Abdel-Rahman Omar, ElHalawani Hesham
a Ain Shams University, Clinical Oncology Department, Faculty of Medicine , Lotfy Elsayed Street, Cairo 11665, Egypt +20 33 028 656 ;
Expert Opin Drug Saf. 2015 Oct;14(10):1495-506. doi: 10.1517/14740338.2015.1074677. Epub 2015 Aug 27.
We performed a systematic review and meta-analysis of the risk of oral and gastrointestinal (GI) mucosal injury associated with ramucirumab.
Eligible studies included randomized Phase II and III trials of patients with solid tumors on ramucirumab: describing events of stomatitis, diarrhea, GI perforation and GI hemorrhage.
Our search strategy yielded 167 potentially relevant citations from Pubmed/Medline, CENTRAL Cochrane registry, European society of medical oncology meeting abstracts and American Society of Clinical Oncology meeting library. After exclusion of ineligible studies, a total of 11 clinical trials were considered eligible for the meta-analysis. The RR of all-grade stomatitis, diarrhea, GI perforation and GI hemorrhage were 1.62 (95% CI 1.31 - 2.00; p < 0.00001), 1.15 (95% CI 1.07 - 1.24; p < 0.0001), 3.29 (95% CI 1.54 - 7.04; p = 0.002) and 1.92 (95% CI 1.03 - 3.57; p = 0.04), respectively. The RR of high-grade stomatitis, diarrhea, GI perforation and GI hemorrhage were 2.72 (95% CI 1.76 - 4.19; p < 0.00001), 1.28 (95% CI 0.96 - 1.71; p = 0.09), 3.37 (95% CI 1.51 - 7.54; p = 0.03) and 1.26 (95% CI 0.79 - 2.01; p = 0.34), respectively.
Our meta-analysis has demonstrated that ramucirumab-based combination treatment is associated with an increased risk of high-grade stomatitis and GI perforation compared to control treatment.
我们对与雷莫西尤单抗相关的口腔和胃肠道（GI）黏膜损伤风险进行了系统评价和荟萃分析。
符合条件的研究包括雷莫西尤单抗治疗实体瘤患者的随机II期和III期试验：描述口腔炎、腹泻、胃肠道穿孔和胃肠道出血事件。
我们的检索策略从PubMed/Medline、CENTRAL Cochrane注册库、欧洲医学肿瘤学会会议摘要和美国临床肿瘤学会会议文库中获得了167条潜在相关引文。排除不合格研究后，共有11项临床试验被认为符合荟萃分析的条件。所有级别口腔炎、腹泻、胃肠道穿孔和胃肠道出血的相对危险度（RR）分别为1.62（95%CI 1.31 - 2.00；p < 0.00001）、1.15（95%CI 1.07 - 1.24；p < 0.0001）、3.29（95%CI 1.54 - 7.04；p = 0.002）和1.92（95%CI 1.03 - 3.57；p = 0.04）。高级别口腔炎、腹泻、胃肠道穿孔和胃肠道出血的RR分别为2.72（95%CI 1.76 - 4.19；p < 0.00001）、1.28（95%CI 0.96 - 1.71；p = 0.09）、3.37（95%CI 1.51 - 7.54；p = 0.03）和1.26（95%CI 0.79 - 2.01；p = 0.34）。
我们的荟萃分析表明，与对照治疗相比，基于雷莫西尤单抗的联合治疗与高级别口腔炎和胃肠道穿孔风险增加相关。
