Wolmark N, Fisher B, Wieand H S
Ann Surg. 1986 Feb;203(2):115-22. doi: 10.1097/00000658-198602000-00001.
This study was carried out in an effort to resolve the dilemma created by three proposed modifications of the Dukes' C class of colorectal cancer. Each modification is based on a separate prognostic discriminant characterized by: the level of histologically positive nodes, the depth of tumor penetration, and the number of histologically positive nodes. Data were derived from 844 patients with Dukes' C lesions randomized into two prospective clinical trials of the NSABP; the mean time on study was 41 months. Analysis of the three modifications as independent variables without regard for possible confounding effects disclosed that each had a highly significant predictive capacity. When each discriminant was examined, this time adjusting for the contribution of the other two discriminants, the effect attributable to the level of positive nodes was markedly attenuated. Thus, the level of positive nodes provided little information over and above that of depth of tumor penetration and the number of positive nodes. Of the two latter discriminants, although both were significant predictors of survival, the number of positive nodes appeared to be the strongest factor. Using both depth of penetration and the number of positive nodes, a unique Dukes' C subset of patients could be identified with a prognosis at least as good as Dukes' B lesions; this group was characterized by partial tumor penetration and the presence of 1-4 positive nodes. It is concluded that both depth of penetration and the number of positive nodes represent appropriate modifications of the initial Dukes scheme, and one discriminant should not be used to the exclusion of the other. The data raise serious doubts relative to the propriety of newly proposed TNM classification schemes that fail to utilize the number of positive nodes as a predictive discriminant.
本研究旨在解决对结直肠癌Dukes C期提出的三种修改方案所造成的困境。每种修改方案都基于一个单独的预后判别指标,其特征分别为:组织学阳性淋巴结的水平、肿瘤浸润深度以及组织学阳性淋巴结的数量。数据来源于844例患有Dukes C期病变的患者,他们被随机纳入NSABP的两项前瞻性临床试验;研究的平均时间为41个月。将这三种修改方案作为独立变量进行分析,而不考虑可能的混杂效应,结果显示每种方案都具有高度显著的预测能力。当对每个判别指标进行检验时,这次对其他两个判别指标的贡献进行了调整,结果发现阳性淋巴结水平所产生的影响明显减弱。因此,阳性淋巴结水平除了肿瘤浸润深度和阳性淋巴结数量之外,几乎没有提供额外的信息。在后面这两个判别指标中,虽然两者都是生存的显著预测指标,但阳性淋巴结数量似乎是最强的因素。利用浸润深度和阳性淋巴结数量,可以识别出一个独特的Dukes C期患者亚组,其预后至少与Dukes B期病变一样好;该组的特征是肿瘤部分浸润且有1 - 4个阳性淋巴结。结论是,浸润深度和阳性淋巴结数量都是对最初Dukes分期方案的适当修改,不应只使用一个判别指标而排除另一个。这些数据对新提出的TNM分类方案的适当性提出了严重质疑,因为这些方案没有将阳性淋巴结数量作为预测判别指标。