In the European Organization for Research and Treatment of Cancer (EORTC) randomized trial 30904, nephron-sparing surgery (NSS) was associated with reduced overall survival compared with radical nephrectomy (RN) over a median follow-up of 9.3 yr (hazard ratio: 1.50; 95% confidence interval [CI], 1.03–2.16).
To examine the impact of NSS relative to RN on kidney function in EORTC 30904.
Design, setting, and participants
This phase 3 international randomized trial was conducted in patients with a small (≤5
Patients were randomized to RN (n
Outcome measurements and statistical analysis
Follow-up estimated glomerular filtration rates (eGFR; milliliters per minute per 1.73 m2) were recorded for 259 subjects in the RN arm and 255 subjects in the NSS arm. Percentages of subjects developing at least moderate renal dysfunction (eGFR <60), advanced kidney disease (eGFR <30), or kidney failure (eGFR <15) were calculated for each treatment arm based on the lowest recorded follow-up eGFR (intent-to-treat analysis).
Results and limitations
With a median follow-up of 6.7 yr, eGFR <60 was reached by 85.7% with RN and 64.7% with NSS, with a difference of 21.0% (95% CI, 13.8–28.3); eGFR <30 was reached by 10.0% with RN and 6.3% with NSS, with a difference of 3.7% (95% CI, –1.0 to 8.5); and eGFR <15 was reached by 1.5% with RN and 1.6% with NSS, with a difference of –0.1% (95% CI, –2.2 to 2.1). Lack of longer follow-up for eGFR is a limitation of these analyses.
Compared with RN, NSS substantially reduced the incidence of at least moderate renal dysfunction (eGFR <60), although with available follow-up 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 nearly identical. The beneficial impact of NSS on eGFR did not result in improved survival in this study population.
EORTC trial 30904; ClinicalTrials.gov identifier
Keywords: Kidney cancer, Nephron-sparing surgery, Radical nephrectomy.
a Department of Urology, University of Rochester Medical Center, Rochester, NY, USA Department of Urology, University of Rochester Medical Center, Rochester, NY, USA
b Department of Biostatistics, EORTC Headquarters, Brussels, Belgium Department of Biostatistics, EORTC Headquarters, Brussels, Belgium
c Department of Urology, Cleveland Clinic, Cleveland, OH, USA Department of Urology, Cleveland Clinic, Cleveland, OH, USA
d Department of Urology, University Hospital K.U. Leuven, Leuven, Belgium Department of Urology, University Hospital K.U. Leuven, Leuven, Belgium
© 2013 European Association of Urology, Published by Elsevier B.V.