Columbia University, New York, NY, USA.
J Oncol Pract. 2012 Sep;8(5):e100-4. doi: 10.1200/JOP.2011.000487. Epub 2012 Jun 26.
Multiple studies have shown that adherence to adjuvant hormonal therapy in women with breast cancer is suboptimal. Measurements of compliance with self-report, pill counts, and/or pharmacy records are susceptible to bias. We assessed the feasibility of using a urine anastrozole assay as an objective biomarker of nonadherence to anastrozole treatment.
We recruited consecutive postmenopausal women, age ≥ 18 years, with hormone-sensitive nonmetastatic breast cancer who were prescribed anastrozole at least 3 months before enrollment. Each completed a short survey to gather information on demographics, anastrozole compliance history, and self-reported medication history, tumor characteristics, and treatment received. A single, random 15-mL urine sample was collected and tested for the presence of anastrozole using a previously validated assay. Patients were told they were part of a study to determine if anastrozole could be detected in the urine.
Among 96 participants, mean age was 63.7 years (range, 51 to 70 years). The population was diverse, with 56.5% white, 57.6% US born, 59.8% unemployed, and 56.6% college educated. Prior treatment included chemotherapy (50%) and/or radiotherapy (58.7%). Mean duration of anastrozole treatment was 2.2 years (standard deviation, 1.6). Four participants reported nonadherence and declined to submit urine samples, and two had no detectable level of anastrozole (six of 96; 6.3%). Detectable levels among adherent women ranged from 49.3 to 632.8 ng/mL.
We demonstrated that collection of urine to measure anastrozole levels is feasible and reliable. Identifying biomarkers to measure adherence is critical for studies investigating interventions to improve hormonal therapy compliance.
多项研究表明，乳腺癌患者辅助激素治疗的依从性并不理想。通过自我报告、药物计数和/或药房记录来衡量依从性很容易产生偏差。我们评估了使用尿液阿那曲唑测定作为阿那曲唑治疗不依从的客观生物标志物的可行性。
我们招募了连续的绝经后妇女，年龄≥18 岁，患有激素敏感的非转移性乳腺癌，在入组前至少 3 个月开始服用阿那曲唑。每位患者都完成了一份简短的调查问卷，以收集人口统计学信息、阿那曲唑依从性史以及自我报告的用药史、肿瘤特征和接受的治疗。收集了单个随机的 15 毫升尿液样本，并使用先前验证的测定法检测阿那曲唑的存在。告知患者他们参与了一项研究，以确定阿那曲唑是否可以在尿液中检测到。
在 96 名参与者中，平均年龄为 63.7 岁（范围，51 至 70 岁）。人群多样化，其中 56.5%为白人，57.6%为美国出生，59.8%失业，56.6%受过大学教育。先前的治疗包括化疗（50%）和/或放疗（58.7%）。阿那曲唑治疗的平均持续时间为 2.2 年（标准差，1.6 年）。4 名报告不依从的患者拒绝提交尿液样本，2 名患者的阿那曲唑水平无法检测到（96 名患者中有 6 名；6.3%）。依从性女性的可检测水平范围为 49.3 至 632.8ng/ml。
我们证明了收集尿液来测量阿那曲唑水平是可行和可靠的。确定用于测量依从性的生物标志物对于研究改善激素治疗依从性的干预措施至关重要。
