title: Clinical observation of Endostar® combined with chemotherapy in advanced colorectal cancer patients.
abstract: OBJECTIVE
  Endostar® (Rh-endostatin injection) is a new recombinant human endostatin developed by Shandong Simcere-Medgenn Bio-Pharmaceutical Co., Ltd in China. This study was performed to evaluate the efficacy and safety of Endostar plus leucovorin calcium/ 5-fluorouracil/oxaliplatin (FOLFOX4) in treating patients with advanced colorectal cancer.
  
  
  METHODS
  Thirty-six patients with advanced colorectal cancer were retrospectively assigned to one of two treatment groups: FOLFOX4 (control) or FOLFOX4 plus Endostar (Endostar) according to patient accreditation. The observational end points were overall response rate, overall survival, progression-free survival and toxicity.
  
  
  RESULTS
  The response rate and progression-free survival of Endostar were significantly better than those of control group (P <0.05), but significance was not observed for median survival. In addition, gastrointestinal side effects and incidence of leucopenia were not lower than in the control group (P<0.05).
  
  
  CONCLUSIONS
  The addition of Endostar to FOLFOX4 resulted in a higher objective response rate and longer time to disease progression. Hypertension and cardiac ischemia were the principal safety concerns, but were manageable. Endostar deserves to be further investigated by randomized controlled clinical trails.
authors.affiliation: Department of Chemotherapy, Jiangsu Cancer Hospital and Research Institute, The Affiliated Jiangsu Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
authors.forename: Hong-Xia
authors.initials: HX
authors.lastname: Xu
authors.forename: Xin-En
authors.initials: XE
authors.lastname: Huang
authors.forename: Zhi-Ying
authors.initials: ZY
authors.lastname: Qian
authors.forename: Xia
authors.initials: X
authors.lastname: Xu
authors.forename: Ying
authors.initials: Y
authors.lastname: Li
authors.forename: Cheng-Guang
authors.initials: CG
authors.lastname: Li
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D043169:Endostatins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D002955:Leucovorin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D043169:Endostatins; D009944:Organoplatinum Compounds; D011994:Recombinant Proteins; C522911:endostar protein; D002955:Leucovorin; D005472:Fluorouracil