Departments of Medicine and Epidemiology, Columbia University Medical Center, New York, NY, USA.
SWOG Statistics and Data Management Center, Seattle, WA, USA.
J Natl Cancer Inst. 2021 Aug 2;113(8):989-996. doi: 10.1093/jnci/djab022.
Nonadherence to aromatase inhibitors (AIs) is common and increases risk of breast cancer (BC) recurrence. We analyzed factors associated with nonadherence among patients enrolled in S1105, a randomized trial of text messaging.
At enrollment, patients were required to have been on an adjuvant AI for at least 30 days and were asked about financial, medication, and demographic factors. They completed patient-reported outcomes (PROs) representing pain (Brief Pain Inventory), endocrine symptoms (Functional Assessment of Cancer Therapy-Endocrine Symptoms), and beliefs about medications (Treatment Satisfaction Questionnaire for Medicine; Brief Medication Questionnaire). Our primary endpoint was AI nonadherence at 36 months, defined as urine AI metabolite assay of less than 10 ng/mL or no submitted specimen. We evaluated the association between individual baseline characteristics and nonadherence with logistic regression. A composite risk score reflecting the number of statistically significant baseline characteristics was examined.
We analyzed data from 702 patients; median age was 60.9 years. Overall, 35.9% patients were nonadherent at 36 months. Younger patients (younger than age 65 years) were more nonadherent (38.8% vs 28.6%, odds ratio [OR] = 1.51, 95% confidence interval [CI] = 1.05 to 2.16; P = .02). Fourteen baseline PRO scales were each statistically significantly associated with nonadherence. In a composite risk model categorized into quartile levels, each increase in risk level was associated with a 46.5% increase in the odds of nonadherence (OR = 1.47, 95% CI =1.26 to 1.70; P < .001). The highest-risk patients were more than 3 times more likely to be nonadherent than the lowest-risk patients (OR = 3.14, 95% CI = 1.97 to 5.02; P < .001).
The presence of multiple baseline PRO-specified risk factors was statistically significantly associated with AI nonadherence. The use of these assessments can help identify patients for targeted interventions to improve adherence.
芳香化酶抑制剂(AIs)的不依从是常见的,并且增加了乳腺癌(BC)复发的风险。我们分析了 S1105 随机试验中接受短信的患者中与不依从相关的因素。
在入组时,患者必须已经服用辅助 AI 至少 30 天,并询问了有关财务,药物和人口统计学因素。他们完成了代表疼痛(简短疼痛清单),内分泌症状(癌症治疗内分泌症状的功能评估)和对药物的信念(药物治疗满意度问卷;简短药物问卷)的患者报告结果(PRO)。我们的主要终点是 36 个月时 AI 不依从,定义为尿液 AI 代谢物检测少于 10ng/ml 或未提交标本。我们使用逻辑回归评估了个体基线特征与不依从之间的关联。检查反映统计学上显著基线特征数量的复合风险评分。
我们分析了 702 名患者的数据;中位年龄为 60.9 岁。总体而言,35.9%的患者在 36 个月时不依从。年龄较小的患者(年龄小于 65 岁)的不依从率更高(38.8%比 28.6%,优势比[OR]为 1.51,95%置信区间[CI]为 1.05 至 2.16;P = 0.02)。14 项基线 PRO 量表在统计学上均与不依从相关。在按四分位水平分类的复合风险模型中,每个风险水平的增加都与不依从的几率增加 46.5%相关(OR = 1.47,95%CI = 1.26 至 1.70;P < 0.001)。最高风险的患者比最低风险的患者不依从的可能性高 3 倍以上(OR = 3.14,95%CI = 1.97 至 5.02;P < 0.001)。
存在多个基线 PRO 指定的危险因素与 AI 不依从有统计学上的显著相关性。这些评估的使用可以帮助识别需要针对性干预以提高依从性的患者。