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日本转移性乳腺癌一线治疗引入 S-1 疗法的成本效果分析:来自随机 III 期 SELECT BC 试验的结果。

Cost-effectiveness analysis of the introduction of S-1 therapy for first-line metastatic breast cancer treatment in Japan: results from the randomized phase III SELECT BC trial.

机构信息

Department of Health and Welfare Services, National Institute of Public Health, 2-3-6 Minami, Wako, Saitama, 351-0197, Japan.

Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, 1-1-1 Noji-higashi, Kusatsu, Shiga, 525-8577, Japan.

出版信息

BMC Cancer. 2017 Nov 17;17(1):773. doi: 10.1186/s12885-017-3774-7.

DOI:10.1186/s12885-017-3774-7
PMID:29149882
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5693567/
Abstract

BACKGROUND

This study evaluated the cost-effectiveness of replacing standard intravenous therapy (taxane) with oral S-1 therapy for first-line metastatic breast cancer treatment.

METHODS

This cost-effectiveness analysis was based on data from a randomized phase III trial (SELECT BC). As cost-effectiveness was a secondary endpoint of the SELECT BC trial, some of the randomized patients participated in an EQ-5D survey (N = 391) and health economic survey (N = 146). The EQ-5D responses, claims, and prescription data were collected for as long as possible until death. The expected quality-adjusted life years (QALY) obtained from each treatment were calculated using patient-level EQ-5D data, and the expected cost was calculated using patient-level claim data. The analysis was performed from the perspective of public healthcare payers.

RESULTS

The estimated EQ-5D least-square means and 95% CI up to 48 months were 0.764 (95% CI, 0.741-0.782) and 0.742 (95% CI, 0.720-0.764) in the S-1 and taxane arms, respectively. The expected QALY was 2.11 for the S-1 arm and 2.04 for the taxane arm, with expected costs of JPY 5.13 million (USD 46,600) and JPY 5.56 million (USD 50,500), respectively. These results show that S-1 is cost-saving. According to probabilistic sensitivity analysis, S-1 was dominant with a probability of 63%. When the willingness to pay (WTP) value was JPY 5 million (USD 45,500) per QALY, the probability of being cost-effective was 92%.

CONCLUSIONS

Our results show that the introduction of oral S-1 therapy for metastatic breast cancer is highly likely to be cost-effective.

TRIAL REGISTRATION

UMIN CTR C000000416 . Registered on May 10, 2006.

摘要

背景

本研究评估了用口服 S-1 治疗替代转移性乳腺癌一线标准静脉治疗(紫杉烷)的成本效益。

方法

本成本效益分析基于一项随机 III 期试验(SELECT BC)的数据。由于 SELECT BC 试验的成本效益是次要终点,部分随机患者参与了 EQ-5D 调查(N=391)和健康经济调查(N=146)。尽可能长时间地收集 EQ-5D 响应、索赔和处方数据,直至死亡。从公共医疗保健支付者的角度计算了每个治疗方案的预期质量调整生命年(QALY),使用患者水平的索赔数据计算了预期成本。

结果

在 48 个月内,S-1 组和紫杉烷组的估计 EQ-5D 最小二乘均值和 95%CI 分别为 0.764(95%CI,0.741-0.782)和 0.742(95%CI,0.720-0.764)。S-1 组的预期 QALY 为 2.11,紫杉烷组为 2.04,预期成本分别为 5130 万日元(46600 美元)和 5560 万日元(50500 美元)。这些结果表明 S-1 具有成本效益。根据概率敏感性分析,S-1 的概率为 63%,具有优势。当每个 QALY 的意愿支付(WTP)值为 500 万日元(45500 美元)时,成本效益的概率为 92%。

结论

我们的研究结果表明,引入口服 S-1 治疗转移性乳腺癌很可能具有成本效益。

试验注册

UMIN CTR C000000416。于 2006 年 5 月 10 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/95bc/5693567/323ca0e56550/12885_2017_3774_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/95bc/5693567/e343203ba962/12885_2017_3774_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/95bc/5693567/323ca0e56550/12885_2017_3774_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/95bc/5693567/e343203ba962/12885_2017_3774_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/95bc/5693567/323ca0e56550/12885_2017_3774_Fig2_HTML.jpg

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