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在前列腺癌的一线长期激素治疗中加入多西他赛(STAMPEDE):建模以估计长期生存、质量调整生存和成本效益。

Addition of Docetaxel to First-line Long-term Hormone Therapy in Prostate Cancer (STAMPEDE): Modelling to Estimate Long-term Survival, Quality-adjusted Survival, and Cost-effectiveness.

机构信息

Centre for Health Economics, University of York, York, UK.

Centre for Health Economics, University of York, York, UK.

出版信息

Eur Urol Oncol. 2018 Dec;1(6):449-458. doi: 10.1016/j.euo.2018.06.004. Epub 2018 Sep 14.

Abstract

BACKGROUND

Results from large randomised controlled trials have shown that adding docetaxel to the standard of care (SOC) for men initiating hormone therapy for prostate cancer (PC) prolongs survival for those with metastatic disease and prolongs failure-free survival for those without. To date there has been no formal assessment of whether funding docetaxel in this setting represents an appropriate use of UK National Health Service (NHS) resources.

OBJECTIVE

To assess whether administering docetaxel to men with PC starting long-term hormone therapy is cost-effective in a UK setting.

DESIGN, SETTING, AND PARTICIPANTS: We modelled health outcomes and costs in the UK NHS using data collected within the STAMPEDE trial, which enrolled men with high-risk, locally advanced metastatic or recurrent PC starting first-line hormone therapy.

INTERVENTION

SOC was hormone therapy for ≥2 yr and radiotherapy in some patients. Docetaxel (75mg/m) was administered alongside SOC for six three-weekly cycles.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs).

RESULTS AND LIMITATIONS

The model predicted that docetaxel would extend survival (discounted quality-adjusted survival) by 0.89 yr (0.51) for metastatic PC and 0.78 yr (0.39) for nonmetastatic PC, and would be cost-effective in metastatic PC (ICER £5514/QALY vs SOC) and nonmetastatic PC (higher QALYs, lower costs vs SOC). Docetaxel remained cost-effective in nonmetastatic PC when the assumption of no survival advantage was modelled.

CONCLUSIONS

Docetaxel is cost-effective among patients with nonmetastatic and metastatic PC in a UK setting. Clinicians should consider whether the evidence is now sufficiently compelling to support docetaxel use in patients with nonmetastatic PC, as the opportunity to offer docetaxel at hormone therapy initiation will be missed for some patients by the time more mature survival data are available.

PATIENT SUMMARY

Starting docetaxel chemotherapy alongside hormone therapy represents a good use of UK National Health Service resources for patients with prostate cancer that is high risk or has spread to other parts of the body.

摘要

背景

大型随机对照试验的结果表明,对于开始接受激素治疗前列腺癌(PC)的男性,在标准治疗(SOC)基础上添加多西他赛可延长转移性疾病患者的生存期,并延长无进展生存期。迄今为止,尚未对在这种情况下为多西他赛提供资金是否代表对英国国民保健服务(NHS)资源的合理使用进行正式评估。

目的

评估在英国环境下,对开始长期激素治疗的 PC 男性使用多西他赛是否具有成本效益。

设计、地点和参与者:我们使用 STAMPEDE 试验中收集的数据,在英国 NHS 中对健康结果和成本进行建模,该试验招募了开始一线激素治疗的高危、局部晚期转移性或复发性 PC 男性。

干预措施

SOC 是至少 2 年的激素治疗和某些患者的放射治疗。多西他赛(75mg/m)与 SOC 一起用于六个三周一次的周期。

测量结果和统计分析

该模型生成了终生预测的成本、生存时间变化、质量调整生命年(QALYs)和增量成本效益比(ICERs)。

结果和局限性

该模型预测,多西他赛将使转移性 PC 的生存时间(贴现质量调整生存时间)延长 0.89 年(0.51),非转移性 PC 的生存时间延长 0.78 年(0.39),并且在转移性 PC 中具有成本效益(ICER £5514/QALY 与 SOC 相比)和非转移性 PC(更高的 QALYs,与 SOC 相比成本更低)。当假设没有生存优势时,多西他赛在非转移性 PC 中仍然具有成本效益。

结论

在英国环境下,多西他赛在非转移性和转移性 PC 患者中具有成本效益。临床医生应考虑是否有足够的证据支持在非转移性 PC 患者中使用多西他赛,因为在获得更成熟的生存数据时,一些患者将错过在激素治疗开始时提供多西他赛的机会。

患者概要

对于高危或已扩散到身体其他部位的前列腺癌患者,在激素治疗的基础上添加多西他赛化疗是对英国国民保健服务资源的合理利用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad74/6692495/830c548fc9b3/gr1.jpg

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