PMID- 30022386
OWN - NLM
STAT- MEDLINE
DCOM- 20190520
LR  - 20210109
IS  - 1699-3055 (Electronic)
IS  - 1699-048X (Linking)
VI  - 21
IP  - 3
DP  - 2019 Mar
TI  - Effectiveness, safety and cost of abiraterone acetate in patients with metastatic 
      castration-resistant prostate cancer: a real-world data analysis.
PG  - 314-323
LID - 10.1007/s12094-018-1921-5 [doi]
AB  - PURPOSE: New therapies with diverse mechanisms of action are available for 
      metastatic castration-resistant prostate cancer (mCRPC). This study aims to 
      evaluate the effectiveness, safety and cost of abiraterone acetate (AA) in 
      patients with mCRPC. MATERIALS AND METHODS: Observational retrospective cohort 
      study in which mCRPC patients who initiated AA between January 1, 2012 and 
      December 31, 2017, were included. The patients were followed-up until death or 
      March 31, 2018. Demographic, clinical and economic data were collected from the 
      corporate electronic information systems. Survival distributions were estimated 
      using the Kaplan-Meier method and compared using the log-rank test. RESULTS: A 
      total of 69 mCRPC patients were started on AA, of whom 18 (26.1%) received prior 
      chemotherapy (post-CT) and 51 (73.9%) did not receive it (CT-naive). A PSA 
      decline of >/= 50% was achieved in five (27.8%) post-CT and 32 (62.7%) CT-naive 
      patients (p = 0.011). Median time to PSA progression, progression-free survival 
      (PFS) and overall survival (OS) were 4.4/7.9 months (p = 0.003), 5.1/7.5 months 
      (p = 0.034) and 12.1/21.3 months (p = 0.119), respectively, for post-CT/CT-naive 
      patients. Treatment-related adverse events (AEs) occurred in 10 (55.6%) post-CT 
      and 11 (21.6%) CT-naive patients (p = 0.007). The most common AEs were 
      hypokalaemia (11.6%), hypertension (8.7%) and fatigue (5.8%). The cost per median 
      PFS month and per median OS month was euro2818.4/euro2784.3 and euro1187.9/euro980.4 for 
      post-CT/CT-naive patients, respectively. CONCLUSIONS: CT-naive patients treated 
      with AA obtained a better clinical benefit in terms of effectiveness, safety and 
      cost-effectiveness ratio than post-CT patients. The effectiveness outcomes were 
      poorer than those reported previously in the clinical trial setting.
FAU - Koninckx, M
AU  - Koninckx M
AUID- ORCID: 0000-0001-8849-3732
AD  - Department of Hospital Pharmacy, Francesc de Borja Hospital of Gandia, Valencia, 
      Spain. koninchk_man@gva.es.
FAU - Marco, J L
AU  - Marco JL
AD  - Department of Hospital Pharmacy, Francesc de Borja Hospital of Gandia, Valencia, 
      Spain.
FAU - Perez, I
AU  - Perez I
AD  - Department of Hospital Pharmacy, Francesc de Borja Hospital of Gandia, Valencia, 
      Spain.
FAU - Faus, M T
AU  - Faus MT
AD  - Department of Hospital Pharmacy, Francesc de Borja Hospital of Gandia, Valencia, 
      Spain.
FAU - Alcolea, V
AU  - Alcolea V
AD  - Department of Medical Oncology, Francesc de Borja Hospital of Gandia, Valencia, 
      Spain.
FAU - Gomez, F
AU  - Gomez F
AD  - Department of Preventive Medicine, Arnau de Vilanova Hospital, Valencia, Spain.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20180718
PL  - Italy
TA  - Clin Transl Oncol
JT  - Clinical & translational oncology : official publication of the Federation of 
      Spanish Oncology Societies and of the National Cancer Institute of Mexico
JID - 101247119
RN  - 0 (Antineoplastic Agents)
RN  - EM5OCB9YJ6 (Abiraterone Acetate)
SB  - IM
MH  - Abiraterone Acetate/economics/*therapeutic use
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/economics/*therapeutic use
MH  - Cohort Studies
MH  - Disease-Free Survival
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Prostatic Neoplasms, Castration-Resistant/*drug therapy/mortality
MH  - Retrospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Abiraterone acetate
OT  - Castration-resistant prostatic cancer
OT  - Chemotherapy
OT  - Cost-effectiveness analysis
OT  - Safety
OT  - Survival analysis
EDAT- 2018/07/20 06:00
MHDA- 2019/05/21 06:00
CRDT- 2018/07/20 06:00
PHST- 2018/06/04 00:00 [received]
PHST- 2018/07/11 00:00 [accepted]
PHST- 2018/07/20 06:00 [pubmed]
PHST- 2019/05/21 06:00 [medline]
PHST- 2018/07/20 06:00 [entrez]
AID - 10.1007/s12094-018-1921-5 [pii]
AID - 10.1007/s12094-018-1921-5 [doi]
PST - ppublish
SO  - Clin Transl Oncol. 2019 Mar;21(3):314-323. doi: 10.1007/s12094-018-1921-5. Epub 
      2018 Jul 18.