title: [A multicenter, randomized, double-blind, placebo-controlled safety study to evaluate the clinical effects and quality of life of paclitaxel-carboplatin (PC) alone or combined with endostar for advanced non-small cell lung cancer (NSCLC)].
abstract: OBJECTIVE
  To analyze the efficacy and quality of life and safety for paclitaxel and carboplatin (TC) and TC combined with endostar in the treatment of advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical study. A total of 126 cases of untreated advanced NSCLC were enrolled in this study. There were 63 patients in the TC control arm and TC combined endostar arm, respectively. All enrolled patients were continuously followed-up for disease progression and death.
  
  
  RESULTS
  The objective response rate (ORR) of TC combined with endostar arm was 39.3%, and that of TC control arm was 23.0%, P = 0.078. The progression-free survival rates for TC combined with endostar arm and TC control arm were 78.3% and 58.8%, respectively, in 24 weeks (P = 0.017). The hazard ratio for the risk of disease progression was 0.35 (95%CI 0.13 to 0.90, P = 0.030). The median time to progression (TTP) of the TC combined with endostar arm was 7.1 months and TC arm 6.3 months (P > 0.05). The follow-up results showed that the median survival time (mOS) of the TC + Endostar arm was 17.6 months; (95%CI 13.4 to 21.7 months), and the TC + placebo arm 15.8 months (95%CI 9.4 to 22.9 months) (P > 0.05). The quality of life scores (LCSS patient scale) after treatment of the TC combined with endostar arm was improved, and that of the TC group was improved after completion of two cycles and three cycles of treatment. The quality of life scores compared with baseline after the completion of one cycle treatment was significantly improved for both the TC combined with endostar arm (P = 0.028 and), and TC arm (P = 0.036). It Indicated that TC combined with endostar treatment improved the patient's quality of life in the early treatment. The difference of adverse and serious adverse event rates between the two groups was not significant (P > 0.05).
  
  
  CONCLUSIONS
  Compared with TC alone treatmrnt, TC combined with endostar treatment can reduce the risk of disease progression at early time (24 weeks), increase the ORR, and can be used as first-line treatment for advanced NSCLC. The TC combined with endostar treatment has good safety and tolerability, improves the quality of life, and not increases serious adverse effects and toxicity for patients with advanced NSCLC.
authors.affiliation: Shanghai Chest Hospital, Shanghai,China. xkyyhan@gmail.com
authors.forename: Bao-hui
authors.initials: BH
authors.lastname: Han
authors.forename: Qing-yu
authors.initials: QY
authors.lastname: Xiu
authors.forename: Hui-min
authors.initials: HM
authors.lastname: Wang
authors.forename: Jie
authors.initials: J
authors.lastname: Shen
authors.forename: Ai-qin
authors.initials: AQ
authors.lastname: Gu
authors.forename: Yi
authors.initials: Y
authors.lastname: Luo
authors.forename: Chun-xue
authors.initials: CX
authors.lastname: Bai
authors.forename: Shu-liang
authors.initials: SL
authors.lastname: Guo
authors.forename: Wen-chao
authors.initials: WC
authors.lastname: Liu
authors.forename: Zhi-xiang
authors.initials: ZX
authors.lastname: Zhuang
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhang
authors.forename: Yi-zhuo
authors.initials: YZ
authors.lastname: Zhao
authors.forename: Li-yan
authors.initials: LY
authors.lastname: Jiang
authors.forename: Chun-lei
authors.initials: CL
authors.lastname: Shi
authors.forename: Bo
authors.initials: B
authors.lastname: Jin
authors.forename: Jian-ying
authors.initials: JY
authors.lastname: Zhou
authors.forename: Xian-qiao
authors.initials: XQ
authors.lastname: Jin
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D004311:Double-Blind Method; D043169:Endostatins / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins; D012074:Remission Induction
chemical_list: D000970:Antineoplastic Agents; D043169:Endostatins; D011994:Recombinant Proteins; D016190:Carboplatin; C522911:endostar protein; D017239:Paclitaxel