Merseburger A S, Wegener G, Horstmann M, Oelke M, Zumbrägel A, Bokemeyer C, Kollmannsberger C, Jonas U, Stenzl A, Kuczyk M
Abteilung für Urologie, Eberhard-Karls-Universität, Tübingen, FRG.
Aktuelle Urol. 2003 Dec;34(7):469-74. doi: 10.1055/s-2003-45267.
As a result of the observation that the potential biological aggressiveness of even early stage renal cell cancer (RCC) strongly correlates with tumor size, the 5th edition of the TNM system (1997), which classifies all renal tumors up to a maximum diameter of 7 cm as T1, was modified in the current classification to distinguish T1a and T1b tumors based on a cut-off of 4 cm. Only a few larger investigations supporting this cut-off are available in the literature and these are based on univariate statistical analysis. To determine whether this cut-off best reflects the correlation between aggressive potential and tumor size and thus differentiates patients at low or high risk of progression, this investigation was performed using both univariate and multivariate statistical analysis.
Between 1981 and 2000, a total of 652 patients underwent tumor nephrectomy for renal cell carcinoma. Of these, the 243 patients with local RCC not extending beyond the renal capsule were subjected to univariate (log rank test) and multivariate (Cox regression model) statistical analysis.
It became evident that, while during univariate analysis the prognostic calue of a cut-off size of 4 cm was confirmed, multivariate analysis identified the highest relative risk of cause-specific death (2.93) in those patients with tumors larger than 5 cm maximum diameter.
The 5 cm cut-off thus appears to best determine the clinical prognosis for patients undergoing tumor nephrectomy for early stage renal call cancer. Taking this into consideration, the present study clearly demonstrates the reed for a multivariate statistical approach when the current modification of the TNM classification system is critically reevaluated.
鉴于观察到即使是早期肾细胞癌(RCC)的潜在生物学侵袭性也与肿瘤大小密切相关,TNM系统第5版(1997年)将最大直径达7 cm的所有肾肿瘤分类为T1,在当前分类中进行了修改,以基于4 cm的临界值区分T1a和T1b肿瘤。文献中仅有少数支持该临界值的较大规模研究,且这些研究基于单变量统计分析。为确定该临界值是否最能反映侵袭潜能与肿瘤大小之间的相关性,从而区分低进展风险或高进展风险的患者,本研究采用了单变量和多变量统计分析。
1981年至2000年间,共有652例患者因肾细胞癌接受了肿瘤肾切除术。其中,243例局限性RCC未超出肾包膜的患者接受了单变量(对数秩检验)和多变量(Cox回归模型)统计分析。
显而易见,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的患者中,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早期肾细胞癌接受肿瘤肾切除术患者的临床预后。考虑到这一点,本研究清楚地表明,在对TNM分类系统的当前修改进行严格重新评估时,采用多变量统计方法的必要性。