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Denis Horgan



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    WS 01 - IASLC Supporting the Implementation of Quality Assured Global CT Screening Workshop (By Invitation Only) (ID 632)

    • Event: WCLC 2017
    • Type: Workshop
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      WS 01.33 - EU Commission Recommendations on Screening (ID 10678)

      15:20 - 15:30  |  Presenting Author(s): Denis Horgan

      • Abstract

      Abstract:
      Screening for diseases - such as breast, prostate and lung cancers - has always been a topic beset with arguments, as well as debates about the pros and cons. The discussion has taken place for some time on both sides of the Atlantic and shows no sign of abating any time soon, with many arguing, for example, that over-testing can very easily lead to over-treatment, including unnecessary invasive surgery. Some have even suggested that the intensive screening for cancer in women’s breasts is due to cosmetic reasons - relating to the perceived attractiveness of breasts and the way that society views a woman with missing breasts - to the detriment of screening for other parts of the body. The latter is surely a patent nonsense, given the number of deaths that could occur with this type of cancer and the amount of fatalities that are actually avoided. Screening should not be about cosmetic issues. Nor should be about cost or, indeed, politics (sexual or otherwise). However, the over-treatment argument has also been used in respect of the aforementioned breast cancer screening, although the figures tend to show that it works very well in a preventative sense and even better in detecting early breast cancer in target age groups. PSA testing for prostate cancer has also come in for similar criticism. The counter-arguments - and they are very strong ones - is that our ‘social contract’ has obligations to ensure to the highest standards possible regarding the health of citizens and that, fiscally, forewarned is forearmed and can save a great deal of money down the line. The majority of experts (and, importantly, patients) would argue that there is a clear added value in properly run screening programmes, although this may vary - as do resources - across the 28 EU Member States. These differences also affect data collection, storage and sharing, the general delivery of healthcare, and levels of reimbursement, to name but a few. The US approach to screening is similar to that found in Europe, but clearly we should be relying on our own data, findings and - crucially - recommendations, without totally relying on theirs. Without doubt, all screening programmes - wherever on the planet they take place - have to be based on gathered evidence of efficacy, cost effectiveness and risk. Any new screening initiative should also factor in education, testing and programme management, as well as other aspects such as quality-assurance measures. Two vital bottom-lines are that access to such screening programmes should be equitable amongst the targeted population, and that benefit can be clearly shown to outweigh any harm. Key to screening will be the issues surrounding how healthcare is governed in the EU and what influence, in effect, Brussels can and does have, bearing in mind that much of the areas of health come under Member State competence (although Europe has stepped up of late in areas such as clinical trials and IVDs). EU healthcare governance can be divided in general into two paradigms - these are top-down regulatory frameworks and/or bottom-up frameworks. Stakeholders will remember the admin and voting nightmare that was the general data protection regulation (which saw more than 4,000 amendments), as well as the clinical trials regulation, which took more than a decade to revise. Arguably, today, guidelines (on screening and more) may well be the way forward, given that they potentially have less rigidity and therefore more flexibility (within strict standards of safety and ethics, of course). We can clearly see that innovation has brought about a greater need for adaptation through appropriate frameworks that must be designed by experts, in consensus - albeit with plenty of necessary input from regulatory bodies. It is vital to ensure that any and all agreed standards can be met down the line. These include the aforementioned ethical considerations, patient safety, certainty within timeframes and facilitation of advancements for the benefit of Europe’s patients and our society in general. Screening needs to be continuously reassessed, with guidelines updated when applicable. Despite arguments of over-treatment and issues of cost, it is one of the most potent preventative tools available to us today.

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    WS 02 - IASLC Symposium on the Advances in Lung Cancer CT Screening (Ticketed Session SOLD OUT) (ID 631)

    • Event: WCLC 2017
    • Type: Symposium
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      WS 02.05 - The European Commission Recommendations on Lung Cancer Screening (ID 10622)

      10:40 - 11:00  |  Presenting Author(s): Denis Horgan

      • Abstract
      • Presentation

      Abstract:
      Around one billion people on the planet are regular smokers. And lung cancer is one of the biggest killers. We all now know that there is a direct connection in many cases. Non-smokers do get lung cancer, but the risks if you are a smoker are significantly. Undoubtedly, tobacco smoking is the major risk factor for lung cancer, although passive smoking, and a family history of lung, head and neck cancer are, among other factors, also important. Figures show that lung cancer causes almost 1.4 million deaths each year worldwide, representing almost one-fifth of all cancer deaths. Within the EU, meanwhile, lung cancer is also the biggest killer of all cancers, responsible for almost 270,000 annual deaths (some 21%). It is at the very least surprising that the biggest cancer killer of all does not have a solid set of screening guidelines across Europe, Doctors need to quickly identify high quality, trustworthy clinical practice guidelines, in order to improve decision making for the benefit of their patients. The Alliance has turned its attention to need for more guidelines across the arena of healthcare, especially in screening for lung cancer. There is a need for agreement and coordination across the European Union’s 28 Member States. In the US, the American Cancer Society has stated that it had “thoroughly reviewed the subject of lung cancer screening” and issued guidelines that are aimed at doctors and other health care providers. Europe, among other things, is looking at risk prediction models to identify patients for screening, plus determination of how many annual screening rounds is enough. Of course, cost-effectiveness questions arise whenever population-wide screening is considered, especially in relation to frequency and duration. Yet, the potential benefit of low-dose CT lung cancer screening would almost certainly see an improvement in the lung cancer mortality rate in Europe. Stakeholders are aware that screening for lung cancer also has potential harms. These include radiation risks (increased risk of other cancers), identification of often harmless nodules, which could lead to further evaluation (including biopsy or surgery), unnecessary fear in the patient and those close to him or her, and over-diagnosis and possibly subsequent treatment of cancerous cells that would cause no ill effects over a lifetime. Often, malignant small lesions are found that would not grow, spread, or cause death. This could lead to over-diagnosis or over-treatment, bringing about extra cost, anxiety and ill-effect (even death) caused by the treatment itself. On the other hand screening can help to ensure that surgery in lung cancer’s early stages can continue to be the most effective treatment for the disease. As it stands, most patients are diagnosed at an advanced stage - usually non-curable. EAPM, along with other aforementioned stakeholders, believes that there is a strong case for lung cancer screening programmes across the 28 EU Member States to reduce the cases of advanced-stage lung cancer. Among recommendations currently being discussed in European forums are the setting of minimum requirements, which should include standardised operating procedures for low-dose imaging, criteria for inclusion (or exclusion) for screening and, of course, smoking cessation programmes. Also important are improving the quality, outcome and cost-effectiveness of screening, reducing radiation risks, and making thorough assessments of other risks, such as co-morbidities. ERS and ESR have stated that “the establishment of a central registry, including biobank and image bank, and preferably on a European level, is strongly encouraged”, and EAPM is in full support of this. Current situation In the US, lung cancer screening has been the subject of major policy decisions and investigations. One finding showed that a screening trial brought about a 20% drop in lung cancer mortality. On the back of this, several mainstream clinical and professional organisation recommended the implementation of screening. In Europe, the Dutch and Belgian NELSON lower-dose computed tomography (CT) trial is producing data on mortality rates (and, of course, cost effectiveness). The NELSON study was designed to investigate whether screening for lung cancer by low-dose CT in high-risk subjects would lead to a decrease in 10-year lung cancer mortality of at least 25%. This to be looked at in comparison to a control group which was not undergoing screening. The NELSON study began in 2003, using men aged 50–75 years from seven districts in the Netherlands and subjects from both sexes from 14 close geographical areas in Belgium. Initially, these subjects were sent a questionnaire about general health, how much they smoked, their cancer history, and several other lifestyle and health factors. Based on the smoking history, the estimated lung cancer mortality risk of the respondents was determined. Next, the required sample size including required participation rate was determined. Thirteen years on and the results from the final, fourth round of what is EU’s largest trial have found that leaving a two-and-a-half-year interval reduced the effect of screening. In essence this means that the cancer rate showed higher levels than found with one-year and two-year screening intervals. Crucially, in the final round, occurrences of the advanced-stage disease were higher than previous rounds and, as discussed above, that invariably means more deaths. Further EU pooled trial results are expected to come along soon, in the wake of NELSON.Conclusions Findings in both Europe and the US strongly suggest that lung cancer screening works. Current evidence is, as yet, limited and the discussion continues. But there is hard evidence, although debate continues about the best way to implement screening of this kind, and even how to properly evaluate ‘cost effectiveness’ - who should decide? Of course, guidelines could help to tether costs, by bringing in improvements to the efficiency of screening methodologies and, thus, programmes themselves. Key to such a situation would be making the best use of efficient risk-assessment methods, top-of-the-range imaging technology, and guidelines that encourage the minimisation of invasive procedures and risk to the patient.

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