title: A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients' persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer.
abstract: Since the rate of persistence to adjuvant endocrine therapy such as 5-year aromatase inhibitors (AI) would decrease over time in patients with hormone-sensitive breast cancer, it is necessary to investigate if a patient support program could modify patients' beliefs and improve their persistence to AI treatment. This was a prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving postmenopausal patients' persistence to adjuvant AI medication for early stage breast cancer (NCT00769080). The primary objective was to compare the rates of 1-year persistence to upfront adjuvant AI for patients in the two observational arms (standard treatment group and standard treatment plus patient support program group). In this study, 262 patients were enrolled in the standard treatment group and 241 patients in the standard treatment plus patient support program group. The mean 1-year persistence rates were 95.9 and 95.8% for the standard treatment group and the standard treatment plus patient support program group, respectively (P=0.95). The mean times to treatment discontinuation were 231.2 days in the standard treatment group and 227.8 days in the standard treatment plus patient support program group, with no statistically significant difference between the two groups (P=0.96). There was also no statistically significant difference in the reason for treatment discontinuation (P=0.32). There was a significant relationship between the patient centered care questionnaire and poor persistence (odds ratio=3.9; 95% CI, 1.1-13.7; P=0.035), suggesting that the persistence rate of patients with whom the doctor always or usually spends time is greater than that of patients with whom the doctor sometimes or never spends time. Patients' persistence to adjuvant AI medication for postmenopausal, early stage breast cancer is relatively high in the first year and is not significantly increased by adding a patient support program to standard treatment.
authors.affiliation: Department of Breast Surgery, Cancer Center and Cancer Institute, Shanghai Medical College, Fudan University, and Shanghai 6th Hospital, 399 Ling-Ling Road, Shanghai, 200032, People's Republic of China.
authors.forename: Ke-Da
authors.initials: KD
authors.lastname: Yu
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhou
authors.forename: Guang-Yu
authors.initials: GY
authors.lastname: Liu
authors.forename: Bin
authors.initials: B
authors.lastname: Li
authors.forename: Ping-Qing
authors.initials: PQ
authors.lastname: He
authors.forename: Hong-Wei
authors.initials: HW
authors.lastname: Zhang
authors.forename: Li-Hua
authors.initials: LH
authors.lastname: Lou
authors.forename: Xiao-Jia
authors.initials: XJ
authors.lastname: Wang
authors.forename: Shui
authors.initials: S
authors.lastname: Wang
authors.forename: Jin-Hai
authors.initials: JH
authors.lastname: Tang
authors.forename: Yin-Hua
authors.initials: YH
authors.lastname: Liu
authors.forename: Xiang
authors.initials: X
authors.lastname: Wang
authors.forename: Ze-Fei
authors.initials: ZF
authors.lastname: Jiang
authors.forename: Li-Wen
authors.initials: LW
authors.lastname: Ma
authors.forename: Lin
authors.initials: L
authors.lastname: Gu
authors.forename: Ming-Zhi
authors.initials: MZ
authors.lastname: Cao
authors.forename: Qing-Yuan
authors.initials: QY
authors.lastname: Zhang
authors.forename: Shen-Ming
authors.initials: SM
authors.lastname: Wang
authors.forename: Feng-Xi
authors.initials: FX
authors.lastname: Su
authors.forename: Hong
authors.initials: H
authors.lastname: Zheng
authors.forename: Hong-Yuan
authors.initials: HY
authors.lastname: Li
authors.forename: Li-Li
authors.initials: LL
authors.lastname: Tang
authors.forename: Sheng-Rong
authors.initials: SR
authors.lastname: Sun
authors.forename: Jin-Ping
authors.initials: JP
authors.lastname: Liu
authors.forename: Zhi-Ming
authors.initials: ZM
authors.lastname: Shao
authors.forename: Zhen-Zhou
authors.initials: ZZ
authors.lastname: Shen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000077384:Anastrozole; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D000077289:Letrozole; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy* / Q000473:pathology; D009570:Nitriles / Q000627:therapeutic use*; D010349:Patient Compliance / Q000706:statistics & numerical data*; D010817:Physician-Patient Relations; D017698:Postmenopause; D010818:Practice Patterns, Physicians'; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D014230:Triazoles / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D047072:Aromatase Inhibitors; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole; D000077289:Letrozole