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基于模型的前列腺癌根治性前列腺切除术与外照射放疗决策支持系统,纳入一项临床试验和一项成本效用研究。

Modeling-Based Decision Support System for Radical Prostatectomy Versus External Beam Radiotherapy for Prostate Cancer Incorporating an Clinical Trial and a Cost-Utility Study.

作者信息

van Wijk Yvonka, Ramaekers Bram, Vanneste Ben G L, Halilaj Iva, Oberije Cary, Chatterjee Avishek, Marcelissen Tom, Jochems Arthur, Woodruff Henry C, Lambin Philippe

机构信息

The D-Lab, Department of Precision Medicine, GROW-School for Oncology and Developmental Biology, Maastricht University, 6229 ER Maastricht, The Netherlands.

Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht University Medical Centre+, 6229 HX Maastricht, The Netherlands.

出版信息

Cancers (Basel). 2021 May 29;13(11):2687. doi: 10.3390/cancers13112687.

Abstract

The aim of this study is to build a decision support system (DSS) to select radical prostatectomy (RP) or external beam radiotherapy (EBRT) for low- to intermediate-risk prostate cancer patients. We used an individual state-transition model based on predictive models for estimating tumor control and toxicity probabilities. We performed analyses on a synthetically generated dataset of 1000 patients with realistic clinical parameters, externally validated by comparison to randomized clinical trials, and set up an in silico clinical trial for elderly patients. We assessed the cost-effectiveness (CE) of the DSS for treatment selection by comparing it to randomized treatment allotment. Using the DSS, 47.8% of synthetic patients were selected for RP and 52.2% for EBRT. During validation, differences with the simulations of late toxicity and biochemical failure never exceeded 2%. The in silico trial showed that for elderly patients, toxicity has more influence on the decision than TCP, and the predicted QoL depends on the initial erectile function. The DSS is estimated to result in cost savings (EUR 323 (95% CI: EUR 213-433)) and more quality-adjusted life years (QALYs; 0.11 years, 95% CI: 0.00-0.22) than randomized treatment selection.

摘要

本研究的目的是构建一个决策支持系统(DSS),用于为低至中危前列腺癌患者选择根治性前列腺切除术(RP)或外照射放疗(EBRT)。我们使用了基于预测模型的个体状态转换模型来估计肿瘤控制和毒性概率。我们对一个合成生成的包含1000例具有实际临床参数患者的数据集进行了分析,并通过与随机临床试验比较进行外部验证,同时为老年患者开展了一项计算机模拟临床试验。我们通过将DSS与随机治疗分配进行比较,评估了其在治疗选择方面的成本效益(CE)。使用DSS,47.8%的合成患者被选择接受RP,52.2%被选择接受EBRT。在验证过程中,与晚期毒性和生化失败模拟结果的差异从未超过2%。计算机模拟试验表明,对于老年患者,毒性对决策的影响大于肿瘤控制概率(TCP),且预测的生活质量(QoL)取决于初始勃起功能。据估计,与随机治疗选择相比,DSS可节省成本(323欧元(95%置信区间:213 - 433欧元))并增加质量调整生命年(QALYs;0.11年,95%置信区间:0.00 - 0.22)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/847c/8198879/daca8e1a4ee2/cancers-13-02687-g002.jpg

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