PMID- 31835965
OWN - NLM
STAT- MEDLINE
DCOM- 20210121
LR  - 20220129
IS  - 1941-837X (Electronic)
IS  - 1369-6998 (Linking)
VI  - 23
IP  - 4
DP  - 2020 Apr
TI  - Real-world incidence and burden of adverse events among non-metastatic prostate 
      cancer patients treated with secondary hormonal therapies following androgen 
      deprivation therapy.
PG  - 330-346
LID - 10.1080/13696998.2019.1705313 [doi]
AB  - Aims: To describe the incidence and identify prognostic factors of central 
      nervous system (CNS) adverse events (AEs) and any AEs (CNS, skin rash, or 
      fracture) and evaluate the healthcare resource utilization (HCRU), direct medical 
      costs, and therapy discontinuation associated with these AEs among non-metastatic 
      prostate cancer (nmPC) patients who received secondary hormone therapies.Methods 
      and results: nmPC patients who had initiated secondary hormonal therapy with 
      enzalutamide, bicalutamide, or abiraterone >/=1 year after androgen deprivation 
      therapy (ADT) were identified in the MarketScan database. Survival analyses were 
      used to describe the incidence of CNS or any AEs. Annual HCRU and costs were 
      compared across patient groups (CNS AE vs no CNS AE; any AE vs no AE) using 
      propensity score weighted generalized linear models. Multivariate Cox 
      proportional hazards models were used to identify AE predictors and compare risks 
      of discontinuation.Results: The analysis included 532 patients who initiated 
      secondary hormonal therapies, among whom 201 (38%) and 244 (46%) experienced a 
      CNS AE and any AE, respectively. Median times to CNS AE and any AE from therapy 
      initiation were 17.90 and 11.00 months, respectively. Predictors of any AE were 
      any AE in the baseline period (</=6 months before starting therapy), Charlson 
      Comorbidity Index (CCI) score (1 vs 0), surgical castration, and older age. 
      Predictors of CNS AEs were CNS AE in the baseline period and CCI score (1 vs 0). 
      CNS and any AEs were associated with significantly higher HCRU. CNS AEs were 
      associated with significantly higher incremental total medical costs ($18,522). 
      CNS AEs and any AEs significantly increased therapy discontinuation risk by 48% 
      and 38%, respectively.Conclusions: AEs increase the economic burden and therapy 
      discontinuation among nmPC patients receiving secondary hormonal therapies 
      subsequent to ADTs. These patients should be carefully evaluated for AEs to 
      reduce therapy discontinuation, HCRU, and direct medical costs.
FAU - Shah, Anuj
AU  - Shah A
AD  - Pharmerit International, Bethesda, MD, USA.
FAU - Shah, Ruchit
AU  - Shah R
AD  - Pharmerit International, Bethesda, MD, USA.
FAU - Kebede, Nehemiah
AU  - Kebede N
AD  - Pharmerit International, Bethesda, MD, USA.
FAU - Mohamed, Ateesha
AU  - Mohamed A
AD  - Bayer Healthcare Pharmaceuticals, Whippany, NJ, USA.
FAU - Botteman, Marc
AU  - Botteman M
AUID- ORCID: 0000-0003-2808-7163
AD  - Pharmerit International, Bethesda, MD, USA.
FAU - Waldeck, Reg
AU  - Waldeck R
AD  - Bayer Healthcare Pharmaceuticals, Whippany, NJ, USA.
FAU - Hussain, Arif
AU  - Hussain A
AD  - University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, MD, 
      USA.
AD  - Baltimore VA Medical Center, Baltimore, MD, USA.
LA  - eng
GR  - I01 BX000545/BX/BLRD VA/United States
PT  - Journal Article
DEP - 20200106
PL  - England
TA  - J Med Econ
JT  - Journal of medical economics
JID - 9892255
RN  - 0 (Androgen Antagonists)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Androgen Antagonists/*adverse effects
MH  - Central Nervous System
MH  - *Cost of Illness
MH  - Databases, Factual
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Health Care Costs
MH  - Hormone Replacement Therapy
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Prostatic Neoplasms/*drug therapy
MH  - Survival Analysis
MH  - United States/epidemiology
OTO - NOTNLM
OT  - C14
OT  - Enzalutamide
OT  - I10
OT  - abiraterone acetate
OT  - advanced prostate cancer
OT  - adverse events
OT  - bicalutamide
OT  - discontinuation
OT  - healthcare costs
EDAT- 2019/12/15 06:00
MHDA- 2021/01/22 06:00
CRDT- 2019/12/15 06:00
PHST- 2019/12/15 06:00 [pubmed]
PHST- 2021/01/22 06:00 [medline]
PHST- 2019/12/15 06:00 [entrez]
AID - 10.1080/13696998.2019.1705313 [doi]
PST - ppublish
SO  - J Med Econ. 2020 Apr;23(4):330-346. doi: 10.1080/13696998.2019.1705313. Epub 2020 
      Jan 6.