预测晚期不可切除肝内胆管癌患者总生存期和无进展生存期列线图的开发与验证
Development and Validation of Nomograms to Predict the Overall Survival and Progression-Free Survival in Patients with Advanced Unresectable Intrahepatic Cholangiocarcinoma.
作者信息
Xian Feng, Song Xuewu, Bie Jun, Xu Guohui
机构信息
Sichuan Cancer Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, People's Republic of China.
Department of Oncology, Nanchong Central Hospital, The Second Clinical College of North Sichuan Medical College, Nanchong, Sichuan, People's Republic of China.
出版信息
Cancer Manag Res. 2024 Dec 18;16:1835-1849. doi: 10.2147/CMAR.S489960. eCollection 2024.
PURPOSE
This study aimed to develop and validate clinical nomograms for predicting progression-free survival (PFS) and overall survival (OS) in unresectable ICC patients.
PATIENTS AND METHODS
Patients with ICC between 1 January 2018 and 31 May 2023 were selected and randomized into a training set and an internal validation set as a 7:3 ratio. Data analysis and modeling were conducted through R software. The univariate and multivariate Cox regression models were used to analyze the prognosis factors affecting OS and PFS. Survival analysis was conducted using the Kaplan-Meier (KM) method, and comparisons were made using the Log rank test. Then, two nomogram models were constructed to predict OS and PFS, respectively. The nomogram was evaluated and calibrated using the Harrell's C-index, receiver operating characteristic curve (ROC), and calibration plots, and the decision curve analysis (DCA) was conducted to assess its clinical utility.
RESULTS
A total of 110 patients were enrolled in this study, with 77 to the training set and 33 to the validation set. In the entire population, the OS rates at 6 and 12 months were 75.5% and 35.5%, respectively, while the PFS rates at 6 and 12 months were 47.3% and 20%, respectively. Cox regression analyses showed that ECOG, Tumor volume, HBsAg and AFP were the prognosis factors of OS, and the predictors in the model of PFS included Gender, Stage of tumor, CDC20 expression and AFP. The nomograms were constructed based on the predictors above. The C-index for predicting OS was 0.802 (0.755, 0.849) in the training set, 0.813 (0.764, 0.862) in the internal validation set; the C-index for predicting PFS was 0.658 (0.568, 0.748) in the training set, and 0.795 (0.705, 0.885) in the internal validation set. Finally, calibration curves and DCA indicated that two nomograms showed favorable performance.
CONCLUSION
Two practical and effective prognostic nomograms were developed to assist clinicians in evaluating OS and PFS in patients with unresectable ICC.
目的
本研究旨在开发并验证用于预测不可切除性肝内胆管癌（ICC）患者无进展生存期（PFS）和总生存期（OS）的临床列线图。
患者与方法
选取2018年1月1日至2023年5月31日期间的ICC患者，并按7:3的比例随机分为训练集和内部验证集。通过R软件进行数据分析和建模。采用单因素和多因素Cox回归模型分析影响OS和PFS的预后因素。使用Kaplan-Meier（KM）法进行生存分析，并采用对数秩检验进行比较。然后，分别构建两个列线图模型来预测OS和PFS。使用Harrell's C指数、受试者工作特征曲线（ROC）和校准图对列线图进行评估和校准，并进行决策曲线分析（DCA）以评估其临床实用性。
结果
本研究共纳入110例患者，其中77例进入训练集，33例进入验证集。在整个研究人群中，6个月和12个月时的OS率分别为75.5%和35.5%，而6个月和12个月时的PFS率分别为47.3%和20%。Cox回归分析显示，ECOG、肿瘤体积、HBsAg和AFP是OS的预后因素，PFS模型中的预测因素包括性别、肿瘤分期、CDC20表达和AFP。基于上述预测因素构建了列线图。训练集中预测OS的C指数为0.802（0.755，0.849），内部验证集中为0.813（0.764，0.862）；训练集中预测PFS的C指数为0.658（0.568，0.748），内部验证集中为0.795（0.705，0.885）。最后，校准曲线和DCA表明两个列线图均表现良好。
结论
开发了两个实用且有效的预后列线图，以协助临床医生评估不可切除性ICC患者的OS和PFS。
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