PMID- 34597353
OWN - NLM
STAT- MEDLINE
DCOM- 20211126
LR  - 20211126
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 16
IP  - 10
DP  - 2021
TI  - Initial dose reduction of enzalutamide does not decrease the incidence of adverse 
      events in castration-resistant prostate cancer.
PG  - e0258160
LID - 10.1371/journal.pone.0258160 [doi]
LID - e0258160
AB  - BACKGROUND: There was no clear evidence whether the initial dose of enzalutamide 
      affects the incidence of adverse events (AEs), and oncological outcome in 
      patients with castration-resistant prostate cancer (CRPC). METHODS: The clinical 
      charts of 233 patients with CRPC treated with enzalutamide were reviewed 
      retrospectively. After 1:3 propensity score matching (PSM), 124 patients were 
      divided into a reduced dose group and a standard dose group, and the prostate 
      specific antigen (PSA) response and the incidence of AEs were compared. RESULTS: 
      190 patients with CRPC initiated with standard dose enzalutamide were younger and 
      better performance status compared with 43 patients beginning with reduced dose. 
      After PSM, the baseline characteristics were not different between the standard 
      and the reduced dose group. In the PSM cohort, the PSA response rate was 
      significantly lower in the reduced dose group than in the standard dose group 
      (-66.3% and -87.4%, p = 0.02). The incidence rates of AEs were not statistically 
      different between the groups (22.6% and 34.4%, respectively, p = 0.24). 
      CONCLUSION: Initiating treatment with a reduced dose of enzalutamide did not 
      significantly decrease the incidence rate of AEs, and it showed poorer PSA 
      response rate. There is no clear rationale for treating with a reduced initial 
      dose of enzalutamide to reduce the incidence of AEs.
FAU - Tsuzuki, Shunsuke
AU  - Tsuzuki S
AUID- ORCID: 0000-0001-6164-4684
AD  - Department of Urology, The Jikei University School of Medicine, Minato-ku, Tokyo, 
      Japan.
FAU - Nakanishi, Shotaro
AU  - Nakanishi S
AD  - Department of Urology, University of the Ryukyus, Graduate School of Medicine, 
      Nishihara, Okinawa, Japan.
FAU - Tamaki, Mitsuyoshi
AU  - Tamaki M
AD  - Department of Urology, University of the Ryukyus, Graduate School of Medicine, 
      Nishihara, Okinawa, Japan.
AD  - Department of Urology, Naha City Hospital, Naha, Okinawa, Japan.
FAU - Oshiro, Takuma
AU  - Oshiro T
AD  - Department of Urology, University of the Ryukyus, Graduate School of Medicine, 
      Nishihara, Okinawa, Japan.
AD  - Department of Urology, Naha City Hospital, Naha, Okinawa, Japan.
FAU - Miki, Jun
AU  - Miki J
AD  - Department of Urology, The Jikei University School of Medicine, Minato-ku, Tokyo, 
      Japan.
FAU - Yamada, Hiroki
AU  - Yamada H
AD  - Department of Urology, The Jikei University School of Medicine, Minato-ku, Tokyo, 
      Japan.
FAU - Shimomura, Tatsuya
AU  - Shimomura T
AD  - Department of Urology, The Jikei University School of Medicine, Minato-ku, Tokyo, 
      Japan.
FAU - Kimura, Takahiro
AU  - Kimura T
AD  - Department of Urology, The Jikei University School of Medicine, Minato-ku, Tokyo, 
      Japan.
FAU - Furuta, Nozomu
AU  - Furuta N
AD  - Department of Urology, The Jikei University School of Medicine, Minato-ku, Tokyo, 
      Japan.
FAU - Saito, Seiichi
AU  - Saito S
AD  - Department of Urology, University of the Ryukyus, Graduate School of Medicine, 
      Nishihara, Okinawa, Japan.
FAU - Egawa, Shin
AU  - Egawa S
AD  - Department of Urology, The Jikei University School of Medicine, Minato-ku, Tokyo, 
      Japan.
LA  - eng
PT  - Journal Article
DEP - 20211001
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Benzamides)
RN  - 0 (Nitriles)
RN  - 2010-15-3 (Phenylthiohydantoin)
RN  - 93T0T9GKNU (enzalutamide)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*administration & dosage/adverse effects
MH  - Benzamides/*administration & dosage/adverse effects
MH  - Cohort Studies
MH  - Dose-Response Relationship, Drug
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Humans
MH  - Male
MH  - Nitriles/*administration & dosage/adverse effects
MH  - Phenylthiohydantoin/*administration & dosage/adverse effects
MH  - Prostate-Specific Antigen/*blood
MH  - Prostatic Neoplasms, Castration-Resistant/blood/*drug 
      therapy/epidemiology/pathology
MH  - Retrospective Studies
MH  - Treatment Outcome
PMC - PMC8486121
COIS- Shin Egawa is a paid consultant/advisor of Takeda, Astellas, AstraZeneca, Sanofi, 
      Janssen, and Pfizer. Takahiro Kimura is a paid consultant/advisor of Astellas, 
      Bayer, Janssen and Sanofi. This does not alter our adherence to PLOS ONE policies 
      on sharing data and materials. Shunsuke Tsuzuki, Shotaro Nakanishi, Mitsuyoshi 
      Tamaki, Takuma Oshiro, Jun Miki, Hiroki Yamada, Tatsuya Shimomura, Nozomu Furuta 
      and Seiichi Saito declare no conflicts of interest. This does not alter our 
      adherence to PLOS ONE policies on sharing data and materials.
EDAT- 2021/10/02 06:00
MHDA- 2021/11/27 06:00
PMCR- 2021/10/01
CRDT- 2021/10/01 17:18
PHST- 2021/07/12 00:00 [received]
PHST- 2021/09/19 00:00 [accepted]
PHST- 2021/10/01 17:18 [entrez]
PHST- 2021/10/02 06:00 [pubmed]
PHST- 2021/11/27 06:00 [medline]
PHST- 2021/10/01 00:00 [pmc-release]
AID - PONE-D-21-17359 [pii]
AID - 10.1371/journal.pone.0258160 [doi]
PST - epublish
SO  - PLoS One. 2021 Oct 1;16(10):e0258160. doi: 10.1371/journal.pone.0258160. 
      eCollection 2021.