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Health-related quality of life and psychological distress during neoadjuvant endocrine therapy with letrozole to determine endocrine responsiveness in postmenopausal breast cancer

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Abstract

Trials of adjuvant endocrine therapy for breast cancer have shown that aromatase inhibitors have little impact on global health-related quality of life (HRQoL), but have significant effects on patient-reported endocrine symptoms (ESs). There are few studies of HRQoL and psychological distress during preoperative endocrine therapy performed to determine endocrine responsiveness. The NEOS trial is a multicenter, phase 3 randomized controlled trial in postmenopausal women with hormone receptor-positive breast cancer. The primary aim of the trial was to evaluate the need for adjuvant chemotherapy in patients with clinical T1c-T2N0M0, hormone receptor-positive tumors who responded to neoadjuvant letrozole (LET) administered for 24–28 weeks before surgery. The primary endpoint was disease-free survival and the secondary endpoints included adverse events, HRQoL, and cost-effectiveness. In a HRQoL sub-study, subjects were assessed at baseline and 4 and 16 weeks after starting neoadjuvant LET, using the functional assessment of cancer therapy-breast and its ES subscale, and the hospital anxiety and depression scale. HRQoL and psychosocial distress were analyzed in the uncontrolled phase during 24–28 weeks of neoadjuvant LET therapy in the NEOS trial. From May 16, 2008, to December 14, 2011, 503 patients were recruited into the HRQoL sub-study. The full analysis set included 497 patients with a mean age of 63-years old. The questionnaire response rates at enrollment and 4 and 16 weeks were 94.4, 90.7, and 89.1 %, respectively. There were no significant changes in the FACT-G or B-trial outcome index over time, but the social and family well-being score and the ES subscale deteriorated significantly, and the number of patients with clinically significant hot flush increased significantly. Anxiety, depression, and emotional well-being improved significantly after neoadjuvant LET. Neoadjuvant endocrine therapy with LET had no impact on global HRQoL, but did influence endocrine-related symptoms such as hot flush. This study is registered as UMIN000001090.

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Acknowledgments

This study was sponsored by Public Health Research Foundation, Comprehensive Support Project for Oncology Research (CSPOR). We thank the patients who participated in this trial, and the staff of the CSPOR-Breast Cancer Group for their contributions to this study.

Conflict of interest

The authors declare that they have no conflicts of interest.

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Authors and Affiliations

  1. Department of Breast and Endocrine Surgery, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

    Naruto Taira

  2. Department of Breast Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan

    Hiroji Iwata

  3. Department of Breast Surgery, Hirosaki Municipal Hospital, 3-8-1 Ohmachi, Hirosaki, Aomori, 036-8004, Japan

    Yoshie Hasegawa

  4. Breast Oncology Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550, Japan

    Takehiko Sakai

  5. Department of Breast Surgery, Hiroshima City Hospital, 7-33 Motomachi, Naka-ku, Hiroshima, 730-8518, Japan

    Kenji Higaki

  6. Department of Veterinary Medical Science, Faculty of Agriculture, The University of Tokyo, 7-3-1 Hongou, Bunkyo-ku, Tokyo, 113-0033, Japan

    Kiyohiro Kihara

  7. Division of Biostatistics, Tohoku University Graduate School of Medicine, 1-1 Seiryo-cho, Aobadai-ku, Sendai, Miyagi, 980-8574, Japan

    Takuhiro Yamaguchi

  8. Department of Breast Oncology, Shikoku Cancer Center, 160 Kou, Minami Umemoto, Matsuyama, Ehime, 791-0280, Japan

    Shozo Ohsumi

  9. Department of Biomedical Sciences, College of Life Sciences, Ritsumeikan University, 1-1-1 Noji Higashi, Kusatsu, Shiga, 525-8577, Japan

    Kojiro Shimozuma

  10. Department of Biostatistics, School of Public Health, The University of Tokyo, 7-3-1 Hongou, Bunkyo-ku, Tokyo, 113-0033, Japan

    Yasuo Ohashi

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  1. Naruto Taira
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  2. Hiroji Iwata
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  3. Yoshie Hasegawa
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  4. Takehiko Sakai
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  5. Kenji Higaki
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  6. Kiyohiro Kihara
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  7. Takuhiro Yamaguchi
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  8. Shozo Ohsumi
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  9. Kojiro Shimozuma
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  10. Yasuo Ohashi
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Correspondence to Naruto Taira.

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Taira, N., Iwata, H., Hasegawa, Y. et al. Health-related quality of life and psychological distress during neoadjuvant endocrine therapy with letrozole to determine endocrine responsiveness in postmenopausal breast cancer. Breast Cancer Res Treat 145, 155–164 (2014). https://doi.org/10.1007/s10549-014-2935-5

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