title: Clinical outcomes among HR+/HER2- metastatic breast cancer patients with multiple metastatic sites: a chart review study in the US.
abstract: BACKGROUND
  Hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2-) is the most common type of metastatic breast cancer (mBC). While mBC patients generally have poor prognosis with limited progression-free survival (PFS) and overall survival (OS), those with multiple metastatic sites may have even worse clinical outcomes due to multiple organ involvement. This study aimed to compare clinical outcomes including PFS, time on treatment (TOT), and OS between HR+/HER2- mBC patients with multiple metastases versus those with a single metastasis in a real-world clinical setting.
  
  
  METHODS
  This was a retrospective chart review study of postmenopausal HR+/HER2- mBC women who had failed a non-steroidal aromatase inhibitor in the adjuvant or metastatic setting and initiated a new treatment for mBC between 07/01/2012 and 04/15/2013. Patients were classified to one of two study groups (multiple metastases or single metastasis) based on the number of non-lymph-node metastases at the initiation of the new treatment. PFS, TOT and OS were compared between the two groups using Kaplan-Meier analyses and multivariable Cox proportional hazard models adjusting for patient disease and treatment characteristics. Separate Cox models were conducted including models with an interaction term between line of therapy and study group to assess the impact of multiple metastases on clinical outcomes across different lines of therapy.
  
  
  RESULTS
  A total of 699 patient charts were collected, including 291 patients with multiple metastases and 408 single metastasis patients. Worse performance status and a higher proportion of prior chemotherapy for mBC were observed among patients with multiple metastases. Overall, patients with multiple metastases had significantly shorter PFS [adjusted hazard ratio (HR) = 1.55, 95 % confidence interval (CI) 1.21-1.98], TOT (adjusted HR = 1.33, 95 % CI 1.05-1.67), and OS (adjusted HR = 1.77, 95 % CI 1.15-2.74) than single metastasis patients. Similar outcomes were observed in each line of therapy.
  
  
  CONCLUSIONS
  Among HR+/HER2- mBC patients, patients with multiple metastases had significantly shorter PFS, TOT, and OS than single metastasis patients, highlighting the substantial clinical burden and unmet need for more efficacious treatments for the former group of patients.
authors.affiliation: Analysis Group, Inc., New York, NY USA.
authors.forename: Jipan
authors.initials: J
authors.lastname: Xie
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ USA.
authors.forename: Yanni
authors.initials: Y
authors.lastname: Hao
authors.affiliation: Analysis Group, Inc., Boston, MA USA.
authors.forename: Nanxin
authors.initials: N
authors.lastname: Li
authors.affiliation: Analysis Group, Inc., Boston, MA USA.
authors.forename: Peggy L
authors.initials: PL
authors.lastname: Lin
authors.affiliation: Analysis Group, Inc., Boston, MA USA.
authors.forename: Erika
authors.initials: E
authors.lastname: Ohashi
authors.affiliation: Analysis Group, Inc., Boston, MA USA.
authors.forename: Valerie
authors.initials: V
authors.lastname: Koo
authors.affiliation: Analysis Group, Inc., New York, NY USA.
authors.forename: Eric Q
authors.initials: EQ
authors.lastname: Wu
keywords: HR+/HER2−; Metastatic breast cancer; Multiple metastases; Overall survival; Progression-free survival; Time on treatment