Quality of life (QOL) changes in breast cancer patients participating in an anastrozole secondary prevention trial

Abstract

1515 Background: Adjuvant aromatase inhibitor (AI) trials have reported a decreased incidence of contralateral breast (CLB) cancer. AIs may be associated with specific changes in QOL parameters but little is known about the mechanism. We hypothesized that 12 months (mos) of adjuvant anastrozole would worsen QOL and that changes in QOL would correlate with changes in circulating estrogens and inflammatory markers. Methods: We collected QOL data at baseline, 3, 6, and 12 mos from a prospective, single-arm study designed to determine the effect of adjuvant anastrozole on CLB density in postmenopausal women with hormone receptor-positive stage 0-III breast cancer who had completed local therapy. QOL was measured by the revised National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptoms questionnaire, Mayo Clinic hot flash diaries, Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study (MOS) sleep scale, MOS sexual function scale, and EuroQOL survey. Estrogens and inflammatory markers (interleukins 6 and 8 and tumor necrosis factor-alpha) concentrations were measured at 0, 6, and 12 mos. Results: From 3/04 to 9/06, 54 predominantly Caucasian women (mean age: 62.9 yrs, range: 47–79) were enrolled in the study. Musculoskeletal symptoms were greater at all treatment time points compared to baseline. Overall, there was no statistically significant change in QOL from baseline to any of the time points or when stratified by age. Although women with BMI ≥ 30 had greater decreases in estrone, estradiol, and estrone sulfate levels over time compared to women with BMI < 30 (p interactions < 0.001), menopausal symptoms increased over time only for women with BMI < 30 (p interaction < 0.03). Analysis of inflammatory markers is underway and the data will be available at the meeting. Conclusions: No significant change in overall QOL from baseline was detected during 12 months of adjuvant anastrozole. Obese women were less likely to develop menopausal symptoms despite a larger decrease in estrogen levels, suggesting an alternate etiology. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Novartis, Pfizer Oncology