多西他赛、阿霉素和环磷酰胺（TAC）辅助治疗淋巴结阳性乳腺癌的成本效益分析：模拟下游效应

Cost-effectiveness analysis of adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) for node-positive breast cancer: modeling the downstream effects.

作者信息

Au Heather-Jane, Golmohammadi Kamran, Younis Tallal, Verma Shailendra, Chia Stephen, Fassbender Konrad, Jacobs Philip

机构信息

Cross Cancer Institute, 11560 University Avenue, Edmonton, AB, Canada T6G 1Z2.

出版信息

Breast Cancer Res Treat. 2009 Apr;114(3):579-87. doi: 10.1007/s10549-008-0034-1. Epub 2008 Apr 29.

DOI:10.1007/s10549-008-0034-1

PMID:18443903

Abstract

PURPOSE

BCIRG 001 demonstrated prolonged disease-free (DFS) and overall survival (OS) but increased toxicity for adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) versus 5-fluorouracil, doxorubicin, cyclophosphamide (FAC) in women with node positive breast cancer (BC). This study evaluates quality-adjusted survival and cost-effectiveness of adjuvant TAC versus FAC, taking downstream decisions and events into account, including palliative chemotherapy with taxanes.

METHODS

We developed a Markov model for a cohort of women with node positive BC eligible for adjuvant anthracyclines. Data input included clinical and resource utilization data collected prospectively from BCIRG 001. Treatment decisions and outcomes with disease recurrence were based on a systematic literature review with validity reviewed by a national panel of Canadian BC oncologists. Direct costs for resource utilization following Canadian practice patterns were included. Unit costs were obtained from provincial cost list and published drug list prices. Utility scores were derived from the literature. An incremental cost-effectiveness ratio (ICER) in cost per quality-adjusted life-years (QALY) gained for TAC versus FAC was calculated.

RESULTS

For 1,000 women with node positive BC, the model showed that TAC would lead to a gain of 313 QALY (370 life years) at an additional cost of $5.8 Million Canadian dollars (Cdn) compared to FAC, over a 10-year time horizon. The ICER of TAC versus FAC was $18,505.54 Cdn per QALY gained. Sensitivity analyses supported the robustness of the model. By one-way sensitivity analyses of over 50 model variables, 95% of the cumulative ICER variation was from $6,000 to $28,000 Cdn/QALY. By multivariate Monte Carlo simulation, there was a 70% probability that the ICER would be under $50,000 CdN/QALY.

CONCLUSION

For women with node positive BC, TAC improves DFS and OS compared to FAC and is a cost-effective adjuvant chemotherapy strategy.

摘要

目的

BCIRG 001研究表明，对于淋巴结阳性乳腺癌（BC）女性患者，辅助性多西他赛、阿霉素和环磷酰胺（TAC）与5-氟尿嘧啶、阿霉素、环磷酰胺（FAC）相比，可延长无病生存期（DFS）和总生存期（OS），但毒性增加。本研究评估辅助性TAC与FAC相比的质量调整生存期和成本效益，同时考虑下游决策和事件，包括紫杉烷类药物的姑息化疗。

方法

我们为符合辅助性蒽环类药物治疗条件的淋巴结阳性BC女性队列建立了一个马尔可夫模型。数据输入包括从BCIRG 001前瞻性收集的临床和资源利用数据。疾病复发后的治疗决策和结果基于系统文献综述，并由加拿大BC肿瘤学家全国小组进行有效性审查。纳入了遵循加拿大实践模式的资源利用直接成本。单位成本从省级成本清单和公布的药品清单价格中获取。效用评分来自文献。计算了TAC与FAC相比每获得一个质量调整生命年（QALY）的增量成本效益比（ICER）。

结果

对于1000名淋巴结阳性BC女性，模型显示，在10年的时间范围内，与FAC相比，TAC将额外增加313个QALY（370个生命年），额外成本为580万加元（Cdn）。TAC与FAC相比的ICER为每获得一个QALY 18,505.54加元（Cdn）。敏感性分析支持了模型的稳健性。通过对50多个模型变量的单因素敏感性分析，95%的累积ICER变化范围为6000至28000加元/QALY。通过多变量蒙特卡罗模拟，ICER低于50,000加元（CdN/QALY）的概率为70%。