A prospective, randomised EORTC intergroup phase 3 study comparing the oncologic outcome of elective nephron-sparing surgery and radical nephrectomy for XXXX .

@entity1 @entity5 @entity1358 @entity1349 @entity703
BACKGROUND: Nephron-sparing surgery (NSS) can safely be performed with slightly higher complication rates than radical nephrectomy (RN), but proof of oncologic effectiveness is lacking. OBJECTIVE: To compare @entity1349 ( @entity1349 ) and time to progression. DESIGN, SETTING, AND @entity1 : From March 1992 to January 2003, when the study was prematurely closed because of poor accrual, 541 @entity1 with small ( <=5 cm), solitary, T1-T2 N0 M0 (Union Internationale Contre le Cancer [UICC] 1978) @entity5 suspicious for @entity1358 ( @entity1358 ) and a normal contralateral kidney were randomised to NSS or RN in European Organisation for Research and Treatment of Cancer Genito-Urinary Group (EORTC-GU) noninferiority phase 3 trial 30904. INTERVENTION: @entity1 were randomised to NSS (n=268) or RN (n=273) together with limited lymph node dissection (LND). MEASUREMENTS: Time to event end points was compared with log-rank test results. RESULTS AND LIMITATIONS: Median follow-up was 9.3 yr. The intention-to-treat (ITT) analysis showed 10-yr @entity1349 rates of 81.1% for RN and 75.7% for NSS. With a hazard ratio (HR) of 1.50 (95% confidence interval [CI], 1.03-2.16), the test for noninferiority is not significant (p=0.77), and test for superiority is significant (p=0.03). In @entity1358 @entity1 and clinically and pathologically eligible @entity1 , the difference is less pronounced (HR=1.43 and HR=1.34, respectively), and the superiority test is no longer significant (p=0.07 and p=0.17, respectively). Only 12 of 117 deaths were the result of @entity703 (four RN and eight NSS). Twenty-one @entity1 progressed (9 after RN and 12 after NSS). Quality of life and renal function outcomes have not been addressed. CONCLUSIONS: Both methods provide excellent oncologic results. In the ITT population, NSS seems to be significantly less effective than RN in terms of @entity1349 . However, in the targeted population of @entity1358 @entity1 , the trend in favour of RN is no longer significant. The small number of progressions and deaths from @entity703 cannot explain any possible @entity1349 differences between treatment types.
