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M. Sagawa

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    MS 15 - Current Screening Trials, Current Evidence and Screening Algorithms (ID 33)

    • Event: WCLC 2015
    • Type: Mini Symposium
    • Track: Screening and Early Detection
    • Presentations: 1
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      MS15.04 - Screening in Japan - The JECS Study (ID 1915)

      14:15 - 15:45  |  Author(s): M. Sagawa

      • Abstract
      • Presentation

      Background Lung cancer is the leading cause of cancer death in Japan as well as western countries. To decrease the lung cancer mortality, lung cancer screening using low-dose thoracic computed tomography (CT) may be a promising measure. Several randomized controlled trials (RCTs) are being conducted in the US and Europe to evaluate the efficacy of lung cancer CT screening, and one of those trials, National Lung Screening Trial (NLST), recently reported favorable results. However, the focus of all trials has been the efficacy in smokers. Adenocarcinomas have increased worldwide in non-smokers, especially in Japan and other Asian countries, and a powerful lung cancer screening modality for non-smokers is also desired. In a recent Japanese cohort study, mortality reduction by thoracic CT screening was suggested even in non-smokers/smokers under 30 pack-years (personal communication). Therefore, we are now conducting the JECS Study (The Japanese randomized trial for evaluating the Efficacy of low-dose thoracic CT Screening for lung cancer in non-smokers and smokers under 30 pack-years). Methods The aim of the JECS study is to assess the efficacy of lung cancer screening tests using low-dose thoracic CT once every five years, compared with chest roentgenography (XP), in people aged 50–64 with a smoking history under 30 pack-years. This study is a multi-regional prospective randomized controlled trial (RCT). The design of the RCT was described elsewhere (Jpn J Clin Oncol 42: 1219-21, 2012). Briefly, participants were recruited from people who ranged from 50-64 years old with smoking history under 30 pack-years, and underwent regular lung cancer screening using chest x-ray in the previous year (this latter requirement may be deleted after 2015). A letter for recruitment to participate in the trial was mailed to each citizen in the target municipalities, who was 50-64 years old with a smoking history under 30 pack-years. The letter explained the eligibility criteria, randomization, follow-up, possible benefit and harm including false-positive, radiation exposure and overdiagnosis. Several meetings were held for those who were interested in the trial for further explanation. People with a history of lung cancer or other malignant diseases as well as a history of thoracic CT screening were excluded. Appropriate written informed consent was completed by each participant who chose to take part in the trial. The participants were randomly assigned into one of 2 groups, a CT group and an XP group. The duration of this screening-follow-up period is 10 years. For the intervention arm, low-dose thoracic CT is provided for each participant in the first year and the sixth year. For the control arm, chest XP is provided for each participant in the first year. All of the participants are encouraged to receive annual routine lung cancer screening using chest XP in the other years. Thoracic CT findings were interpreted by two physicians, based upon the “Low-dose CT Lung Cancer Screening Guidelines for Pulmonary Nodules Management” established by the Japanese Society of CT Screening. A positive rate under 5% is preferred. The interpretation of chest XP findings is performed according to “The Manual of the Lung Cancer Screening” section in the “General rule for clinical and pathological record of lung cancer” published by the Japan Lung Cancer Society. The lung cancer incidence and mortality would be compared. The design of the trial was approved by the Institutional Review Board of the Kanazawa Medical University in 2009, and was registered on the University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR), Japan in 2011 (registration number: UMIN000005909). The sample size, 17,500 subjects for each arm, is required to detect a 60% mortality reduction after 10 years. At the first step, 3,000 subjects are needed for evaluating QOL and value of contamination of the study. Results As of March 1, 2015, local governments of 20 municipalities in 7 prefectures in Japan permitted that we sent invitation letters for the JECS Study to residents. A letter for recruitment was mailed to each of 9,268 people who were 50-64 years old with a smoking history under 30 pack-years and underwent regular lung cancer screening in the previous year. Of them, 1,812 people (19.6%) sent us a reply letter and wanted to attend one of the meetings for further explanation. One thousand five hundred people actually attended one of the meetings. Finally 1,458 people participated in the JECS Study (15.7% of people who was invited and 97.2% of people who attended a meeting). Of them, 720 people were assigned to CT group and remaining 738 people were assigned to XP group. The screening results of 48 of the 720 people who received low-dose thoracic CT screening (6.7%) were positive, whereas 20 of 738 people who underwent chest XP screening (2.7%) were positive. Until now, three lung cancer patients were diagnosed and 22 patients were under follow-up for the suspicion of having lung cancer in this whole cohort. Comments The results of the NLST demonstrated the efficacy of thoracic CT screening in smokers. However, the efficacy in non-smokers is still completely unknown. Therefore, we started to conduct a randomized trial, the JECS study, to evaluate the efficacy of low-dose thoracic CT screening for lung cancer in non-smokers/smokers under 30 pack-years. This is a first RCT in the world for not heavy-smokers. The preliminary results of this study indicated that 15.7% of the people who received the recruitment letter participated in the RCT. The compliance rate was high in comparison to that in the PLCO or the ITALUNG trial (0.3-7.2%). Over 97% of the 1,500 people who attended a meeting participated in the RCT, which was extremely high. This indicated that the letter for recruitment was effective both for excluding ineligible subjects and for explaining the contents of the trial. The compliance in the preliminary results for this study was very high, and the above RCT appears to be feasible in Japan, if the sufficient budget is obtained. This study was supported in part by the Health and Labour Sciences Research Grant from the Ministry of Health, Labour and Welfare, Japan.

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