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Eiki Ichihara



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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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      P3.01-088k - Significance of Second Rebiopsy for Detecting T790M Mutation (ID 8642)

      09:30 - 09:30  |  Presenting Author(s): Eiki Ichihara

      • Abstract

      Background:
      Osimertinib is an essential drug for the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) T790M mutation and rebiopsy is recommended for detecting T790M. However, significance of repeating rebiopsy in NSCLCs that were T790M negative with first rebiopsy remains unclear. Here, we sought to clarify this issue using a retrospective cohort.

      Method:
      We reviewed the medical records of patients with consecutive advanced NSCLC harboring activating EGFR mutations who underwent EGFR tyrosine kinase inhibitor (TKI) at Okayama University Hospital between Jan 2015 and Jan 2017.

      Result:
      In total, 104 patients were included in this study, and 47 patients underwent rebiopsy after acquiring resistance to prior EGFR TKIs. Preexisting activating EGFR mutations were found in all the 47 rebiopsied samples. Nineteen of them were T790M positive (40%). In the remaining 28 patients (T790M negative with first rebiopsy), 18 patients underwent additional rebiopsies following to interval therapies. Eleven (61%) of them were T790M positive with 2nd/3rd rebiopsy (10 with 2nd rebiopsy and 1 with 3rd rebiopsy). In majority of the 11 patients, rebiopsied samples were obtained from different lesions between first and 2nd/3rd rebiopsy (8/11, 73%). We also evaluated the efficacy of osimertinib in the 11 patients who needed 2nd/3rd rebiopsy for detecting T790M. Osimertinib showed good activity with the objective response rate 56% and the median progression free survival 5.5 months (95% confidence interval 4.1-6.9), though it is worse compared to with historical control osimertinib therapy.

      Conclusion:
      T790M could be found even in T790M negative NSCLCs with first rebiospy. Data will be updated at the meeting.

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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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      P3.04-002 - A Randomized Phase II Study of Carboplatin plus Nab-Paclitaxel with or Without Nintedanib for NSCLC with IPF (J-SONIC): Trial in Progress (ID 9627)

      09:30 - 09:30  |  Author(s): Eiki Ichihara

      • Abstract

      Background:
      Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease characterized by worsening dyspnea and progressive loss of lung function. Acute exacerbation of IPF is associated with high morbidity and mortality. Several studies have provided evidence of an association between lung cancer and IPF, with a prevalence of lung cancer in IPF patients ranging from 9.8% to 38%. Although the efficacy of nintedanib for IPF has been demonstrated, it has remained unknown whether this agent also reduces the risk of chemotherapy-induced acute exacerbation of IPF. Patients with interstitial pneumonia have been excluded from most prospective clinical trials for NSCLC because of the risk of acute exacerbation, with only two prospective single-arm phase II studies having been reported. In addition, it has been difficult to perform a randomized prospective clinical trial for patients with advanced NSCLC and IPF because of their rarity. The optimal chemotherapy regimen for advanced NSCLC with IPF has thus remained unclear.

      Method:
      Chemotherapy-naïve patients with advanced NSCLC associated with IPF (enrollment target of n = 170) are randomized at a 1:1 ratio to receive four cycles of carboplatin (AUC 6 on day 1) plus nab-paclitaxel (100 mg/m[2] on days 1, 8, and 15) administered every 3 weeks either without (arm A) or with (arm B) nintedanib (150 mg b.i.d., daily), to be followed in arm B by single-agent administration of nintedanib (150 mg b.i.d., daily). The primary end point of the study is time to acute exacerbation of IPF.Figure 1



      Result:
      Section not applicable

      Conclusion:
      J-SONIC is the first randomized controlled study for treatment of NSCLC associated with IPF. The goal of the study is to demonstrate that nintedanib in combination with carboplatin plus nab-paclitaxel prolongs time to acute exacerbation of IPF compared with carboplatin plus nab-paclitaxel alone. Study enrollment began in May 2017 and is to continue for 3 years.