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新辅助治疗的局部晚期直肠癌无肝病生存和总生存预后列线图的开发与外部验证:一项基于FOWARC试验的队列后研究

Development and external validation of prognostic nomograms for liver disease-free and overall survival in locally advanced rectal cancer with neoadjuvant therapy: a post cohort study based on the FOWARC trial.

作者信息

Zhou Jiaming, Li Tuoyang, Xiao Yuanlv, Lin Jinxin, Chen Xiaoqiong, Peng Shaoyong, Huang Mingzhe, Shi Xuebin, Cai Linbin, Huang Pinzhu, Huang Meijin

机构信息

Department of Colon and Rectum Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.

Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.

出版信息

Ann Transl Med. 2022 Jun;10(12):694. doi: 10.21037/atm-22-2790.

Abstract

BACKGROUND

There is still a lack of nomograms that can accurately predict liver metastasis and poor prognosis after neoadjuvant therapy for locally advanced rectal cancer (LARC). Effective nomograms may help clinicians better identify LARC patients with potential high-risk risks, so as to carry out more targeted monitoring, treatment and follow-up.

METHODS

The nomograms were based on the FOWARC trial (NCT01211210), which included 302 LARC patients who underwent neoadjuvant treatment before surgery at the Sixth Affiliated Hospital of Sun Yat-sen University from 2011 to 2014. The predictive accuracy and discriminative ability of the nomograms were determined by the concordance index (C-index) and calibration curve. The results were validated using bootstrap resampling and a prospective study on 100 patients in 2017.

RESULTS

The 3-year liver disease-free survival (LDFS) rate after neoadjuvant treatment for LARC was 91.65% (training cohort 92.22%, validation cohort 90.01%). Factors associated with LDFS were hepatitis B virus (HBV) infection, anemia, lymph node number, postoperative T stage and tumor nodule, which were all included in the nomogram for LDFS. The C-indies of the nomogram for LDFS were 0.828 and 0.845 in the training and validation cohorts. The 3-year overall survival (OS) rate was 94.14% (training cohort 94.13%, validation cohort 94.05%). Factors in the nomogram for OS were mesorectal fascia involvement (MRF), postoperative N stage, pathological differentiation, tumor nodule and neural invasion. The C-indies of the nomogram for predicting OS were 0.73 and 0.774 in the training and validation cohorts. The calibration curve for the survival probability showed good agreement between the nomogram predictions and the actual observations.

CONCLUSIONS

The nomograms established in this study can effectively predict LDFS and has good clinical application potential for OS in LARC patients treated with neoadjuvant therapy.

摘要

背景

目前仍缺乏能够准确预测局部晚期直肠癌(LARC)新辅助治疗后肝转移和不良预后的列线图。有效的列线图可能有助于临床医生更好地识别具有潜在高风险的LARC患者,从而进行更有针对性的监测、治疗和随访。

方法

这些列线图基于FOWARC试验(NCT01211210),该试验纳入了2011年至2014年在中山大学附属第六医院接受术前新辅助治疗的302例LARC患者。列线图的预测准确性和判别能力通过一致性指数(C指数)和校准曲线来确定。结果通过自举重采样和2017年对100例患者的前瞻性研究进行验证。

结果

LARC新辅助治疗后的3年无肝病生存率(LDFS)为91.65%(训练队列92.22%,验证队列90.01%)。与LDFS相关的因素包括乙型肝炎病毒(HBV)感染、贫血、淋巴结数量、术后T分期和肿瘤结节,这些均被纳入LDFS列线图。LDFS列线图在训练队列和验证队列中的C指数分别为0.828和0.845。3年总生存率(OS)为94.14%(训练队列94.13%,验证队列94.05%)。OS列线图中的因素包括直肠系膜筋膜受累(MRF)、术后N分期、病理分化、肿瘤结节和神经侵犯。预测OS的列线图在训练队列和验证队列中的C指数分别为0.73和0.774。生存概率的校准曲线显示列线图预测与实际观察结果之间具有良好的一致性。

结论

本研究建立的列线图能够有效预测LDFS,对接受新辅助治疗的LARC患者的OS具有良好的临床应用潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67e3/9279784/7bf7422b7cab/atm-10-12-694-f1.jpg

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