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H. Asahina



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    P2.01 - Advanced NSCLC (ID 618)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.01-005 - A Randomized Phase II Trial of Erlotinib vs S-1 in Patients with NSCLC as Third- or Fourth-Line Therapy (HOT1002) (ID 7579)

      09:00 - 09:00  |  Author(s): H. Asahina

      • Abstract
      • Slides

      Background:
      Because of the improved efficacy of first and second-line therapy in patients (pts) with non-small cell lung cancer (NSCLC) with wild type EGFR, a high proportion of patients receive third-line therapy and beyond. When this study was planned, erlotinib, an EGFR tyrosine kinase inhibitor, was recommended as standard second-line therapy, irrespective of EGFR status, based on the results of BR 21 study. We conducted the Hokkaido Lung Cancer Clinical Study Group (HOT) 1002 trial, to compare erlotinib (E) with S-1 (S) for NSCLC as third or fourth-line therapy.

      Method:
      This study was a multicenter, randomized phase II study in Japan. All eligible pts had a recurrent or advanced NSCLC with wild type or unknown EGFR and had progressed after two or three previous chemotherapies. Pts were randomly assigned and treated with E or S until either disease progression or unacceptable toxicity. The primary endpoint was the disease control rate (DCR). The secondary endpoints included the overall survival (OS), progression-free survival (PFS), response rate (RR), toxicity and quality of life (QOL).

      Result:
      From May 2011 to March 2016, 37 pts were randomly assigned to receive erlotinib (n=19) or S-1 (n=18). This study was terminated immaturely because of the poor pts accrual. The median number of treatment cycles was 3 (range 1-10) in E and 4 (range 1-11) in S. DCR/RR was 42.1%/15.8% in E and 66.7%/16.7% in S. Median PFS/OS (months) was 1.6 (95% CI; 0.8-3.7)/ 8.0 (95% CI; 4.2-13.3) in E and 3.3 (95% CI; 1.5-5.8)/12.2 (95% CI; 5.5-16.3) in S (p=0.094/0.42). Although the patient number was too small for statistical comparison, S group showed better PFS than E group both as third-line (1.5 vs 2.7 months) and fourth-line (3.3 vs.5.9 months). In both treatment groups, the most commonly reported Gr 3-4 non-hematological toxicities were fatigue, anorexia and nausea. There was one Gr 5 event pneumonitis in S. No significant difference was seen in QOL.

      Conclusion:
      Although this trial had no statistical power to draw any conclusions, treatment with S-1 as a third-/fourth-line showed numerically better clinical outcomes compared with erlotinib.

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    P3.04 - Clinical Design, Statistics and Clinical Trials (ID 720)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Clinical Design, Statistics and Clinical Trials
    • Presentations: 1
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      P3.04-004 - Treatment Rationale and Study Design for the TAKUMI Trial (ID 9691)

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

      • Abstract
      • Slides

      Background:
      50%-60% of patients after the first-generation EGFR-TKI, gefitinib and erlotinib showed acquired resistance of T790M mutation and osimertinib is a standard regimen for this population. However, the median PFS by osimertinib alone is 8-10M and a better strategy is needed. One promising option is a combination of osimertinib and chemotherapy, and previous trials have suggested the promising efficacy by the combined treatment of EGFR-TKI with pemetrexed. We here present the treatment rationale and study design of TAKUMI trial, a multicenter randomized phase Ⅱ study of of osimertinib (Tagrisso) alone versus osimertinib plus carboplatin/pemetrexed for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy and whose tumours harbour a T790M mutatIon within the epidermal growth factor receptor gene.

      Method:
      Figure 1schema of this study



      Result:
      Section not applicable

      Conclusion:
      Section not applicable

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