title: Disease and Treatment Characteristics of Men Diagnosed With Metastatic Hormone-Sensitive Prostate Cancer in Real Life: Analysis From a Commercial Claims Database.
abstract: Our understanding of the clinical characteristics and treatment patterns of men who present with newly diagnosed metastatic (M1) hormone-sensitive prostate cancer is based mainly on clinical trial data. We sought to characterize the M1 population seen in routine clinical practice using a commercial claims database.
  
  
  
  A US claims (2000-2013) database was used to identify patients with an index diagnosis of prostate cancer. M1 patients were identified by "International Classification of Diseases, 9th revision, Clinical Modification" diagnosis codes of metastasis to bone, viscera, distant lymph node, and unspecified sites within 90 days of the prostate cancer diagnosis. Progression to castration-resistant prostate cancer was identified by exposure to ≥ 1 drugs approved for castration-resistant prostate cancer, including docetaxel, abiraterone acetate, cabazitaxel, enzalutamide, sipuleucel-T, mitoxantrone, estramustine, and radium-223.
  
  
  
  Among 326,907 patients with an index prostate cancer diagnosis, 9199 (2.8%) had M1 disease, including 6955 with specified metastatic disease involving the bone (77%), viscera (38%), or lymph nodes (21%). The initial treatment of M1 disease was castration in 51%, localized therapy in 16%, prostate cancer drug only in 18%, and no treatment in 15%. The median time to first castration was 33 days.
  
  
  
  The proportion of men with prostate cancer who presented with M1 disease was consistent with other observations. Only 51% of the patients were treated according to national guidelines recommending medical or surgical castration. The proportion with visceral involvement at presentation was greater than expected from the clinical trials data in the same population. Just as seen in other medical conditions, clinical trial data are not representative of real-life patients seen in routine clinical practice.
authors.affiliation: University of Colorado Cancer Center, Medical Oncology, Aurora, CO. Electronic address: Thomas.Flaig@ucdenver.edu.
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Flaig
authors.affiliation: SmartAnalyst Inc., New York, NY.
authors.forename: Ravi C
authors.initials: RC
authors.lastname: Potluri
authors.affiliation: Janssen Global Services, Global Medical Affairs, Raritan, NJ.
authors.forename: Yvette
authors.initials: Y
authors.lastname: Ng
authors.affiliation: Janssen Global Services, Global Medical Affairs, Raritan, NJ.
authors.forename: Mary B
authors.initials: MB
authors.lastname: Todd
authors.affiliation: Janssen Global Services, Global Market Access Analytics, Raritan, NJ.
authors.forename: Maneesha
authors.initials: M
authors.lastname: Mehra
authors.affiliation: Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Celestia S
authors.initials: CS
authors.lastname: Higano
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016208:Databases, Factual; D018450:Disease Progression; D006801:Humans; D007348:Insurance, Health; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017410:Practice Guidelines as Topic; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000628:therapy*; D012189:Retrospective Studies; D057832:Watchful Waiting
chemical_list: D000970:Antineoplastic Agents
keywords: Castration-resistant prostate cancer; Claims data; M1 disease; Metastatic patterns; Treatment patterns