Interest in Lung Cancer Screening (LCS) in the UK has notably sparked in recent years, with a number of stakeholders ranging from NHS England, the Macmillan Cancer Improvement Partnership (MICP), Cancer Research UK, and the UCLH Cancer Collaborative, to high profile technology partners such as Siemens Healthineers, giving active attention to the potential population health benefits. LCS started out as a fervently debated topic following early reported activities in the late 1990s: a lot of work was subsequently carried out to determine the role of Computerised Tomography (CT), with necessary attention to uncertainty about risks (notably radiation), cost-effectiveness, and application of screening in a clinical setting. However, the announcement of the results of the American National Lung Screening Trial (NLST), demonstrating a 20% reduction in lung cancer specific mortality with screening by Low Dose CT (LDCT) in a high risk population, marked a turning point, being the first Randomized Controlled Trial (RCT) demonstrating mortality reduction with an imaging modality aimed at early lung cancer detection.
It is well documented that lung cancer kills more people in the UK (5-year survival < 13%) than any other cancer. Following the NLST in the USA, in the UK the National Institute for Health Research (NIHR) notably funded the UK Lung Cancer Screening (UKLS) pilot under its Health Technology Assessment (HTA) programme. The UKLS provided evidence in addition to existing data to suggest that LCS in the UK could potentially be implemented in the 60-75 years age group, selected via the Liverpool Lung Project risk model version 2 and using CT volumetry-based management protocols. The UKLS has notably transpired alongside a number of other European based RCT’s, commencing within the last circa 15 years, with similar target populations, that have now, or are imminently concluding (including Netherlands’ NELSON, Denmark’s DLCST, Italy’s MILD and ITALUNG, and Germany’s LUSI). It is timely to note that the data is intended to be pooled in 2017, to provide European mortality and cost-effectiveness data.
Many healthcare professionals reading this article will be aware that NHS England’s ‘Five Year Forward View’ (FYFV) articulated an ambitious integration agenda in 2014 for primary, secondary and social care, and highlighted the 3 key challenges to close the Health & Wellbeing Gap, the Care Quality Gap and the NHS Funding Gap. In 2015, Sustainability & Transformation Plans (STPs) and New Care Models/ Vanguards were outlined as the key delivery vehicles of the FYFV. The process notably moved into gear in 2016 to establish 44 STP footprints and associated plans covering October 2016 to March 2021. We now have initial publication of plans for all the STPs (currently non-statutory bodies supported by NHSE, NHSI, CQC, NICE, HEE & PHE): in essence, these are local blueprints, collaboratively developed to address the FYFV challenges, based on place and population needs, rather than organisational boundaries.
Interestingly, whilst the STP process has been progressing in England, National Cancer Strategy has also been progressing: both are referenced and interlinked in the March 2017 ‘Next Steps on the NHS FYFV’. The ‘Next Steps’, the cancer strategy’s ‘Achieving World-Class Cancer Outcomes: taking the strategy forward’ and virtually all the STP plans, articulate the message of achieving significantly enhanced cancer prevention and earlier diagnosis. The ‘Next Steps’ pledged to increase current capacity and open new ‘Rapid Diagnostic and Assessment Centres’ and facilitate patient access to state of the art new and upgraded linear accelerators (LINACs) across the country. ‘Achieving World-Class Cancer Outcomes’ pledged that; ‘Cancer Alliances’ would be rolled out across England, to provide cancer specific leadership for the new STPs; that by 2020 people will be diagnosed with cancer, or that cancer will be excluded, within 28 days of GP referral; and that 6 ‘Multidisciplinary Diagnostic Centres’ pilots for ‘non-specific but concerning’ symptoms would run over 2 years and work with ‘Cancer Alliances’ to replicate good practice countrywide.
Now that the UKLS has concluded, we await NICE policy regarding assessment of LDCT, with potential comment pending in January 2019. In the interim, public interest in LCS has increased following media reporting of the University Hospital of South Manchester (UHSM) Early Diagnosis Lung Disease Pilot funded by MCIP ahead of national policy and any consideration of a national screening programme. The pilot included patients aged between 55 and 74, with a smoking history, attending a participating GP practice and offered Lung Health Checks (LHCs). About half of the assessed patients proceeded to immediate LDCT; and consultant radiologists from across Greater Manchester hospitals impressively coordinated to facilitate rapid scan reporting. Whilst not a formal RCT, public engagement was notably significant and the pilot clearly contributed to demonstration of effectiveness of early diagnosis and community adoption rates.
Following the earlier NLST, several medical societies now actually recommend LDCT for LCS and notably in the USA, Medicare and Medicaid now provide associated insurance coverage. Millions of healthy high risk individuals are therefore theoretically eligible for LDCT LCS. Whilst this is not yet true in the UK, there is clearly demonstrable interest in LDCT LCS and a national drive to achieve earlier lung cancer diagnosis. Notably, the BMJ featured a report in February 2017: analysis of a 10-year lung cancer screening study that examined high-risk smokers with more than 20 pack-years of smoking history, and highlighting a conclusion that despite inevitable risk associated with ionizing radiation from LDCT LCS, that the benefits of lung screening outweigh any potential harms from radiation. Based on a calculation of actual radiation dose, the review concluded that cumulative dose in the 10th year of screening was less than 10 mSv for men and 13 mSv for women, generating 1 radiation-induced major cancer for every 108 lung cancers that would be detected through screening. Whilst non-negligible, the risk was considered acceptable due to the substantial mortality reduction. Siemens Healthineers are pushing even further, having long standing experience in dose reduction technology, and can leverage a unique LDCT empowered product range. By virtue of spectral filtering / tin filter mode on its high end 192/384 slice ‘Somatom Force’, and now also on its 16/32 slice ‘Somatom Go Now’, Siemens Healthineers provides market leading potential dose reduction of up to 50% in lung and colon exams and establishes a new standard in the examination of high-risk, asymptomatic patients.
Further validation in the UK is now set to be established by the ‘UCLH Cancer Collaborative’ under the New care Models Programme, which under UK national cancer strategy, is now also a designated ‘Cancer Alliance’. It is noted that its associated ‘Lung Cancer Programme’ will like preceding RCT’s, utilise LHCs and LDCT; is intending 20,000 participants; and will run in North and East London from 2017 for 3.5 years. It is also noted that Third Sector partners are heavily invested in the NHS England, ‘Accelerate, Coordinate, Evaluate (ACE) Progamme’, with aim to develop the knowledge base on early diagnosis, evaluating and spreading good practice, to inform cancer commissioning in England - specifically; a shift from late to early diagnosis of cancer at stages I & II; a decrease in cancer diagnoses via emergency presentations; and improvements in overall patient experience. The programme notably had a number of cluster projects focusing on early lung cancer diagnosis: those focusing on lung cancer pathways for patients presenting with symptoms have recently concluded: however, others exploring impact of proactive approaches such as LDCT screening for patients at higher risk of lung cancer, many of whom would be asymptomatic, are notably working to a longer time frame. Siemens Healthineers is therefore remaining close to the LDCT LCS journey in the UK, and is committed to maintaining market leading dose to maximize the potential for LCS to contribute to earlier lung cancer diagnosis.