{"title":"ramucirumab治疗胃或胃食管交界处腺癌的有效性和安全性:系统综述和荟萃分析。","authors":"Ruiqi Ren, Zhewei Zhang, Shaokun Zhai, Jiahui Yang, BaihaiTihan Tusong, Jingzhou Wang","doi":"10.1007/s00228-024-03734-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1697-1714"},"PeriodicalIF":2.4000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of ramucirumab for gastric or gastro-esophageal junction adenocarcinoma: a systematic review and meta-analysis.\",\"authors\":\"Ruiqi Ren, Zhewei Zhang, Shaokun Zhai, Jiahui Yang, BaihaiTihan Tusong, Jingzhou Wang\",\"doi\":\"10.1007/s00228-024-03734-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Ramucirumab significantly improves the prognosis of patients with gastric or gastroesophageal junction adenocarcinoma. 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引用次数: 0
摘要
目的:本研究基于ramucirumab单克隆抗体与随机对照试验中对照治疗的比较,旨在阐明ramucirumab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:方法:系统检索了PubMed、Embase、Cochrane和Web of Science,以获得截至2023年4月13日有关ramucirumab治疗胃或胃食管交界处(GEJ)腺癌的试验。我们纳入的随机对照试验(RCT)评估了ramucirumab作为单药或与其他化疗药物联合干预治疗胃或胃食管交界处(GEJ)腺癌的有效性和安全性:在筛选了2200项研究后,我们最终纳入了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,ramucirumab单药可显著改善总生存期(OS)(危险比[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])。ramucirumab与紫杉醇联合治疗也获得了类似的结果。在拉莫单抗与紫杉醇联合治疗中,与单药治疗相比,观察到三种严重不良反应(等级≥3),且风险显著增加(OR > 2)。这些不良反应包括蛋白尿(OR = 5.37,95% CI [1.22,23.54])、高血压(OR = 4.02,95% CI [2.63,6.14])和胃肠道穿孔(OR = 4.64,95% CI [1.00,21.60])。亚组分析进一步表明,拉穆单抗对非东亚和东亚人群均有效,其中东亚患者更容易出现蛋白尿,而高血压发生率较低。此外,拉穆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较高:结论:Ramucirumab能明显改善胃癌或胃食管交界腺癌患者的预后。结论:Ramucirumab可明显改善胃癌或胃食管交界处腺癌患者的预后,与紫杉醇联合使用时,必须密切监测蛋白尿(尤其是在东亚人群中)、高血压(尤其是在非东亚人群中)和胃肠道穿孔等不良反应。
Efficacy and safety of ramucirumab for gastric or gastro-esophageal junction adenocarcinoma: a systematic review and meta-analysis.
Purpose: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
期刊介绍:
The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed.
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