Schmidt Nina, Jacob Louis, Coleman Robert, Kostev Karel, Hadji Peyman
IMS HEALTH GmbH & Co. OHG, Epidemiology, Real World Evidence Solutions, Darmstädter Landstraße 108, 60598, Frankfurt, Germany.
Department of Biology, École Normale Supérieure de Lyon, Lyon, France.
Breast Cancer Res Treat. 2016 Jan;155(1):151-7. doi: 10.1007/s10549-015-3661-3. Epub 2015 Dec 19.
No study has yet analyzed the impact of compliance with aromatase inhibitor(AI) treatments on fracture risk in a real-world setting in women with breast cancer. In this study, 8732 women with BC treated with AI, 8732 treated with tamoxifen (TAM), and 8732 age-matched women without BC selected from the Disease Analyzer database (IMS Health) were included. The main outcome measure was the impact of compliance with AI treatment on fracture risk. Demographic data included age, body mass index (BMI), and smoking status. Alcohol dependency, dementia, bone density, visual disturbances, diabetes, and use of corticosteroids were also assessed. Kaplan-Meier curves were used to analyze the proportion of patients with fracture over time, and multivariate Cox regression models were performed to assess the adjusted fracture risk. Mean age was 67.3 years. 17.6, 8.7, and 8.8 % of AI, TAM, and non-cancer patients, respectively, were diagnosed with fracture within 5 years after the index date (p < 0.001). The proportion of women receiving AI with fracture increased with treatment compliance, rising from 8.6 % when treatment persisted for less than a year to 18.0 % when it persisted for between 4 and 5 years (p < 0.001). By contrast, the proportion of fractures in women with BC receiving TAM for the same time periods decreased from 13.0 to 7.9 % (p < 0.001). The risk of fracture was higher in women with BC using AI than in the non-cancer group (HR = 3.00; p < 0.0001). Finally, current smoking status, BMI, dementia, and prescription of corticosteroids had significant impacts on fracture risk. Compliance with AI treatment in women with BC is associated with a clear increase in the risk of fracture, which is much higher than previously reported.
尚无研究分析在现实环境中,接受芳香化酶抑制剂(AI)治疗的乳腺癌女性的依从性对骨折风险的影响。本研究纳入了8732例接受AI治疗的乳腺癌女性、8732例接受他莫昔芬(TAM)治疗的乳腺癌女性,以及从疾病分析数据库(艾美仕市场研究公司)中选取的8732例年龄匹配的无乳腺癌女性。主要结局指标是AI治疗依从性对骨折风险的影响。人口统计学数据包括年龄、体重指数(BMI)和吸烟状况。还评估了酒精依赖、痴呆、骨密度、视觉障碍、糖尿病和皮质类固醇的使用情况。采用Kaplan-Meier曲线分析随时间发生骨折的患者比例,并进行多变量Cox回归模型以评估调整后的骨折风险。平均年龄为67.3岁。在索引日期后的5年内,分别有17.6%、8.7%和8.8%的AI组、TAM组和非癌症患者被诊断为骨折(p<0.001)。接受AI治疗且发生骨折的女性比例随治疗依从性增加,从治疗持续时间少于1年时的8.6%上升至持续4至5年时的18.0%(p<0.001)。相比之下,同期接受TAM治疗的乳腺癌女性骨折比例从13.0%降至7.9%(p<0.001)。使用AI的乳腺癌女性骨折风险高于非癌症组(风险比=3.00;p<0.0001)。最后,当前吸烟状况、BMI、痴呆和皮质类固醇处方对骨折风险有显著影响。乳腺癌女性对AI治疗的依从性与骨折风险明显增加相关,这一风险比先前报道的要高得多。