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转移性胰腺癌总生存期的预测:基于开放临床试验和真实世界研究数据构建并验证预后列线图

Prediction of overall survival for metastatic pancreatic cancer: Development and validation of a prognostic nomogram with data from open clinical trial and real-world study.

作者信息

Hang Junjie, Wu Lixia, Zhu Lina, Sun Zhiqiang, Wang Ge, Pan Jingjing, Zheng Suhua, Xu Kequn, Du Jiadi, Jiang Hua

机构信息

Department of Oncology, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University, Changzhou, China.

Department of Oncology, Shanghai JingAn District ZhaBei Central Hospital, Shanghai, China.

出版信息

Cancer Med. 2018 Jul;7(7):2974-2984. doi: 10.1002/cam4.1573. Epub 2018 Jun 1.

Abstract

It is necessary to develop prognostic tools of metastatic pancreatic cancer (MPC) for optimizing therapeutic strategies. Thus, we tried to develop and validate a prognostic nomogram of MPC. Data from 3 clinical trials (NCT00844649, NCT01124786, and NCT00574275) and 133 Chinese MPC patients were used for analysis. The former 2 trials were taken as the training cohort while NCT00574275 was used as the validation cohort. In addition, 133 MPC patients treated in China were taken as the testing cohort. Cox regression model was used to investigate prognostic factors in the training cohort. With these factors, we established a nomogram and verified it by Harrell's concordance index (C-index) and calibration plots. Furthermore, the nomogram was externally validated in the validation cohort and testing cohort. In the training cohort (n = 445), performance status, liver metastasis, Carbohydrate antigen 19-9 (CA19-9) log-value, absolute neutrophil count (ANC), and albumin were independent prognostic factors for overall survival (OS). A nomogram was established with these factors to predict OS and survival probabilities. The nomogram showed an acceptable discrimination ability (C-index: .683) and good calibration, and was further externally validated in the validation cohort (n = 273, C-index: .699) and testing cohort (n = 133, C-index: .653).The nomogram total points (NTP) had the potential to stratify patients into 3-risk groups with median OS of 11.7, 7.0 and 3.7 months (P < .001), respectively. In conclusion, the prognostic nomogram with NTP can predict OS for patients with MPC with considerable accuracy.

摘要

有必要开发转移性胰腺癌(MPC)的预后工具,以优化治疗策略。因此,我们试图开发并验证MPC的预后列线图。来自3项临床试验(NCT00844649、NCT01124786和NCT00574275)的数据以及133例中国MPC患者被用于分析。前2项试验作为训练队列,而NCT00574275用作验证队列。此外,133例在中国接受治疗的MPC患者作为测试队列。采用Cox回归模型研究训练队列中的预后因素。利用这些因素,我们建立了一个列线图,并通过Harrell一致性指数(C指数)和校准图进行验证。此外,该列线图在验证队列和测试队列中进行了外部验证。在训练队列(n = 445)中,体能状态、肝转移、糖类抗原19-9(CA19-9)对数、绝对中性粒细胞计数(ANC)和白蛋白是总生存期(OS)的独立预后因素。利用这些因素建立了一个列线图来预测OS和生存概率。该列线图显示出可接受的区分能力(C指数:.683)和良好的校准,并且在验证队列(n = 273,C指数:.699)和测试队列(n = 133,C指数:.653)中进一步进行了外部验证。列线图总分(NTP)有可能将患者分为3个风险组,OS中位数分别为11.7、7.0和3.7个月(P <.001)。总之,具有NTP的预后列线图能够以相当高的准确性预测MPC患者的OS。

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