精准医学的代价：基因检测指导早期乳腺癌患者治疗的成本效益

　　编者按：以下数据来自美国统计学模型研究结果，无法完全代表中国患者实际情况和临床医生具体意见。以下原文为在线预先发表版，并非最终正式发表版。以下文字由谷歌翻译提供支持，欢迎留言提出修改建议，谢谢！

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　　乳腺导管原位癌（DCIS）约占乳腺癌的25%，DCIS患者保乳术后接受辅助放疗可使10年患侧乳腺事件（IBE）风险由25%～30%减少至大约15%。对于保乳术后的DCIS患者，21基因检测（Oncotype DX）DCIS评分简表可用于估计IBE风险，以指导是否进行辅助放疗。由于21基因检测费用高达3416美元，故有必要对其成本效益进行分析。

　　2016年9月12日，美国临床肿瘤学会官方期刊《临床肿瘤学杂志》在线发表哈佛放射肿瘤学（住院医师规范化培训）项目、布莱根女子医院、达纳法伯癌症研究所、贝斯以色列女执事医疗中心、德克萨斯大学西南医学中心的研究报告，分析了采用该检测策略的成本效益。

　　该研究对符合美国东部肿瘤学协作组（ECOG）E5194研究入组条件的60岁女性，建立了一个模拟10年结局的马尔可夫模型（第1组：中低分级DCIS，≤2.5厘米；第2组：高分级DCIS，≤1厘米），分别采用五种策略：1、不检测21基因，全不放疗；2、不检测21基因，仅对第2组（高分级DCIS）放疗；3、低分级DCIS不放疗，中高分级DCIS检测21基因，对中高风险评分者放疗；4、检测21基因，对中高风险评分者放疗；5、不检测21基因，全部放疗。

　　该研究从文献和医疗保险索赔账单提取效用和成本数据，以确定增量成本效益比（ICER）并检查预防每个IBE所需放疗人数。

　　结果发现，所有进行21基因检测DCIS评分的策略均不具成本效益。最具成本效益的策略（全不放疗或全部放疗）对于接受或不接受放疗与保持不复发之间效用的微小差别具有敏感性。与策略1相比，策略2～5预防每个IBE所需放疗人数分别为10.5、9.1、7.5、13.1。

　　采用21基因检测DCIS评分的策略，虽然可以降低预防每个IBE进行放疗患者的比例，但是均不具成本效益。放射治疗的成本效益具有强烈效用敏感性，突出患者意愿对于该决策的重要性。医生应该与每位患者进行讨论，权衡辅助放疗与否的利弊，以最大限度地提高生活质量结局。

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J Clin Oncol. 2016 Sep 12. [Epub ahead of print]

Cost Effectiveness of the Oncotype DX DCIS Score for Guiding Treatment of Patients With Ductal Carcinoma In Situ.

Ann C. Raldow, David Sher, Aileen B. Chen, Abram Recht, Rinaa S. Punglia.

Harvard Radiation Oncology Program; Brigham and Women's Hospital/Dana-Farber Cancer Institute; Beth Israel Deaconess Medical Center, Boston, MA; University of Texas Southwestern Medical Center, Dallas, TX.

PURPOSE: The Oncotype DX DCIS Score short form (DCIS Score) estimates the risk of an ipsilateral breast event (IBE) in patients with ductal carcinoma in situ (DCIS) treated with breast-conserving surgery without adjuvant radiation therapy (RT). We determined the cost effectiveness of strategies using this test.

MATERIALS AND METHODS: We developed a Markov model simulating 10-year outcomes for 60-year-old women eligible for the Eastern Cooperative Oncology Group E5194 study (cohort 1: low/intermediate-grade DCIS, ≤ 2.5 cm; cohort 2: high-grade DCIS, ≤ 1 cm) with each of five strategies: (1) no testing, no RT; (2) no testing, RT only for cohort 2; (3) no RT for low-grade DCIS, test for intermediate- and high-grade DCIS, RT for intermediate- or high-risk scores; (4) test all, RT for intermediate- or high-risk scores; and (5) no testing, RT for all. We used utilities and costs extracted from the literature and Medicare claims to determine incremental cost-effectiveness ratios and examined the number of women needed to irradiate per IBE prevented.

RESULTS: No strategy using the DCIS Score was cost effective. The most cost-effective strategy (RT for none or RT for all) was sensitive to small differences between the utilities of receiving or not receiving RT and remaining without recurrence. The numbers needed to irradiate per IBE prevented were 10.5, 9.1, 7.5, and 13.1 for strategies 2 to 5, respectively, relative to strategy 1.

CONCLUSION: Strategies using the DCIS Score lowered the proportion of women undergoing RT per IBE prevented. However, no strategy incorporating the DCIS Score was cost effective. The cost effectiveness of RT was exquisitely utility sensitive, highlighting the importance of engaging patient preferences in this decision. Physicians should discuss trade-offs associated with omitting or adding adjuvant RT with each patient to maximize quality-of-life outcomes.

Presented at the American Society for Radiation Oncology 2015 Annual Meeting, San Antonio, TX, October 18-21, 2015.

DOI: 10.1200/JCO.2016.67.8532