PMID- 35692766
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 12
DP  - 2022
TI  - Efficacy and Safety of Placebo During the Maintenance Therapy of Ovarian Cancer 
      in Randomized Controlled Trials: A Systematic Review and Meta-analysis.
PG  - 796983
LID - 10.3389/fonc.2022.796983 [doi]
LID - 796983
AB  - INTRODUCTION: This meta-analysis evaluated the efficacy and safety of placebo 
      during the maintenance therapy of ovarian cancer (OC) patients in randomized 
      controlled trials (RCTs). METHODS: A comprehensive literature review was 
      performed for RCTs published up to and including August 2020 from four electronic 
      databases. We analyzed the efficacy and safety in the control arms of the 
      maintenance therapy in advanced OC patients. Hazard ratios (HRs) and the 
      corresponding 95% confidence intervals (CIs) of progression-free survival (PFS) 
      and overall survival (OS) were estimated in the placebo arms and the observation 
      arms, respectively, using the Frequency Framework method. We also calculated the 
      incidences of common adverse effects (AEs) in the placebo arms. RESULTS: In 
      total, 41 articles with 20,099 (4,787 in the placebo arms, 3,420 in the 
      observation arms, and 11,892 in the experiment arms) patients were included in 
      this meta-analysis. Compared with observation, placebo did not improve or reduce 
      PFS (HR, 1.02; 95% CI, 0.87-1.20; P = 0.81) and OS (HR, 1.02; 95% CI, 0.89-1.16; 
      P = 0.76) of OC patients, while other treatments, except for radiotherapy, 
      significantly improved PFS and OS (all P < 0.05). The incidences of AEs produced 
      by placebo were 94.03% in all grades and 20.22% in grade >/=3. The incidences of 
      AEs were 29.75% in fatigue, 26.38% in nausea, 24.34% in abdominal pain, 18.92% in 
      constipation, 16.65% in diarrhea, 14.55% in vomiting, 13.89% in hypertension, and 
      13.14% in headache. CONCLUSIONS: Placebo did not improve or reduce the PFS and OS 
      benefits of OC patients in RCTs but increased the incidences of AEs.
CI  - Copyright (c) 2022 Wang, Zhao, Bin, Zhang, Sun, Wang, Feng, Ji, He, Chen and Li.
FAU - Wang, Jin-Feng
AU  - Wang JF
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an, China.
FAU - Zhao, Lan-Bo
AU  - Zhao LB
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an, China.
FAU - Bin, Ya-di
AU  - Bin YD
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an, China.
FAU - Zhang, Kai-Lu
AU  - Zhang KL
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an, China.
FAU - Sun, Chao
AU  - Sun C
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an, China.
FAU - Wang, Yi-Ran
AU  - Wang YR
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an, China.
FAU - Feng, Xue
AU  - Feng X
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an, China.
FAU - Ji, Jing
AU  - Ji J
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an, China.
FAU - He, Li-Song
AU  - He LS
AD  - School of Finance, Xi'an Eurasia University, Xi'an, China.
FAU - Chen, Fang-Yao
AU  - Chen FY
AD  - Department of Epidemiology and Biostatistics, School of Public Health, Xi'an 
      Jiaotong University Health Science Center, Xi'an, China.
FAU - Li, Qi-Ling
AU  - Li QL
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi'an 
      Jiaotong University, Xi'an, China.
LA  - eng
PT  - Systematic Review
DEP - 20220525
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC9174428
OTO - NOTNLM
OT  - efficacy
OT  - maintenance therapy
OT  - ovarian cancer
OT  - placebo
OT  - randomized controlled trials
OT  - safety
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/06/14 06:00
MHDA- 2022/06/14 06:01
PMCR- 2022/01/01
CRDT- 2022/06/13 03:04
PHST- 2021/10/18 00:00 [received]
PHST- 2022/04/22 00:00 [accepted]
PHST- 2022/06/13 03:04 [entrez]
PHST- 2022/06/14 06:00 [pubmed]
PHST- 2022/06/14 06:01 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2022.796983 [doi]
PST - epublish
SO  - Front Oncol. 2022 May 25;12:796983. doi: 10.3389/fonc.2022.796983. eCollection 
      2022.