医学
培美曲塞
临床研究阶段
内科学
不利影响
临床终点
酪氨酸激酶抑制剂
肿瘤科
临床试验
胃肠病学
化疗
癌症
顺铂
作者
Chengjuan Fan,Qiuyu Zhao,Li Li,Weitao Shen,Yang Du,Chong Teng,Feng Gao,Xiaowei Song,Qi Jiang,Dayong Huang,Yinghua Jin,Yanju Lv,Lingxiao Wei,Tiejun Shi,Xue Zhao,Naisheng Gao,Zhao-Peng Jiang,Tao Xin
标识
DOI:10.1016/j.jtho.2021.04.018
摘要
We aimed to evaluate the efficacy and safety of intrathecal pemetrexed (IP) for treating EGFR-mutant leptomeningeal metastases (LMs) from EGFR-mutant NSCLC.Patients with EGFR-mutant NSCLC with LM who had failed tyrosine kinase inhibitors were recruited. The dose of IP was escalated from 15 mg to 80 mg using an accelerated titration design in a phase 1 study. The recommended dose (RD) determined in phase 1 was used in the phase 2 study. The primary end point was treatment efficacy measured as the clinical response rate. Overall survival and adverse events (AEs) were evaluated as secondary end points.The RD observed in the phase 1 study was 50 mg pemetrexed. A total of 30 cases of LM-NSCLC were enrolled in the phase 2 study, including 14 males and 16 females. Four patients did not survive for 4 weeks and could not be evaluated for efficacy. The clinical response rate was 84.6% (22 of 26). The median overall survival of all patients was 9.0 months (n = 30, 95% confidence interval: 6.6-11.4 mo). Most AEs were mild, and the most frequent AE of any grade was myelosuppression (n = 9, 30%), which returned to normal after symptomatic treatment.This study revealed that 50 mg pemetrexed is the RD which results in few AEs and a good response rate. IP is an effective treatment for patients with EGFR-mutant NSCLC-LM who had failed on tyrosine kinase inhibitor.
科研通智能强力驱动
Strongly Powered by AbleSci AI