氟唑帕利单药对比联合阿帕替尼治疗胚系BRCA1/2突变的HER2－转移性乳腺癌的成本-效用分析 点击下载
| 论文标题： | 氟唑帕利单药对比联合阿帕替尼治疗胚系BRCA1/2突变的HER2－转移性乳腺癌的成本-效用分析 |
| 英文标题： | |
| 中文摘要： | 目的 从我国卫生体系视角，评价氟唑帕利单药对比联合阿帕替尼用于伴有胚系BRCA1/2突变的人表皮生长因子受体2阴性（HER2－）转移性乳腺癌二线及后线治疗的经济性。方法基于FABULOUS研究，建立分区生存模型模拟疾病进展过程，模拟周期为21d，研究时限为10年，贴现率为4.5%。模型以质量调整生命年（QALYs）及总成本作为产出评价指标，采用成本-效用分析法进行分析，通过比较两种方案的增量成本-效果比（ICER）和意愿支付（WTP）阈值来评价方案经济性。WTP阈值设为2025年我国2倍人均GDP（199330元/QALY）。通过单因素敏感性分析、概率敏感性分析和情境分析以检验模型稳健性。结果对于伴有胚系BRCA1/2突变的HER2－转移性乳腺癌患者，使用氟唑帕利联合阿帕替尼方案较氟唑帕利单药方案可获得更多健康获益（1.91QALYsvs.1.69QALYs），同时总成本更低（1634119.3元vs.1855264.2元），为绝对优势方案。单因素及概率敏感性分析结果表明基础分析结果稳健。情境分析结果中，变动研究时限为5年或将贴现率调整为3%，基础分析结论均保持稳健；但当变动外推分布模型时，结果发生翻转。结论在现有WTP阈值下，与氟唑帕利单药方案相比，氟唑帕利联合阿帕替尼方案用于我国伴有胚系BRCA1/2突变的HER2－转移性乳腺癌患者的二线及后线治疗更具经济性。 |
| 英文摘要： | OBJECTIVE To evaluate the cost-effectiveness of fluzoparib monotherapy versus combination with apatinib as second-line or later-line treatment for patients with germline BRCA1 / 2 -mutated human epidermal growth factor receptor 2-negative （HER2－） metastatic breast cancer， from the perspective of the Chinese healthcare system. METHODS Based on the FABULOUS trial， a partitioned survival model was developed to simulate disease progression， with a cycle length of 21 days and a time horizon of 10 years. A discount rate of 4.5% per annum was applied. Model outputs included total costs and quality-adjusted life years （QALYs）. Cost-utility analysis was conducted by comparing the incremental cost-effectiveness ratio （ICER） between the two regimens against a willingness-to-pay （WTP） threshold set at twice China’s per capita gross domestic product in 2025 （199 330 yuan/QALY）. Robustness of the base-case results was tested through one-way sensitivity analysis， probabilistic sensitivity analysis， and scenario analyses. RESULTS For patients with germline BRCA1/2 -mutated HER2－ metastatic breast cancer， fluzoparib combination with apatinib provided greater health benefits （1.91 QALYs vs. 1.69 QALYs） and incurred lower total costs （1 634 119.3 yuan vs. 1 855 264.2 yuan） compared with fluzoparib monotherapy， thus representing a dominant strategy. One-way sensitivity and probabilistic sensitivity analyses confirmed the robustness of the base-case findings. Scenario analyses showed that the conclusion remained robust when the time horizon was shortened to 5 years or when the discount rate was changed to 3%； however， the results reversed when the extrapolation distribution model was altered. CONCLUSIONS Under the current WTP threshold， compared with fluzoparib monotherapy， the combination of fluzoparib and apatinib is more cost-effective as a second-line or later-line treatment for Chinese patients with germline BRCA1 / 2 -mutated HER2－ metastatic breast cancer. |
| 期刊： | 2026年第37卷第14期 |
| 作者： | 王丽媛；张伶俐；侯艳红 |
| 英文作者： | WANG Liyuan，ZHANG Lingli，HOU Yanhong |
| 关键字： | 氟唑帕利; 阿帕替尼; 胚系BRCA1/2突变; 人表皮生长因子受体2阴性; 转移性乳腺癌; 成本-效用分析; 分区生存模型 |
| KEYWORDS： | fluzoparib; apatinib; germline BRCA1/2 mutation; human epidermal growth factor receptor 2-negative; metastatic breast cancer; cost-effectiveness analysis; partitioned survival model |
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