title: Risk of oral and gastrointestinal mucosal injury in patients with solid tumors treated with ramucirumab: a systematic review and meta-analysis.
abstract: BACKGROUND
  We performed a systematic review and meta-analysis of the risk of oral and gastrointestinal (GI) mucosal injury associated with ramucirumab.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: a Ain Shams University, Clinical Oncology Department, Faculty of Medicine , Lotfy Elsayed Street, Cairo 11665, Egypt +20 33 028 656 ; omar.abdelrhman@med.asu.edu.eg.
authors: Omar
authors: O
authors: Abdel-Rahman
authors: a Ain Shams University, Clinical Oncology Department, Faculty of Medicine , Lotfy Elsayed Street, Cairo 11665, Egypt +20 33 028 656 ; omar.abdelrhman@med.asu.edu.eg.
authors: Hesham
authors: H
authors: ElHalawani
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D000096662:Ramucirumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000096662:Ramucirumab
keywords: diarrhea; gastrointestinal perforation; ramucirumab; stomatitis