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M. Tammemägi



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    MA 14 - Diagnostic Radiology, Staging and Screening for Lung Cancer I (ID 672)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Radiology/Staging/Screening
    • Presentations: 2
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      MA 14.11 - Malignancy Risk Prediction of Pulmonary Nodule in Lung Cancer Screening – Diameter Or Volumetric Measurement  (ID 9113)

      15:45 - 17:30  |  Author(s): M. Tammemägi

      • Abstract
      • Presentation
      • Slides

      Background:
      Nodule size is an important parameter to determine malignancy risk. Semi-automated size measurements have the potential to replace manual measurements due to their higher accuracy and reproducibility, and less inter/intra-user variation. However, controversy exists regarding the relative accuracy of 2D diameter versus 3D volumetric measurement to predict malignancy risk. The objective of this study is to compare nodule malignancy prediction models based on 2D mean diameter versus volumetric measurement, both generated by a CAD Software.

      Method:
      We analyzed baseline LDCT reconstructed using high spatial frequency algorithm from 1746 participants (47% women, 53% men, age: 62.5 ± 5.8 yrs) in the Pan-Canadian Early Detection of Lung Cancer Study (PanCan), who had ≥1 non-calcified nodules ≥3mm in diameter. CAD software (CIRRUS Lung Screening, Radboud University Medical Center, Nijmegen, the Netherlands) performed an automatic nodule segmentation, which could be optimised manually, measurement of mean diameter and volume was generated. Malignant or benign nodule status was confirmed by pathology or prolonged follow-up (median follow-up 5.5 years). Logistic regression models predicting cancer were prepared with one including mean diameter and the other including volume. The discrimination, the ability to classify cancer versus benign nodules correctly, was evaluated by the area under the receiver operator characteristic cure (AUC). The calibration - do predicted probabilities match observed probabilities, was assessed using Spiegelhalter’s z-test and graphically by plotting the observed and predicted mean probabilities of cancer by deciles of model risk.

      Result:
      There were in total 5878 nodules, including 119 cancers in 115 individuals. Both models gave similar predictive performances. AUC was 0.947 (95% CI 0.922-0.964) in the mean diameter model and 0.946 (95% CI 0.921-0.966) in the volumetric model (p=0.83). The calibrations were similar between the two models (figure). Figure 1



      Conclusion:
      The predictive performances of nodule malignancy prediction models using mean 2D nodule diameter and 3D volumetric data were indistinguishable.

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      MA 14.14 - The First 100 Days: Early findings from the Lung Cancer Screening Pilot for People at High Risk in Ontario, Canada (ID 8579)

      15:45 - 17:30  |  Author(s): M. Tammemägi

      • Abstract
      • Presentation
      • Slides

      Background:
      An estimated 330,000 people in the province of Ontario are at high risk of developing lung cancer and eligible for screening with low-dose computed tomography (LDCT). On June 1 2017 Cancer Care Ontario launched the Lung Cancer Screening Pilot for People at High Risk with the purpose of informing the design and implementation of a province-wide organized screening program. Organized screening is available at 3 hospitals, and provider and public recruitment strategies are being implemented to engage the target population in regional catchment areas. Key aspects of pilot design include eligibility based on the PLCO~M2012noRace~ risk prediction model, navigation support, informed participation, embedded smoking cessation services, radiology quality assurance, LDCT findings categorized in accordance with Lung-RADS™, provision of same-visit screening results and seamless transition to a Diagnostic Assessment Program (DAP) for assessment of findings suspicious for lung cancer. Data collected for 3,000 participants over a 2-year period will inform a comprehensive evaluation of the pilot.

      Method:
      Indicators were selected to assess impacts of early recruitment efforts and outcomes of key screening processes related to eligibility assessment, the LDCT scan and smoking cessation. Data were collected by the pilot sites and submitted to Cancer Care Ontario. Participant feedback on the screening experience was collected by survey. Data were collected in June and July 2017; data from August 2017 will be available for presentation.

      Result:
      The majority (87%) of the 862 people recruited into the pilot were provider-referred. Of the 472 people who completed a risk assessment, 71% were found to be eligible for screening (PLCO~M2012noRace~ 6-year risk ≥2.0%). Baseline LDCT scans were conducted for 156 participants; approximately 8% of these participants were referred to a DAP for further assessment. Uptake of smoking cessation services by current smokers was high (data to be included in presentation). Feedback surveys were received from 78 of 156 participants screened. Overall experience with the screening visit was rated as ‘excellent’ by 91% of respondents, and 70% indicated a preference to receive results during the same visit as the LDCT.

      Conclusion:
      Provider-led recruitment supports the identification of screen-eligible individuals. Implementation of navigator-guided organized screening, following a detailed screening pathway that features provision of same-visit results, has contributed to high participant satisfaction to date. To our knowledge, this pilot involves the most detailed organized screening pathway and comprehensive evaluation plan developed to date. Learnings from this pilot will be highly relevant to jurisdictions around the world that are adopting screening.

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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 20.11 - Chronic Obstructive Pulmonary Disease Prevalence in a Lung Cancer Screening Population (ID 9588)

      14:30 - 16:15  |  Author(s): M. Tammemägi

      • Abstract
      • Presentation
      • Slides

      Background:
      Chronic obstructive pulmonary disease (COPD) and lung cancer are associated through tobacco use. COPD is underdiagnosed in both the primary care and lung cancer populations. Diagnosis of COPD should lead to improved care and quality of life. Screening programs could provide an opportunity to capture undiagnosed COPD. We analyzed the Pan-Canadian Early Detection of Lung Cancer Study (PanCan Study) to evaluate the prevalence of COPD in a screening population.

      Method:
      The PanCan Study was a single arm lung cancer screening trial which recruited individuals to low dose CT scan, autofluorescence bronchoscopy, and biomarker screening. Eligible individuals were 50-75 years of age, had smoked within 15 years, and had a minimum six-year risk of lung cancer ≥ 2% based on a risk prediction model derived from PLCO study data, which included COPD as a risk factor. Consenting subjects completed a questionnaire including background medical conditions, high-risk work exposures, and smoking history. Baseline spirometry was performed, and COPD was defined by GOLD criteria. For individuals not receiving post-bronchodilator spirometry, COPD was defined as ‘probable’ if GOLD criteria were met pre-bronchodilator and there was no prior diagnosis of asthma. Individuals with definite or probable COPD were defined as having COPD.

      Result:
      Of 2537 individuals recruited, 2514 had available spirometry data. Mean age was 62.3 years, 55.3% were male, median pack-years smoked was 50, 62.3% were active smokers, 45.1% had symptoms of dyspnea, 52.4% cough, and 37.5% wheeze. 35.2% had worked in a high-risk occupation. Overall, 1136 (45.2%) met spirometry criteria for COPD. Of 1987 individuals without a prior history of COPD, 41.9% met spirometry criteria for COPD, of which 53.7% had moderate to severe disease. Of 527 individuals (21%) reporting a diagnosis of COPD at baseline, 57.5% met spirometry criteria for COPD, 32.2% did not, and 10.3% had a prior diagnosis of asthma. In a multivariate model for risk of COPD, age (odds ratio (OR)~per year~ 1.06), dyspnea (OR 1.42), being a current smoker (OR 1.43), and pack-years (log transformed OR 1.42) were significant (all p < 0.001) as were high-risk occupation (OR 1.24, p=0.013) and wheeze (OR 1.24, p = 0.024).

      Conclusion:
      A diagnosis of COPD by spirometry is common in a lung cancer screening trial population. Individuals with a pre-existing self-reported diagnosis of COPD often fail to meet spirometry criteria for their diagnosis. Testing a lung cancer screening population for COPD could significantly improve COPD diagnosis and treatment.

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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): M. Tammemägi

      • 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): M. Tammemägi

      • 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: 2
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      P2.13-011 - Optimal Selection Criteria for LDCT Lung Cancer Screening (ID 9628)

      09:30 - 16:00  |  Author(s): M. Tammemägi

      • 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.

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      P2.13-012 - Recruitment for Lung Cancer Screening (ID 9673)

      09:30 - 16:00  |  Author(s): M. Tammemägi

      • Abstract

      Background:
      The efficiency of a lung cancer screening program with low dose computed tomography (LDCT) is influenced by the screening uptake. The most efficient method to improve participation rate of individuals in the general population who are eligible for screening has not been determined. We evaluated different methods of recruitment on the participation rate.

      Method:
      The BC lung screening trial is part of the International Lung Screen Trial (ILST) in Canada, Australia, the UK and Hong Kong. ILST aims at defining the optimal selection criteria for LDCT by comparing the relative sensitivity of the US Preventative Services Task Force criteria versus the PLCOm2012 prediction model with 6-year lung cancer risk>=1.5%. Individuals with a chest CT within 2 years are excluded from the screening study. Different methods [social media, radio, newspaper, QuitNow smoking cessation program, BC Lung Association and referrals by general practitioners (GP)] to recruit eligible individuals are compared.

      Result:
      Of the 802 participants referred or self-referred to the study, 364 (41% female, 59% males, 53% ex-smokers and 47% current smokers) were eligible. The largest draw was radio which reached 64% of respondents, however only 29% of these were eligible. General practitioners (GP) reached only 24% but of these 70 % were eligible. 13% had a CT scan within 2 years, and but only 40% would have been eligible via risk criteria (Table 1). Table1. Figure 1



      Conclusion:
      The largest number of eligible participants were referred by their GPs. Media (radio) reached a larger number of participants but many were ineligible. A combined approach of media publicity and GP referrals may be the best way to reach the target the population. Ad hoc screening is likely occurring in the absence of a publicly funded screening program inappropriately exposing participants outside of the criteria.