A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Paclitaxel-Carboplatin Alone or with Endostar for Advanced Non-small Cell Lung Cancer
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Paclitaxel-Carboplatin Alone or with Endostar for Advanced Non-small Cell Lung Cancer
复制标题
DOI：
10.1097/jto.0b013e3182166b6b
复制
发表时间：
2011-06-01
影响因子：
20.4
通讯作者：
Jin, Xianqiao
中科院分区：
文献类型：
--
作者：
Han, Baohui;Xiu, Qingyu;Jin, Xianqiao
简介：重组人内皮抑素是一种新型肿瘤血管生成抑制剂，特异性作用于新生血管内皮细胞。研究表明，恩度联合长春瑞滨-顺铂化疗可以提高晚期非小细胞肺癌（NSCLC）患者的客观缓解率（ORR）和总生存期（OS）。本研究旨在探讨恩度联合紫杉醇卡铂（TC）治疗晚期NSCLC患者的临床疗效。方法：开展II期、多中心、随机、双盲、安慰剂对照研究。患者被随机分配至治疗组（TC + 恩度）或对照组（TC + 安慰剂）。在每个周期结束时评估疗效。随访持续至疾病进展或死亡。结果：共有126例患者入组，其中122例可评估，每组61例。治疗组的 ORR 为 39.3%，对照组为 23.0%（p = 0.078），疾病控制率分别为 90.2% 和 67.2%（p = 0.004）。治疗组和对照组的中位无进展生存期 (PFS) 分别为 7.1 个月和 6.3 个月 (p = 0.522)，24 周 PFS 率为 78% 和 59% (p = 0.017)，中位 OS 分别为 17.6 个月和 15.8 个月 (p = 0.696)。两组之间无论是不良事件发生率还是严重不良事件发生率均无显着差异。 结论：在既往未经治疗的晚期 NSCLC 患者中，TC 加恩度治疗似乎可以改善 ORR。然而，两组之间的 PFS 或 OS 差异无统计学意义。 TC 加恩度治疗表现出良好的安全性。
Introduction: Recombinant human endostatin is a novel inhibitor of tumor angiogenesis that acts specifically on neovascular endothelial cells. Studies have shown that endostar plus vinorelbine-cisplatin chemotherapy could improve objective response rates (ORR) and overall survival (OS) of advanced non-small cell lung cancer (NSCLC) patients. This study is to explore the clinical efficacy of endostar plus paclitaxel-carboplatin (TC) in advanced NSCLC patients.Methods: A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out. Patients were randomly assigned to the treatment (TC + endostar) or the control group (TC + placebo). The efficacy was evaluated at the end of each cycle. Follow-up continued until disease progression or death.Results: A total of 126 patients were enrolled, of whom 122 were evaluable, with 61 in each group. ORR was 39.3% in the treatment group versus 23.0% in the control group (p = 0.078), and the disease control rate was 90.2% versus 67.2% (p = 0.004), respectively. The median progression-free survival (PFS) was 7.1 versus 6.3 months (p = 0.522) in the treatment and control groups, the 24-week rate of PFS was 78% versus 59% (p = 0.017), and the median OS was 17.6 versus 15.8 months (p = 0.696), respectively. There were no significant differences, either in the incidence of adverse events or serious adverse events, between the two groups.Conclusions: In previously untreated, advanced NSCLC patients, treatment with TC plus endostar seemed to improve ORR. However, the differences in PFS or OS between the two groups were not statistically significant. Treatment with TC plus endostar exhibited a good safety profile.