title: Health-related quality of life of postmenopausal Chinese women with hormone receptor-positive early breast cancer during treatment with adjuvant aromatase inhibitors: a prospective, multicenter, non-interventional study.
abstract: BACKGROUND
  Estimating quality of life (QoL) in patients with breast cancer is of importance in assessing treatment outcomes. Adjuvant endocrine therapy is widely used for hormone receptor-positive (HR+) early-stage breast cancer (EBC), and evidence suggests that aromatase inhibitors (AIs) may improve QoL for these patients. This study evaluated QoL in postmenopausal Chinese patients with HR+ EBC taking AIs.
  
  
  METHODS
  This was a prospective, multicenter, and observational study that had no intent to intervene in the current treatment of recruited patients. Eligible patients were recruited within 7 days of beginning adjuvant treatment with AIs. The Functional Assessment of Cancer Therapy-Breast (FACT-B) scale was used to evaluate the patients' QoL. Data were collected at baseline and at 6, 12, 18, and 24 months.
  
  
  RESULTS
  From June 2010 to October 2013, a total of 494 patients with HR+ EBC were recruited from 21 centers. There was a 7.51-point increase in the patients' mean FACT-B trial outcome index (TOI), from 90.69 at baseline to 98.72 at 24 months (P < .0001). The mean TOI scores at baseline, 6, 12, and 18 months were 90.69, 94.36, 97.71, and 96.75, respectively (P < .0001, for all). The mean (FACT-B) emotional well-being subscale scores at baseline, 6, 12, 18, and 24 months were 16.32, 16.55, 17.34 (P < .0001), 17.47 (P < .0001), and 17.85 (P < .0001), respectively, and social well-being scores were 18.61, 19.14 (P < .04), 19.35 (P < .008), 18.32, and 18.40, respectively. In the mixed model, baseline TOI, clinical visits, prior chemotherapies, age group, and axillary lymph-node dissection presented statistically significant effects on the change of FACT-B TOI and FACT-B SWB, whereas only baseline TOI, clinical visits, and prior chemotherapies presented statistically significant effects on the change of FACT-B EWB. FACT-B TOI, being the most pertinent and precise indicator of patient-reported QoL, demonstrated significant changes reflecting clinical benefit of adjuvant AIs endocrine therapy in the QoL of HR + EBC patients.
  
  
  CONCLUSIONS
  The study demonstrated significant improvements in the long-term QoL of postmenopausal Chinese patients with HR+ EBC at 6, 12, 18, and 24 months after starting treatment with AIs. The current study indicates improved long-term QoL with AI adjuvant treatment, which will aid clinicians in optimizing treatment to yield effective healthcare outcomes.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01144572.
authors.affiliation: Department of Breast Surgery, Fudan University Shanghai Cancer Center, No. 270 Dongan Road, Xuhui District, Shanghai, 200032, China.
authors.forename: Ayong
authors.initials: A
authors.lastname: Cao
authors.affiliation: Department of Breast Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300060, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Department of Breast Surgery, Jiangsu Province Hospital, Nanjing, China.
authors.forename: Xiaoan
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Oncology Surgery, Ningbo Medical Treatment Center Lihuili Hospital, Ningbo, 315000, China.
authors.forename: Weizhu
authors.initials: W
authors.lastname: Wu
authors.affiliation: Breast Disease Center, Peking University First Hospital, Beijing, 100034, China.
authors.forename: Yinhua
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Breast Surgery, First Hospital of Jilin University, Changchun, 130021, China.
authors.forename: Zhimin
authors.initials: Z
authors.lastname: Fan
authors.affiliation: Breast Disease Center, Guangdong Women and Children's Hospital and Health Institute, Guangzhou, 510010, China.
authors.forename: Anqin
authors.initials: A
authors.lastname: Zhang
authors.affiliation: Department of Breast Disease, Yunnan Tumor Hospital, Kunming, 650118, China.
authors.forename: Tianning
authors.initials: T
authors.lastname: Zhou
authors.affiliation: Breast Disease Center, First Affiliated Hospital of Medicine College of Zhejiang University, Hangzhou, 310006, China.
authors.forename: Peifen
authors.initials: P
authors.lastname: Fu
authors.affiliation: Breast Disease Center, Peking University People's Hospital, Beijing, 100044, China.
authors.forename: Shu
authors.initials: S
authors.lastname: Wang
authors.affiliation: Medical Oncology Center, Hunan Tumor Hospital, Changsha, 410000, China.
authors.forename: Quchang
authors.initials: Q
authors.lastname: Ouyang
authors.affiliation: Department of General Surgery, Jiangsu Cancer Hospital, Nanjing, 210009, China.
authors.forename: Jinhai
authors.initials: J
authors.lastname: Tang
authors.affiliation: Department of General Surgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, 100020, China.
authors.forename: Hongchuan
authors.initials: H
authors.lastname: Jiang
authors.affiliation: Department of Oncology Surgery, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, 325000, China.
authors.forename: Xiaohua
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Breast Surgery, The Tumor Hospital of Harbin Medical University, Harbin, 150040, China.
authors.forename: Da
authors.initials: D
authors.lastname: Pang
authors.affiliation: Department of Surgical Oncology, The First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University, Xi'an, 710000, China.
authors.forename: Jianjun
authors.initials: J
authors.lastname: He
authors.affiliation: Department of Breast and Thyroid Surgery, Shanghai Tenth People's Hospital, Shanghai, 200072, China.
authors.forename: Linxiang
authors.initials: L
authors.lastname: Shi
authors.affiliation: Department of Breast and Thyroid Surgery, Shenzhen Second Hospital, Shenzhen, 518000, China.
authors.forename: Xianming
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Breast Surgery, Shanghai Changhai Hospital, Shanghai, 200433, China.
authors.forename: Yuan
authors.initials: Y
authors.lastname: Sheng
authors.affiliation: Department of Breast Surgery, The Affiliated Hospital of Guiyang Medical College, Guiyang, Guizhou, 550004, China.
authors.forename: Dahua
authors.initials: D
authors.lastname: Mao
authors.affiliation: Department of Breast Surgery, Fudan University Shanghai Cancer Center, No. 270 Dongan Road, Xuhui District, Shanghai, 200032, China. Shaozhm2015@163.com.
authors.forename: Zhimin
authors.initials: Z
authors.lastname: Shao
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D044466:Asian People; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000503:physiopathology*; D002681:China; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause / Q000502:physiology*; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D047072:Aromatase Inhibitors
keywords: Adjuvant; Aromatase inhibitors; Early breast cancer; Functional Assessment of Cancer Therapy-Breast; Hormone receptor-positive early-stage breast cancer postmenopause; Prospective; Quality of life; Trial outcome index