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前列腺癌主动监测、手术与放疗的 ProtecT 随机临床试验成本效果分析

The ProtecT randomised trial cost-effectiveness analysis comparing active monitoring, surgery, or radiotherapy for prostate cancer.

机构信息

Bristol Medical School, University of Bristol, Bristol, UK.

Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.

出版信息

Br J Cancer. 2020 Sep;123(7):1063-1070. doi: 10.1038/s41416-020-0978-4. Epub 2020 Jul 16.

Abstract

BACKGROUND

There is limited evidence relating to the cost-effectiveness of treatments for localised prostate cancer.

METHODS

The cost-effectiveness of active monitoring, surgery, and radiotherapy was evaluated within the Prostate Testing for Cancer and Treatment (ProtecT) randomised controlled trial from a UK NHS perspective at 10 years' median follow-up. Prostate cancer resource-use collected from hospital records and trial participants was valued using UK reference-costs. QALYs (quality-adjusted-life-years) were calculated from patient-reported EQ-5D-3L measurements. Adjusted mean costs, QALYs, and incremental cost-effectiveness ratios were calculated; cost-effectiveness acceptability curves and sensitivity analyses addressed uncertainty; subgroup analyses considered age and disease-risk.

RESULTS

Adjusted mean QALYs were similar between groups: 6.89 (active monitoring), 7.09 (radiotherapy), and 6.91 (surgery). Active monitoring had lower adjusted mean costs (£5913) than radiotherapy (£7361) and surgery (£7519). Radiotherapy was the most likely (58% probability) cost-effective option at the UK NICE willingness-to-pay threshold (£20,000 per QALY). Subgroup analyses confirmed radiotherapy was cost-effective for older men and intermediate/high-risk disease groups; active monitoring was more likely to be the cost-effective option for younger men and low-risk groups.

CONCLUSIONS

Longer follow-up and modelling are required to determine the most cost-effective treatment for localised prostate cancer over a man's lifetime.

TRIAL REGISTRATION

Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).

摘要

背景

针对局限性前列腺癌的治疗方法,其成本效益的相关证据有限。

方法

在中位随访 10 年时,从英国国家医疗服务体系(NHS)的角度,基于前列腺癌检测和治疗(ProtecT)随机对照试验的数据,评估主动监测、手术和放疗的成本效益。从医院记录和试验参与者收集的前列腺癌资源使用情况,使用英国参考成本进行评估。通过患者报告的 EQ-5D-3L 测量值计算 QALYs(质量调整生命年)。计算调整后的平均成本、QALYs 和增量成本效益比;使用成本效益接受曲线和敏感性分析来处理不确定性;亚组分析考虑了年龄和疾病风险。

结果

各组之间调整后的平均 QALY 相似:主动监测组为 6.89,放疗组为 7.09,手术组为 6.91。主动监测的调整后平均成本(5913 英镑)低于放疗(7361 英镑)和手术(7519 英镑)。在英国 NICE 支付意愿阈值(每 QALY20,000 英镑)下,放疗最有可能(58%的概率)具有成本效益。亚组分析证实,对于年龄较大的男性和中/高危疾病组,放疗是一种具有成本效益的选择;对于年龄较小的男性和低危组,主动监测更有可能成为具有成本效益的选择。

结论

需要进行更长时间的随访和建模,以确定在男性的一生中,哪种治疗方法对局限性前列腺癌最具成本效益。

试验注册

当前对照试验编号,ISRCTN86403035;ClinicalTrials.gov 编号,NCT02044172。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e9b9/7524753/7d2cc05202bd/41416_2020_978_Fig1_HTML.jpg

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