摘要
目的:观察新药盐酸埃克替尼用于中国非小细胞肺癌(NSCLC)患者的安全性、耐受性、疗效及生存情况。方法:单中心、开放的I期研究,采取剂量递增的方法,直至疾病进展或出现不能耐受的毒性反应。结果:40例NSCLC患者入组。150 mg组1例完全缓解(CR),6例部分缓解(PR),8例疾病稳定(SD);200 mg组1例PR,4例SD;125 mg组2例PR,6例SD;不同剂量组患者的疗效在统计学上未见明显差异(P=0.272 4)。总客观缓解率(ORR)和总疾病控制率(DCR)分别为25%和70%。中位无疾病进展存活(PFS)和中位总生存(OS)时间分别为160 d(95%CI:72～236 d)和454 d(95%CI:226～582 d)。35%的患者出现不良反应,主要有皮疹(25%)和腹泻等。结论:埃克替尼的疗效达到同类产品水平,其安全性和耐受性较好,最常见的不良反应是皮疹、腹泻。
Objective： To observe the safety, toleration, dose-correlated efficacy and survival in treatment with icotinib for Chinese patients with non-small cell lung cancers （NSCLC）. Methods： In a single center, open phase I clinical trial, Chinese NSCLC patients were selected, and they took various doses of icotinib till disease progression or intolerance of toxic reactions. Results： Totally 40 NSCLC patients were selected in the trial. In 150 mg （bid） dose group, 1 patient appeared complete remission （CR）, 6 partial remission （PD） and 8 stable disease （SD） ; other 8 patients appeared progressive disease （PD）. Of 9 patients in 200 mg （bid） dose group, 1 patient appeared PR, 4 SD and 4 PD. Of 8 patients in 125 mg （tid） dose group, 2 patients appeared PR and 6 SD. No significant difference was observed among the three dose groups （P = 0. 272 4）. The total ORR and total DCR were 25% and 70% , respectively. The median progression free survival （PFS） and the median overall survival were 160 days （95% CI： 72 - 236 days） and 454 days （95% CI： 226 -582 days）, respectively. Adverse effects （AE） appeared in 35% patients, including skin rash （25%） , diarrhea and etc. Conclusions： The effica- cy of icotinib has reached the level of similar products. Icotinib is safe, and the common adverse effects are reversi- ble skin rash and diarrhea.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2012年第17期2051-2055,共5页
Chinese Journal of New Drugs
关键词
非小细胞肺癌
盐酸埃克替尼
安全性
耐受性
疗效
non-small cell lung cancer （NSCLC）
icotinib hydrochloride
safety
toleration
therapeutic effect
