Zhang Yixin, Zhang Li, Zhao Yuli, Wang Sen, Feng Li
Department of Medical Ultrasound, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Medicine and Health Key Laboratory of Abdominal Medical Imaging, Jinan, China.
Department of Medical Ultrasound, Shandong Provincial Qianfoshan Hospital, Shandong First Medical University, Jinan, China.
Front Oncol. 2022 Oct 21;12:945867. doi: 10.3389/fonc.2022.945867. eCollection 2022.
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% : 0.33 to 0.78), =3.07, =0.002. Recurrence free survival (RFS): from time of randomization: HR=0.43 (95% : 0.30 to 0.62), =4.61, <0.001; from time of tissue procurement: HR=0.45 (95% : 0.31 to 0.65), =4.26, <0.001. RFS median time: from time of randomization: HR=1.57 (95% : 1.16 to 2.11), =2.95, =0.003; from time of tissue procurement: HR=2.16 (95% : 1.12 to 4.17), =2.29, =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.
https://www.crd.york.ac.uk/prospero/, identifier (CRD42022300367).
近年来，许多临床试验已证明Gemogenovatucel-T（Vigil）治疗晚期卵巢癌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（RCT）探索Gemogenovatucel-T（Vigil）在晚期卵巢癌一线维持治疗中的安全性和有效性。截至2021年12月31日，在PubMed、Embase、Cochrane图书馆和Web of Science中检索关于Gemogenovatucel-T（Vigil）免疫疗法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、无复发生存期中位数以及并发症。共获得36篇文章，最终7项合适的RCT纳入本荟萃分析，总样本量为322例患者。总生存期（OS）：从随机分组时间起：HR = 0.48（95%CI：0.32至0.72），Z = 3.55，P < 0.001；从组织采集时间起：HR = 0.51（95%：0.33至0.78），= 3.07，= 0.002。无复发生存期（RFS）：从随机分组时间起：HR = 0.43（95%：0.30至0.62），= 4.61，< 0.001；从组织采集时间起：HR = 0.45（95%：0.31至0.65），= 4.26，< 0.001。RFS中位数时间：从随机分组时间起：HR = 1.57（95%：1.16至2.11），= 2.95，= 0.003；从组织采集时间起：HR = 2.16（95%：1.12至4.17），= 2.29，= 0.022。本研究发现，Gemogenovatucel-T（Vigil）免疫疗法可显著改善总生存期和无复发生存期，尤其是对于BRCA野生型的晚期卵巢癌患者。同时，Gemogenovatucel-T（Vigil）治疗比其他治疗方式更安全，且无任何毒性作用。
