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A. McWilliams



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    MA 20 - Recent Advances in Pulmonology/Endoscopy (ID 685)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Pulmonology/Endoscopy
    • Presentations: 1
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      MA 20.07 - Endobronchial Ultrasound Elastography: Mediastinal Staging in Non-Small Cell Lung Cancer and Technical Factors (ID 9387)

      14:30 - 16:15  |  Author(s): A. McWilliams

      • Abstract
      • Presentation
      • Slides

      Background:
      Endobronchial ultrasound (EBUS) transbronchial needle aspiration (TBNA) is the standard of care for diagnosis and mediastinal staging of non-small cell lung cancer (NSCLC). Studies suggest that elastography, an ultrasonic measure of tissue elasticity, may identify malignant lymph nodes (LNs) with sufficient accuracy to guide which LNs need sampling at EBUS and reduce the time and complexity of staging procedures. This study aims to confirm these findings while also describing technical factors that affect elastographic measurements.

      Method:
      All patients undergoing EBUS TBNA to investigate possible NSCLC were prospectively recruited. Elastographic analysis was performed prior to TBNA of LNs and later correlated with pathology from EBUS TBNA and/or surgical specimens. All LNs were classified qualitatively according to elastographic colour pattern: predominantly blue, predominantly green and mixed. Strain ratios (SR) were calculated to give quantitative measures of elasticity. Measures were compared to PET and sub-group analyses according to LN FDG avidity were performed. Finally the influence of various technical factors (probe pressure, Region of interest selection, and frame average function) were assessed.

      Result:
      There were 82 LNs from 50 patients who underwent EBUS elastography with the final diagnosis being malignant in 29(35%) and non-malignant in 57(69%). PET was available for 58 LNs. Diagnostic indices relating to elastographic features and effects of various technical factors are shown in Table 1.

      Table 1 Diagnostic indices for elastographic identification of malignant LNs (A) and Effects of technical factors (B)
      A. Variable Sensitivity Specificity PPV NPV
      Elastography All 88% 47% 42% 90%
      Elastography PET Positive 90% 64% 66% 90%
      Elastography PET negative 63% 88% 70% 85%
      Strain Ratio All Pending Pending Pending Pending
      Strain Ratio PET positive Pending Pending Pending Pending
      Strain Ratio PET negative Pending Pending Pending Pending
      Sonographic features 81% 60% 54% 84%
      PET All 82% 51% 52% 81%
      B. Variation in technique Difference p value
      Probe Pressure - colour map Pending Pending
      Probe pressure - strain ratio Pending Pending
      ROI pressure Pending Pending
      ROI Placement Pending Pending
      Frame average - colour map Pending Pending


      Conclusion:
      EBUS elastography can identify malignant LNs with equivalent power to sonography and FDG PET and may have a role in selecting which PET-negative nodes require sampling in staging procedures. It is highly dependent on technique which must be standardised to ensure accuracy of results. Please note: Data acquisition is still underway and planned to continue for a further 2 months. Analysis shall be complete by the time of the conference.

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    OA 15 - Diagnostic Radiology, Staging and Screening for Lung Cancer II (ID 684)

    • Event: WCLC 2017
    • Type: Oral
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      OA 15.01 - Lung Cancer Screening: Participant Selection by Risk Model – the Pan-Canadian Study (ID 8466)

      14:30 - 16:15  |  Author(s): A. McWilliams

      • Abstract
      • Presentation
      • Slides

      Background:
      Retrospective studies indicate that selecting individuals for low dose computed tomography (LDCT) lung cancer screening based on a highly predictive risk model is superior to applying National Lung Screening Trial (NLST)-like criteria, which use only categorized age, pack-year and smoking quit-time information. The Pan-Canadian Early Detection of Lung Cancer Study (PanCan Study) was designed to prospectively evaluate whether individuals at high risk for lung cancer could be identified for screening using a risk prediction model. This paper describes the study design and results.

      Method:
      2537 individuals were recruited through 8 centers across Canada based on a ≥2% of lung cancer risk estimated by the PanCan model, a precursor to the validated PLCOm2012 model. Individuals were screened at baseline and 1 and 4 years post-baseline.

      Result:
      At a median 5.5 years of follow-up, 164 individuals (6.5%) were diagnosed with 172 lung cancers. This was a significantly greater percentage of persons diagnosed with lung cancers than was observed in the NLST(4.0%)(p<0·001). Compared to 57% observed in the NLST, 77% of lung cancers in the PanCan Study were early stage (I or II) (p<0.001) and to 25% in a comparable population, age 50-75 during 2007-2009 in Ontario, Canada’s largest province, (p<0·001).

      Conclusion:
      Enrolling high-risk individuals into a LDCT screening study or program using a highly predictive risk model, is efficient in identifying individuals who will be diagnosed with lung cancer and is compatible with a strong stage shift – identifying a high proportion at early, potentially curable stage. Funding This study was funded by the Terry Fox Research Institute and Canadian Partnership Against Cancer. ClinicalTrials.gov number, NCT00751660

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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): A. McWilliams

      • 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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      P2.13-002 - The LungScreen WA Project: Feasibility of LDCT Screening with the PLCO<sub>m2012</sub> Risk Model and PanCan Nodule Risk Calculator (ID 8427)

      09:30 - 16:00  |  Author(s): A. McWilliams

      • Abstract
      • Slides

      Background:
      Low-dose CT (LDCT) screening for lung cancer is currently recommended in the USA but not in Australia, as there remain important knowledge gaps. We aimed to evaluate the feasibility of lung cancer screening in the Australian healthcare setting using the PLCO~m2012~ model to identify high-risk participants and the PanCan nodule malignancy risk-calculator to guide management of detected pulmonary nodules.

      Method:
      Current/former smokers, aged 55-74 years, were recruited from the community. Eligibility for LDCT-screening was defined as PLCO~m2012~ ≥1.51% over 6 years. Participants underwent interview, spirometry and LDCT. Detected nodules were managed with a risk-based algorithm using the PanCan nodule calculator (highest-risk nodule score used if multiple nodules present). If risk-score <1.5%: repeat LDCT at 24 months; 1.5-6%: LDCT at 12 and 24 months; 6-10%: LDCT at 3, 12 and 24 months; >10%: consider immediate investigation. If no nodules detected, no further LDCT arranged. We report results after 24-month follow-up.

      Result:
      We received 104 enquiries – 54 were eligible and 49 underwent screening LDCT. Results are summarised in Table 1. In participants with pulmonary nodules (n=26), the PanCan risk-score was <1.5% in 12 (46.2%), 1.5-6% in 5 (19.2%), 6-10% in 6 (23.1%) and >10% in 2 (7.7%). Of note, 65% of nodule-positive participants did not require further investigation within the first year of screening. Lung cancers were identified in 2 (4.1%) participants – 1 underwent surgical resection of a Stage 1b adenocarcinoma, the other had an enlarging nodule treated with stereotactic radiotherapy (no biopsy due to surrounding emphysema). A further participant is due surgery for a 53mm[3] slow-growing nodule with growth between 12 and 24 month scans. Table 1. Characteristics and LDCT findings of screened-individuals. Figure 1



      Conclusion:
      A targeted, algorithmic approach to lung cancer screening is feasible and identifies early-stage lung cancers. Use of the PanCan nodule risk calculator simplifies downstream investigation after baseline LDCT.

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