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Opinion: Updated Screening Guidance Needs More Commitment, Action Steps

Prof. Denis Horgan, executive director for the European Alliance for Personalised Medicine, writes that while the intentions behind the EU’s new cancer screening recommendations are laudable, they lack a roadmap for turning ideas into reality.

By

Denis Horgan, PhD, LLM, MSc, BCL

Estimated Read Time:

11 minutes

Global Initiatives, Screening/ED
Denis Horgan, PhD, LLM, MSc, BCL

“Cancer screening saves lives.1 We can speak of cure following early detection in some cancers. It is additionally an investment as it will lead to lower health costs.”

Thus spoke European Union health commissioner Stella Kyriakides as she delivered the EU’s updated cancer screening recommendations in late September.2 The recommendations are in many respects bold and ambitious and contain the seeds of actions that could save many lives and reduce much suffering in Europe as standards of detection and early diagnosis improve across many forms of cancer.

But for lung cancer patients, more than fine words will be required to deliver on the promise. Yes, lung cancer is included for the first time as a possible field of action. What remains opaque, however, is what sort of actions must be taken. The risk is that without a more focused vision, accompanied by precise planning and commitments, lung cancer patients may continue to be disadvantaged. Lung cancer patients—as well as their families and the health systems in Europe—face a dangerous implementation gap that the recommendation does not go far enough to fulfill.

Unlike the provisions for breast and cervical cancer, which already benefit from systematic screening programs in many countries,3 screening for lung cancer in Europe remains patchy at best. Thus, the updated recommendations should have included clear and explicit commitments—and a degree of encouragement. More than three decades of research and evidence have laid the foundations on which national, regional, and local screening programs can be developed. But more precision is needed—which is the burden of this essay.

The Recommendations

The broad thesis of the recommendations is excellent, and its intentions are laudable. But it stops short of indicating pathways that will be essential to turn its ideas into reality. And its endorsement of embracing progress is undercut repeatedly by conditions and concessions and compromises that tend to reinforce the status quo rather than pushing open the door to innovation and a wider deployment of screening. The recommendation says it is part of a new EU approach to evidence-based, patient-centred cancer prevention. It explicitly recognises that “evidence shows the efficacy of screening for breast, colorectal, cervical, lung, and prostate cancers.”6

The recommendation notes that the aim is to remedy the out-of-date nature of the current 20-year-old recommendation, because no new screening tests and protocols have been validated and introduced in the member states since 2003.

“Further development of cancer screening programs should be implemented,” it says in its first paragraphs.7 There is a powerful and welcome pro-innovation tone, which is gratifying to read. However, compare that vision to the myriad conditions and exceptions with which the recommendation seeks to restrain the impetus for change, and clutters the very pathways towards that better world it evokes.

Compared to the primary aim of updating the screening recommendations for breast, cervical, and colorectal cancer, extending cancer screening to lung and prostate cancer is mentioned only as a secondary—and tenuous—goal. The recommendation notes that lung cancer was deemed only “potentially suitable for inclusion in future recommendations” in the EU’s 2019 joint partnership on cancer and in the Beating Cancer Plan. Population screening programs should be extended to cancers only “where scientific evidence demonstrates a good harm-benefit ratio, cost efficiency, advantages of early detection, and feasibility throughout the Union,” it states.7

While the new cancer screening scheme is designed to ensure that 90% of the EU population who qualify are offered screening by 2025, this benefit is restricted to breast, cervical and colorectal cancers—despite one of the aims of the recommendations being to tackle disparities.10

“Healthcare providers should be aware of all the potential benefits and risks of screening for a given type of cancer before embarking on new organized cancer screening programs,” the recommendation warns. Member states should implement new cancer screening tests in routine healthcare “only after they have been evaluated in a randomised controlled trial.”7 They should consider the introduction into routine healthcare of potentially promising new screening tests that are currently being evaluated in randomized controlled trials “once the evidence is conclusive and other relevant aspects such as cost-effectiveness in the different healthcare systems have been taken into account.” And ethical, legal, social, medical, organizational, and socio-economic aspects must be considered before decisions can be made on the implementation of cancer screening programs.7,8,9

This is quite a litany of conditions. It is not that the recommendation is wrong in pointing out that there are challenges in achieving more effective screening for Europe’s citizens. However, the recommendation risks failing in its ambitions because the guidance is overloaded with what are bound to appear as warnings. The overall impact will be to discourage rather than to encourage improvements.

What is Needed?

Much is missing from the recommendation. For example, while it offers a clear recognition of the incidence of cancer, it does not address the significance of lung cancer as a major health risk. Yet lung cancer ranks as the third most common cancer and survival rates are significantly lower (19%) than in other common cancers, including breast cancer (90%), prostate cancer (98%), and colorectal cancer (65%), according to the European Cancer Information System.11

Lung cancer has the highest economic cost of overall cancer costs in Europe.13 European cancer mortality projections predict a downward trend in most cancer types with an exception for lung cancer, where mortality is expected to rise.16

And it is not just a question of numbers.

The nature of lung cancer makes it particularly apt for screening. Its high mortality rates are inextricably correlated with the late-stage diagnosis, which leaves patients and medical professionals with limited treatment options. Detection—when it happens early—can transform the prospects for patients. Lung cancer detected at Stage 1 of the disease has a very good prognosis (~ 75% over 5-years) compared to Stage 4 which has <10% 5-years survival rate.17

For breast cancer, early screening is widely implemented across Europe with a regulatory framework of standardized guidelines and quality assurance regulations, resulting in significant reduction in patient mortality and healthcare costs. However, this is not the case for lung cancer, where there is a clear lack of coordinated actions for large scale population screening aimed at early diagnosis.

The economic impact of lung cancer is high in both direct and indirect costs, globally representing 15% to 23% of total cancer-related losses.19 In the EU, direct costs of caring for patients with the disease amount to €3 billion per year, and taking disability and premature mortality into account, total annual costs amount to more than €100 billion. The financial repercussions are evident and well understood, but do not seem to have influenced the text of the recommendation.

The recommendation’s support for continuing evolution does not translate into support for research into and development of lung cancer screening technology and pathways, new laboratory tests and biomarkers to refine risk assessment, risk stratification techniques, or the use of artificial intelligence in interpretation of results—all of which will be essential to create a functioning lung cancer screening system across Europe. The recommendation also fails to consider the unique features of lung cancer, and merely lumps it together with prostate and gastric cancer, despite the obvious differences in their nature and manifestation.

Overall, what is most conspicuously missing is any sense of long-term vision for lung cancer screening. The absence is reminiscent of the lack of vision that has characterized many EU healthcare initiatives—which has condemned them to almost immediate obsolescence or irrelevance.

Going Forward

More than a checklist, the recommendation should offer a broad vision of the role and potential of lung cancer screening during the next decade, as part of a developed lung cancer early-detection policy with clear metrics. It is essential to set EU targets to identify lung cancer early, and to persuade member states to add early detection and treatment of lung cancer to their national cancer control plans.

To be meaningful, targets need agreement on fixed timelines for preparations and for implementation. National policymakers deserve support in designing the most appropriate and cost-effective lung cancer screening programs for their healthcare systems, and mechanisms should facilitate the sharing of good practices between EU countries to ensure continual improvement.

If lung cancer is to reach its main target population, effective mechanisms for the recruitment of high-risk and hard-to-reach individuals must be designed and continually refined. Clear requirements are needed for quality and safety covering service delivery, healthcare workforce, information, medical products, financing, leadership, and governance. And access and coverage need improved efficiency.

There should be systematic engagement with lung cancer screening on standardized protocols and standardized screening guidelines across Europe, along with training programs for healthcare professionals. Programs could be made more effective through standardization of pulmonary nodule classification and measurement—one of the areas requiring greater coherence—and specific training of radiologists.

Programs complementing lung cancer screening are also required. Worldwide, tobacco use is the single greatest avoidable risk factor for lung cancer mortality. Therefore, smoking cessation programs hold a great potential for cost-effective lung cancer prevention. Other factors such as environmental exposures and genetic susceptibility should not be ignored in the design of high-risk population assessment models. Overall, the need is for a European roadmap towards the implementation of lung cancer screening, focused on reducing the variability of radiological protocols, management systems, CT systems, artificial intelligence solutions, recruitment strategies and setting benchmarking platforms and uniform quality controls.

So too does the hesitation factor in relation to healthcare innovation. One of the major paying organisations for European healthcare, AIM, has come out strongly against lung cancer screening, arguing that the “science is not solid enough.” This is the tip of an iceberg of reticence about the take-up of innovation—and insistence on absolute certainty in the face of substantial evidence risks costing rather than saving lives.

The European healthcare system remains highly focused on treatment, to the detriment of diagnostics. But if EU healthcare systems do not evolve, the EU will fall behind other regions in terms of innovation and attracting investment—and fail their patients. It has taken nearly 20 years to update the recommendation—and it is still deficient.

Systematic action and a political will to sustain and develop lung cancer screening programs are necessary now. Despite what could be done, the lack of coordinated actions and a lack of political will to contemplate necessary change is still evident in Europe.


References


About the Authors

Denis Horgan, PhD, LLM, MSc, BCL

Denis Horgan, PhD, LLM, MSc, BCL

Professor Denis Horgan is the executive director of the European Alliance for Personalised Medicine, Brussels, Belgium, and Chair of the International Cancer Genome Consortium’s Accelerating Research in Genomic Oncology (ARGO) initiative’s independent advisory committee.