Prospective randomized and multicentric evaluation of cognition in menopausal breast cancer patients receiving adjuvant hormonotherapy: a phase III study (Preliminary results).

Background: Cognitive impairment has been considered to be a possible adverse effect of aromatase inhibitors (AI). The aim of the study was to compare the impact of tamoxifen or AI on verbal memory (Rey auditory-verbal learning test) and other cognitive functions (memory, executive and attentional functions) after 6 months of treatment. Methods: In this randomized, open-label phase III study, menopausal patients treated with adjuvant hormonotherapy for early breast cancer were enrolled at the end of the radiotherapy. Patients over 70 years, with a history of cognitive disorder or with prior chemotherapy were excluded. Detailed neuropsychological assessments and quality of life evaluations were performed before the 1st administration of hormonotherapy and then 6 months later. Considering the usual norms of the auditivo-verbal Rey test, an alpha risk of 5% and a 95% power, 27 patients per arm had to be included. Statistical analyses included Chi2 test and Student tests when appropriate. Results: 62 consecutive evaluable patients were randomized in 2 arms between March 2009 and April 2011. Patients received tamoxifen in arm A (n = 31) and AI in arm B (letrozole n=17; anastrozole n=12; exemestane n= 2). Median age at inclusion was 61.4 years. The median time since menopause was 10 years. Characteristics of the breast tumor and initial neuropsychological evaluations did not differ significantly between the 2 arms. After 6 months, we observed a significant decline of the performance at the episodic memory test (immediate recall of the Rey auditory verbal learning test) (p = 0.0015) in arm A only and a significant improvement on executive measures (Trail Making Test and Stroop test) (respectively p = 0.03/p = 0.002) in arm B. Quality of life didn't differ after 6 months of treatment. Conclusions: These preliminary results do not support that AI have a worse adverse effect on cognitive functions than tamoxifen after 6 months of treatment. A confirmation is planned after one year of treatment. [ABSTRACT FROM AUTHOR]