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)

  • 23935

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    P3.01-076 - QTWiST Analysis to Compare the Benefit of Gefitinib Versus Pemetrexed Platinum for Patients with EGFR Mutated NSCLC (ID 10431)

    09:30 - 09:30  |  Author(s): A. Kapoor
    • Abstract

    Background:
    In an open-label, Phase 3 randomized study (Clinical trial registry of India: CTRI/2015/08/006113), Gefitinib was found to be superior to Pemetrexed-Platinum in terms of progression-free survival in patients with EGFR mutated NSCLC. In this analysis, we aimed to assess the benefit of gefitinib over Pemetrexed platinum using quality-adjusted time without symptom or toxicity analysis method.
    
    Method:
    In this phase III, randomized study EGFR activating mutated patients were randomized in 1:1 fashion to either receive pemetrexed-carboplatin followed by maintenance pemetrexed or gefitinib till progression. Patients post progression received the treatment received in other arm if they were fit. These patients were followed up until death. Toxicity during the whole course of treatment was documented in accordance with CTCAE version 4.02 criteria. For QTWiST analysis, the overall survival and progression-free survival were documented. The overall survival was partitioned in 3 health states. These were TOX, TWiST, and REL. TOX state comprised of time in months spent by the patient in grade 2 or above toxicity post randomization but before the first progression. TWiST state comprised of time in months spent by the patient post randomization but before the first progression without grade 2 or above toxicity. REL state was defined as the time in months spent post the first progression until death. RStudio will be used for analysis. The data will be censored for this analysis on 30th June 2017. The restricted mean of all three health states would be calculated using non-parametric 500 boot straps. The time spent in each state will be weighted by a corresponding health-state utility coefficient for QTWiST calculation. A threshold utility analysis will be performed using utility values between 0-1. Where 0 represents a health state similar to death and 1 represents a perfect health state.
    
    Result:
    The restricted mean health state duration in months for each state with its 95% CI for each arm, the difference between the 2 arms for each health state with its 95%CI and corresponding p-value will be provided. The results of threshold utility analysis with the corresponding QTWiST difference between the 2 arms with p-value would be presented.
    
    Conclusion:
    LBA: Not applicable