Platinum Priority – Kidney CancerEditorial by R. Houston Thompson on pp. 378–379 of this issueRenal Function After Nephron-sparing Surgery Versus Radical Nephrectomy: Results from EORTC Randomized Trial 30904☆
Introduction
According to a recent systematic review of 20 observational studies, in patients with a small renal mass (T1a and selected T1b tumors), nephron-sparing surgery (NSS) is associated with improved overall survival compared with radical nephrectomy (RN) [1]. These findings were attributed to similar oncologic outcomes after NSS and RN, with better preservation of renal function after NSS [1]. However, these studies were limited by their observational design and thus subject to selection bias.
In 2011, Van Poppel et al. presented results of a randomized trial of NSS versus RN for a small (≤5 cm) solitary renal mass, with a prospective assessment of renal function, oncologic outcomes, and overall and cause-specific survival [2]. Median follow-up for all-cause mortality was 9.3 yr. In the intention-to-treat analysis, overall survival was better in the RN arm compared with the NSS arm (hazard ratio [HR]:1.50; 95% confidence interval [CI], 1.03–2.16; p = 0.03) [2]. This difference, however, could not be attributed to differences in kidney cancer mortality. Among the 273 patients randomized to RN, 4 patients died from kidney cancer and 46 died from other causes. Among the 268 patients randomized to NSS, 8 patients died from kidney cancer and 59 died from other causes. The difference in kidney cancer mortality (NSS vs RN) was not statistically significant (p = 0.23) [2]. The impact of NSS relative to RN on postoperative kidney function as assessed by the estimated glomerular filtration rate (eGFR) has not been previously reported. The main objective of this analysis was to examine the incidence of at least moderate renal dysfunction (eGFR <60), advanced kidney disease (eGFR <30), and kidney failure (eGFR <15) in the RN and the NSS arms of European Organization for Research and Treatment of Cancer (EORTC) trial 30904. In exploratory analyses, we investigated whether the effect of NSS relative to RN on kidney function depends on baseline creatinine and comorbidities.
Section snippets
Study design
This study was a randomized trial of RN versus NSS, with all-cause mortality as the primary end point. Details of the study design were reported elsewhere [2], [3]. Eligibility criteria included a solitary renal mass suspicious for renal cell carcinoma ≤5 cm, a radiographically normal contralateral kidney, and a World Health Organization performance status of 0–2. Preoperative serum creatinine (SC) was documented as ≤1.25 × upper limit of normal (ULN), 1.26–2.5 × ULN, or 2.6–5.0 × ULN (ie, exact
Results
From March 1992 to January 2003, 541 patients from 45 institutions [2] were randomized to undergo RN (n = 273) or NSS (n = 268). In each intervention arm, 12 patients had no information on follow-up SC and were excluded from the current analyses. Among the remaining patients, the sex of two patients in the RN arm and one patient in the NSS arm was unknown. They were also excluded because their eGFR could not be calculated (Fig. 1). Hence the current analyses were based on 259 patients randomized to
Discussion
Our current analyses demonstrated that over a median follow-up of 6.7 yr for eGFR, NSS compared with RN substantially reduced the incidence of at least moderate renal dysfunction stage A (eGFR <60) and stage B (eGFR <45) based on both lowest eGFR and last eGFR, although the incidence of advanced kidney disease (eGFR <30) was relatively similar in the two treatment arms, and the incidence of kidney failure (eGFR <15) was essentially identical. The beneficial impact of NSS on eGFR did not result
Conclusions
In EORTC 30904, the only randomized trial of RN versus NSS completed to date, over a median follow-up of 6.7 yr for eGFR, NSS substantially reduced the incidence of at least moderate renal dysfunction (eGFR <60), although the incidence of advanced kidney disease (eGFR <30) was relatively similar in the two treatment arms and the incidence of kidney failure (eGFR <15) nearly identical. The beneficial impact of NSS on eGFR did not result in improved survival in this study population with a median
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