Author of

• 18975

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  P3.01 - Advanced NSCLC (ID 621)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 24597

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    P3.01-088b - Is Efficacy Result in Phase 2 Trial Replicated in Phase 3 Trial in Advanced NSCLC: A Meta-Analysis (ID 9125)

    09:30 - 09:30  |  Presenting Author(s): R. Shibaki
    • Abstract
    • Slides

    Background:
    Phase 3 trial has been mandatory to establish new treatment. However, molecular targeted agents were often approved based on phase 2 trials. There have not been fully investigated whether efficacy data in phase 2 would be replicated in phase 3.
    
    Method:
    We extracted phase 2 and 3 trials for advanced non-small cell lung cancer (NSCLC) using platinum doublet (Plt) or EGFR-tyrosine kinase inhibitor (TKI) monotherapy, published between 2005 and 2015. Overall response rate (ORR) and median progression-free survival (PFS) in each study were collected. We compared these data between phase 2 and 3.
    
    Result:
    155 phase 2 trials and 13 phase 3 trials were adopted as Plt trials, while 21 phase 2 trials and 6 phase 3 trials were adopted as TKI trials. Plt trials had larger sample size (median number of patients: 47 in phase 2, and 203 in phase 3) than TKI trials (median number of patients: 29 in phase 2, and 101.5 in phase 3). In Plt trials, median ORR and median of median PFS were 31% and 5.2 months in phase 2, while 27% and 4.7 months in phase 3. There was statistically significant difference between phase 2 and phase 3 in ORR and mPFS (p = 0.03 and 0.03, respectively). In TKI trials, median ORR and median of median PFS were 64.0% and 9.7 months in phase 2, while 64.5% and 10.9 months in phase 3. There were not significant difference between phase 2 and phase 3 either in ORR and mPFS (p = 0.88 and 0.31, respectively). Among TKI trials, equivalence of efficacy data between phase 2 and phase 3 was also investigated in ORR and mPFS, but not proved (p = 0.30 and 0.45, respectively).
    
    Conclusion:
    Efficacy of TKI in phase 2 trial was well replicated in phase 3 trial.
    
    

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