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K. Mori



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    P2.15 - SCLC/Neuroendocrine Tumors (ID 716)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: SCLC/Neuroendocrine Tumors
    • Presentations: 1
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      P2.15-005 - Post-Progression Survival Is Strongly Linked to Overall Survival in Refractory Small-Cell Lung Cancer Patients Who Received Amrubicin (ID 8845)

      09:30 - 09:30  |  Author(s): K. Mori

      • Abstract

      Background:
      The benefits of second-line chemotherapy on the overall survival (OS) of small-cell lung cancer (SCLC) patients might be confounded by subsequent therapies. In this study, we aimed to determine the influence of progression-free survival (PFS) and of post-progression survival (PPS) on OS after second-line chemotherapy in patients with refractory SCLC treated with amrubicin monotherapy.

      Method:
      We analyzed the data of 35 patients with refractory SCLC who were treated with amrubicin monotherapy as second-line chemotherapy between July 2005 and December 2015. The correlations of PFS and PPS with OS were statistically analyzed at the individual level using Spearman rank correlation and linear regression analyses.

      Result:
      The correlation between PPS and OS was strong (r = 0.88, p < 0.05, R[2 ]= 0.87), while that between PFS and OS was weak (r = 0.60, p < 0.05, R[2] = 0.15). The number of regimens administered after disease progression post-second-line chemotherapy was significantly associated with PPS (p = 0.003).

      Conclusion:
      OS is more strongly linked to PPS than to PFS in refractory SCLC patients who undergo amrubicin monotherapy as a second-line treatment. Moreover, receiving additional regimens after second-line treatment is a significant independent prognostic factor for PPS. Taken together, our results indicate that additional treatments administered after second-line chemotherapy favorably affect the OS of refractory SCLC patients treated with amrubicin monotherapy.

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    P3.01 - Advanced NSCLC (ID 621)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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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  |  Author(s): K. Mori

      • 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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