MP50-01 RESULTS FROM A MULTI-INSTITUTIONAL, PROSPECTIVE CLINICAL TRIAL OF DELAYED INTERVENTION AND SURVEILLANCE FOR SMALL RENAL MASSES: THE DISSRM REGISTRY

Abstract

You have accessJournal of UrologyKidney Cancer: Evaluation and Staging III1 Apr 2015MP50-01 RESULTS FROM A MULTI-INSTITUTIONAL, PROSPECTIVE CLINICAL TRIAL OF DELAYED INTERVENTION AND SURVEILLANCE FOR SMALL RENAL MASSES: THE DISSRM REGISTRY Phillip Pierorazio, Michael Johnson, Mark Ball, Michael Gorin, Peter Chang, Andrew Wagner, James McKiernan, Bruce Trock, and Mohamad Allaf Phillip PierorazioPhillip Pierorazio More articles by this author , Michael JohnsonMichael Johnson More articles by this author , Mark BallMark Ball More articles by this author , Michael GorinMichael Gorin More articles by this author , Peter ChangPeter Chang More articles by this author , Andrew WagnerAndrew Wagner More articles by this author , James McKiernanJames McKiernan More articles by this author , Bruce TrockBruce Trock More articles by this author , and Mohamad AllafMohamad Allaf More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1666AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES A growing body of retrospective literature has emerged demonstrating the safety of active surveillance (AS) for select patients with small renal masses (SRM). The prospective, multi-institutional Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry was opened January 1, 2009, to track the outcomes of patients with SRM ≤4.0 cm who chose management with either primary intervention (PI) or AS. METHODS Patients were enrolled following consultation and choice of AS or PI. Those electing AS followed an imaging protocol every 4-6 months for 2 years, then every 6-12 months for 3 years. The registry was designed and powered as a non-inferiority study, with the ability to distinguish a maximally clinically-significant difference in disease-specific survival of 5% at 5 years with 445 patients enrolled (assuming 30% elect AS). Survival estimates were calculated with the Kaplan-Meier method and differences between groups were compared with the log-rank test and multivariable Cox proportional hazards regression modeling. Analyses were performed in an intention-to-treat manner, with patients crossing over to delayed intervention (DI) considered in the AS cohort. RESULTS As of November 1, 2014, 497 patients were enrolled in the DISSRM registry: 274 (55.1%) elected PI, 223 (44.9%) AS, of which 21 (9.4%) crossed over to DI. The median follow-up was 2.1 years (range: 0-5) and 161 (32.3%) patients had follow-up >3 years. In total 23 patients died: 10 PI and 13 AS. Two patients in the PI arm died of RCC. Overall survival for PI and AS was 98.4% and 95.7% at 2 years, and 92.0% and 74.9% at 5 years respectively (log-rank, p=0.06). CSS was 98.5% and 100% at 5 years respectively (log rank p0.3). In regression modeling, while there was evidence that AS was associated with an increased the risk of all-cause mortality, the results did not meet conventional levels of statistical significance (Hazard Ratio: 2.2, 95% CI 0.95-5.0, p=0.07). Age (HR 1.09, 95% CI 1.04-1.14, <0.001) and cardiovascular index score >1 (HR 3.0, 95% CI1.7-12.6, 0.003) predicted all-cause mortality. Notably tumor size, ECOG performance status and R.E.N.A.L. nephrometry score were not predictive of overall survival. CONCLUSIONS In a well-selected cohort with 5-years of prospective data, overall and disease-specific survival were not significantly different among patients with a SRM undergoing PI and AS. Therefore, AS with DI appears to be a non-inferior management strategy for well-selected patients with SRM. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e611 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Phillip Pierorazio More articles by this author Michael Johnson More articles by this author Mark Ball More articles by this author Michael Gorin More articles by this author Peter Chang More articles by this author Andrew Wagner More articles by this author James McKiernan More articles by this author Bruce Trock More articles by this author Mohamad Allaf More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...