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C. Berg



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    P1.04 - Clinical Design, Statistics and Clinical Trials (ID 690)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Clinical Design, Statistics and Clinical Trials
    • Presentations: 1
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      P1.04-003 - The International Lung Screen Trial: A Multi-Centre Study to Evaluate LDCT Screening Selection Criteria and Nodule Management (ID 8141)

      09:30 - 16:00  |  Author(s): C. Berg

      • Abstract
      • Slides

      Background:
      There remain important knowledge gaps surrounding the optimal selection criteria of high-risk individuals for low-dose CT (LDCT) screening for lung cancer and the optimal management of screening-detected pulmonary nodules. The International Lung Screen Trial (ILST) is an international, multi-centre prospective cohort study with recruitment sites in Canada and Australia. The rationale and design for the study are presented here. The PLCO~m2012~ risk prediction model[1] may have higher sensitivity and positive predictive value in identifying individuals who develop lung cancer compared to the United States Preventive Services Task Force (USPSTF) criteria. The PanCan model[2] calculates malignancy probability in screen-detected nodules and provides a risk-based approach to managing pulmonary nodules. Both models will be prospectively tested in this study. Primary aims: (a) to define the optimal selection criteria for LDCT screening, (b) to evaluate pulmonary nodule management using the PanCan nodule risk calculator.

      Method:
      We aim to recruit 4,000 high-risk individuals with 5 years follow up. Eligible participants are current or former smokers, aged 55-80 years, with a PLCO~m2012~ lung cancer risk of ≥1.51% over 6 years or USPSTF criteria (age as above, plus ≥30 pack year history of smoking and smoking cessation <15 years ago). Exclusion criteria include: symptoms suspicious of lung cancer, severe co-morbidity, previous lung cancer and chest CT within the last 2 years. Baseline assessment includes interview, smoking status assessment and pulmonary function testing. Eligible individuals are offered a baseline screening LDCT and subsequent interval surveillance LDCTs dependent on the PanCan risk score. Participants with no nodules or nodule risk score of <1.5% will have biennial LDCT screening. Participants with nodule malignancy risk score ≥10%, or significant growth in subsequent scan will be considered suspicious for lung cancer and undergo clinical review for further investigation. The primary outcome is the proportion of lung cancers detected by either selection criteria. Secondary outcomes include: number needed to screen, cancer detection rate, lung cancer mortality, cancer stage distribution, resection rate, number of interval cancers, recall rate, invasive procedure rate, benign biopsy/surgery rate, screening-related adverse events and comprehensive healthcare economic evaluation.

      Result:
      This study is currently in its recruitment phase. Results will be reported in future conferences and peer-reviewed publications.

      Conclusion:
      The ILST trial will provide a clearer understanding on the optimum selection criteria for LDCT screening for lung cancer and prospective validation of the PanCan model. ClinicalTrials.gov number: NCT02871856 References: Tammemägi MC et al (2013). NEJM; 368:728-736. McWilliams A et al (2013). NEJM; 369:910-919.

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    P2.13 - Radiology/Staging/Screening (ID 714)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      P2.13-011 - Optimal Selection Criteria for LDCT Lung Cancer Screening (ID 9628)

      09:30 - 16:00  |  Author(s): C. Berg

      • Abstract

      Background:
      Lung cancer screening programs with low dose computed tomography (LDCT) could be economically viable if they targeted high-risk people. The optimal selection criteria have not been defined in prospective clinical trials. The goal of this prospective study is to test the hypothesis that lung cancer screening based on a highly predictive risk model: The Prostate, Lung, Colon, Ovarian (PLCO~m2012~) is superior to applying National Lung Screening Trial (NLST)-like criteria.

      Method:
      Participants were enrolled through three screening studies, two in Canada (Vancouver and Alberta) and one in London, UK. Eligibility included a PLCOm2012 6-year lung cancer risk ≥1.5% or NLST-like criteria (≥30 pack-years smoking history and quit ≤15 years with some variation in age limits – 55 to 80 years in BC, 55 to 74 in Alberta and 60 to 75 in UCL). The proportion of participants who have been found to have lung cancer or high risk lung nodules, requiring repeat imaging studies or biopsy prior to the next scheduled annual screening were compared between the two selection methods.

      Result:
      The demographics of participants are shown in Table 1. To date, 1,533 received a LDCT, of these, 341 met the PLCOm2012 criteria alone, 169 met NLST-like criteria and 1023 met both criteria. Twenty-seven participants have been found to have lung cancers. All 27 met the PLCOm2012 selection criteria alone while 62% met NLST- like criteria. No lung cancer was found in participants who met NLST-like criteria alone. There are 129 participants with suspicious lung nodules under close surveillance or scheduled for biopsy. Among these, 97% met the PLCOm2012 criteria and 74% met NLST-like criteria.

      Table 1. Clinical and Demographic Features of Study Cohorts
      Study Site British Columbia Alberta London Total
      No. Contacted 802 1661 1990 4453
      No. Eligible 364 741 812 1917
      No. Screened 241 688 604 1533
      Age (yrs) 65+/- 6.3 63.5 +/- 4.2 66+/-4.2 64.8+/- 5.7
      Sex (female/Male) 91F:150M 342F:346M 273F:331M 706M;827M
      Current:Former Smoker 103CS:138Ex 341CS:347Ex 443CS:161Ex 887CS:646Ex
      Pack Years (Mean +/-SD) 47.3+/-22 42.4+/-15.8 47.7+/-22.3 45.3+/-19.8
      Median Follow-up(months) 7.5 9.7 9.7
      No. of lung Cancers 3 7 17 27
      Participants with suspicios nodules 21 41 67 129


      Conclusion:
      Our preliminary results show that fewer people are eligible for screening using NLST-like criteria compare to a highly predictive risk model such as PLCOm2012. Thirty-seven percent more participants with lung cancer are identified by PLCOm2012.