Kuczyk M, Wegener G, Merseburger A S, Anastasiadis A, Machtens S, Zumbrägel A, Hartmann J T, Bokemeyer C, Jonas Udo, Stenzl A
Department of Urology, Eberhard Karls University, Hoppe Seyler Strasse 3, 72076 Tübingen, Germany.
World J Urol. 2005 Feb;23(1):50-4. doi: 10.1007/s00345-004-0483-z. Epub 2005 Feb 24.
As the biological behaviour of even early stage renal cell cancer (RCC) strongly correlates with tumor size, it has been argued that the inclusion of RCC up to a maximum diameter of 7 cm into a common subgroup classified as T1 according to the 5th edition of the TNM system would not adequately represent the different biological aggressiveness of these malignancies. Taking this into account, the TNM classification, which now categorizes T1 RCC as T1a and T1b according to a cutoff size of 4 cm, was recently modified. However, only a few larger investigations, mainly based on univariate statistical analyses, that support the suitability of this cutoff are at present available from the literature. Therefore, it was the aim of the present investigation to determine the tumor size that best separates patients with low responses from those with high risk for tumor progression by univariate (log rank test) and multivariate (Cox regression model) statistical analyses. Between 1981 and 2000, 652 patients (443 males and 209 females) underwent tumor nephrectomy in our clinic for the diagnosis of RCC. Of these, 243 patients revealed primary tumors with a local growth not extending beyond the renal capsula at the time of surgery. For the different cutoff levels (starting from 2 cm in increments of 1 cm up to 8 cm) that were selected to subdivide the patients into groups according to the maximum tumor diameter, the correlation between tumor size and overall survival was determined by univariate and multivariate statistical analyses. It became evident that although during univariate analysis the prognostic value of a cutoff size of 4 cm was confirmed, multivariate analysis identified the highest relative risk for cause-specific death (2.93) for patients having tumors larger than 5 cm in maximum diameter. Therefore, the 5 cm cutoff seems to best determine the clinical prognosis of patients undergoing tumor nephrectomy for early stage RCC. The present study demonstrates the need for multivariate statistical approaches when the latest modification of the TNM classification system is critically evaluated.
由于即使是早期肾细胞癌(RCC)的生物学行为也与肿瘤大小密切相关,有人认为,根据TNM系统第5版将最大直径达7 cm的RCC纳入分类为T1的同一亚组中,并不能充分体现这些恶性肿瘤不同的生物学侵袭性。考虑到这一点,TNM分类最近进行了修改,现在根据4 cm的临界大小将T1期RCC分为T1a和T1b。然而,目前文献中仅有少数主要基于单变量统计分析的较大规模研究支持这一临界值的适用性。因此,本研究的目的是通过单变量(对数秩检验)和多变量(Cox回归模型)统计分析,确定能最佳区分低反应患者和高肿瘤进展风险患者的肿瘤大小。1981年至2000年期间,652例患者(443例男性和209例女性)在我们诊所接受了肿瘤肾切除术以诊断RCC。其中,243例患者的原发性肿瘤在手术时局部生长未超出肾包膜。为了根据最大肿瘤直径将患者分为不同组而选择了不同的临界水平(从2 cm开始,以1 cm为增量直至8 cm),通过单变量和多变量统计分析确定肿瘤大小与总生存期之间的相关性。结果表明,虽然在单变量分析中4 cm临界大小的预后价值得到了证实,但多变量分析确定最大直径大于5 cm的患者特定病因死亡的相对风险最高(2.93)。因此,5 cm的临界值似乎最能确定接受早期RCC肿瘤肾切除术患者的临床预后。本研究表明,在对TNM分类系统的最新修改进行严格评估时,需要采用多变量统计方法。