Renal Function After Nephron-sparing Surgery Versus Radical Nephrectomy: Results from EORTC Randomized Trial 30904
Mené sur 541 patients atteints d'un cancer du rein (durée médiane de suivi : 6,7 ans ; taille de la tumeur ≤ 5cm), cet essai de phase III évalue, par rapport à une néphrectomie radicale, les effets d'une chirurgie conservatrice du néphron sur la fonction rénale
Background : 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). Objective : 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 (≤5cm) renal mass and normal contralateral kidney who were enrolled from March 1992 to January 2003. Intervention : Patients were randomized to RN (n=273) or NSS (n=268). 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. Conclusions : 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. Registration : EORTC trial 30904; ClinicalTrials.gov identifier NCT00002473. Take Home Message : Compared with radical nephrectomy, nephron-sparing surgery substantially reduced the incidence of moderate renal dysfunction but did not result in improved survival with available follow-up.