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内分泌治疗(包括卵巢抑制)的依从性:一项针对美国早期乳腺癌女性的大型观察性队列研究。

Adherence to endocrine therapy including ovarian suppression: A large observational cohort study of US women with early breast cancer.

机构信息

Division of Oncology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.

出版信息

Cancer. 2021 Apr 15;127(8):1220-1227. doi: 10.1002/cncr.33367. Epub 2021 Jan 28.

DOI:10.1002/cncr.33367
PMID:33508140
Abstract

BACKGROUND

Recent clinical trials support adding ovarian suppression (OS) to oral endocrine therapy (ET) for premenopausal women with early breast cancer. The adoption of OS among real-world populations and the impact of OS on ET adherence have not been evaluated.

METHODS

This study examined a retrospective, observational cohort of women under the age of 50 years with incident early breast cancer from 2001 to 2016. The IBM MarketScan Commercial insurance claims database was used to identify new users of ET with or without OS and to track discontinuation of or adherence to ET. In all, 21,948 women filled at least 1 prescription for ET within 12 months of their diagnosis after a washout period of 12 months with no prior claims. Patients who received an aromatase inhibitor without a synchronous OS drug were excluded.

RESULTS

Use of OS increased over time and reached 11.3% in 2016. In an unadjusted analysis, 40.2% of ET+OS users discontinued ET early, whereas 48.8% of tamoxifen-alone users did. In adjusted analyses, ET+OS users had a similar likelihood of discontinuing ET in comparison with tamoxifen-alone users (hazard ratio, 0.92; 95% confidence interval, 0.83-1.03). Approximately 30% of women had low adherence over the first year of use. The likelihood of high adherence was similar, regardless of OS exposure.

CONCLUSIONS

The use of OS among young, commercially insured patients with breast cancer increased over time in agreement with recent clinical trial results but remained relatively low. Nonadherence to ET was common, but the use of OS was not associated with lower adherence to ET in this observational, nonrandomized cohort. These findings may reassure oncologists that use of OS does not endanger ET adherence, although prospective studies are needed for confirmation.

摘要

背景

最近的临床试验支持对接受早期乳腺癌治疗的绝经前女性在口服内分泌治疗(ET)的基础上添加卵巢抑制(OS)。尚未评估 OS 在真实人群中的应用情况以及 OS 对 ET 依从性的影响。

方法

本研究分析了 2001 年至 2016 年期间年龄在 50 岁以下、患有早期乳腺癌的女性的回顾性观察性队列。使用 IBM MarketScan 商业保险索赔数据库来识别新使用 ET 且未使用 OS 或使用 OS 的患者,并追踪其 ET 的停药或依从情况。所有患者在洗脱期 12 个月内(即无先前索赔的 12 个月)至少有 1 次 ET 处方。排除使用芳香化酶抑制剂但无同步 OS 药物的患者。

结果

OS 的使用随时间增加,2016 年达到 11.3%。未经调整的分析显示,40.2%的 ET+OS 使用者早期停止使用 ET,而单独使用他莫昔芬的使用者为 48.8%。在调整分析中,ET+OS 使用者与单独使用他莫昔芬的使用者相比,停止使用 ET 的可能性相似(风险比,0.92;95%置信区间,0.83-1.03)。大约 30%的女性在使用 ET 的第一年依从性较低。无论是否有 OS 暴露,高依从性的可能性都相似。

结论

在接受商业保险的年轻乳腺癌患者中,OS 的使用随着时间的推移增加,与最近的临床试验结果一致,但仍然相对较低。ET 不依从很常见,但在这个观察性、非随机队列中,OS 的使用与 ET 不依从无关。这些发现可能使肿瘤学家放心,OS 的使用不会危及 ET 的依从性,尽管需要前瞻性研究来证实。

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