随机试验：短信对减少早期乳腺癌女性辅助芳香酶抑制剂治疗早期停药的影响：SWOG S1105。
Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105.
机构信息
Columbia University Medical Center, New York, NY.
SWOG Statistics and Data Management Center, Seattle, WA.
出版信息
J Clin Oncol. 2020 Jul 1;38(19):2122-2129. doi: 10.1200/JCO.19.02699. Epub 2020 May 5.
PURPOSE
Nonadherence to aromatase inhibitors (AIs) for breast cancer is common and increases the risk of recurrence. Text messaging increases adherence to medications for chronic conditions.
METHODS
We conducted a randomized clinical trial of text messaging (TM) versus no text messaging (No-TM) at 40 sites in the United States. Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months. Test messages were sent twice a week over 36 months. Content themes focused on overcoming barriers to medication adherence and included cues to action, statements related to medication efficacy, and reinforcements of the recommendation to take AIs. Both groups were assessed every 3 months. The primary outcome was time to adherence failure (AF), where AF was defined as urine AI metabolite assay results satisfying one of the following: < 10 ng/mL, undetectable, or no submitted specimen. A stratified log-rank test was conducted. Multiple sensitivity analyses were performed.
RESULTS
In total, 724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline. Observed adherence at 36 months was 55.5% for TM and 55.4% for No-TM. The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; = .18). Multiple time to AF sensitivity analyses showed similar nonsignificant results. Three-year self-reported time to AF (10.4% 10.3%; HR, 1.16 [95% CI, 0.69 to 1.98]; = .57) and site-reported time to AF (21.9% 18.9%; HR, 1.31 [95% CI, 0.86 to 2.01]; = .21) also did not differ by arm.
CONCLUSION
To our knowledge, this was the first large, long-term, randomized trial of an intervention directed at improving AI adherence. We found high rates of AI AF. Twice-weekly text reminders did not improve adherence to AIs. Improving long-term adherence will likely require personalized and sustained behavioral interventions.
目的
乳腺癌患者不依从芳香化酶抑制剂（AIs）的情况很常见，并且会增加复发的风险。短信可以提高慢性病患者的药物依从性。
方法
我们在美国的 40 个地点进行了一项短信（TM）与无短信（No-TM）对照的随机临床试验。符合条件的患者是正在服用 AI 且超过 30 天、计划服用时间≥36 个月的绝经后早期乳腺癌女性。在 36 个月期间，每周发送两次测试短信。短信内容的主题侧重于克服药物依从性的障碍，包括行动提示、与药物疗效相关的声明，以及加强服用 AI 的建议。两组每 3 个月评估一次。主要结局是依从性失败（AF）时间，AF 定义为尿液 AI 代谢物检测结果满足以下条件之一：<10ng/mL、检测不到或未提交标本。采用分层对数秩检验进行分析。进行了多次敏感性分析。
结果
2012 年 5 月至 2013 年 9 月期间共登记了 724 名患者，其中基线时符合条件的有 702 名患者（TM 组 348 名，No-TM 组 354 名）。TM 组和 No-TM 组在 36 个月时的观察到的依从率分别为 55.5%和 55.4%。主要分析结果显示，两组间 AF 时间无差异（3 年 AF：TM 组 81.9%，No-TM 组 85.6%；HR，0.89[95%CI，0.76 至 1.05]；=.18）。多次分析 AF 时间的敏感性结果也显示出相似的非显著性结果。3 年自我报告的 AF 时间（TM 组 10.4%，No-TM 组 10.3%；HR，1.16[95%CI，0.69 至 1.98]；=.57）和站点报告的 AF 时间（TM 组 21.9%，No-TM 组 18.9%；HR，1.31[95%CI，0.86 至 2.01]；=.21）也没有因干预而不同。
结论
据我们所知，这是第一项针对改善 AI 依从性的大型、长期、随机试验。我们发现 AI 依从性失败的发生率很高。每周两次的短信提醒并不能提高 AI 的依从性。要提高长期依从性，可能需要个性化和持续的行为干预。
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