Efficacy and Safety of Placebo During the Maintenance Therapy of Ovarian Cancer in Randomized Controlled Trials: A Systematic Review and Meta-analysis

Frontiers in Oncology

Fang-yao Chen¹  Ya-di Bin²  Xue Feng²  Jing Ji²  Lan-bo Zhao²  Chao Sun²  Kai-lu Zhang²  Yi-ran Wang²  Jin-feng Wang²  Qi-ling Li²  Li-song He³ 

[1] Department of Epidemiology and Biostatistics, School of Public Health, Xi’an Jiaotong University Health Science Center, Xi’an, China;Department of Obstetrics and Gynecology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China;School of Finance, Xi’an Eurasia University, Xi’an, China;

关键词: ovarian cancer;    maintenance therapy;    efficacy;    safety;    placebo;    randomized controlled trials;   

DOI  :  10.3389/fonc.2022.796983

来源: DOAJ

【 摘 要 】

IntroductionThis meta-analysis evaluated the efficacy and safety of placebo during the maintenance therapy of ovarian cancer (OC) patients in randomized controlled trials (RCTs).MethodsA 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.ResultsIn 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.ConclusionsPlacebo did not improve or reduce the PFS and OS benefits of OC patients in RCTs but increased the incidences of AEs.

【 授权许可】

Unknown