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    P2.13 - Targeted Therapy (Not CME Accredited Session) (ID 962)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.13-38 - Impact of Tyrosine Kinase Inhibitor (TKI) Dose on Outcomes of Patients with Lung Cancer (ID 11770)

      16:45 - 18:00  |  Author(s): Kevin Sullivan

      • Abstract
      • Slides

      Background

      FDA approved starting doses of TKis are based on maximum tolerated dose (MTD) in clinical trials. In practice however, patients are started on lower doses due to tolerability concerns or dose-reduced subsequently for toxicity. Very few studies have addressed the impact of dose on clinical outcomes.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      An IRB approved chart review of lung cancer patients receiving oral TKI therapy between 1/2014 and 6/2017 at our institution was conducted. Patients who were started on TKIs at the FDA dose (Group A) dose were compared to those started on a lower dose (Group B) for progression free survival (PFS), overall survival (OS), and time-to-discontinuation. Fisher’s exact test was used to compare groups on categorical variables and the Mann-Whitney test was used for continuous variables. The Kaplan-Meier method was used to estimate time-to-event stratified by group, and Cox regression models were used to adjust for potential confounders.

      4c3880bb027f159e801041b1021e88e8 Result

      Seventy-nine patients were treated with an EGFR inhibitor and 11 patients were treated an ALK inhibitor. The Kaplan-Meier estimates of the median time-to-progression for Group A (n = 67) and Group B (n = 23) were 13.4 months (95% CI: 8.88, 15.55) and 15.1 months (95% CI: 5.56, 21.5), respectively; and for time-to-discontinuation, the estimates were 13.5 months (95% CI: 11, 20.15) for Group A and 21.5 months (95% CI: 6.44, ) for Group B. Median time to death was not estimable for OS. The predicted OS probability at approximately 15 months post treatment initiation for Group A was 81.8% (95% CI: 0.69, 0.90) vs. 80.5% (95% CI: 0.55, 0.92) for Group B. No statistically significant differences resulted from the Cox regression models.

      8eea62084ca7e541d918e823422bd82e Conclusion

      We found no evidence to support that patients who initiated therapy at full dose have different outcomes with respect to OS and PFS compared to those who initiated at a lower starting dose. Future prospective studies are needed to further evaluate this finding. Future clinical trials should report minimal effective dose in addition to MTD.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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