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临床病理参数能否预测 ypT0-2 期直肠癌的淋巴结转移?CAO/ARO/AIO-94 和 CAO/ARO/AIO-04 三期临床试验结果。

Can clinicopathological parameters predict for lymph node metastases in ypT0-2 rectal carcinoma? Results of the CAO/ARO/AIO-94 and CAO/ARO/AIO-04 phase 3 trials.

机构信息

Department of Radiotherapy and Oncology, University of Frankfurt, Germany.

Institute of Pathology, University of Erlangen, Nürnberg, Germany.

出版信息

Radiother Oncol. 2018 Sep;128(3):557-563. doi: 10.1016/j.radonc.2018.06.008. Epub 2018 Jun 18.

DOI:10.1016/j.radonc.2018.06.008
PMID:29929861
Abstract

BACKGROUND

The advent of less radical surgical approaches has generated concern about leaving locoregional lymph node metastases (LNM) unresected that could lead to adverse outcome. We examined the prognostic role of clinicopathological factors for ypN-positivity in patients with ypT0-2 rectal carcinoma treated within the CAO/ARO/AIO-94 and CAO/ARO/AIO-04 randomized phase 3 trials.

METHODS

The correlation of clinicopathological factors with ypN-status (ypN0 vs ypN1/2) was examined in n = 776 patients with ypT0-2 rectal carcinoma after preoperative CRT and total mesorectal excision surgery using Pearson's Chi-squared test for categorical variables and Kruskal-Wallis' test for continuous variables. Multivariable analysis was performed using binary logistic regression to identify independent prognosticators for ypN-positivity.

RESULTS

Residual LNM (ypN+) were found in 6%, 20.8% and 21.4% of patients with ypT0, ypT1 and ypT2 carcinomas, respectively. Independent prognosticators for LNM were advanced ypT category (p = 0.002) and lymphatic invasion (p = 0.020). In a separate multivariable analysis performed upon exclusion of ypT-category due to multicollinearity with residual tumor diameter (RTD), lymphatic invasion (p = 0.015) and RTD ≥10 mm (p = 0.005) demonstrated strong correlation with LNM.

CONCLUSION

Advanced ypT-stage, lymphatic invasion and RTD ≥10 mm were prognostic factors for LNM in patients ypT0-2 rectal carcinoma treated with CRT and surgery within both phase 3 trials. The high incidence of LNM in the ypT1-2 group needs to be taken into consideration in the context of oncological safety and indicate that LE should be advocated with great caution in this patient subgroup. The prognostic pathological factor identified here could help guide decision of LE vs TME after standard CRT.

摘要

背景

微创手术方法的出现引发了人们对未切除局部区域淋巴结转移(LNM)的担忧,这些转移可能导致不良预后。我们在 CAO/ARO/AIO-94 和 CAO/ARO/AIO-04 随机 III 期临床试验中检查了接受术前放化疗和全直肠系膜切除术治疗的 ypT0-2 直肠癌患者的临床病理因素与 ypN 状态(ypN0 与 ypN1/2)之间的相关性。

方法

对 n=776 例接受术前放化疗和全直肠系膜切除术治疗的 ypT0-2 直肠癌患者的 ypN 状态(ypN0 与 ypN1/2)与临床病理因素进行了相关性分析,采用 Pearson 卡方检验分析分类变量,采用 Kruskal-Wallis 检验分析连续变量。采用二元逻辑回归分析确定 ypN 阳性的独立预后因素。

结果

ypT0、ypT1 和 ypT2 癌患者的残留 LNM(ypN+)分别为 6%、20.8%和 21.4%。ypT 分期较晚(p=0.002)和淋巴管浸润(p=0.020)是 LNM 的独立预后因素。在排除由于残余肿瘤直径(RTD)存在多重共线性而导致的 ypT 分期后,进行了另一项多变量分析,结果显示淋巴管浸润(p=0.015)和 RTD≥10mm(p=0.005)与 LNM 密切相关。

结论

在接受 CRT 和手术治疗的 III 期临床试验中,ypT 分期较晚、淋巴管浸润和 RTD≥10mm 是 ypT0-2 直肠癌患者 LNM 的预后因素。ypT1-2 组中 LNM 的高发生率需要考虑到肿瘤学安全性,并表明在该患者亚组中应谨慎采用淋巴结清扫术。这里确定的预后病理因素可以帮助指导标准 CRT 后淋巴结清扫术与全直肠系膜切除术的决策。

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