794P - Real world data analysis of incident metastatic (M1) prostate cancer (PC) patients (pts): US claims database analysis

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Prostate Cancer
Aetiology, Epidemiology, Screening and Prevention
Basic Scientific Principles
Presenter Thomas Flaig
Citation Annals of Oncology (2014) 25 (suppl_4): iv255-iv279. 10.1093/annonc/mdu336
Authors T. Flaig1, M. Mehra2, R. Potluri3, Y. Ng2, M. Todd4, C. Higano5
  • 1Division Of Medical Oncology, University of Colorado Cancer Center, 80045 - Aurora/US
  • 2Hub General, Janssen Global Services, Raritan/US
  • 3Biostats, SmartAnalyst Inc, New York/US
  • 4Oncology, Janssen Global Services, Raritan/US
  • 5Department Of Medicine, University of Washington, Fred Hutchinson Cancer Research Center, 98109 - Seattle/US



Newly diagnosed (dx) M1 PC pts have a poor prognosis (median survival 3.7 yrs [Hussain, NEJM 2013]), and their characterization is mainly based on clinical trial data. We conducted a retrospective analysis to characterize newly dx M1 pts in a real world setting.


The Truven Health Analytics MarketScan® US claims database from 2000-2013 was used to identify pts with an index PC dx. M1 pts were identified by diagnosis codes of metastasis to bone, visceral, distant lymph node, and nonspecific sites within 90 days of PC dx. Prior to index PC dx, pts had ≥ 180 days without any PC dx and up to 5 yrs without any other primary malignancy. Medical/surgical castration and prostatectomy/radiation (RP/RT) were identified by NDC and CPT4 codes. Progression to metastatic castration-resistant PC (mCRPC) was identified by exposure to ≥ 1 approved mCRPC drugs: docetaxel, abiraterone acetate, cabazitaxel, enzalutamide, sipuleucel-t, mitoxantrone, estramustine, and radium-223.


326,907 pts (median age 64 yrs) with an index PC dx were identified. 2.8% (9199) had M1 disease (median age 68 yrs) with a median follow-up of 1.7 yrs. 2244 pts (24%) had only nonspecified metastasis. The remaining 6955 pts had metastasis to bone (77%; 53% of these with > 1 site), any viscera (38%), or any lymph node (21%); 5% had metastasis to all 3 sites. 51% of M1 pts underwent castration; 16% localized therapy (mainly RT [75%]); 18% single-agent therapy (bicalutamide or steroid); 15% did not receive any of these treatments. Median time to castration was 33 days; 78% of these pts underwent castration within 90 days. Median time to RP/RT was 72 days. 65% of pts with any bone metastasis underwent castration, 35% of pts with visceral only metastasis received single-agent therapy, and 98% of pts with metastasis to all 3 sites received treatment. 22% of pts who underwent castration progressed to mCRPC; median time from initial dx with M1 disease to mCRPC treatment was 404 days.


Acknowledging limitations to claims data analyses due to variations in coding practices, these findings suggest that management of newly dx M1 pts is more diverse than recommended US treatment guidelines. Further research to validate these findings is warranted.


T. Flaig: is an employee of and has intellectual property interests with Aurora Oncology, has served as a consultant with GTx, and has received research funding from BNIT, Dendreon, Genentech, GTx, Janssen, Medivation, Novartis, Sanofi, and Exelixis; M. Mehra: is an employee of Janssen and owns stock in Johnson & Johnson; R. Potluri: is an employee of SmartAnalyst and has served as a consultant/advisor to Janssen.

Y. Ng: is an employee of Janssen and holds stock in Johnson & Johnson; M. Todd: is an employee of Janssen and owns stock in Johnson & Johnson; C. Higano: has served as a consultant/advisor for Astellas/Medivation, Bayer, Dendreon, and Johnson & Johnson and received research funding from Algeta, Aragon, Astellas/Medivation, Dendreon, and Sanofi.