Health-related quality of life, psychological distress, and adverse events in postmenopausal women with breast cancer who receive tamoxifen, exemestane, or anastrozole as adjuvant endocrine therapy: National Surgical Adjuvant Study of Breast Cancer 04 (N-SAS BC 04)

Abstract

Health-related quality of life (HRQOL), symptoms of depression, and adverse events (AEs) were compared between Japanese postmenopausal patients with hormone-sensitive breast cancer (BC) who received adjuvant tamoxifen, exemestane, or anastrozole in an open-labeled, randomized, multicenter trial designated as the National Surgical Adjuvant Study of Breast Cancer (N-SAS BC) 04 substudy of the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial. During the first year of treatment, HRQOL and symptoms of depression were analyzed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and its Endocrine Symptom Subscale (ES), and the Center for Epidemiologic Studies Depression Scale (CES-D), respectively. In addition, predefined AEs were analyzed. A total of 166 eligible patients were randomly assigned to receive adjuvant tamoxifen, exemestane, or anastrozole. FACT-B scores increased after treatment began and remained significantly higher in the tamoxifen group than in the exemestane group or anastrozole group during the first year (P = 0.045). FACT-B scores were similar in the exemestane group and anastrozole group. ES scores and CES-D scores were similar in all treatment groups. Arthralgia and fatigue were less frequent, but vaginal discharge was more frequent in the tamoxifen group than in the exemestane group or anastrozole group. HRQOL was better in Japanese postmenopausal women treated with tamoxifen than those treated with exemestane or anastrozole. HRQOL and AEs were similar with exemestane and anastrozole. Given the results of the TEAM trial, upfront use of tamoxifen followed by an aromatase inhibitor (AI) may be an important option for adjuvant endocrine therapy in Japanese postmenopausal women.

The impact of adjuvant endocrine therapy in early breast cancer on quality-of-life: an overview of prospective trials

“…Differently, ES scores were similar in the three arms. As for depression issues, CES-D scores were largely comparable in the three groups [34,36].…”

Does Efficacy of Adjuvant Endocrine Therapy Correlate with Breast Cancer Patients? Ethnicity?

“…On the other hand, HRQOL scores were similar between Caucasian patients treated with adjuvant tamoxifen and adjuvant AIs [16,17]. A better HRQOL observed in Japanese patients taking tamoxifen may be due to the fact that a fatigue was significantly less frequent in Japanese patients taking tamoxifen than Caucasian patients [15]. One of the reasons for this might be due to the different metabolism of tamoxifen between Japanese patients and Caucasian patients.…”

“…For instance, a variant allele of CYP2D6*10 having a decreased activity is found in 51% of Asians; however, it is rare in Caucasians [13]. All these results suggest that the efficacy of tamoxifen may differ between races.Health-related Quality of Life (HRQOL) scores were higher in Japanese women with breast cancer who took adjuvant tamoxifen compared with adjuvant anastrozole or exemestane [15]. On the other hand, HRQOL scores were similar between Caucasian patients treated with adjuvant tamoxifen and adjuvant AIs [16,17].…”

“…Health-related Quality of Life (HRQOL) scores were higher in Japanese women with breast cancer who took adjuvant tamoxifen compared with adjuvant anastrozole or exemestane [15]. On the other hand, HRQOL scores were similar between Caucasian patients treated with adjuvant tamoxifen and adjuvant AIs [16,17].…”

Racial Differences in Depressive Symptoms and Self-Rated Health Among Breast Cancer Survivors on Aromatase Inhibitor Therapy

“…Some data suggest that there is a correlation between the reduction of estrogen and the onset of depression (Bower, 2008;Halbreich, 1997;Massie, 2004); therefore, it is possible that AI therapy may increase the risk of depression among cancer survivors. Several studies conducted among Japanese breast cancer survivors showed no difference in depressive symptoms, as measured using the Center for Epidemiological Studies-Depression (CES-D) scale, among women treated with exemestane, tamoxifen, or anastrozole during the first year of treatment, and no difference in depressive symptoms among breast cancer survivors who switched from tamoxifen to anastrozole compared to those who remained on tamoxifen (Ohsumi et al, 2011;Takei, 2012). In general, these studies are limited by the fact that they have been conducted within clinical trials, where patients are healthier than the general breast cancer population, and the comparison group is on other hormonal therapies, which may be associated with psychosocial side effects themselves.…”