一个头对头药物随机对照临床试验的分析.pptx

Analysis of a head to head randomized clinical trial 一个头对头药物随机对照临床试验的分析杨学宁 Xue-ning Yang, MD 广东省医学科学院 Guangdong Academy of Medical Sciences 广东省肺癌研究所 Guangdong Lung Cancer Institute 《循证医学》杂志 Journal of Evidence-based Medicine 2 icotinib icotinib erlotinib gefitinib ? A randomized, double-blind phase III study of Icotinib versus Gefitinib in patients with advanced non-small cell lung cancer ( NSCLC) previously treated with chemotherapy ( ICOGEN ) ? Y. Sun , Y. Shi, L. Zhang , X. Liu, C. Zhou, L. Zhang, D. Wang, Q. Li, S. Zhang, S. Qin, C. Hu , Y. Zhang, J. Chen, Y. Song, ? J. F. Feng , Y. Cheng, H. Zhang, Y. Wu, N. Xu , J. Zhou Study design Exploratory Mutational analysis of EGFR between Icotinib and Gefitiinib in NSCLC patients ? Patients and Methods – Patients with NSCLC progressed after one or two lines of – chemotherapies were randomized to receive Icotinib – (125mg Tid ) or Gefitinib (250mg Qd ). – The primary endpoint: PFS. – The second endpoints: OS, ORR, TTP,QOL and tolerability. – Mutational analysis of EGFR gene was performed using the DsX Scorpion ARMS from Qiagen Results ? Figure 1. Median PFS between Icotinib and Gefitinib in FAS population ( Ic vs Ge: vs , HR: , -) Figure 2. Median OS between Icotinib and Gefitinib in FAS population (Ic vs Ge: 14M vs ) With % maturity, OS was similar between Ic and Ge groups ( median OS was 504 d and 531 d, respectively ). Table 1. Safety and tolerability in ITT population Figure 4. Median PFS between EGFR mutants and wild type in Icotinib (M vs W: vs ) and Gefitinib (M vs W: vs ) in FAS population