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A Multicenter, Open-Label, Randomized Phase II Controlled Study of rh-Endostatin (Endostar) in Combination with Chemotherapy in Previously Untreated Extensive-Stage Small-Cell Lung Cancer  期刊论文  

  • 编号:
    33b5f81e-7d60-47e1-b8dc-4a48fa381e89
  • 作者:
    Lu, Shun(陆舜)#*[1]Li, Lu[2];Luo, Yi[3];Zhang, Li[4];Wu, Gang[5];Chen, Zhiwei[1];Huang, Cheng[6];Guo, Shuliang[7];Zhang, Yiping[8];Song, Xiangqun[9];Yu, Yongfeng[1];Zhou, Caicun[10];Li, Wei(李薇)[11]Liao, Meilin[1];Li, Baolan[12];Xu, Liyan[12];Chen, Ping[13];Hu, Chunhong[13];Hu, Chengping[14];
  • 语种:
    English
  • 期刊:
    JOURNAL OF THORACIC ONCOLOGY ISSN:1556-0864 2015 年 10 卷 1 期 (206 - 211) ; JAN
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  • 摘要:

    Background: Based on promising efficacy in a single-arm study, a randomized phase II trial was designed to compare the efficacy and safety of adding rh-endostatin (Endostar) to first-line standard etoposide and carboplatin (EC) chemotherapy for treatment of extensive-stage small-cell lung cancer. Methods: One hundred forty Chinese patients with pathologically confirmed, extensive-stage small-cell lung cancer were randomly assigned to EC alone or rh-endostatin + EC for 4-6 cycles, followed by single-agent rh-endostatin until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival, Objective response rate (ORR), and quality of life. Results: Median PFS was 6.4 months with rh-endostatin + EC (n = 69) and 5.9 months with EC (n = 69) (hazard ratio 0.8 [95% confidence interval 0.6-1.1]). PFS was significantly higher with rh-endostatin + EC than with EC (hazard ratio 0.4 [0.2-0.9; p = 0.020]) in female. Median overall survival was similar in both groups (12.1 versus 12.4 months, respectively [p = 0.82]). ORR was higher in the rh-endostatin + EC group (75.4%) than in the EC group (66.7%) (p = 0.348). The efficacy of rh-endostatin + EC relative to that of EC was reflected by greater improvements in patient-assessed quality of life scores after 4 and 6 weeks of treatment. There was no difference between each regimen in the incidence of nonhematological or Grade III-IV hematological toxicities. Conclusions: Addition of rh-endostatin to EC for the treatment of extensive-stage small-cell lung cancer had an acceptable toxicity profile, but did not improve overall survival, PFS, and ORR.

  • 推荐引用方式
    GB/T 7714:
    Lu Shun,Li Lu,Luo Yi, et al. A Multicenter, Open-Label, Randomized Phase II Controlled Study of rh-Endostatin (Endostar) in Combination with Chemotherapy in Previously Untreated Extensive-Stage Small-Cell Lung Cancer [J].JOURNAL OF THORACIC ONCOLOGY,2015,10(1):206-211.
  • APA:
    Lu Shun,Li Lu,Luo Yi,Zhang Li,&Hu Chengping.(2015).A Multicenter, Open-Label, Randomized Phase II Controlled Study of rh-Endostatin (Endostar) in Combination with Chemotherapy in Previously Untreated Extensive-Stage Small-Cell Lung Cancer .JOURNAL OF THORACIC ONCOLOGY,10(1):206-211.
  • MLA:
    Lu Shun, et al. "A Multicenter, Open-Label, Randomized Phase II Controlled Study of rh-Endostatin (Endostar) in Combination with Chemotherapy in Previously Untreated Extensive-Stage Small-Cell Lung Cancer" .JOURNAL OF THORACIC ONCOLOGY 10,1(2015):206-211.
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