Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2015 Sep;68(3):408-15.
doi: 10.1016/j.eururo.2015.02.001. Epub 2015 Feb 16.

Five-year analysis of a multi-institutional prospective clinical trial of delayed intervention and surveillance for small renal masses: the DISSRM registry

Phillip M Pierorazio  1 , Michael H Johnson  2 , Mark W Ball  2 , Michael A Gorin  2 , Bruce J Trock  2 , Peter Chang  3 , Andrew A Wagner  3 , James M McKiernan  4 , Mohamad E Allaf  2
Affiliations
Clinical Trial

Five-year analysis of a multi-institutional prospective clinical trial of delayed intervention and surveillance for small renal masses: the DISSRM registry

Phillip M Pierorazio et al. Eur Urol. 2015 Sep.

Abstract

Background: A growing body of retrospective literature is emerging regarding active surveillance (AS) for patients with small renal masses (SRMs). There are limited prospective data evaluating the effectiveness of AS compared to primary intervention (PI).

Objective: To determine the characteristics and clinical outcomes of patients who chose AS for management of their SRM.

Design, setting, and participants: From 2009 to 2014, the multi-institutional Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) registry prospectively enrolled 497 patients with solid renal masses ≤4.0cm who chose PI or AS.

Intervention: AS versus PI.

Outcome measurements and statistical analysis: The registry was designed and powered as a noninferiority study based on historic recurrence rates for PI. Analyses were performed in an intention-to-treat manner. Primary outcomes were overall survival (OS) and cancer-specific survival (CSS).

Results and limitations: Of the 497 patients enrolled, 274 (55%) chose PI and 223 (45%) chose AS, of whom 21 (9%) crossed over to delayed intervention. AS patients were older, had worse Eastern Cooperative Oncology Group scores, total comorbidities, and cardiovascular comorbidities, had smaller tumors, and more often had multiple and bilateral lesions. OS for PI and AS was 98% and 96% at 2 yr, and 92% and 75% at 5 yr, respectively (log rank, p=0.06). At 5 yr, CSS was 99% and 100% for PI and AS, respectively (p=0.3). AS was not predictive of OS or CSS in regression modeling with relatively short follow-up.

Conclusions: In a well-selected cohort with up to 5 yr of prospective follow-up, AS was not inferior to PI.

Patient summary: The current report is among the first prospective analyses of patients electing for active surveillance of a small renal mass. Discussion of active surveillance should become part of the standard discussion for management of small renal masses.

Keywords: Active surveillance; Kidney neoplasm; Outcomes; Renal cell carcinoma; Treatment.

PubMed Disclaimer

Comment in

MeSH terms

Supplementary concepts