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H. Yan



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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-044 - Progression-free survival is a poor surrogate endpoint for overall survival in the first line EGFR-TKI treatment in advanced non-small-cell lung cancer with EGFR mutation (ID 2969)

      09:30 - 09:30  |  Author(s): H. Yan

      • Abstract

      Background
      （Although epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs), gefitinib and erlotinib have shown antitumor activity in patients with non-small cell lung cancer (NSCLC) , it is unclear if progrssion-free survival（PFS）could be a good surrogate endpoint for overall survival(OS) in the clinical trials of first-line EGFR-TKIs treatment in patients with advanced NSCLC, especially with activating EGFR mutation.）

      Methods
      A PubMed search identified 12 randomized trials comparing first-line EGFR-TKIs treatment with chemotherapy in patients with advanced NSCLC. A total of 1816 patients were enrolled and EGFR mutation status was known in 554 patients. Linear regression analysis was carried out to estimate the correlation of PFS, response rate (RR), and survival post-progression (SPP) with OS

      Results
      PFS, RR and PPS were all strongly associated with OS（r=0.942, 0.982 and 0.895, respectively, P< 0.01） for all trials. But in trials enolled patients with EGFR mutation, PFS and RR were poor correlate with OS (r =-0.121 and 0.131, respectively, P< 0.01), while PPS strongly associated with OS (r =0.849, P<0.01 ）PFS, RR and PPS were all strongly associated with OS（r=0.942, 0.982 and 0.895, respectively, P< 0.01） for all trials. But in trials enolled patients with EGFR mutation, PFS and RR were poor correlate with OS (r =-0.121 and 0.131, respectively, P< 0.01), while PPS strongly associated with OS (r =0.849, P<0.01 ）

      Conclusion
      Our findings indicate that PFS is a poor surrogate endpoint for OS in the first line EGFR-TKI treatment in advanced EGFR mutation NSCLC. Further studies are needed to search for appropriate surrogate endpoint for OS.