Developing a pan-European technical standard for a comprehensive high-quality lung cancer computed tomography screening programme: an ERS technical standard

Baldwin, David R; O’Dowd, Emma; Tietzova, Ilona; Klinke, Anna; Heuvelmans, Marjolein A; Snoeckx, Annemiek; Ashraf, Haseem; Kauczor, Hans‐Ulrich; Nagavci, Blin; Oudkerk, Matthijs; Putora, Paul Martin; Rzyman, Witold; Veronesi, Giulia; Kitts, Andrea Borondy; Gratacós, Antoni Rosell; Meerbeeck, Jan P. van; Blum, T

doi:10.1183/13993003.00128-2023

Cited by 14 publications

(8 citation statements)

References 234 publications

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“…The median surveillance was 15 months (IQR [13][14][15][16][17]. Due to the COVID-19 pandemic, continued follow up was not feasible firstly for those subjects with a baseline LDCT scan clinically not significant and secondly for patients with nodules considered to be low risk.…”

Section: Results Overviewmentioning

confidence: 99%

“…Low-dose computed tomography (LDCT) is gaining constant traction as a screening tool for lung cancer [8]. International scientific societies have indeed developed protocols for high-risk subgroups (active or former smokers aged 50 years or older) [9][10][11][12][13][14][15]. In the USA, the Centers for Medicare & Medicaid services (CMS) has recently announced a national coverage determination that expanded reimbursement for lung cancer LDCT screening to improve health outcomes for people with lung cancer [15].…”

Section: Introductionmentioning

confidence: 99%

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The Smokers Health Multiple ACtions (SMAC-1) Trial: Study Design and Results of the Baseline Round

Antonicelli,

Muriana,

Favaro

et al. 2024

Cancers

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Background: Lung cancer screening with low-dose helical computed tomography (LDCT) reduces mortality in high-risk subjects. Cigarette smoking is linked to up to 90% of lung cancer deaths. Even more so, it is a key risk factor for many other cancers and cardiovascular and pulmonary diseases. The Smokers health Multiple ACtions (SMAC-1) trial aimed to demonstrate the feasibility and effectiveness of an integrated program based on the early detection of smoking-related thoraco-cardiovascular diseases in high-risk subjects, combined with primary prevention. A new multi-component screening design was utilized to strengthen the framework on conventional lung cancer screening programs. We report here the study design and the results from our baseline round, focusing on oncological findings. Methods: High-risk subjects were defined as being >55 years of age and active smokers or formers who had quit within 15 years (>30 pack/y). A PLCOm2012 threshold >2% was chosen. Subject outreach was streamlined through media campaign and general practitioners’ engagement. Eligible subjects, upon written informed consent, underwent a psychology consultation, blood sample collection, self-evaluation questionnaire, spirometry, and LDCT scan. Blood samples were analyzed for pentraxin-3 protein levels, interleukins, microRNA, and circulating tumor cells. Cardiovascular risk assessment and coronary artery calcium (CAC) scoring were performed. Direct and indirect costs were analyzed focusing on the incremental cost-effectiveness ratio per quality-adjusted life years gained in different scenarios. Personalized screening time-intervals were determined using the “Maisonneuve risk re-calculation model”, and a threshold <0.6% was chosen for the biennial round. Results: In total, 3228 subjects were willing to be enrolled. Out of 1654 eligible subjects, 1112 participated. The mean age was 64 years (M/F 62/38%), with a mean PLCOm2012 of 5.6%. Former and active smokers represented 23% and 77% of the subjects, respectively. At least one nodule was identified in 348 subjects. LDCTs showed no clinically significant findings in 762 subjects (69%); thus, they were referred for annual/biennial LDCTs based on the Maisonneuve risk (mean value = 0.44%). Lung nodule active surveillance was indicated for 122 subjects (11%). Forty-four subjects with baseline suspicious nodules underwent a PET-FDG and twenty-seven a CT-guided lung biopsy. Finally, a total of 32 cancers were diagnosed, of which 30 were lung cancers (2.7%) and 2 were extrapulmonary cancers (malignant pleural mesothelioma and thymoma). Finally, 25 subjects underwent lung surgery (2.25%). Importantly, there were zero false positives and two false negatives with CT-guided biopsy, of which the patients were operated on with no stage shift. The final pathology included lung adenocarcinomas (69%), squamous cell carcinomas (10%), and others (21%). Pathological staging showed 14 stage I (47%) and 16 stage II-IV (53%) cancers. Conclusions: LDCTs continue to confirm their efficacy in safely detecting early-stage lung cancer in high-risk subjects, with a negligible risk of false-positive results. Re-calculating the risk of developing lung cancer after baseline LDCTs with the Maisonneuve model allows us to optimize time intervals to subsequent screening. The Smokers health Multiple ACtions (SMAC-1) trial offers solid support for policy assessments by policymakers. We trust that this will help in developing guidelines for the large-scale implementation of lung cancer screening, paving the way for better outcomes for lung cancer patients.

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Section: Results Overviewmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Smokers Health Multiple ACtions (SMAC-1) Trial: Study Design and Results of the Baseline Round

Antonicelli,

Muriana,

Favaro

et al. 2024

Cancers

Self Cite

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“…Results must also be communicated promptly and effectively among healthcare staff to enable timely management and follow-up of findings. A recent ERS Technical Standard recommends outcomes are communicated within four weeks of the LDCT 60 .…”

Section: Communication Of Resultsmentioning

confidence: 99%

Quality requirements to establish a successful lung cancer screening program

Burzic,

Baldwin

2024

BRN

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Lung cancer is the leading cause of cancer-related deaths globally. There is a strong body of evidence from the last two decades to support the effectiveness of lung cancer screening (LCS) with low radiation dose computed tomography (LDCT) in reducing lung cancer mortality and all-cause mortality. National programmes are approved and either ongoing or in planning in Poland, Croatia, the UK, Canada, Australia and the US. Other countries are proceeding with pilot programmes, some of which are framed as research studies. The European Commission's Group of Chief Scientific Advisors recommended that lung cancer screening (LCS) be added to the other established cancer screening programs in Europe and the European Council recommended that LCS be implemented in a stepwise approach depending on national priorities. However, it is essential that clinical and cost-effectiveness shown in studies and pilot programmes are replicated in national programmes. This is achieved through the use of evidence-based strategies across each element of screening from participant selection to treatment. This review addresses key quality requirements identified in the literature which must form part of a successful LCS program. We describe the challenges and, where possible, suggest solutions for the implementation of screening. We will highlight the areas for further research including risk-prediction models for screening eligibility, optimising recruitment methods, personalisation of screening intervals, biomarkers, smoking cessation integration, and artificial intelligence.

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“…Early identification and treatment are crucial to improve the prognosis of lung cancer patients. The incidence of pulmonary nodules has been increasing in recent years due in part to the increased use and improved sensitivity of imaging modalities such as chest computed tomography (CT) scans [3]. Biopsy or surgical resection may be necessary to obtain a definitive diagnosis in cases where malignancy is suspected [4].…”

Section: Introductionmentioning

confidence: 99%

Advances in the Treatment of Pulmonary Nodules

Zhang,

Wu,

Yang

et al. 2024

Respiration

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Background: Early detection and accurate diagnosis of pulmonary nodules are crucial for improving patient outcomes. While surgical resection of malignant nodules is still the preferred treatment option, it may not be feasible for all patients. We aimed to discuss the advances in the treatment of pulmonary nodules, especially stereotactic body radiotherapy (SBRT) and interventional pulmonology technologies, and provide a range of recommendations based on our expertise and experience. Summary: Interventional pulmonology is an increasingly important approach for the management of pulmonary nodules. While more studies are needed to fully evaluate its long-term outcomes and benefits, the available evidence suggests that this technique can provide a minimally invasive and effective alternative for treating small malignancies in selected patients. We conducted a systematic literature review in PubMed, designed a framework to include the advances in surgery, SBRT, and interventional pulmonology for the treatment of pulmonary nodules, and provided a range of recommendations based on our expertise and experience. Key Messages: As such, alternative therapeutic options such as SBRT and ablation are becoming increasingly important and viable. With recent advancements in bronchoscopy techniques, ablation via bronchoscopy has emerged as a promising option for treating pulmonary nodules. This study reviewed the advances of interventional pulmonology in the treatment of peripheral lung cancer patients that are not surgical candidates. We also discussed the challenges and limitations associated with ablation, such as the risk of complications and the potential for incomplete nodule eradication. These advancements hold great promise for improving the efficacy and safety of interventional pulmonology in treating pulmonary nodules.

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Developing a pan-European technical standard for a comprehensive high-quality lung cancer computed tomography screening programme: an ERS technical standard

Cited by 14 publications

References 234 publications

The Smokers Health Multiple ACtions (SMAC-1) Trial: Study Design and Results of the Baseline Round

The Smokers Health Multiple ACtions (SMAC-1) Trial: Study Design and Results of the Baseline Round

Quality requirements to establish a successful lung cancer screening program

Advances in the Treatment of Pulmonary Nodules

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