创新药物埃克替尼临床研究进展及研究方向

晚期非小细胞肺癌（NSCLC）是全世界范围内主要的癌症死亡原因之一。晚期NSCLC的治疗主要是姑息性治疗和以铂类为基础的化疗，但上述治疗手段近几年已逐渐进入平台期。表皮生长因子受体酪氨酸激酶抑制剂（EGFR～TKIs），如吉非替尼，厄洛替尼和阿法替尼的出现延长了患者的无进展生存期，与化疗相比具有较好的安全性，明显改善了患者生活质量，特别是对EGFR基因突变的晚期NSCLC患者获益更加明显。盐酸埃克替尼是我国自主研发的口服高选择性EGFR—TKIs抑制剂，属1．1类新药。其Ⅲ期注册性研究（ICOGEN）结果表明对于既往接受过化疗失败的患者，埃克替尼疗效与吉非替尼相似，且安全性更优。基于该研究，2011年6月CFDA批准埃克替尼用于既往化疗失败的晚期非小细胞肺癌。本文将探讨埃克替尼相关临床研究进展，以及其未来研发等几个方面。

A Review of Icotinib in Clinical Research and Future Direction

Abstract.. Non-small cell lung cancer （NSCLC） is the leading cause of cancer mortality worldwide. Treatments for advanced NSCLC are largely palliative and the benefit plateau appears to have reached with the traditional platinum-based chemotherapy regimens. The management of NSCLC has changed dramatically in the last decade. A number of well documented clinical studies demonstrated that the epidermal growth factor receptor tyrosine kinase inhibitors （EGFR TKIs） showed better survival benefit compared with the standard treatment in patients with NSCLC. Moreover, icotinib, a novel EGFR-TKIs, has finished its phase Ⅲ trial （ICOGEN） with encouraging efficacy and safety profile, and was approved for treating advanced NSCLC patients who failed with previous chemotherapies by China Food and Drug Administration recently. This review will discuss the role of icotinib in solid tumour, and its potential application and ongoing investigations.