Department of Urology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium.
Eur Urol. 2011 Apr;59(4):543-52. doi: 10.1016/j.eururo.2010.12.013. Epub 2010 Dec 22.
Nephron-sparing surgery (NSS) can safely be performed with slightly higher complication rates than radical nephrectomy (RN), but proof of oncologic effectiveness is lacking.
To compare overall survival (OS) and time to progression.
DESIGN, SETTING, AND PARTICIPANTS: From March 1992 to January 2003, when the study was prematurely closed because of poor accrual, 541 patients with small (≤5 cm), solitary, T1-T2 N0 M0 (Union Internationale Contre le Cancer [UICC] 1978) tumours suspicious for renal cell carcinoma (RCC) 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.
Patients were randomised to NSS (n=268) or RN (n=273) together with limited lymph node dissection (LND).
Time to event end points was compared with log-rank test results.
Median follow-up was 9.3 yr. The intention-to-treat (ITT) analysis showed 10-yr OS 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 RCC patients and clinically and pathologically eligible patients, 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 renal cancer (four RN and eight NSS). Twenty-one patients progressed (9 after RN and 12 after NSS). Quality of life and renal function outcomes have not been addressed.
Both methods provide excellent oncologic results. In the ITT population, NSS seems to be significantly less effective than RN in terms of OS. However, in the targeted population of RCC patients, the trend in favour of RN is no longer significant. The small number of progressions and deaths from renal cancer cannot explain any possible OS differences between treatment types.
与根治性肾切除术（RN）相比，保肾手术（NSS）的并发症发生率略高，但缺乏肿瘤有效性的证据。
比较总生存（OS）和无进展时间。
设计、设置和参与者：从 1992 年 3 月至 2003 年 1 月，当研究因入组人数不足而提前关闭时，欧洲癌症研究与治疗组织（EORTC）生殖泌尿系统组（EORTC-GU）非劣效性 30904 三期临床试验中，541 名患有小（≤5cm）、单发、T1-T2 N0 M0（国际抗癌联盟[UICC]1978）疑似肾细胞癌（RCC）且对侧肾脏正常的患者被随机分配至 NSS 或 RN。
患者被随机分配至 NSS（n=268）或 RN（n=273），并进行有限的淋巴结清扫（LND）。
使用对数秩检验比较时间事件终点。
中位随访时间为 9.3 年。意向治疗（ITT）分析显示，RN 的 10 年 OS 率为 81.1%，NSS 为 75.7%。非劣效性检验的风险比（HR）为 1.50（95%置信区间[CI]，1.03-2.16），检验结果不显著（p=0.77），优势检验结果显著（p=0.03）。在 RCC 患者和临床及病理上符合条件的患者中，差异不明显（HR=1.43 和 HR=1.34），优势检验不再显著（p=0.07 和 p=0.17）。117 例死亡中仅有 12 例（4 例 RN 和 8 例 NSS）为肾癌所致。21 例患者出现进展（9 例 RN，12 例 NSS）。未解决生活质量和肾功能结局问题。
两种方法均提供了出色的肿瘤学结果。在 ITT 人群中，NSS 的 OS 效果明显不如 RN。然而，在 RCC 患者的目标人群中，RN 治疗的优势不再显著。肾癌进展和死亡的数量较少，无法解释两种治疗方法之间可能存在的 OS 差异。
