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Kuan Pin Lim
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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 - 16:00 | Presenting Author(s): Kuan Pin Lim
- 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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P2.13 - Radiology/Staging/Screening (ID 714)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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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 | Presenting Author(s): Kuan Pin Lim
- Abstract
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.
