DME临床科研设计与评价一个头对头药物随机对照临床试验分析Analysis of a RCT.pptxVIP

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2018-06-15 发布于福建
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DME临床科研设计与评价一个头对头药物随机对照临床试验分析Analysis of a RCT.pptx

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DME临床科研设计与评价一个头对头药物随机对照临床试验分析Analysis of a RCT

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 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:4.6M vs 3.4M, HR: 0.835, 0.667-1.046) Figure 2. Median OS between Icotinib and Gefitinib in FAS population (Ic vs Ge: 14M vs 15.6M) With 49.4% 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: 6.6M vs 2.4M) and Gefitinib (M vs W:5.3m vs 2.2m) in FAS population Conclusion The study met the primary objective which demonstrated non-inferiority of Icotinib to Gefitinib in terms of PFS. The non-inferiority of Icotinib also extends to the secondary objectives of OS, ORR, DCR and improvement of QOL. Icotinib had a more favourable tolerability profile than Gefitinib. Similar to Gefitinib, patients with EGFR mutations respond to Icotinib much better than patients with the w