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雷莫西尤单抗治疗癌症患者时高血压的发生率及风险:已发表研究的荟萃分析

Incidence and risk of hypertension with ramucirumab in cancer patients: a meta-analysis of published studies.

作者信息

Wang Jianhua, Wang Zexing, Zhao Yunzhao

机构信息

Department of General Surgery, Jiansu Province of Traditional Chinese Medicine, 100 Shizi Street, Hongshan Road, Nanjing, 210028, Jiangsu, People's Republic of China.

出版信息

Clin Drug Investig. 2015 Apr;35(4):221-8. doi: 10.1007/s40261-015-0272-z.

DOI:10.1007/s40261-015-0272-z
PMID:25697774
Abstract

BACKGROUND AND OBJECTIVE

Ramucirumab is a novel antiangiogenic agent approved as second-line therapy for patients with advanced stomach cancer and gastroesophageal junction adenocarcinoma. Although existing evidence from clinical trials has demonstrated hypertension is one of the major adverse events of this agent, overall risks have yet to be reported.

METHODS

We carried out a meta-analysis of published studies to determine the overall incidence and relative risk (RR) of hypertension associated with ramucirumab. Statistical analyses were conducted to calculate the summary incidence, RRs, and 95 % confidence intervals (CIs) by using a random effects model.

RESULTS

Eleven studies with a total of 3,851 patients with multiple cancers were included. The overall incidence of all-grade hypertension was 20.0 % (95 % CI 15.0-26.0) with 8.6 % (95 % CI 6.3-11.7) being high-grade hypertension. The risk of developing hypertension was greater in ramucirumab-treated patients (RR for all grades 2.77, 95 % CI 1.94-3.94, p < 0.001, RR for high-grade 3.58, 95 % CI 2.45-5.23, p < 0.001).

CONCLUSIONS

Administration of ramucirumab to patients with cancer is associated with increased risk of hypertension.

摘要

背景与目的

雷莫西尤单抗是一种新型抗血管生成药物,被批准用于晚期胃癌和胃食管交界腺癌患者的二线治疗。尽管临床试验的现有证据表明高血压是该药物的主要不良事件之一,但总体风险尚未见报道。

方法

我们对已发表的研究进行了荟萃分析,以确定与雷莫西尤单抗相关的高血压的总体发生率和相对风险(RR)。采用随机效应模型进行统计分析,计算汇总发生率、RR及95%置信区间(CI)。

结果

纳入11项研究,共3851例患有多种癌症的患者。所有级别的高血压总体发生率为20.0%(95%CI 15.0 - 26.0),其中重度高血压为8.6%(95%CI 6.3 - 11.7)。接受雷莫西尤单抗治疗的患者发生高血压的风险更高(所有级别RR为2.77,95%CI 1.94 - 3.94,p < 0.001;重度RR为3.58,95%CI 2.45 - 5.23,p < 0.001)。

结论

对癌症患者使用雷莫西尤单抗与高血压风险增加相关。

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本文引用的文献

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Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
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Primary results of ROSE/TRIO-12, a randomized placebo-controlled phase III trial evaluating the addition of ramucirumab to first-line docetaxel chemotherapy in metastatic breast cancer.ROSE/TRIO-12 的主要结果,这是一项随机安慰剂对照 III 期试验,评估了在转移性乳腺癌中添加雷莫芦单抗到一线多西他赛化疗中的疗效。
J Clin Oncol. 2015 Jan 10;33(2):141-8. doi: 10.1200/JCO.2014.57.1513. Epub 2014 Sep 2.
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癌症治疗中的高血压性心脏毒性——辅助治疗、传统化疗及新型疗法的系统分析——流行病学、发病率及病理生理学
J Clin Med. 2020 Oct 18;9(10):3346. doi: 10.3390/jcm9103346.
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Hypertension management in cardio-oncology.心血管肿瘤学中的高血压管理。
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A phase 2, single-arm study of ramucirumab in patients with metastatic renal cell carcinoma with disease progression on or intolerance to tyrosine kinase inhibitor therapy.一项雷莫芦单抗治疗转移性肾细胞癌患者的 2 期单臂研究,这些患者在接受酪氨酸激酶抑制剂治疗时或治疗后出现疾病进展或不耐受。
Cancer. 2014 Jun 1;120(11):1647-55. doi: 10.1002/cncr.28634. Epub 2014 Feb 27.