title: Adverse Events and Efficacy of Cixutumumab in Phase II Clinical Trials: A systematic Review and Meta-Analysis.
abstract: OBJECTIVE
  Cixutumumab is a monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF1R). We sought to evaluate the efficacy of cixutumumab in the treatment of cancer, and to comprehensively assess the associated adverse events in phase II clinical trials.
  
  
  METHODS
  Data were collected from PubMed, Embase, and Clinicaltrials.gov. The improvement on progression-free survival (PFS) was evaluated by hazard ratio (HR) and 95% confidence intervals (95% CIs). We also carried a meta-analysis to comprehensively evaluate the incidence of adverse events.
  
  
  RESULTS
  The adverse events that were mentioned most frequently were hyperglycemia, anemia, nausea, fatigue, and thrombocytopenia. The most frequent adverse events were hyponatremia (40.28%), fatigue (35.18%), and skin rash (35.11%). Results showed that cixutumumab treatments did not benefit PFS (HR 1.03, 95% CI 0.83-1.26, p = 0.979). The complete response (CR) was rarely seen in phase II trials.
  
  
  CONCLUSIONS
  Cixutumumab was well tolerated when used alone and in combination therapies, but its antitumor activity was low in the existing phase II clinical trials. An acceptable incidence of adverse effects supports further investigation of this drug, provided that it shows antitumor activity in combination with other drugs.
authors.affiliation: Institute of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China.|Department of Chemotherapy, Cancer Center, Qilu Hospital of Shandong University, 8, Jinan, Shandong, 250012, People's Republic of China.
authors.forename: Hongxin
authors.initials: H
authors.lastname: Cao
authors.affiliation: Institute of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China.
authors.forename: Lixuan
authors.initials: L
authors.lastname: Cui
authors.affiliation: Department of Thoracic Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Ma
authors.affiliation: Department of Thoracic Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China.
authors.forename: Linhai
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Institute of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China.
authors.forename: Kai
authors.initials: K
authors.lastname: Wang
authors.affiliation: Department of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Ni
authors.affiliation: Department of Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, 250021, China. wyb0616@163.com.
authors.forename: Yibing
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Institute of Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China. dujiajun@sdu.edu.cn.|Department of Thoracic Surgery, Shandong Provincial Hospital Affiliated to Shandong University, Shandong University, Jinan, 250021, China. dujiajun@sdu.edu.cn.
authors.forename: Jiajun
authors.initials: J
authors.lastname: Du
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D018572:Disease-Free Survival; D006801:Humans; D017526:Receptor, IGF Type 1; D017451:Receptors, Somatomedin / Q000187:drug effects
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C000597236:IGF1R protein, human; D017451:Receptors, Somatomedin; C557414:cixutumumab; D017526:Receptor, IGF Type 1