术中快速预测乳腺癌非前哨淋巴结转移模型的建立与验证研究

发布时间：2018-08-08 11:02

【摘要】：背景与目的:大部分前哨淋巴结(sentinel lymph node,SLN)阳性而接受腋窝淋巴结清扫术(axillary lymph node dissection,ALND)的患者,腋窝非前哨淋巴结(non-sentinel lymph node,n SLN)并没有发生转移,因此准确预测n SLN转移至关重要。该研究将建立基于分子诊断一步核酸扩增法(onestep nucleic acid amplification,OSNA)的术中快速预测乳腺癌n SLN转移的模型,以期有效指导乳腺癌后续治疗。方法:利用2010年OSNA临床试验入组的552例患者中SLN阳性、并接受ALND的103例患者数据,建立基于分子诊断的乳腺癌NSLN转移的预测模型,并利用2015年OSNA临床试验入组的327例患者中61例符合相同条件的患者数据进行验证。结果:原发肿瘤大小、SLN总肿瘤负荷、SLN阳性数及阴性数是NSLN转移的四个独立相关因素,利用这四个因素建立预测列线图,得出建模组患者的受试者工作特征(receiver operating characteristic curve,ROC)曲线的曲线下面积(area under the ROC curve,AUC)为0.814,验证组患者的AUC为0.842。利用验证组61例患者影像学评估的肿瘤大小替代病理大小对本模型进行了验证,得出AUC为0.838,与模型验证性AUC相比差异无统计学意义(P=0.740 6)。结论:基于分子诊断的乳腺癌预测n SLN转移的模型既可以术中快速预测腋窝淋巴结转移风险,也可以术后常规预测,明显优于其他预测模型,对后续腋窝的处理及放疗靶区勾画具有更好的指导价值。
[Abstract]:Background & objective: non-sentinel lymph noden SLN does not metastasize in most sentinel lymph node patients who are positive for axillary lymph node dissection after axillary lymph node dissection (ALND), so it is very important to accurately predict n SLN metastasis. In this study, an intraoperative model of rapid prediction of n SLN metastasis of breast cancer based on one-step nucleic acid amplification method for molecular diagnosis was established to effectively guide the follow-up treatment of breast cancer. Methods: a molecular diagnostic predictive model of NSLN metastasis of breast cancer was established from 552 patients with SLN positive in 2010 OSNA clinical trial and 103 patients with ALND. The data of 61 of 327 patients in the 2015 OSNA clinical trial were used to verify the same condition. Results: the positive and negative number of SLN in primary tumor size and total tumor load were four independent correlation factors of NSLN metastasis. The area under the curve of (receiver operating characteristic curve was 0.814 in the model group, and the AUC in the validation group was 0.842. The tumor size of 61 patients in the validation group was used to evaluate the tumor size instead of pathological size. The results showed that the AUC was 0.838, and there was no significant difference compared with the model confirmatory AUC (P0. 7406). Conclusion: the model of predicting n SLN metastasis of breast cancer based on molecular diagnosis can predict the risk of axillary lymph node metastasis quickly during operation and routine prediction after operation, which is superior to other prediction models. It has better guiding value for the treatment of axilla and the drawing of radiotherapy target area.
【作者单位】：济南大学山东省医学科学院医学与生命科学学院;山东大学附属山东省肿瘤医院乳腺病中心;山东省医学科学院;
【基金】：国家自然科学基金(81502314);国家自然科学基金(81672638)
【分类号】：R737.9

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