Randomized phase II study of recombinant human endostatin in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer (NCT00912392).
机构：[1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai, China[2]Department of Thoracic Oncology, Cancer Center, West China Hospital, Medical School, Sichuan Universitity, Chengdu, China四川大学华西医院[3]Hunan Provincial Tumor Hospital, Changsha, China[4]Sun Yat-sen University Cancer Center, Guangzhou, China[5]Wuhan Union Hospital, Wuhan, China华中科技大学同济医学院附属协和医院[6]The Second Xiangya Hospital of Central South University, Changsha, China[7]Fujian Provincial Tumor Hospital, Fuzhou, China[8]The First Affiliated Hospital of Chongqing Medical Hospital, Chongqing, China[9]Zhejiang Cancer Hospital, Hangzhou, China浙江省肿瘤医院[10]Guangxi Zhuang Autonomous Region Tumor Hospital, Nanning, China[11]Shanghai Pulmonary Hospital, Shanghai, China[12]The First Hospital of Jilin University, Changchun, China[13]Xiangya Hospital of Central South University, Changsha, China
出处：
ISSN：
摘要：
Background: Endostar (recombinant human endostatin) is a novel antiangiogenesis drug developed in China for non-small cell lung cancer (NSCLC). Because of promising efficacy signals, we performed a randomized phase II trial to assess the efficacy and safety of adding endostar to first-line standard chemotherapy for treatment of chemonaive extensive-stage small-cell lung cancer (SCLC). Methods: Extensive-stage SCLC patients with a performance status 0-2 were randomly assigned to endostar group (endostar 7.5mg/m2 D1-D14 with carboplatin AUC=5 plus etoposide 60mg/m2 D1-D5 of a 21-day cycle for six cycles) or the control group (the same dose of carboplatin plus etoposide). Patients in endostar treatment group with CR, PR and SD were treated with single-agent endostar until progression or unacceptable toxicity. The primary end point is progression-free survival (PFS). The secondary end points are overall survival (OS) and response rate (RR). Results: 140 patients were enrolled from June 2009 to June 2011, and 137 patients were included in full analysis set. 68 patients were randomly assigned to the endostar treatment and 69 patients to the control group. Median age was 57 years and 80.9% for male in the endostar group while median age was 58 years and 85.5% for male in the control group. Median PFS was similar for endostar and control group (6.2 v 5.9 months, P=0.163, HR 0.762; 95%CI 0.519-1.119). Median overall survival (OS) was also similar for both groups (12.4 v 12.3 months, P=0.475, HR 0.835; 95%CI 0.508-1.371). Overall RR were 76.5% for endostar group and 68.1% for the control group (p=0.275). 20 patients in the endostar group completed six cycles of therapy and subsequently treated with single-agent endostar as maintenance therapy and the median PFS and OS were 6.8 and 12.4 months respectively. The rate of ≥ 3 grade adverse events occurred in both groups was similar and no new or unexpected safety signals for endostar were observed. Conclusions: The addition of endostar to carboplatin plus etoposide for treatment of extensive stage SCLC didn’t improve the PFS significantly, with an acceptable toxicity profile. And no improvement in OS was observed.
第一作者机构：[1]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai, China[2]Department of Thoracic Oncology, Cancer Center, West China Hospital, Medical School, Sichuan Universitity, Chengdu, China[3]Hunan Provincial Tumor Hospital, Changsha, China[4]Sun Yat-sen University Cancer Center, Guangzhou, China[5]Wuhan Union Hospital, Wuhan, China[6]The Second Xiangya Hospital of Central South University, Changsha, China[7]Fujian Provincial Tumor Hospital, Fuzhou, China[8]The First Affiliated Hospital of Chongqing Medical Hospital, Chongqing, China[9]Zhejiang Cancer Hospital, Hangzhou, China[10]Guangxi Zhuang Autonomous Region Tumor Hospital, Nanning, China[11]Shanghai Pulmonary Hospital, Shanghai, China[12]The First Hospital of Jilin University, Changchun, China[13]Xiangya Hospital of Central South University, Changsha, China
推荐引用方式(GB/T 7714)：
Lu Shun,Li Lu,Luo Yi,et al.Randomized phase II study of recombinant human endostatin in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer (NCT00912392).[J].JOURNAL OF CLINICAL ONCOLOGY.2012,30(15):
APA：
Lu, Shun,Li, Lu,Luo, Yi,Zhang, Li,Chen, Zhiwei...&Hu, Cheng-ping.(2012).Randomized phase II study of recombinant human endostatin in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer (NCT00912392)..JOURNAL OF CLINICAL ONCOLOGY,30,(15)
MLA：
Lu, Shun,et al."Randomized phase II study of recombinant human endostatin in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer (NCT00912392).".JOURNAL OF CLINICAL ONCOLOGY 30..15(2012)
医学