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1. 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

Author

Weizhu Wu, Linxiang Shi, Jin Zhang, Peifen Fu, Xiaohua Zhang, Zhimin Shao, Dahua Mao, Jinhai Tang, Da Pang, Anqin Zhang, Yin-Hua Liu, Tianning Zhou, Xiaoan Liu, Ayong Cao, Xianming Wang, Hongchuan Jiang, Quchang Ouyang, Yuan Sheng, Jianjun He, Shu Wang, and Zhimin Fan

Subjects
Quality of life, China, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Trial outcome index, Antineoplastic Agents, Breast Neoplasms, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Asian People, Internal medicine, medicine, Humans, Prospective Studies, 030212 general & internal medicine, Aromatase, Prospective cohort study, Adjuvant, Aged, Gynecology, biology, Aromatase Inhibitors, business.industry, Research, Early breast cancer, Public Health, Environmental and Occupational Health, Cancer, General Medicine, Middle Aged, medicine.disease, Postmenopause, Prospective, Dissection, 030220 oncology & carcinogenesis, biology.protein, Drug Therapy, Combination, Female, Observational study, Hormone receptor-positive early-stage breast cancer postmenopause, Functional Assessment of Cancer Therapy-Breast, business
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

Published
2016
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2. 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.

Author

Ayong Cao, Jin Zhang, Xiaoan Liu, Weizhu Wu, Yinhua Liu, Zhimin Fan, Anqin Zhang, Tianning Zhou, Peifen Fu, Shu Wang, Quchang Ouyang, Jinhai Tang, Hongchuan Jiang, Xiaohua Zhang, Da Pang, Jianjun He, Linxiang Shi, Xianming Wang, Yuan Sheng, and Dahua Mao

Subjects
QUALITY of life, CANCER treatment, HEALTH outcome assessment, IMMUNOLOGICAL adjuvants, BREAST cancer treatment, ANTINEOPLASTIC agents, AROMATASE inhibitors, ASIANS, BREAST tumors, COMBINATION drug therapy, CLINICAL trials, COMPARATIVE studies, LONGITUDINAL method, RESEARCH methodology, MEDICAL cooperation, RESEARCH, TIME, EVALUATION research, POSTMENOPAUSE, THERAPEUTICS
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.Trial Registration: Clinicaltrials.gov NCT01144572. [ABSTRACT FROM AUTHOR]

Published
2016
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