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JuYoun Park



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    MA19 - Looking at PROs in Greater Detail - What Patients Actually Want and Expect (ID 147)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
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      MA19.06 - Successful Development of Realtime Automatically Updated Data Warehouse in Health Care (ROOT-S) (Now Available) (ID 584)

      11:30 - 13:00  |  Author(s): JuYoun Park

      • Abstract
      • Presentation
      • Slides

      Background

      Clinical information is often not recorded in an organized way, and converting it to a structured format can be a time-consuming task that may not successfully capture all facets of the information. Clinical Data Warehouse is a real time database that consolidates data from a variety of clinical sources to present a unified view. However, the clinical data extracted from the CDW have not only structured data (SD) but also natural language (NP) generated during clinical practice, and there is a limitation that it is difficult to apply to clinical trials because it is not structured and formatted to find key-point contents. This study aims at developing a systematic and comprehensive cohort through an automatic real-time update system called CDW.

      Method

      The aim of this study was to evaluate clinical data of non-small cell lung cancer, small cell lung cancer, head and neck cancer, thymic cancer, and mesothelioma. In this study, we developed a unique algorithm that is optimized for each disease category using comprehensive natural language processing (NLP) systems and structured information from unstructured free text and structured data capture (SDC). We developed an algorithm using clinical information of patients diagnosed and treated during the past 10 years and designated validation sets of patients diagnosed and treated in 2018 for validation that these algorithms work automatically.

      Result

      We collected clinical data of 23,735 NSCLC patients, 2,077 SCLC patients, 5,032 head and neck cancer patients, 3,948 esophageal cancer patients, 747 thymic cancer patients and 138 mesothelioma patients diagnosed at Samsung Medical Center. We could demonstrate using the validation set that the program accurately extracts the data needed for the cohort of each cancer. The program is updated automatically every 24 hours, the source of each data is indicated separately, and the data that need to be integrated is transformed and systematically organized. The biggest advantage is that the scattered information is systematically integrated and automatically buildup to match the patient's cohort, so you can capture most updated survival or test results or treatment outcomes almost in real time. Data on the development of this program will be presented.

      Conclusion

      This study is the first study that successfully developed and validated real-time updated cohort using CDW. This study suggests a blueprint for constructing a big data -based cohort for clinical research and is expected to be a landmark trial. The detailed analysis of each cancer through the development of the program will be presented.

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    MA21 - Non EGFR/MET Targeted Therapies (ID 153)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
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      MA21.10 - Phase II Study of 160mg of Osimertinib in EGFR T790M Positive NSCLC with Brain or Leptomeningeal Metastases Who Progressed on Prior EGFR TKI (Now Available) (ID 1705)

      14:30 - 16:00  |  Author(s): JuYoun Park

      • Abstract
      • Presentation
      • Slides

      Background

      EGFR tyrosine kinase inhibitor (TKI) has successfully improved clinical outcome in non-small cell lung cancer (NSCLC) with activating EGFR mutation. However, up to 40% of TKI treated patients present with disease progression in the central nerve system (CNS) either as brain metastases (BM) or leptomeningeal metastases (LM). Osimertinib is a 3rd generation EGFR TKI effective in T790M mutant NSCLC and characterized by high blood-brain barrier penetration. In this phase II, multicenter prospective single-arm two cohort study, the clinical efficacy of 160mg of osimertinib in T790M mutant BM or LM patients progressed on prior EGFR TKI was evaluated. (NCT0325712)

      Method

      BM only patients were included in the BM cohort (n=40). Patients with cerebrospinal cytology confirmed LM with or without BM were included in the LM cohort (n=40). 3rd generation TKI, including 80mg of osimertinib, was exposed to 18 patients in BM and 16 patients in LM cohort. T790M need to be identified from either tissue, plasma or cerebrospinal fluid. The primary endpoint was overall response rate (ORR) (H1=30%) for BM cohort and overall survival (OS) (H1=5months) for LM cohort, respectively.

      Result

      Median follow-up duration was 7.9 months for BM and 8.3 months for LM cohort. In BM cohort, median progression-free survival (PFS) was 7.3 months (95% confidential interval [CI] 3.6-13.7), and median OS was not reached (NR). Intracranial ORR and disease control rate (DCR) was 40.0% and 77.5%. Extracranial ORR and DCR was 30.0% and 67.5%. In LM cohort, median PFS was 8.9 months (95%CI 5.6-NR) and median OS was 13.2 months (95%CI 8.0-NR). When response of leptomeningeal lesion is separately evaluated, CR rate was 25.0% (n=10) and non-CR/non-PR rate was 65.0% (n=26). Extracranial ORR and DCR was 22.5% and 85.0%. Intracranial median PFS was not reached in both BM and LM cohort. Grade 3 adverse event (AE) was observed in 7 BM and 11 LM patients. Four patients required dose reduction due to AE. Among the patients who previously received 3rd generation TKI, 33.3% (6 out of 18) in BM cohort and 81.2% (13 out of 16) in LM cohort showed an intracranial DCR to 160mg of osimertinib. Extended survival analyses and exploratory outcomes will be presented at the conference.

      Conclusion

      In this study, 160mg of osimertinib demonstrated promising ORR and survival benefit with tolerable safety profile in EGFR T790M positive NSCLC patients with CNS metastasis who progressed on prior EGFR TKI.

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    P2.14 - Targeted Therapy (ID 183)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.14-57 - Efficacy of 3rd Generation EGFR-TKIs After Failing First or Second Generation EGFR-TKIs in EGFR Mutation-Positive NSCLC (ROOT-EGFR) (ID 1474)

      10:15 - 18:15  |  Author(s): JuYoun Park

      • Abstract

      Background

      Over the past decade, treatment of EGFR mutation –positive NSCLC has been revolutionized with the development of next generation EGFR TKIs. Four epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), erlotinib, gefitinib, afatinib and osimertinib, are currently available in Korea. Recent trials have compared the available and emerging EGFR TKIs head to head. The highly anticipated findings of the phase III FLAURA trial showed a nearly doubling of PFS with frontline osimertinib, a third-generation TKI, versus erlotinib or gefitinib.The optimal sequence of EGFR TKIs is still controversial. And many countries 3rd generation EGFR TKI is not readily available. The purpose of this study is to analyze the efficacy in patients who received first-line gefitinib, erlotinib, or afatinib and followed by 3rd generation EGFR-TKIs.

      Method

      This non-interventional observational study through big data analysis will retrospectively collect de-identified patient data from clinical data warehouse (CDW) using a unique algorithm with Standard Query Language (SQL) called ROOT project.

      Result

      Over 10 years, 2,358 patients were diagnosed recurrent or metastatic non-small cell lung cancer and received 1st or 2nd generation EGFR TKIs at Samsung Medical Center. 72.9% (1720/2358) of EGFR mutation-positive NSCLC patients received 1st or 2nd generation EGFR-TKIs as first line palliative chemotherapy. In total population, 30.8% (727/2358) patients received 3rd generation EGFR TKIs. Among them, patients who received 3rd generation EGFR TKI after 1st or 2nd generation EGF TKIs showed better overall survival (45.0 months (95% CI, 41.8-48.2). Among 1720 patients who received 1st or 2nd generation EGFR-TKIs as first line palliative chemotherapy, 313 patients received 3rd generation EGFR-TKIs as 2nd line chemotherapy and 200 patients received as more than 3rd line chemotherapy. However, there was no difference of overall survival between them (44.0 months vs 47.0months, p-value=0.104).

      Conclusion

      This study was meaningful as a study of what can be the best sequence in EGFR-TKI treatment. Updated and detail clinical and exploratory biomarker outcome will be presented at the meeting.