Abstract P6-08-08: Three months of adjuvant hormone therapy does not increase fatigue or cognitive failure: results of a prospective early stage breast cancer trial.

Abstract

Abstract INTRODUCTION: The diagnosis and treatment of breast cancer may alter a patient's mental and physical quality of life. Fatigue and impaired cognition have been reported after chemotherapy and hormone therapy. The purpose of this study was to prospectively determine the incidence of fatigue and cognitive changes in early stage breast cancer patients during adjuvant hormone therapy and to evaluate the relationship of dysfunction with other risk factors. METHODS: Fifty-four consecutive patients of a single medical oncologist with newly diagnosed hormone dependent breast cancer prescribed adjuvant hormone therapy enrolled in this prospective study. Data collected included age, race, menopausal status, breast cancer stage, body mass index, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-F, Fatigue Assessment Scale (FAS), short form 36 (SF-36), cognitive failure questionnaire (CFQ), Beck depression inventory (BDI-2), Epworth sleepiness scale, and facial recognition (FR) and sheep dash time (SDT) to assess executive functioning. All tests were administered by one nurse prior to hormone initiation (0 mo) and after 3 months (3 mo) of therapy. Statistical analysis was performed using Student t test for paired data with a p value of <0.05 considered significant. RESULTS: After 3 months of therapy, 52 of 54 patients were reevaluated (1 patient dropped out and 1 excluded for metastatic disease). Of the remaining 52 patients, the mean age was 54 years (range 30–76) with self-reported race of white 38, black 13 and Indian 1 patient and 39 (75%) patients were postmenopausal. Initial tumor stage was 0 in 8 patients, 1 in 23, 2 in 20, and 3 in 1. Although the baseline mental health of patients assessed by SF-36 mental health (MH) domain was low (70 ±22.0 [mean ±SD]) after 3 months it improved to 55 ±8.1, P < 0.0001. No change was found in the SF-36 domains of physical health or vitality. At baseline, 15 of 52 patients (36%) reported significant fatigue (FAS score ≥22). After 3 months of therapy fatigue as measured by either the FACIT-F (0 mo:30 ±11.2; 3 mo:31 ±9.5, p = 0.37) or FAS (0 mo:20 ±8.5; 3 mo: 20 ±7.6, p = 0.53) remained unchanged. No change was noted in depression as determined by the BDI-2 score (0 mo: 9 ±8.1 versus 3 mo:9 ± 9, p = NS) or Epworth sleepiness scores (0 mo:7 ±4.5 versus 3 mo:8 ±4.7, p = NS). The initial CFQ was considered positive (>43) in 48 (92%) of patients. There was no significant change in the CFQ, SDT, or FR (CFQ 0 mo:67±12.9, 3 mo:67±13.0, p = 0.453; SDT: 0 mo:0.56±0.292 secs, 3 mo:0.52±0.223 secs, p = 0.144). BMI rose minimally after hormone therapy (0 mos:28.8 ±6.41; 3 mo:29.1 ±6.43, p = 0.0498). CONCLUSION: Prior to adjuvant hormone therapy institution, breast cancer patients often have significant problems with fatigue, cognitive failure, and overall mental health. Overall mental health improved during the first three months of hormone therapy. However, there was no significant change in fatigue, cognitive failure, depression score, reaction time, or facial recognition. Longer follow–up will be performed to assess the possible cumulative effects of hormone therapy on fatigue or cognitive function. Supported by Ride Cincinnati Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P6-08-08.