AUTHOR=Zhang Yixin , Zhang Li , Zhao Yuli , Wang Sen , Feng Li 

TITLE=Efficacy and safety of Gemogenovatucel-T (Vigil) immunotherapy for advanced ovarian carcinoma: A systematic review and meta-analysis of randomized controlled trials

JOURNAL=Frontiers in Oncology

VOLUME=12

YEAR=2022

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.945867

DOI=10.3389/fonc.2022.945867

ISSN=2234-943X

ABSTRACT=<p>In recent years, many clinical trials have shown the safety and efficacy of Gemogenovatucel-T (Vigil) in the treatment of advanced OC patients. The purpose of this study was to explore the safety and efficacy of Gemogenovatucel-T (Vigil) in the first-line maintenance of advanced ovarian carcinoma based on the randomized controlled trials (RCTs). Randomized controlled trials (RCTs) on Gemogenovatucel-T (Vigil) immunotherapy for advanced ovarian carcinoma were searched in PubMed, Embase, Cochrane Library and Web of Science up to December 31, 2021. The following study characteristics were investigated: baseline study characteristics, overall survival, recurrence free survival, recurrence free survival median time, and complication. A total of 36 articles were obtained, and seven suitable RCTs with a total sample size of 322 patients were eventually included in this meta-analysis. Overall survival (OS): from time of randomization: HR=0.48 (95% CI: 0.32 to 0.72), Z=3.55, P&lt;0.001; from time of tissue procurement: HR=0.51 (95% <italic>CI</italic>: 0.33 to 0.78), <italic>Z</italic>=3.07, <italic>P</italic>=0.002. Recurrence free survival (RFS): from time of randomization: HR=0.43 (95% <italic>CI</italic>: 0.30 to 0.62), <italic>Z</italic>=4.61, <italic>P</italic>&lt;0.001; from time of tissue procurement: HR=0.45 (95% <italic>CI</italic>: 0.31 to 0.65), <italic>Z</italic>=4.26, <italic>P</italic>&lt;0.001. RFS median time: from time of randomization: HR=1.57 (95% <italic>CI</italic>: 1.16 to 2.11), <italic>Z</italic>=2.95, <italic>P</italic>=0.003; from time of tissue procurement: HR=2.16 (95% <italic>CI</italic>: 1.12 to 4.17), <italic>Z</italic>=2.29, <italic>P</italic>=0.022. This study found that Gemogenovatucel-T (Vigil) immunotherapy provided significant OS and RFS benefits, particularly in advanced OC patients with BRCA wild type. At the same time, treatment with the Gemogenovatucel-T (Vigil) is safer than other treatment modalities and does not have any toxic effects.</p><sec><title>Systematic Review Registration</title><p><uri xlink:href="https://www.crd.york.ac.uk/prospero/" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.crd.york.ac.uk/prospero/</uri>, identifier (CRD42022300367).</p></sec>