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芬兰早期乳腺癌短程辅助曲妥珠单抗治疗:基于 FinHer 试验 5 年随访结果的成本效益和信息价值分析。

Short-course adjuvant trastuzumab therapy in early stage breast cancer in Finland: cost-effectiveness and value of information analysis based on the 5-year follow-up results of the FinHer Trial.

机构信息

University of Eastern Finland, School of Pharmacy, Pharmacoeconomics and Outcomes Research Unit, Kuopio, Finland.

出版信息

Acta Oncol. 2011 Apr;50(3):344-52. doi: 10.3109/0284186X.2011.553841. Epub 2011 Feb 8.

Abstract

BACKGROUND

Trastuzumab is a standard treatment of HER2-positive early breast cancer in many countries, and it is usually given as a one year adjuvant treatment. However, its cost-effectiveness has not been assessed in Finland. The Finland Herceptin (FinHer) trial has compared a shorter 9-week treatment protocol against no trastuzumab with promising results. The aim of this study was to assess the potential cost-effectiveness of the 9-week treatment based on the recently published five-year follow-up results of the FinHer trial.

METHODS

An evaluation model of breast cancer treatment was constructed using fitted survival estimates and a long-term Markov model. The cost-effectiveness of 9-week adjuvant treatment was assessed in a Finnish setting, compared to treatment without trastuzumab. The analysis was performed from a societal perspective, and a 3% discount rate was applied for future costs and outcomes. Value of information analysis was performed to estimate the potential value of further research.

RESULTS

According to the probabilistic analysis, the incremental cost-effectiveness ratio was €12 000 per quality adjusted life year (QALY), and €9300 per life year gained (LYG), when comparing adjuvant trastuzumab therapy to standard treatment without trastuzumab. The modelled incremental outcomes for trastuzumab treatment were 0.66 QALY and 0.85 LYG for a lifetime perspective. Value of information analysis showed that additional research on treatment effects would be most valuable for reducing uncertainty in the adoption decision.

CONCLUSIONS

Adjuvant 9-week trastuzumab is likely to be a cost-effective treatment in the Finnish setting. Results from an ongoing trial comparing adjuvant 9-week treatment with the 12-month treatment will play a key role in addressing the uncertainty related to the treatment effect and potential cost-effectiveness of these two treatment protocols.

摘要

背景

曲妥珠单抗是许多国家治疗 HER2 阳性早期乳腺癌的标准治疗方法,通常作为辅助治疗使用一年。然而,其成本效益尚未在芬兰进行评估。芬兰赫赛汀(FinHer)试验比较了较短的 9 周治疗方案与不使用曲妥珠单抗的方案,结果令人鼓舞。本研究旨在根据最近发表的 FinHer 试验 5 年随访结果,评估 9 周治疗的潜在成本效益。

方法

使用拟合的生存估计和长期马尔可夫模型构建了乳腺癌治疗评估模型。在芬兰环境中,比较了 9 周辅助治疗与不使用曲妥珠单抗的治疗,评估了 9 周辅助治疗的成本效益。分析采用社会视角进行,未来成本和结果采用 3%的贴现率贴现。进行了信息价值分析,以估计进一步研究的潜在价值。

结果

根据概率分析,与不使用曲妥珠单抗的标准治疗相比,辅助曲妥珠单抗治疗的增量成本效益比为每质量调整生命年 12000 欧元(€),每获得 1 个生命年(LYG)为 9300€。曲妥珠单抗治疗的模型增量结果为终生视角下的 0.66 QALY 和 0.85 LYG。信息价值分析表明,关于治疗效果的进一步研究将对减少决策不确定性最有价值。

结论

在芬兰环境下,辅助 9 周曲妥珠单抗治疗可能具有成本效益。正在进行的比较辅助 9 周治疗与 12 个月治疗的试验结果将在解决治疗效果和这两种治疗方案潜在成本效益的不确定性方面发挥关键作用。

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