2N0M0) RCCs were enrolled in a prospective phase II trial assessing the effect of neoadjuvant axitinib prior to surgery (PN or RN). Main inclusion criteria were: age ≥ 18, histologically proven clear cell RCC, MDRD creatinin clearance ≥ 60 ml/min, cT2a N0NxM0 tumors (&[null]> 7cm; ≤ 10 cm). Medical treatment consisted in axitinib 5 mg up to 10 mg tw/d during 2 to 6 months prior surgery according to radiological response. RESULTS A total of 18 patients including 11 men (61%) and 7 women (39%) with a median age of 60 yrs were enrolled. Median baseline tumor size, RENAL score, serum creatinine and MDRD estimated GFR were: 7.6 cm, 11, 0.8 mg/dl and 96.5 ml/min respectively. Duration of treatment was 2, 4 and 6 months in 12 (66%), 3 (17%) and 3 cases (17%), respectively. Median interval from treatment stop to surgery was 6 days. After neoadjuvant treatment median tumor size and RENAL score decreased to 6.2 cm and 10. 89% of patients presented a decrease in maximum tumor diameter, with median size reduction of 19%. Out of the 17 patients who were operated, 16 (94%) underwent a PN (9 robotic & 7 open), including 67% of the cases which were performed for tumors ≤ 7cm. At 1 month from surgery, median serum creatinin and MDRD estimated GFR were 0.9 mg/dl and 87 ml/min, respectively. Medical and surgical complications included 1 embolization for severe bleeding and 1 Clavien V complication at 1 month after surgery due to massive myocardial infarction. CONCLUSIONS Neoadjuvant axitinib in cT2 renal tumors allowed cT1 downstaging and nephron sparing surgery in almost 70% of the cases. However, PN procedures remained high complexity cases requiring adequate surgeon expertise and information of the patients for possible morbidity of these procedures. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e962 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Cedric Lebacle More articles by this author Jean Christophe Bernhard More articles by this author Karim Bensalah More articles by this author Herve Baumert More articles by this author Herve Lang More articles by this author Didier Jacqmin More articles by this author Brigitte Duclos More articles by this author Alain Ravaud More articles by this author Brigitte Laguerre More articles by this author Laurence Albiges More articles by this author Armelle Arnoux More articles by this author Bernard Escudier More articles by this author Jean Jacques Patard More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...