Shihezi University School of Medicine, Bei-Er-Lu, Shihezi, 832000, Xinjiang, China.
Eur J Clin Pharmacol. 2024 Nov;80(11):1697-1714. doi: 10.1007/s00228-024-03734-1. Epub 2024 Aug 5.
Based on the comparison of ramucirumab monoclonal antibody with control treatments in randomized controlled trials, this study aims to elucidate the role of ramucirumab monoclonal antibody in cancer therapy and its potential side effects, providing scientific evidence for clinical treatment.
PubMed, Embase, Cochrane, and Web of Science were searched systematically to obtain the trials on ramucirumab in the treatment of gastric or gastroesophageal junction (GEJ) adenocarcinoma up to April 13, 2023. We included randomized controlled trials (RCTs) evaluating the efficacy and safety of ramucirumab as monotherapy and in combination with other chemotherapy agents as interventions for treating gastric or gastroesophageal junction (GEJ) adenocarcinoma.
After screening 2200 studies, we finally included 8 eligible studies (involving a total of 3,283 participants). Meta-analysis results showed that compared to the control group, ramucirumab monotherapy significantly improved overall survival (OS) (hazard ratio [HR] = 0.77, 95% confidence interval [CI] [0.67, 0.89]) and progression-free survival (PFS) (HR = 0.48, 95% CI [0.40, 0.58]). Similar results were obtained for ramucirumab combined with paclitaxel. In the treatment combining ramucirumab with paclitaxel, compared to monotherapy, three severe adverse reactions (grade ≥ 3) were observed with significantly increased risks (OR > 2). These include proteinuria (OR = 5.37, 95% CI [1.22, 23.54]), hypertension (OR = 4.02, 95% CI [2.63, 6.14]), and gastrointestinal perforation (OR = 4.64, 95% CI [1.00, 21.60]). Subgroup analysis further indicated that ramucirumab is effective in both non-East Asian and East Asian populations, with East Asian patients more prone to developing proteinuria, while having a lower incidence of hypertension. Additionally, ramucirumab demonstrated comparable efficacy between first-line and second-line treatments, with a higher incidence of proteinuria observed in second-line therapy.
Ramucirumab significantly improves the prognosis of patients with gastric or gastroesophageal junction adenocarcinoma. When used in combination with paclitaxel, close monitoring of adverse reactions such as proteinuria (especially in East Asian populations), hypertension (especially in non-East Asian populations), and gastrointestinal perforation is essential.
本研究通过比较雷莫芦单抗单克隆抗体与随机对照试验中的对照治疗,旨在阐明雷莫芦单抗单克隆抗体在癌症治疗中的作用及其潜在的副作用,为临床治疗提供科学依据。
系统检索 PubMed、Embase、Cochrane 和 Web of Science 数据库,收集截至 2023 年 4 月 13 日雷莫芦单抗治疗胃或胃食管结合部(GEJ)腺癌的试验。纳入雷莫芦单抗单药及联合其他化疗药物作为干预措施治疗胃或胃食管结合部(GEJ)腺癌的随机对照试验(RCT)。
经过 2200 项研究的筛选,最终纳入 8 项符合条件的研究(共涉及 3283 名参与者)。Meta 分析结果显示,与对照组相比,雷莫芦单抗单药治疗可显著改善总生存期(OS)(风险比[HR] = 0.77,95%置信区间[CI] [0.67, 0.89])和无进展生存期(PFS)(HR = 0.48,95% CI [0.40, 0.58])。雷莫芦单抗联合紫杉醇的结果类似。在雷莫芦单抗联合紫杉醇的治疗中,与单药治疗相比,有三种严重不良事件(≥3 级)的风险显著增加(OR > 2)。这些事件包括蛋白尿(OR = 5.37,95% CI [1.22, 23.54])、高血压(OR = 4.02,95% CI [2.63, 6.14])和胃肠穿孔(OR = 4.64,95% CI [1.00, 21.60])。亚组分析进一步表明,雷莫芦单抗在非东亚和东亚人群中均有效,东亚患者更易发生蛋白尿,而高血压发生率较低。此外,雷莫芦单抗在一线和二线治疗中的疗效相当,二线治疗中蛋白尿的发生率更高。
雷莫芦单抗显著改善胃或胃食管结合部腺癌患者的预后。当与紫杉醇联合使用时,需要密切监测蛋白尿(特别是在东亚人群中)、高血压(特别是在非东亚人群中)和胃肠穿孔等不良反应。