title: 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.
authors.affiliation: Division of Breast Surgery, Saitama Cancer Center, 818 Komuro Ina, Kita-Adachi, Saitama 362-0806, Japan. h-takei@cancer-c.pref.saitama.jp
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Takei
authors.forename: Shozo
authors.initials: S
authors.lastname: Ohsumi
authors.forename: Kojiro
authors.initials: K
authors.lastname: Shimozuma
authors.forename: Megumi
authors.initials: M
authors.lastname: Takehara
authors.forename: Kimito
authors.initials: K
authors.lastname: Suemasu
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hozumi
mesh_terms: D000368:Aged; D000077384:Anastrozole; D000730:Androstadienes / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000523:psychology / Q000601:surgery; D002277:Carcinoma / Q000188:drug therapy* / Q000523:psychology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003863:Depression / Q000139:chemically induced; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy* / Q000523:psychology / Q000601:surgery; D009570:Nitriles / Q000008:administration & dosage; D017698:Postmenopause; D011788:Quality of Life; D013315:Stress, Psychological / Q000139:chemically induced*; D011795:Surveys and Questionnaires; D013629:Tamoxifen / Q000008:administration & dosage; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage
chemical_list: D000730:Androstadienes; D009570:Nitriles; D014230:Triazoles; D013629:Tamoxifen; D000077384:Anastrozole; C056516:exemestane