[Assessment of the quality of life of women with breast cancer in adjuvant treatment with tamoxifen or aromatase inhibitors--a randomized trial].

PURPOSE: To evaluate and compare the impact on quality of life of tamoxifen and aromatase inhibitors (AIN's) in adjuvant settings, at women with breast cancer. METHODS: From a total of 441 patients with breast cancer with hormonal treatment, were selected 177 of patients with adjuvant hormonal treatment (95 with tamoxifen treatment and 82 with AIN's treatment). These patients have completed the EORTC QLQ C-30 and EORTC QLQ BR23 questionnaires after 1 month of treatment (baseline), at 2 year of treatment with tamoxifen versus aromatase inhibitors (exemestane, anastrazole, letrozole). Mean change score from baseline and 2 years of treatment were compared in the both arms (tamoxifen vs. AIN's). RESULTS: In both arms, after two years, a decreased QOL was observed as compared with the baseline. In the tamoxifen arm, global health status (GHS) and breast symptoms score (BRBS) were similar comparative with AIN's arm at baseline, with a similar status at 2 years measurement. CONCLUSIONS: The global health status (GHS) and breast symptoms score (BRBS) shows that there is no difference in the QOL at the women with breast cancer treated with tamoxifen, comparative with the women treated with AIN's. We conclude that AIN's did not have an adverse impact on overall QOL, comparative with tamoxifen, in adjuvant settings.