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乐伐替尼在癌症治疗中的安全性和疗效概况:一项系统评价和荟萃分析。

Safety and efficacy profile of lenvatinib in cancer therapy: a systematic review and meta-analysis.

作者信息

Zhu Chenjing, Ma Xuelei, Hu Yuanyuan, Guo Linghong, Chen Bo, Shen Kai, Xiao Yue

机构信息

State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, and Collaborative Innovation Center for Biotherapy, Chengdu 610041, PR China.

West China School of Medicine, West China Hospital, Sichuan University, Chengdu 610041, PR China.

出版信息

Oncotarget. 2016 Jul 12;7(28):44545-44557. doi: 10.18632/oncotarget.10019.

DOI:10.18632/oncotarget.10019
PMID:27329593
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5190117/
Abstract

To systematically review the safety and efficacy of lenvatinib in the treatment of patients, we retrieved all the relevant clinical trials on the adverse events (AEs) and survival outcomes of lenvatinib through PubMed, Medline, Embase, Web of Science and Cochrane Collaboration's Central register of controlled trial. Fourteen eligible studies involving a total of 978 patients were included in our analysis. The most common all-grade AEs observed in patients treated with lenvatinib were hematuria (56.6%), fatigue (52.2%) and decreased appetite (50.5%). The most frequently observed grade ≥3 AEs were thrombocytopenia (25.4%), hypertension (17.7%) and edema peripheral (15.5%). The incidences of both all-grade and high-grade hypertension were significantly increased. Meanwhile, the controlled trial suggested that progression free survival (PFS) was significantly longer in the lenvatinib group than the placebo group. Subgroup analyses showed that mean PFS for renal cell carcinoma was 10.933±1.828 months (95% CI 7.350-14.515, p < 0.001), and that for thyroid cancer was 18.344±0.083 months (95% CI 18.181-18.506, p < 0.001). In conclusion, lenvatinib is an effective agent in thyroid cancer. Early monitoring and effective management of side effects are crucial for the safe use of this drug.

摘要

为了系统评价乐伐替尼治疗患者的安全性和有效性,我们通过PubMed、Medline、Embase、Web of Science和Cochrane协作网对照试验中央注册库检索了所有关于乐伐替尼不良事件(AE)和生存结局的相关临床试验。我们的分析纳入了14项符合条件的研究,共978例患者。接受乐伐替尼治疗的患者中观察到的最常见的所有级别AE为血尿(56.6%)、疲劳(52.2%)和食欲减退(50.5%)。最常观察到的≥3级AE为血小板减少(25.4%)、高血压(17.7%)和外周水肿(15.5%)。所有级别和高级别高血压的发生率均显著增加。同时,对照试验表明,乐伐替尼组的无进展生存期(PFS)显著长于安慰剂组。亚组分析显示,肾细胞癌的平均PFS为10.933±1.828个月(95%CI 7.350-14.515,p<0.001),甲状腺癌的平均PFS为18.344±0.083个月(95%CI 18.181-18.506,p<0.001)。总之,乐伐替尼是治疗甲状腺癌的有效药物。早期监测和有效管理副作用对于安全使用该药物至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bea3/5190117/c3995678b8da/oncotarget-07-44545-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bea3/5190117/a62567614689/oncotarget-07-44545-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bea3/5190117/0fc71ee1faa2/oncotarget-07-44545-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bea3/5190117/a037492750ea/oncotarget-07-44545-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bea3/5190117/c3995678b8da/oncotarget-07-44545-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bea3/5190117/a62567614689/oncotarget-07-44545-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bea3/5190117/0fc71ee1faa2/oncotarget-07-44545-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bea3/5190117/a037492750ea/oncotarget-07-44545-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bea3/5190117/c3995678b8da/oncotarget-07-44545-g004.jpg

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Cancer Chemother Pharmacol. 2015 Dec;76(6):1153-61. doi: 10.1007/s00280-015-2899-0. Epub 2015 Nov 3.
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Phase 1b study of lenvatinib (E7080) in combination with temozolomide for treatment of advanced melanoma.乐伐替尼(E7080)联合替莫唑胺治疗晚期黑色素瘤的1b期研究。
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Safety and Pharmacokinetics of Lenvatinib in Patients with Advanced Hepatocellular Carcinoma.
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