title: A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of paclitaxel-carboplatin alone or with endostar for advanced non-small cell lung cancer.
abstract: BACKGROUND
  Recombinant human endostatin is a novel inhibitor of tumor angiogenesis that acts specifically on neovascular endothelial cells. Studies have shown that endostar plus vinorelbine-cisplatin chemotherapy could improve objective response rates (ORR) and overall survival (OS) of advanced non-small cell lung cancer (NSCLC) patients. This study is to explore the clinical efficacy of endostar plus paclitaxel-carboplatin (TC) in advanced NSCLC patients.
  
  
  METHODS
  A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out. Patients were randomly assigned to the treatment (TC + endostar) or the control group (TC + placebo). The efficacy was evaluated at the end of each cycle. Follow-up continued until disease progression or death.
  
  
  RESULTS
  A total of 126 patients were enrolled, of whom 122 were evaluable, with 61 in each group. ORR was 39.3% in the treatment group versus 23.0% in the control group (p = 0.078), and the disease control rate was 90.2% versus 67.2% (p = 0.004), respectively. The median progression-free survival (PFS) was 7.1 versus 6.3 months (p = 0.522) in the treatment and control groups, the 24-week rate of PFS was 78% versus 59% (p = 0.017), and the median OS was 17.6 versus 15.8 months (p = 0.696), respectively. There were no significant differences, either in the incidence of adverse events or serious adverse events, between the two groups.
  
  
  CONCLUSIONS
  In previously untreated, advanced NSCLC patients, treatment with TC plus endostar seemed to improve ORR. However, the differences in PFS or OS between the two groups were not statistically significant. Treatment with TC plus endostar exhibited a good safety profile.
authors.affiliation: Shanghai Chest Hospital, Shanghai, China. xkyyhan@gmail.com
authors.forename: Baohui
authors.initials: B
authors.lastname: Han
authors.forename: Qingyu
authors.initials: Q
authors.lastname: Xiu
authors.forename: Huimin
authors.initials: H
authors.lastname: Wang
authors.forename: Jie
authors.initials: J
authors.lastname: Shen
authors.forename: Aiqin
authors.initials: A
authors.lastname: Gu
authors.forename: Yi
authors.initials: Y
authors.lastname: Luo
authors.forename: Chunxue
authors.initials: C
authors.lastname: Bai
authors.forename: Shuliang
authors.initials: S
authors.lastname: Guo
authors.forename: Wenchao
authors.initials: W
authors.lastname: Liu
authors.forename: Zhixiang
authors.initials: Z
authors.lastname: Zhuang
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhang
authors.forename: Yizhuo
authors.initials: Y
authors.lastname: Zhao
authors.forename: Liyan
authors.initials: L
authors.lastname: Jiang
authors.forename: Jianying
authors.initials: J
authors.lastname: Zhou
authors.forename: Xianqiao
authors.initials: X
authors.lastname: Jin
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000098:blood supply / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D043169:Endostatins / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000098:blood supply / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009389:Neovascularization, Pathologic / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D043169:Endostatins; D011994:Recombinant Proteins; D016190:Carboplatin; C522911:endostar protein; D017239:Paclitaxel