The Population-level Effect of Adjuvant Therapies on Breast Cancer Recurrence: Application of the Trend-in-Trend Design.

IF 4.7 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Epidemiology Pub Date : 2024-09-01 Epub Date: 2024-08-06 DOI:10.1097/EDE.0000000000001753
Lindsay J Collin, Lance A Waller, Deirdre P Cronin-Fenton, Thomas P Ahern, Michael Goodman, Lauren E McCullough, Anders Kjærsgaard, Kirsten M Woolpert, Rebecca A Silliman, Peer M Christiansen, Bent Ejlertsen, Henrik Toft Sørensen, Timothy L Lash
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Abstract

Purpose: Breast cancer has an average 10-year relative survival reaching 84%. This favorable survival is due, in part, to the introduction of biomarker-guided therapies. We estimated the population-level effect of the introduction of two adjuvant therapies-tamoxifen and trastuzumab-on recurrence using the trend-in-trend pharmacoepidemiologic study design.

Methods: We ascertained data on women diagnosed with nonmetastatic breast cancer who were registered in the Danish Breast Cancer Group clinical database. We used the trend-in-trend design to estimate the population-level effect of the introduction of (1) tamoxifen for postmenopausal women with estrogen receptor (ER)-positive breast cancer in 1982, (2) tamoxifen for premenopausal women diagnosed with ER-positive breast cancer in 1999, and (3) trastuzumab for women <60 years diagnosed with human epidermal growth factor receptor 2-positive breast cancer in 2007.

Results: For the population-level effect of the introduction of tamoxifen among premenopausal women diagnosed with ER-positive breast cancer in 1999, the risk of recurrence decreased by nearly one-half (OR = 0.52), consistent with evidence from clinical trials; however, the estimate was imprecise (95% confidence interval [CI] = 0.25, 1.85). We observed an imprecise association between tamoxifen use and recurrence from the time it was introduced in 1982 (OR = 1.24 95% CI = 0.46, 5.11), inconsistent with prior knowledge from clinical trials. For the introduction of trastuzumab in 2007, the estimate was also consistent with trial evidence, though imprecise (OR = 0.51; 95% CI = 0.21, 22.4).

Conclusions: We demonstrated how novel pharmacoepidemiologic analytic designs can be used to evaluate the routine clinical care and effectiveness of therapeutic advancements in a population-based setting while considering some limitations of the approach.

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辅助疗法对乳腺癌复发的人群效应:应用趋势中趋势设计。
目的:乳腺癌的 10 年平均相对生存率高达 84%。这种良好的生存率部分归功于生物标志物指导疗法的引入。我们采用趋势中趋势药物流行病学研究设计,估算了两种辅助疗法--他莫昔芬和曲妥珠单抗的引入对人群复发的影响:我们确定了丹麦乳腺癌小组临床数据库中登记的非转移性乳腺癌女性患者的数据。我们采用趋势中趋势的设计方法,估算了(1)1982 年对绝经后雌激素受体(ER)阳性乳腺癌妇女使用他莫昔芬、(2)1999 年对绝经前诊断为 ER 阳性乳腺癌的妇女使用他莫昔芬以及(3)对妇女使用曲妥珠单抗的人群效应:在 1999 年确诊为 ER 阳性乳腺癌的绝经前妇女中引入他莫昔芬的人群效应中,复发风险降低了近一半(OR = 0.52),这与临床试验的证据一致;然而,该估计值并不精确(95% 置信区间 [CI] = 0.25,1.85)。我们观察到,自1982年他莫昔芬问世以来,使用他莫昔芬与复发之间的关系并不精确(OR = 1.24 95% CI = 0.46, 5.11),这与之前临床试验的结果不一致。至于 2007 年引入的曲妥珠单抗,尽管不精确(OR = 0.51; 95% CI = 0.21, 22.4),但估计值也与试验证据一致:我们展示了如何利用新型药物流行病学分析设计来评估基于人群的常规临床护理和治疗进展的有效性,同时也考虑了该方法的一些局限性。
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来源期刊
Epidemiology
Epidemiology 医学-公共卫生、环境卫生与职业卫生
CiteScore
6.70
自引率
3.70%
发文量
177
审稿时长
6-12 weeks
期刊介绍: Epidemiology publishes original research from all fields of epidemiology. The journal also welcomes review articles and meta-analyses, novel hypotheses, descriptions and applications of new methods, and discussions of research theory or public health policy. We give special consideration to papers from developing countries.
期刊最新文献
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