Long-term results of a randomized, double-blind, and placebo-controlled phase III trial: Endostar (rh-endostatin) versus placebo in combination with vinorelbine and cisplatin in advanced non-small cell lung cancer

Yan Sun, Jin Wan Wang, Yong Yu Liu, Qi Tao Yu, Yi Ping Zhang, Kai Li, Li Yan Xu, Su Xia Luo, Feng Zhan Qin, Zheng Tang Chen, Wen Chao Liu, Qing Hua Zhou, Qiang Chen, Ke Jun Nan, Xiao Qing Liu, Wei Liu, Hou Jie Liang, Hui Shan Lu, Xiu Wen Wang, Jie Jun WangShu Ping Song, Yuan Rong Tu, Jing Min Zhou, Wei Lian Li, Chen Yao

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

Abstract

Background:: Phase II-III trials in patients with untreated and previously treated locally advanced or non-small cell lung cancer (NSCLC) suggested that Endostar was able to enhance the effect of platinum-based chemotherapy (NP regimen) with tolerable adverse effects. Methods: Four hundred and eighty six patients were randomized into two arms: study arm A: NP plus Endostar (n = 322; vinorelbine, cisplatin, Endostar), and study arm B: NP plus placebo (n = 164; vinorelbine, cisplatin, 0.9% sodium chloride). Patients were treated every third week for two to six cycles. Results:: Overall response rates were 35.4% in arm A and 19.5% in arm B (P = 0.0003). The median time to progression was 6.3 months for arm A and 3.6 months for B, respectively (P < 0.001). The clinical benefit rates were 73.3% in arm A and 64.0% in arm B (P = 0.035). Grade 3/4 neutropenia, anemia, and nausea/vomiting were 28.5%, 3.4%, and 8.0%, respectively, in Arm A compared with 28.2%, 3.0%, and 6.6%, respectively, in Arm B (P > 0.05). There were two treatment related deaths in arm A and one in arm B (P > 0.05). The median overall survival was longer in arm A than in arm B (P < 0.0001). Conclusion:: Long-term follow-up revealed that the addition of Endostar to an NP regimen can result in a significant clinical and survival benefit in advanced NSCLC patients, compared with NP alone.

Original languageEnglish
Pages (from-to)440-448
Number of pages9
JournalThoracic Cancer
Volume4
Issue number4
DOIs
StatePublished - Nov 2013

Keywords

  • Advanced and relapsed NSCLC
  • Angiogenesis inhibitor
  • Endostar
  • NP regimen
  • Recombinant human endostatin
  • Survival benefit

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