Zhang Wen, Zhang Yiping, Zhao Qiong, Liu Xiguang, Chen Likun, Pan Hongming, Li Yuping, Lu You, Huang Jianjin, Zhang Zhe, Du Kaiqi, Zhang Suning, Li Tao, Lu Liqin, Yu Guangmao, Wang Yang, Yuan Xiaobin, Yang Min, Ma Yongbin, Tan Fenlai
Department of Cardiothoracic Surgery, the First Affiliated Hospital of People's Liberation Army General Hospital (304 Hospital), Beijing 100048, China.
Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China.
J Thorac Dis. 2020 Mar;12(3):639-650. doi: 10.21037/jtd.2019.12.115.
Lung cancer is a global health problem with a high mortality, and the development of target therapy has led to a revolution in the treatment of lung cancer in recent years. Favorable efficacy and safety of icotinib have been demonstrated in patients with non-small cell lung cancer (NSCLC). Currently, minimal data are available to describe the long-term safety of icotinib in NSCLC patients.
We reviewed the safety data from 1,321 advanced NSCLC patients who were treated with icotinib. The primary endpoint was the long-term safety, defined as any adverse drug reactions (ADRs) occurred after 6 months of icotinib administration.
Fewer ADRs were noticed over 6 month administration of icotinib than within 6 months in overall population (24.3% 65.4%), and elderly patients (23.6% 66.9%). The majority of ADRs were grade 1-2 in severity over 6 month exposure of icotinib in overall population as well as elderly patients. In overall population, the most common ADRs of icotinib during long-term use were rash (16.4%) and diarrhea (5.3%), while the incidences were 31.8% and 13.2% in the induction period, respectively. In elderly population, the most common ADRs of icotinib during long-term use were rash (15.7%) and diarrhea (4.7%), while the incidences were 27.8% and 14.9% in the induction period, respectively, and more inching was observed in the induction period as compared with long term use (6.3% 0.3%).
There was an evidence of decreased frequency of icotinib-induced ADRs over time, and icotinib was well-tolerated in elderly NSCLC patients.
肺癌是一个全球性的健康问题，死亡率很高，近年来靶向治疗的发展给肺癌治疗带来了一场革命。已在非小细胞肺癌（NSCLC）患者中证实了埃克替尼具有良好的疗效和安全性。目前，描述埃克替尼在NSCLC患者中长期安全性的数据极少。
我们回顾了1321例接受埃克替尼治疗的晚期NSCLC患者的安全性数据。主要终点是长期安全性，定义为埃克替尼给药6个月后发生的任何药物不良反应（ADR）。
在总体人群（24.3%对65.4%）和老年患者（23.6%对66.9%）中，埃克替尼给药6个月期间注意到的ADR比6个月内更少。在总体人群以及老年患者中，埃克替尼暴露6个月期间，大多数ADR的严重程度为1-2级。在总体人群中，埃克替尼长期使用期间最常见的ADR是皮疹（16.4%）和腹泻（5.3%），而在诱导期发生率分别为31.8%和13.2%。在老年人群中，埃克替尼长期使用期间最常见的ADR是皮疹（15.7%）和腹泻（4.7%），而在诱导期发生率分别为27.8%和14.9%，与长期使用相比，诱导期观察到更多的瘙痒（6.3%对0.3%）。
有证据表明随着时间推移埃克替尼诱导的ADR频率降低，并且埃克替尼在老年NSCLC患者中耐受性良好。
