Investigational New Drugs

, Volume 30, Issue 3, pp 1144–1149 | Cite as

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

  • Xin Zhao
  • Kai Mei
  • Xiaohong Cai
  • Jing Chen
  • Jingrui Yu
  • Chengya Zhou
  • Qiu Li


Purpose 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). Patients and 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/ m2 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. Conclusion The addition of rh-endostatin to gemcitabine plus cisplatin chemotherapy for first-line treatment of NSCLC improves objective response and may improve survival.


Toxicity Chemotherapy Cancer Response rate Non-small-cell lung cancer 



The authors wish to thank all the patients who chose to participate in this trial.


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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Xin Zhao
    • 1
  • Kai Mei
    • 1
  • Xiaohong Cai
    • 1
  • Jing Chen
    • 1
  • Jingrui Yu
    • 1
  • Chengya Zhou
    • 1
  • Qiu Li
    • 2
  1. 1.The Department of Medical OncologySichuan Cancer HospitalChengduChina
  2. 2.The Department of Medical Oncology, Cancer Center, State Key Laboratory of Biotherapy, West China HospitalSichuan UniversityChengduChina

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