title: [Efficacy and safety of rh-endostatin combined with docetaxel in second-line or intolerant toxicity for first-line treatment in patients with advanced non-small cell lung cancer].
abstract: OBJECTIVE
  To analyze the efficacy and safety of combination of rh-endostatin (Endostar) with docetaxel treatment on patients of non-small cell lung cancer (NSCLC) who presented PD or intolerable toxicity in/after first-line chemotherapy.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled and multi-center clinical trial was conducted. Patients with stage IIIB/IV of NSCLC experienced previous chemotherapy of one-regimen were screened for this trial. A total of 68 cases were included in this study. Single docetaxel and that combined with endostar were conducted in two arms. The response, time to progression (TTP) and adverse effects were observed in both arms.
  
  
  RESULTS
  The objective response rate (ORR) and clinical benefit rate (CBR) were 0 and 62.5% in the combined arm, along with 0 and 53.3% in the single docetaxel arm, with a non-significant difference between the two groups (all P > 0.05), respectively. The median TTPs in the combined and single docetaxel arms were 2.63 and 2.07 months, respectively (P = 0.079). The median TTPs of the participants with progressive disease (PD) after first-line chemotherapy were 1.33 and 1.67 months in the combined and single docetaxel arms, respectively (P = 0.946). The median TTPs of the participants with intolerant adverse effects in first-line chemotherapy were 4.70 months and 3.17 months in the combined and single docetaxel arms, respectively (P = 0.070). The median TTPs of the patients with SD after 2 therapeutic cycles in the combined and single docetaxel arms were 6.23 months and 3.27 months, respectively (P = 0.040). The differences between two arms were non-significant in adverse, serious adverse and cardiovascular adverse effects (all P > 0.05).
  
  
  CONCLUSIONS
  Endostar may prolong TTP in patients with advanced NSCLC benefited from docetaxel treatment without increased toxicities.
authors: Department of Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin 300060, China.
authors: Jing
authors: J
authors: Wang
authors: Kai
authors: K
authors: Li
authors: Tong
authors: T
authors: Sun
authors: Ming-jun
authors: MJ
authors: Zhang
authors: Wei-lian
authors: WL
authors: Li
authors: Qiang
authors: Q
authors: Yao
authors: Wei
authors: W
authors: Liu
authors: Cui-min
authors: CM
authors: Ding
authors: Zhi-yong
authors: ZY
authors: He
authors: Wei-dong
authors: WD
authors: Mao
authors: Hui-min
authors: HM
authors: Wang
authors: Yu
authors: Y
authors: Zhang
authors: Xin-li
authors: XL
authors: Zhou
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D000077143:Docetaxel; D004311:Double-Blind Method; D043169:Endostatins / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D012074:Remission Induction; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043169:Endostatins; D043823:Taxoids; D000077143:Docetaxel