title: Health-related quality of life and psychological distress during neoadjuvant endocrine therapy with letrozole to determine endocrine responsiveness in postmenopausal breast cancer.
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.
authors.affiliation: Department of Breast and Endocrine Surgery, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan, ntaira@md.okayama-u.ac.jp.
authors.forename: Naruto
authors.initials: N
authors.lastname: Taira
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
authors.forename: Yoshie
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Takehiko
authors.initials: T
authors.lastname: Sakai
authors.forename: Kenji
authors.initials: K
authors.lastname: Higaki
authors.forename: Kiyohiro
authors.initials: K
authors.lastname: Kihara
authors.forename: Takuhiro
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Shozo
authors.initials: S
authors.lastname: Ohsumi
authors.forename: Kojiro
authors.initials: K
authors.lastname: Shimozuma
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000077289:Letrozole; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009570:Nitriles / Q000627:therapeutic use*; D017698:Postmenopause; D011788:Quality of Life / Q000523:psychology*; D013315:Stress, Psychological; D011795:Surveys and Questionnaires; D014230:Triazoles / Q000627:therapeutic use*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D014230:Triazoles; D000077289:Letrozole