title: A randomized phase II study of recombinant human endostatin plus gemcitabine/cisplatin compared with gemcitabine/cisplatin alone as first-line therapy in advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  Studies indicate that recombinant human endostatin (rh-endostatin) can inhibit tumor endothelial cell proliferation, angiogenesis, and tumor growth. This study assessed the efficacy of the combination of standard gemcitabine plus cisplatin chemotherapy with rh-endostatin in patients with non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Chemotherapy-naive patients with stage IIIB to IV NSCLC were randomly (1:1) assigned to receive gemcitabine/cisplatin chemotherapy alone or with 7.5 mg/ m(2) of intravenously rh-endostatin on days 1 to 14 of each 3-week cycle. The primary end point was objective response rate (ORR).
  
  
  RESULTS
  Baseline characteristics were similar between treatment arms. The best ORRs for rh-endostatin arm (n = 33) and chemotherapy-alone arm were 37.5% (95% CI: 21.3 to 47.2%) and 28.6% (95% CI: 19.8 to 37.6%), respectively. Median survival was 12.4 months in the rh-endostatin arm and 9.8 months in the chemotherapy-alone arm, and 1-year survival was 51.6% and 38.7%, respectively. Mild palpitions, diarrhea, and liver dysfunction were the most common rh-endostatin-related adverse events. Grade 3/4 hematological toxicities were all reported similar for patients in the two arms.
  
  
  CONCLUSIONS
  The addition of rh-endostatin to gemcitabine plus cisplatin chemotherapy for first-line treatment of NSCLC improves objective response and may improve survival.
authors.affiliation: The Department of Medical Oncology, Sichuan Cancer Hospital, No.55, Ren Min Nan Road, Chengdu, Sichuan, 610041, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Zhao
authors.forename: Kai
authors.initials: K
authors.lastname: Mei
authors.forename: Xiaohong
authors.initials: X
authors.lastname: Cai
authors.forename: Jing
authors.initials: J
authors.lastname: Chen
authors.forename: Jingrui
authors.initials: J
authors.lastname: Yu
authors.forename: Chengya
authors.initials: C
authors.lastname: Zhou
authors.forename: Qiu
authors.initials: Q
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D043169:Endostatins / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D043169:Endostatins; D011994:Recombinant Proteins; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine