重组人血管内皮抑制素(恩度)治疗非小细胞肺癌研究进展

Advances in research on recombinant human endostatin(Endostar TM) in the treatment of non-small cell lung cancer

重组人血管内皮抑素注射液(rh-endostatin,YH16),商品名为恩度(EndostarTM)是我国学者自主研发的一种新型重组人血管内皮抑制药物,临床前研究显示该药能抑制血管内皮细胞增殖、血管生成和肿瘤生长。Ⅰ期临床结果证明该药单用临床应用安全有效。Ⅱ、Ⅲ期临床研究表明恩度与化疗方案联合具有协同作用,能明显提高晚期非小细胞肺癌(NSCLC)的有效率及中位疾病进展时间,且安全性较好,不增加化疗的不良反应,是晚期NSCLC的一种安全、有效的治疗方案。该文综述了近年来恩度治疗NSCLC的临床研究及应用进展。

The recombinant human endostatin（rh-endostatin,EndostarTM,YH-16） for injection is a new drug developed by Chinese scholars independently.The pre-clinical studies indicated that rh-endostatin could inhibit tumor endothelial cell proliferation,angiogenesis and tumor growth.PhaseⅠstudy revealed that YH-16 was effective as a single agent with good tolerance in clinical use.PhaseⅡand phase Ⅲ indicated that the its combination use with vinorelbine and cisplatin（NP） regimen resulted in significantly and clinically meaningful improvement in the response rate（RR） and mean time to tumor progression（TTP）,and showed a synergic activity and good safety without increasing side effects of chemotherapy,which was a safe and effective treatment for advanced non-small cell lung cancer（NSCLC）.The clinical research and applications of Endostar in NSCLC are reviewed.