title: Impact of symptomatic skeletal events on health-care resource utilization and quality of life among patients with castration-resistant prostate cancer and bone metastases.
abstract: Data regarding the impact of symptomatic skeletal events (SSEs) on health economics and patient-reported outcomes in men with castration-resistant prostate cancer (CRPC) and bone metastases from a clinical setting are lacking. Hence, this study aimed to quantify the effects of SSEs on health-care resource utilization (HRU), health-related quality of life (HRQoL) and pain in men with CRPC metastasized to bone.
  
  
  
  This cohort study included men with CRPC and bone metastasis treated at a tertiary center during December 1996-July 2015. SSEs, including pathological fracture, radiation to bone, spinal cord compression and bone surgery, as well as HRU were identified retrospectively through medical records and clinical database. A subset of surviving patients completed Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory-Short Form (BPI-SF) questionnaires. The incremental effect of SSEs on HRU was evaluated using multivariable generalized linear regression. Questionnaire scores were compared using effect sizes (ES); ES⩾0.33 indicated meaningful differences between SSE and non-SSE cohorts. Lower scores suggest lower HRQoL and pain.
  
  
  
  Of the 832 patients, 207 developed ⩾1 SSE (mean 1.5±0.8) during follow-up (median 2.1 years). Radiation to bone was the most common SSE (84.1%). SSE cohort had significantly higher emergency room (incidence rate ratio (IRR)=1.48; P=0.006), outpatient (IRR=1.17; P=0.005) and inpatient (IRR=1.74; P<0.001) visits. Of the 107 eligible survey patients, 103 (96.3%) responded. SSE cohort had lower mean FACT-P functional well-being (17.5 vs 19.8; P=0.158; ES=0.36), higher mean pain severity (2.5 vs 1.6; P=0.048; ES=0.47) and worst pain scores (3.6 vs 2.3; P=0.033; ES=0.50) compared with the non-SSE cohort, indicating meaningful differences between cohorts.
  
  
  
  This study demonstrated high economic and HRQoL burden of SSEs. The findings underscore the need for better supportive and disease-modifying treatments for these patients.
authors.affiliation: Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.|Division of Hematology/Oncology, University of California, Moores Cancer Center, San Diego, CA, USA.
authors.forename: R
authors.initials: R
authors.lastname: McKay
authors.affiliation: Analysis Group, Inc., Boston, MA, USA.
authors.forename: B
authors.initials: B
authors.lastname: Haider
authors.affiliation: Analysis Group, Inc., Boston, MA, USA.
authors.forename: M S
authors.initials: MS
authors.lastname: Duh
authors.affiliation: Bayer Healthcare Pharmaceuticals, Wayne, NJ, USA.
authors.forename: A
authors.initials: A
authors.lastname: Valderrama
authors.affiliation: Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Nakabayashi
authors.affiliation: Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Fiorillo
authors.affiliation: Analysis Group, Inc., Boston, MA, USA.
authors.forename: L
authors.initials: L
authors.lastname: Ristovska
authors.affiliation: Bayer Healthcare Pharmaceuticals, Wayne, NJ, USA.
authors.forename: L
authors.initials: L
authors.lastname: Wen
authors.affiliation: Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.|Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: P
authors.initials: P
authors.lastname: Kantoff
mesh_terms: D000230:Adenocarcinoma / Q000556:secondary* / Q000628:therapy; D000368:Aged; D001859:Bone Neoplasms / Q000556:secondary* / Q000628:therapy; D015331:Cohort Studies; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D016522:Oncology Service, Hospital / Q000706:statistics & numerical data*; D010146:Pain; D064129:Prostatic Neoplasms, Castration-Resistant / Q000473:pathology* / Q000628:therapy; D011788:Quality of Life; D012189:Retrospective Studies