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Takefumi Komiya



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    OA02 - Screening and IO Toxicity (ID 2)

    • Event: NACLC 2019
    • Type: Oral Abstract Session
    • Track:
    • Presentations: 1
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      OA02.03 - CNS Metastasis as Exclusion Criteria in Clinical Trials Involving Extensive-Stage Small Cell Lung Cancer (ID 45)

      09:45 - 11:15  |  Presenting Author(s): Takefumi Komiya

      • Abstract
      • Slides

      Background:
      Clinical trials involving small cell lung cancer (SCLC) have varying enrollment criteria regarding central nervous system (CNS) metastases. This article intends to document the current landscape of CNS metastases exclusion in clinical trials involving SCLC.


      Method:
      We completed an online search of interventional clinical trials for extensive-stage small cell lung cancer (ES-SCLC) using the clinicaltrials.gov website. Trials of any status were queried by the word “extensive-stage small cell lung cancer." Studies not including ES-SCLC or requiring the presence of CNS metastases were excluded. Based on the information in exclusion criteria, they were classified into a group of strict exclusion, allowed only if treated, allowed without treatment, or undefined. Relationships between status of CNS metastasis in exclusion criteria and study characteristics (trial status, trial design, sponsor, location, and treatment groups) were investigated by chi-squared test. A P-value <0.05 was considered as significant.


      Results:
      Results showed 214 matched trials, 10 of which were excluded. Of the remaining 204 trials, 32 strictly excluded any form or history of CNS metastases, 129 allowed patients that are undergoing or have undergone CNS-specific therapy, 9 allowed patients without any CNS-specific therapy, and 34 did not mention any criteria involving CNS metastases. Studies with strict exclusion conducted outside the US (13 of 44, 29.5%) and with a single treatment (14 of 49, 28.6%) had significantly higher incidence of strict exclusion than studies including the US and with combination treatment (p=0.026 and 0.039, respectively). There is a trend that ongoing studies have higher rate of strict exclusion than completed studies (p=0.117).


      Conclusion:
      Our study indicates that non-US, single treatment, and current studies more commonly exclude patients with CNS metastasis in ES-SCLC trials. More details will be presented at the meeting.

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    P1 - Poster Viewing (ID 5)

    • Event: NACLC 2019
    • Type: Poster Session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 10/11/2019, 16:45 - 18:00, Exhibit Hall
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      P1.06 - An Overview of Lung and Breast Cancer Using the National Cancer Database (ID 27)

      16:45 - 18:00  |  Author(s): Takefumi Komiya

      • Abstract

      Background:
      The National Cancer Database (NCDB) is a clinical oncology database utilized by many researchers and clinicians internationally. The NCDB incorporates data from more than 34 million historical patient records which has been useful for those pursuing oncologic research and patient care1. We sought to investigate the various trends in data of two of the most common cancers, lung and breast, published using the NCDB.


      Method:
      We selected a multitude of pre-determined variables for analysis. We then performed two separate literature searches using an advanced PubMed search builder: one using “breast cancer” and “national cancer database” and another using “lung cancer” and “national cancer database.” The data was combined to determine each variables’ association with journal impact factor using both univariate and multivariate analyses. P< 0.05 was considered as statistically significant.


      Results:
      A total of 191 published studies were identified. We found that a journal impact factor > 5 was associated with a publication year prior to 2017 (univariate analysis OR 2.68, 95% CI 1.38-5.21, p-value 0.004 and multivariate analysis OR 3.47, 95% CI 1.62-7.42, p-value 0.001) and a sample size > 10,000 (univariate analysis OR 3.27, 95% CI 1.43-7.50, p-value 0.005 and multivariate analysis OR 4.68, 95% CI 1.89-11.6, p-value 0.0008). Variables such as number of authors (?5 vs. >5), region (US vs. non-US), cancer type (lung vs. breast), stage (including vs. excluding stage IV), treatment outcome (yes vs. no) and treatment incidence (yes vs. no) were not significant for an association with an impact factor > 5.


      Conclusion:
      Based on our data, studies published after 2017 using the NCDB were associated with a lower impact factor. This could suggest that the quality of the NCDB data may be declining over time. References: 1“National Cancer Database.” American College of Surgeons, American College of Surgeons, www.facs.org/quality-programs/cancer/ncdbchart3.jpg.