MP16-12 SELECTIVE INTERNAL RADIATION THERAPY (SIRT) WITH YTTRIUM-90 (Y-90) RESIN MICROSPHERES IN PATIENTS WITH PRIMARY RENAL CELL CARCINOMA (RCC): IMPACT ON RENAL FUNCTION AND QUALITY OF LIFE IN THE RESIRT STUDY

Abstract

You have accessJournal of UrologyKidney Cancer: Advanced (including Drug Therapy) II1 Apr 2017MP16-12 SELECTIVE INTERNAL RADIATION THERAPY (SIRT) WITH YTTRIUM-90 (Y-90) RESIN MICROSPHERES IN PATIENTS WITH PRIMARY RENAL CELL CARCINOMA (RCC): IMPACT ON RENAL FUNCTION AND QUALITY OF LIFE IN THE RESIRT STUDY Peter Aslan, William Clark, Manish Patel, Justin Vass, David N. Cade, Suresh Janeendra de Silva, and Paul L. de Souza Peter AslanPeter Aslan More articles by this author , William ClarkWilliam Clark More articles by this author , Manish PatelManish Patel More articles by this author , Justin VassJustin Vass More articles by this author , David N. CadeDavid N. Cade More articles by this author , Suresh Janeendra de SilvaSuresh Janeendra de Silva More articles by this author , and Paul L. de SouzaPaul L. de Souza More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.518AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Endpoints for RCC continue to evolve with increased emphasis on patient-reported outcomes alongside efficacy and safety. SIRT is a procedure used for unresectable liver tumors that may bring benefits in primary RCC patients (pts) unsuitable for nephrectomy. RESIRT is the first study to evaluate SIRT for primary RCC aiming to assess safety as a primary objective. Secondary objectives included quality of life (QoL). METHODS RCC pts not amenable for or who declined conventional therapy were eligible. A single transfemoral microcatheter administration of Y-90 resin microspheres (Sirtex, Australia) was delivered super-selectively via the renal artery to the tumor at intended radiation doses of 75, 100, 150, 200, 300 Gray and a procedural endpoint of imminent stasis in a dose-escalation design. Pts were assessed for 12 months (mo) after SIRT. The primary endpoint was safety/toxicity 30 days post-SIRT. Secondary endpoints included safety/toxicity at other time points, renal function and QoL assessed by the RCC QoL Symptom Index with scores ranging from 0 (worst) to 100 (best). RESULTS 21 pts were recruited: mean age 75.0 years (± 9.3); 8 (38%) had metastases and 12 (57%) had chronic kidney disease stage 3; 7 (33%) had prior total contralateral nephrectomy, 1 (5%) received pazopanib and 1 (5%) progressed after cryotherapy to the target organ. Median follow-up was 12.0 mo (95% CI 11.9-12.1); 14 pts completed 12 mo follow-up, 5 died before study completion (all mRCC at study entry), 1 withdrew and 1 is still in follow-up. The intended Y-90 doses were delivered without any dose-limiting toxicity. 18 (86%) pts reported adverse events (AEs) of any causality within 30 days of SIRT and 4 (19%) reported serious AEs (SAEs), none of which was SIRT related. Over 12 mo, 10 (47.6%) pts reported grade ≥3 AEs and 10 (47.6%) pts experienced SAEs but none of these was SIRT related. Mean creatinine clearance was 76.1 mL/min at baseline and 68.9 mL/min at 12 mo. Mean serum creatinine levels and blood urea levels were stable during the study period. The mean (±SD) QoL score was 74.6 (±15.8) at baseline and 74.8 (±13.4) at 12 mo. The mean change from baseline was 1.7 (±12.5) at day 30 (p=0.565) and -4.1 (±14.7) at 12 mo (p=0.319). CONCLUSIONS This pilot study demonstrated good tolerability of SIRT using Y-90 resin microspheres for RCC at all dose levels including imminent stasis with no major impact on renal function or QoL over 12 months. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e184 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Peter Aslan More articles by this author William Clark More articles by this author Manish Patel More articles by this author Justin Vass More articles by this author David N. Cade More articles by this author Suresh Janeendra de Silva More articles by this author Paul L. de Souza More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...