Breast Cancer Research and Treatment

, Volume 133, Issue 1, pp 227–236 | Cite as

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)

  • Hiroyuki Takei
  • Shozo Ohsumi
  • Kojiro Shimozuma
  • Megumi Takehara
  • Kimito Suemasu
  • Yasuo Ohashi
  • Yasuo Hozumi
Clinical trial


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.


Quality of life Adverse event Breast cancer Exemestane Anastrozole Tamoxifen 



Adverse event


Aromatase inhibitor


Arimidex, tamoxifen, alone or in combination


Breast cancer


Breast cancer subscale


Bone mineral density


Center for epidemiologic studies depression scale


Cytochrome P450


Disease-free survival


Endocrine symptom subscale


Functional assessment of cancer therapy-breast


Functional assessment of cancer therapy-general


Health-related quality of life


National Surgical Adjuvant Study of Breast Cancer


Tamoxifen exemestane adjuvant multinational



We thank all the patients, investigators, and clinical research coordinators who participated in N-SAS BC 04. Data management and statistical analysis services were provided by the non-profit organization Japan Clinical Research Support Unit (Tokyo, Japan), and medical writing services were provided by Statcom Co., Ltd. (Tokyo, Japan).

Conflict of interest



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Copyright information

© Springer Science+Business Media, LLC. 2012

Authors and Affiliations

  • Hiroyuki Takei
    • 1
  • Shozo Ohsumi
    • 2
  • Kojiro Shimozuma
    • 3
  • Megumi Takehara
    • 4
  • Kimito Suemasu
    • 5
  • Yasuo Ohashi
    • 6
  • Yasuo Hozumi
    • 4
  1. 1.Division of Breast SurgerySaitama Cancer CenterKita-Adachi, SaitamaJapan
  2. 2.Department of Breast OncologyNational Hospital Organization Shikoku Cancer CenterEhimeJapan
  3. 3.Department of Biomedical Sciences, College of Life SciencesRitsumeikan UniversityShigaJapan
  4. 4.Division of Breast and General SurgeryJichi Medical UniversityTochigiJapan
  5. 5.Arche Clinic Breast CenterSaitamaJapan
  6. 6.Department of BiostatisticsThe University of TokyoTokyoJapan

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