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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)

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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.

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Abbreviations

AE:

Adverse event

AI:

Aromatase inhibitor

ATAC:

Arimidex, tamoxifen, alone or in combination

BC:

Breast cancer

BCS:

Breast cancer subscale

BMD:

Bone mineral density

CES-D:

Center for epidemiologic studies depression scale

CYP:

Cytochrome P450

DFS:

Disease-free survival

ES:

Endocrine symptom subscale

FACT-B:

Functional assessment of cancer therapy-breast

FACT-G:

Functional assessment of cancer therapy-general

HRQOL:

Health-related quality of life

N-SAS BC:

National Surgical Adjuvant Study of Breast Cancer

TEAM:

Tamoxifen exemestane adjuvant multinational

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Acknowledgments

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

None.

Author information

Authors and Affiliations

  1. Division of Breast Surgery, Saitama Cancer Center, 818 Komuro Ina, Kita-Adachi, Saitama, 362-0806, Japan

    Hiroyuki Takei

  2. Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan

    Shozo Ohsumi

  3. Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, Shiga, Japan

    Kojiro Shimozuma

  4. Division of Breast and General Surgery, Jichi Medical University, Tochigi, Japan

    Megumi Takehara & Yasuo Hozumi

  5. Arche Clinic Breast Center, Saitama, Japan

    Kimito Suemasu

  6. Department of Biostatistics, The University of Tokyo, Tokyo, Japan

    Yasuo Ohashi

Authors
  1. Hiroyuki Takei
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  2. Shozo Ohsumi
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  3. Kojiro Shimozuma
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  4. Megumi Takehara
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  5. Kimito Suemasu
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  6. Yasuo Ohashi
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  7. Yasuo Hozumi
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Corresponding author

Correspondence to Hiroyuki Takei.

Additional information

This study was funded by the Comprehensive Support Project for Oncology Research (CSPOR) and for Health Outcomes Research (CSP-HOR) of the Public Health Research Foundation. The corporate and individual sponsors of this study are listed on the CSPOR website (http://www.csp.or.jp/cspor/kyousan_e.html). The pharmaceutical manufacturer/distributor who had provided financial contributions as a corporate sponsor took no part in this study, other than providing information relevant to proper use of the study drugs. All decisions concerning the planning, implementation, and publication of this study were made by the Executive Committee.

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Takei, H., Ohsumi, S., Shimozuma, K. et al. 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). Breast Cancer Res Treat 133, 227–236 (2012). https://doi.org/10.1007/s10549-011-1943-y

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  • DOI: https://doi.org/10.1007/s10549-011-1943-y

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