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Aromatase inhibitors and the risk of colorectal cancer in postmenopausal women with breast cancer.
Annals of Oncology ( IF 50.5 ) Pub Date : 2018-03-01 , DOI: 10.1093/annonc/mdx822
F Khosrow-Khavar 1 , H Yin 2 , A Barkun 3 , N Bouganim 4 , L Azoulay 5
Affiliation  

Background A large trial of postmenopausal women with breast cancer reported an imbalance in colorectal cancer events with aromatase inhibitors (AIs), compared with tamoxifen in the adjuvant setting. This unexpected signal was observed within 3 years of randomization. To date, no observational studies have examined this important safety question in the natural setting of clinical practice. Thus, the objective of this study was to determine whether AIs, when compared with tamoxifen, are associated with increased risk of colorectal cancer in postmenopausal women with breast cancer. Patients and methods Using the UK Clinical Practice Research Datalink, we identified women, at least 55 years of age, with breast cancer newly treated with either AIs or tamoxifen between 1 January 1996 and 30 September 2015, with follow-up until 30 September 2016. High-dimensional propensity score-adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) of incident colorectal cancer associated with AIs when compared with tamoxifen overall, by cumulative duration of use, and time since initiation. All exposures were lagged by 1 year for latency considerations. Results A total of 9701 and 8893 patients initiated AIs and tamoxifen as first-line hormonal therapy (median follow-up of 2.4 and 2.9 years, respectively). Compared with tamoxifen, AIs were not associated with an increased risk of colorectal cancer (incidence rates of 150 per 100 000 person-years in both groups; adjusted HR: 0.90, 95% CI: 0.53-1.52). Similarly, there was no evidence of an association with cumulative duration of use (P-heterogeneity = 0.54), and time since initiation (P-heterogeneity = 0.66). Conclusions In this first population-based study, the use of AIs was not associated with an increased risk of colorectal cancer. These findings should provide reassurance to the concerned stakeholders.

中文翻译:

芳香化酶抑制剂和绝经后乳腺癌女性患结直肠癌的风险。

背景绝经后乳腺癌的一项大型试验报告说,与辅助治疗中的他莫昔芬相比,使用芳香化酶抑制剂(AIs)的大肠癌事件失衡。在随机分配的3年内观察到了这种意外信号。迄今为止,还没有观察性研究在临床实践的自然环境中研究过这个重要的安全性问题。因此,本研究的目的是确定与三苯氧胺相比,AIs是否与绝经后乳腺癌女性大肠癌风险增加相关。患者和方法使用英国临床实践研究数据链,我们确定了至少55岁的女性,这些女性在1996年1月1日至2015年9月30日之间接受AI或他莫昔芬新治疗,并随访至2016年9月30日。使用高维倾向得分调整的Cox比例风险模型来评估与他莫昔芬总体相比,与使用他莫昔芬相关的大肠癌的风险比(HRs),95%置信区间(CIs),累积使用时间和持续时间引发。考虑到延迟问题,所有曝光都被滞后了1年。结果共有9701例患者和8893例患者开始了AIs和他莫昔芬的一线激素治疗(中位随访时间分别为2.4年和2.9年)。与他莫昔芬相比,AIs与大肠癌的风险增加无关(两组的发病率均为每10万人年150例;校正后的HR:0.90,95%CI:0.53-1.52)。同样,也没有证据表明使用时间与累积使用时间相关(P-异质性= 0.54),起始时间和时间(P-异质性= 0.66)。结论在第一项基于人群的研究中,使用AI并不会增加结直肠癌的风险。这些调查结果应使有关利益攸关方放心。
更新日期:2017-12-27
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