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在意大利,对人表皮生长因子受体 2(HER2)阳性高危早期乳腺癌新辅助联合治疗中添加帕妥珠单抗的成本-后果分析。

A cost-consequence analysis of adding pertuzumab to the neoadjuvant combination therapy in HER2-positive high-risk early breast cancer in Italy.

机构信息

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.

Phase 1 Research Centre, ASST-Monza (MB), 20900, Monza, Italy; School of Medicine and Surgery, University of Milano-Bicocca, 20900, Monza, Italy.

出版信息

Breast. 2023 Oct;71:113-121. doi: 10.1016/j.breast.2023.08.005. Epub 2023 Aug 8.

Abstract

INTRODUCTION

Clinical trials confirmed the beneficial effects of adding pertuzumab (P) to the combination of trastuzumab-chemotherapy (TC) in the (neo)adjuvant setting of high-risk HER2-positive early breast cancer (HER2+BC). We evaluated the clinical, economic and societal impact of adding pertuzumab to neoadjuvant TC combination (TPC) in Italy.

METHODS

A cost-consequence analysis comparing TPC vs. TC was performed developing a cohort-based multi-state Markov model to estimate the clinical, societal and economic impact of the neoadjuvant therapy of TPC versus TC in HER2+BC at high-risk of recurrence. The model works on a cycle length of 1 month and 5-years-time horizon. Literature review-based data were used to populate the model. The following clinical and economic outcomes were estimated: cumulative incidence of loco-regional/distant recurrences, life of years and QALY and both direct and indirect costs (€). Finally, sensitivity analyses were performed.

RESULTS

TPC was associated with a 75,630 € saved of direct costs. Specifically, it was associated with an initial increase of treatment costs (+4.8%) followed by reduction of recurrence management cost (-20.4%). TPC was also associated with an indirect cost reduction of 1.40%, as well as decreased incidence of distant recurrence (-20.14%), days of work lost (-1.53%) and days lived with disability (-0.50%). Furthermore, TPC reported 10,47 QALY gained (+2.77%) compared to TC. The probability to achieve the pathological complete response (pCR) was the parameter that mostly affected the results in the sensitivity analysis.

CONCLUSION

Our findings suggested that TPC combination could be a cost-saving option in patients with HER2+BC at high-risk of recurrence.

摘要

简介

临床试验证实,在高危人表皮生长因子受体 2 阳性(HER2+)早期乳腺癌(BC)的新辅助治疗中,加入曲妥珠单抗(P)可使曲妥珠单抗-化疗(TC)联合治疗(TPC)获益。本研究旨在评估在意大利新辅助 TC 联合治疗(TPC)中加入帕妥珠单抗对临床、经济和社会的影响。

方法

通过构建基于队列的多状态马尔可夫模型,开展 TC 与 TPC 对比的成本-后果分析,以评估 TPC 新辅助治疗与 TC 新辅助治疗在高复发风险的 HER2+BC 中的临床、社会和经济影响。模型的时间范围为 5 年,每个周期为 1 个月。模型使用基于文献综述的数据进行填充。估计了以下临床和经济结果:局部/远处复发的累积发生率、生存年数和 QALY,以及直接和间接成本(€)。最后,还进行了敏感性分析。

结果

TPC 与直接成本节约 75630 欧元相关。具体而言,TPC 与初始治疗费用增加(+4.8%)相关,随后复发管理费用减少(-20.4%)。TPC 还与间接成本降低 1.40%、远处复发发生率降低(-20.14%)、工作天数减少(-1.53%)和残疾天数减少(-0.50%)相关。此外,与 TC 相比,TPC 组报告了 10.47 个质量调整生命年(QALY)的增加(+2.77%)。在敏感性分析中,对结果影响最大的参数是达到病理完全缓解(pCR)的概率。

结论

本研究结果表明,对于高复发风险的 HER2+BC 患者,TPC 联合治疗可能是一种节省成本的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4db/10428118/a52b4aaf0b6c/gr1.jpg

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