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.

Abstract

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.

DOI: 10.1097/JTO.0000000000000343

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@article{Lu2015AMO, title={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.}, author={Shun Lu and Lu Li and Yi Luo and Li Zhang and Gang Wu and Zhiwei Chen and Cheng Huang and Shuliang Guo and Yiping Zhang and Xiangqun Song and Yongfeng Yu and Caicun Zhou and Wei Li and Meilin Liao and Baolan Li and Liyan Xu and Ping Chen and Chunhong Hu and Cheng-ping Hu}, journal={Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer}, year={2015}, volume={10 1}, pages={206-11} }