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放射外科治疗脑转移瘤的医疗卫生经济评估

Medical and health economic assessment of radiosurgery for the treatment of brain metastasis.

作者信息

Müller-Riemenschneider Falk, Schwarzbach Christoph, Bockelbrink Angelina, Ernst Iris, Vauth Christoph, Willich Stefan N, von der Schulenburg Johann-Matthias

机构信息

Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin, Berlin, Deutschland.

出版信息

GMS Health Technol Assess. 2009 Mar 9;5:Doc03. doi: 10.3205/hta000065.


DOI:10.3205/hta000065
PMID:21289890
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3011285/
Abstract

BACKGROUND: Radiotherapy for patients suffering from malignant neoplasms has developed greatly during the past decades. Stereotactic radiosurgery (SRS) is one important radiotherapeutic option which is defined by a single and highly focussed application of radiation during a specified time interval. One of its important indications is the treatment of brain metastases. OBJECTIVES: The objective of this HTA is to summarise the current literature concerning the treatment of brain metastasis and to compare SRS as a single or additional treatment option to alternative treatment options with regard to their medical effectiveness/efficacy, safety and cost-effectiveness as well as their ethical, social and legal implications. METHODS: A structured search and hand search of identified literature are performed from January 2002 through August 2007 to identify relevant publications published in English or German. Studies targeting patients with single or multiple brain metastases are included. The methodological quality of included studies is assessed according to quality criteria, based on the criteria of evidence based medicine. RESULTS: Of 1,495 publications 15 medical studies meet the inclusion criteria. Overall study quality is limited and with the exception of two randomized controlleed trials (RCT) and two meta-analyses only historical cohort studies are identified. Reported outcome measures are highly variable between studies. Studies with high methodological quality provide evidence, that whole-brain radiotherapy (WBRT) in addition to SRS and SRS in addition to WBRT is associated with improved local tumour control rates and neurological function. However, only in patients with single brain metastasis, RPA-class 1 (RPA = Recursive partitioning analysis) and certain primary tumour entities, this combination of SRS and WBRT is associated with superior survival compared to WBRT alone. Studies report no significant differences in adverse events between treatment groups. Methodologically less rigorous studies provide no conclusive evidence with regard to medical effectiveness and safety, comparing SRS to WBRT, neurosurgery (NS) or hypofractionated radiotherapy (HCSRT). The quality of life is not investigated in any of the studies. Within the searched databases a total of 320 economic publications are identified. Five publications are eligible for this report. The five reports have a quiet variable quality. Concerning the economic efficiency of alternative equipment, while assuming equal effectiveness, the calculations show, that economic efficiency depends to a large extend on the number of patients treated. In case the two alternative equipments are used solely for SRS, the Gamma Knife might be more cost-efficient. Otherwise an adapted linear accelerator is most likely to be beneficial because of its flexibility. One Health Technology Assessment (HTA) states, that the cost for a Gamma Knife and a dedicated linear accelerator are comparable, while an adapted version is cheaper. No reports concerning ethical, legal and social aspects are identified. DISCUSSION: Overall, quantity and quality of identified studies is limited. However, the identified studies indicate that the prognosis of patients with brain metastases is despite highly developed and modern treatment regimes still limited. Conclusive evidence with regard to the effectiveness of identified interventions is only available for the combined treatment of SRS and WBRT compared to SRS or WBRT alone. Furthermore, there is insufficient evidence to compare SRS with WBRT, NS or HCSRT. The efficiency of the different equipments depends to a great extent on the number and the indications of the patients treated. If dedicated systems are used to their full capacity, there is some evidence for superior cost-effectiveness. If more treatment flexibility is required, adapted systems seem to be advantageous. However, equal treatment effectiveness is a necessary assumption for these conclusions. The need for a treatment precision can influence the purchase decision. No reports concerning more recent therapeutic alternatives are currently available. CONCLUSION: Combination of SRS and WBRT is associated with improved local tumour control and neurological function compared to SRS or WBRT alone. However, only for patients with single metastasis there is strong evidence that this results in improved survival compared to WBRT alone. Methodologically rigorous studies are warranted to investigate SRS compared to WBRT and NS and to investigate the quality of life in patients undergoing these treatment regimes. Concerning the type of equipment used, economic efficiency depends to a great extend on the capacity at which the system can be used. Dedicated systems might be favourable for a high number of patients, while lower patient counts probably favour adapted systems with their superior treatment flexibility. Using the equipment at its full capacity may result in a limited number of machines, what in turn may give rise to the question of an equal and easy access to this technology. Studies focusing on the comparative effectiveness and cost-effectiveness of different treatment options and their combinations, especially for the German setting, are warranted.

摘要

背景:在过去几十年间,针对恶性肿瘤患者的放射治疗取得了长足发展。立体定向放射外科(SRS)是一种重要的放射治疗方法,其定义为在特定时间间隔内单次高度聚焦的放射应用。其重要适应症之一是治疗脑转移瘤。 目的:本卫生技术评估(HTA)的目的是总结当前关于脑转移瘤治疗的文献,并就其医学有效性/疗效、安全性和成本效益以及伦理、社会和法律影响,将SRS作为单一或辅助治疗选择与其他替代治疗选择进行比较。 方法:于2002年1月至2007年8月对已识别文献进行结构化检索和手工检索,以识别用英文或德文发表的相关出版物。纳入针对单发或多发脑转移瘤患者的研究。根据基于循证医学标准的质量标准评估纳入研究的方法学质量。 结果:在1495篇出版物中,有15项医学研究符合纳入标准。总体研究质量有限,除两项随机对照试验(RCT)和两项荟萃分析外,仅识别出历史队列研究。各研究报告的结局指标差异很大。方法学质量高的研究提供了证据,表明SRS联合全脑放疗(WBRT)以及WBRT联合SRS与局部肿瘤控制率和神经功能改善相关。然而,仅在单发脑转移瘤患者、RPA 1级(RPA = 递归分区分析)和某些原发肿瘤实体中,SRS与WBRT联合治疗相比单纯WBRT具有更好的生存率。研究报告各治疗组之间不良事件无显著差异。方法学上不太严格的研究在比较SRS与WBRT、神经外科手术(NS)或低分割放疗(HCSRT)的医学有效性和安全性方面未提供确凿证据。所有研究均未调查生活质量。在检索的数据库中总共识别出320篇经济出版物。五篇出版物符合本报告要求。这五篇报告质量差异很大。关于替代设备的经济效率,在假设有效性相同的情况下,计算表明,经济效率在很大程度上取决于治疗的患者数量。如果两种替代设备仅用于SRS,伽玛刀可能更具成本效益。否则,由于其灵活性,适配的直线加速器可能最有益。一项卫生技术评估(HTA)指出,伽玛刀和专用直线加速器的成本相当,而适配版本更便宜。未识别出关于伦理、法律和社会方面的报告。 讨论:总体而言,已识别研究的数量和质量有限。然而,已识别研究表明,尽管有高度发达和现代的治疗方案,脑转移瘤患者的预后仍然有限。关于已识别干预措施有效性的确凿证据仅适用于SRS与WBRT联合治疗与单纯SRS或WBRT的比较。此外,没有足够的证据将SRS与WBRT、NS或HCSRT进行比较。不同设备的效率在很大程度上取决于治疗患者的数量和适应症。如果专用系统满负荷使用,有一些证据表明成本效益更高。如果需要更大的治疗灵活性,适配系统似乎更具优势。然而,这些结论的必要假设是治疗效果相同。对治疗精度的需求可能会影响购买决策。目前没有关于更新的治疗替代方案的报告。 结论:与单纯SRS或WBRT相比,SRS与WBRT联合治疗与局部肿瘤控制和神经功能改善相关。然而,仅对于单发转移瘤患者有强有力的证据表明,与单纯WBRT相比,这会导致生存率提高。需要进行方法学严谨的研究来比较SRS与WBRT和NS,并调查接受这些治疗方案患者的生活质量。关于使用的设备类型问题,经济效率在很大程度上取决于系统的使用能力。专用系统可能有利于大量患者,而患者数量较少时可能更倾向于具有更好治疗灵活性的适配系统。满负荷使用设备可能会导致机器数量有限,这反过来可能会引发能否平等且方便地获得该技术的问题。有必要开展关注不同治疗选择及其组合的比较有效性和成本效益的研究,特别是针对德国情况的研究。

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