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70 基因签名与圣加仑指南和 Adjuvant Online 在早期乳腺癌中的成本效益比较。

Cost-effectiveness of the 70-gene signature versus St. Gallen guidelines and Adjuvant Online for early breast cancer.

机构信息

Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (NKI-AVL), Department of Psychosocial Research and Epidemiology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands.

出版信息

Eur J Cancer. 2010 May;46(8):1382-91. doi: 10.1016/j.ejca.2010.02.035. Epub 2010 Mar 30.

Abstract

BACKGROUND

The 70-gene signature (MammaPrint) is a prognostic test used to guide adjuvant treatment decisions in patients with node-negative breast cancer. In order to decide upon its use, a systematic comparative analysis of the effects of the 70-gene signature, the Sankt Gallen guidelines and the Adjuvant Online Software for these patients on survival, quality of life and costs is warranted.

METHODS

A Markov decision model was used to simulate the 20-year costs and outcomes (survival and quality-of-life adjusted survival (QALYs)) in a hypothetical cohort of node-negative, estrogen receptor positive breast cancer patients. Sensitivity and specificity of the three prognostic tools were based on 5 and 10 years breast cancer specific survival and distant metastasis as first event, derived from a pooled analysis consisting of 305 tumour samples from 3 previously reported validation studies concerning the 70-gene signature.

RESULTS

Small differences in survival, but substantial differences in quality-adjusted survival between the prognostic tools were observed. Quality-adjusted survival was highest when using the 70-gene signature. Based on costs per QALY, the 70-gene has the highest probability of being cost-effective for a willingness to pay for a QALY higher than euro12.000. Sankt Gallen showed the highest survival rates compared to the 70-gene signature, but leads to a substantial larger amount of adjuvant chemotherapy and lower cost-effectiveness, thus demanding a high willingness to pay to save a life year.

CONCLUSIONS

When deciding upon the cost-effectiveness of the prognostic tests, the 70-gene signature improves quality-adjusted survival and has the highest probability of being cost-effective.

摘要

背景

70 基因特征(MammaPrint)是一种预后测试,用于指导淋巴结阴性乳腺癌患者的辅助治疗决策。为了决定是否使用该测试,需要对 70 基因特征、圣加仑指南和这些患者的 Adjuvant Online 软件在生存、生活质量和成本方面的效果进行系统的比较分析。

方法

使用马尔可夫决策模型来模拟假设的淋巴结阴性、雌激素受体阳性乳腺癌患者队列的 20 年成本和结果(生存和调整生活质量的生存(QALYs))。三种预后工具的敏感性和特异性基于 5 年和 10 年乳腺癌特异性生存和远处转移作为第一事件,源自一个包含 305 个肿瘤样本的汇总分析,该样本来自先前报道的 3 项关于 70 基因特征的验证研究。

结果

在生存方面存在微小差异,但在预后工具之间观察到了显著的调整生存质量差异。使用 70 基因特征时,调整后的生存质量最高。基于每 QALY 的成本,70 基因具有最高的成本效益概率,对于每 QALY 高于 12000 欧元的意愿支付。圣加仑与 70 基因特征相比显示出较高的生存率,但导致辅助化疗量显著增加,成本效益降低,因此需要较高的意愿支付来挽救一个生命年。

结论

在决定预后测试的成本效益时,70 基因特征可提高调整后的生存质量,并且具有最高的成本效益概率。

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