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K. Canfell
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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
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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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 - 09:30 | Author(s): K. Canfell
- Abstract
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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P3.06 - Epidemiology/Primary Prevention/Tobacco Control and Cessation (ID 722)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Epidemiology/Primary Prevention/Tobacco Control and Cessation
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.06-008 - Lung Cancer Pathways: A Five-Year Program to Reduce Impact Through Epidemiological Modelling and Investment in Prioritized Interventions (ID 9858)
09:30 - 09:30 | Author(s): K. Canfell
- Abstract
Background:
Pathways is a five-year program of targeted research to identify and implement those interventions that will have the greatest impact in reducing lung cancer incidence and mortality, and improving quality of life. It includes a sharply-focused research program to identify relevant interventions and health actions, a consultative phase with national and international experts to prioritise ‘best value’ interventions, whilst considering the broader political and economic issues around implementation and policy change. A final decision and investment stage will direct funding and research activities to implement the ‘best value’ interventions in lung cancer prevention, screening, early intervention, treatment and supportive care.
Method:
A microsimulation model (‘Policy1’) has been designed using a powerful, flexible platform that can be programmed with information about multiple aspects of lung cancer to formulate an evidence base for determining the ‘best value’ interventions by comparing the impact and costs of interventions. These aspects include the ‘natural history’ of the disease, prevention actions (including tobacco control and lifestyle interventions), individual risk factors and screening behaviours, and cancer treatment type and uptake in various population subgroups. Policy1 is informed by work programs in statistical projections of lung cancer mortality (based on available mortality data and Australian smoking survey data), systematic reviews, big data and epidemiological analysis, and implementation science, to address health behaviour change and contextual factors. A Scientific Advisory Committee (SAC) of key stakeholders provides content expertise and strategic advice about pursuing detailed analyses selected interventions.
Result:
The statistical projections program indicates that lung cancer mortality rates for males will continue to decline and plateau after 2035, while for females, the mortality rate is expected to decrease steadily after 2014. Data from over sixty years of Australian tobacco smoking surveys has been used to estimate smoking prevalence, tobacco consumption, quit rates and duration of smoking. Seven scoping reviews have been completed in the areas of preventative strategies, early diagnosis, treatment regimens and clinical practice guidelines, health services interventions, psychosocial and palliative care. Key questions have been formulated and presented to the SAC to guide selection of ‘best value’ interventions for detailed exploration.
Conclusion:
Pathways presents an innovative approach to addressing those interventions that are likely have the greatest impact on improving lung cancer outcomes. The program will make a significant contribution to reducing the burden of illness in the Australian population by engaging with key stakeholders, guiding future research priorities, and translating research evidence into action.
