Wang Kai, Qu Xiao, Wang Ying, Dong Wei, Shen Hongchang, Zhang Tiehong, Ni Yang, Liu Qi, Du Jiajun
Institute of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, 324 Jingwu Road, Jinan, 250021, People's Republic of China.
Department of Thoracic Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, 324 Jingwu Road, Jinan, 250021, People's Republic of China.
Clin Drug Investig. 2016 Jan;36(1):27-39. doi: 10.1007/s40261-015-0355-x.
Ramucirumab is a fully immunoglobulin G (lgG) monoclonal antibody targeting vascular endothelial growth factor receptor type 2 (VEGFR2). Previous clinical trials suggested ramucirumab could improve the survival and increase the risk of adverse effects. Here, we aimed to assess the efficacy and safety of ramucirumab in the treatment of advanced solid tumors.
Publications were searched from Pubmed, Embase database and clinicaltrials.gov. Hazard ratio (HR) and 95% confidence interval (95% CI) were calculated to evaluate efficacy, and the risk ratio (RR) for adverse effects.
Ten relevant studies were included. Ramucirumab resulted in significant benefit in overall survival [OS, HR and 95% CI 0.87 (0.82-0.93), I(2): 0.0%] and progression-free survival [PFS, HR and 95% CI 0.74 (0.66-0.82), I(2): 67.4%]. Also the difference of time to progression (TTP) and objective response rate (ORR) between two groups were also significant [0.70 (0.57-0.88) and 1.78 (1.40-2.25), respectively]. Ramucirumab could increase the risk of total adverse effects (TAEs, of any grade) by 1% (from 0 to 2%) and severe adverse effects (SAEs, grade > 2) by 17% (from 9 to 26%). The most frequently occurring TAEs were fatigue (54.71%), neutropenia (42.74%), bleeding (37.55%), nausea (34.63%) and stomatitis (33.74%). Most frequently occurring SAEs (grade ≥3) were neutropenia (33.43%), fatigue (12.08%), leukopenia (10.59%), hypertension (8.99%) and liver injury (8.74%).
Ramucirumab could improve OS and PFS for patients suffering from advanced solid tumors. Ramucirumab could increase the risk of TAEs and SAEs.
雷莫西尤单抗是一种完全人免疫球蛋白G（IgG）单克隆抗体，靶向血管内皮生长因子受体2（VEGFR2）。既往临床试验表明，雷莫西尤单抗可改善生存情况，但会增加不良反应风险。在此，我们旨在评估雷莫西尤单抗治疗晚期实体瘤的疗效和安全性。
从PubMed、Embase数据库和ClinicalTrials.gov检索相关文献。计算风险比（HR）和95%置信区间（95%CI）以评估疗效，以及不良反应的风险比（RR）。
纳入10项相关研究。雷莫西尤单抗在总生存期[OS，HR和95%CI为0.87（0.82 - 0.93），I²：0.0%]和无进展生存期[PFS，HR和95%CI为0.74（0.66 - 0.82），I²：67.4%]方面带来显著获益。两组之间的疾病进展时间（TTP）和客观缓解率（ORR）差异也具有显著性[分别为0.70（0.57 - 0.88）和1.78（1.40 - 2.25）]。雷莫西尤单抗可使任何级别的总不良反应（TAEs）风险增加1%（从0%增至2%），严重不良反应（SAEs，2级以上）风险增加17%（从9%增至26%）。最常出现的TAEs为疲劳（54.71%）、中性粒细胞减少（42.74%）、出血（37.55%）、恶心（34.63%）和口腔炎（33.74%）。最常出现的SAEs（≥3级）为中性粒细胞减少（33.43%）、疲劳（12.08%）、白细胞减少（10.59%）、高血压（8.99%）和肝损伤（8.74%）。
雷莫西尤单抗可改善晚期实体瘤患者的OS和PFS。雷莫西尤单抗会增加TAEs和SAEs的风险。
