Use of a urine anastrozole assay to determine treatment discontinuation among women with hormone-sensitive breast cancer: a pilot study.

PURPOSE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Asthma, allergy, and IgE levels in NYC head start children.

BACKGROUND: Among preschool-age children in New York City neighborhoods with high asthma hospitalization rates, we analyzed the associations of total immunoglobulin E (IgE), specific IgE to common indoor allergens, and allergy symptoms with asthma. METHODS: Parents of children in New York City Head Start programs were asked to complete a questionnaire covering demographic factors, health history (including respiratory conditions), lifestyle, and home environment. Children's serum samples were analyzed for total IgE and specific IgE antibodies to cockroach, dust mite, mouse, and cat allergens by immunoassay. Logistic regression was used to model the association between asthma and IgE, controlling for age, gender, ethnicity/national origin, BMI, parental asthma, smokers in the household, and allergy symptoms (e.g., runny nose, rash). RESULTS: Among 453 participating children (mean age 4.0+/-0.5 years), 150 (33%) met our criteria for asthma. In our multivariable logistic regression models, children with asthma were more likely than other children to be sensitized to each allergen, to be sensitized to any of the four allergens (OR=1.6, 95% CI 1.0-2.6), or to be in the highest quartile of total IgE (OR=3.1, 95% CI 1.5-6.4). Allergy symptoms based on questionnaire responses were independently associated with asthma (OR=3.7, 95% CI 2.3-5.9). CONCLUSIONS: Among preschool-aged urban children, asthma was associated with total IgE and sensitization to cat, mouse, cockroach, and dust mite allergens. However, allergy symptoms were more prevalent and more strongly associated with asthma than was any allergen-specific IgE; such symptoms may precede elevated specific IgE or represent a different pathway to asthma.