Efficacy and safety of Gemogenovatucel-T (Vigil) immunotherapy for advanced ovarian carcinoma: A systematic review and meta-analysis of randomized controlled trials.
Efficacy and safety of Gemogenovatucel-T (Vigil) immunotherapy for advanced ovarian carcinoma: A systematic review and meta-analysis of randomized controlled trials.
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Gemogenovatucel-T (Vigil) 免疫疗法治疗晚期卵巢癌的疗效和安全性：随机对照试验的系统评价和荟萃分析
DOI：
10.3389/fonc.2022.945867
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发表时间：
2022
影响因子：
4.7
通讯作者：
Feng, Li
中科院分区：
文献类型：
--
作者：
Zhang, Yixin;Zhang, Li;Zhao, Yuli;Wang, Sen;Feng, Li
近年来，许多临床试验显示了Gemogenovatucel-T（Vigil）治疗晚期OC患者的安全性和有效性。本研究的目的是基于随机对照试验（RCTs），探讨吉莫金诺韦-T（Vigil）一线维持治疗晚期卵巢癌的安全性和有效性。在PubMed、Embase、科克伦图书馆和Web of Science中检索截至2021年12月31日的关于Gemogenovatucel-T（Vigil）免疫治疗晚期卵巢癌的随机对照试验（RCT）。研究了以下研究特征：基线研究特征、总生存期、无复发生存期、无复发生存中位时间和并发症。共获得36篇文章，最终纳入7项合适的RCT，总样本量为322例患者。总生存期（OS）：自随机化时起：HR=0.48（95% CI：0.32 - 0.72），Z=3.55，P<0.001;从组织采集时：HR=0.51（95% CI：0.33 - 0.78），Z=3.07，P=0.002。无复发生存期（RFS）：从随机化开始：HR=0.43（95% CI：0.30 - 0.62），Z=4.61，P<0.001;从组织采集开始：HR=0.45（95% CI：0.31 - 0.65），Z=4.26，P<0.001。RFS中位时间：自随机化时起：HR=1.57（95% CI：1.16 - 2.11），Z=2.95，P=0.003;从组织采集时：HR=2.16（95% CI：1.12 - 4.17），Z=2.29，P=0.022。这项研究发现，Gemogenovatucel-T（Vigil）免疫治疗提供了显著的OS和RFS获益，特别是在BRCA野生型晚期OC患者中。同时，使用Gemogenovatucel-T（Vigil）治疗比其他治疗方式更安全，并且没有任何毒性作用。系统性综述注册https：//www.crd.york.ac.uk/pagio/，标识符（CRD 42022300367）。
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<0.001; from time of tissue procurement: HR=0.51 (95% CI: 0.33 to 0.78), Z=3.07, P=0.002. Recurrence free survival (RFS): from time of randomization: HR=0.43 (95% CI: 0.30 to 0.62), Z=4.61, P<0.001; from time of tissue procurement: HR=0.45 (95% CI: 0.31 to 0.65), Z=4.26, P<0.001. RFS median time: from time of randomization: HR=1.57 (95% CI: 1.16 to 2.11), Z=2.95, P=0.003; from time of tissue procurement: HR=2.16 (95% CI: 1.12 to 4.17), Z=2.29, P=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. Systematic Review Registration https://www.crd.york.ac.uk/prospero/, identifier (CRD42022300367).
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影响因子：
51.1
作者：
Pujade-Lauraine, Eric;Ledermann, Jonathan A.;Pautier, Patricia
通讯作者：
Pautier, Patricia
影响因子：
10.3
作者：
du Bois, A;Lück, HJ;Pfisterer, J
通讯作者：
Pfisterer, J
影响因子：
6.4
作者：
Rocconi, Rodney P.;Stevens, Erin E.;Nemunaitis, John
通讯作者：
Nemunaitis, John
影响因子：
7.8
作者：
Rocconi RP;Stanbery L;Madeira da Silva L;Barrington RA;Aaron P;Manning L;Horvath S;Wallraven G;Bognar E;Walter A;Nemunaitis J
通讯作者：
Nemunaitis J
影响因子：
158.5
作者：
Gonzalez-Martin, A.;Pothuri, B.;Monk, B. J.
通讯作者：
Monk, B. J.