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Breast cancer

EU breast cancer research targets personalized treatment

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100000000000039F000002FF80EE847AToday, in most developed countries, one in eight women will likely develop breast cancer during their lifetime. Boosting support for early detection, more effective treatments and better palliative care has been the focus of Breast Cancer Awareness Month this October. One promising avenue which a number of EU-funded research projects are taking is personalised medicine – adjusting treatment to a patient’s specific circumstances and condition.

From lab to clinic

The EU project TRANSBIG has been linking laboratory work more closely to treatment with 'translational' research, says scientific director Fatima Cardoso of the Champalimaud Clinical Center in Lisbon, Portugal.: “TRANSBIG contributed to tackling the fragmentation in breast cancer translational research by strengthening relationships between leading European researchers in the field. It has also led to the successful launch of what is viewed as one of Europe’s most innovative breast cancer trials of the past decade.”

The results of the trial, known as MINDACT, will be available in 2015. The trial is investigating whether genomic analysis can help physicians make better decisions on whether a patient can avoid chemotherapy after breast cancer surgery.

Clinical trials have shown that chemotherapy, while effective, can also lead to secondary cancers, damage to the heart, early menopause and reduced cognitive functions. And a substantial proportion of patients with early-stage breast cancer are thought to be over-treated, says Cardoso. MINDACT may avoid chemotherapy in 10 – 20 % of patients.

MINDACT has enrolled more than 6 600 women in 9 countries for the research, managed by the European Organisation for the Research and Treatment of Cancer (EORTC), and developed in collaboration with the Breast International Group (BIG), coordinator of TRANSBIG.

“Hundreds of thousands of women can benefit from translating research breakthroughs to life-saving treatments for breast cancer,” said EU Research, Innovation and Science Commissioner Máire Geoghegan-Quinn. “Cancer research has been a priority for EU research funding. Some €1.4 billion was devoted to translational cancer research from 2007 to 2013. We will continue that focus under Horizon 2020, speeding up the transfer of basic knowledge to early diagnosis, preventive and therapeutic approaches.

Other EU research projects on breast cancer include EPIC, which studied how changes to a person’s diet could potentially prevent breast cancer. The CareMore and CTCTRAP projects are focusing on circulating tumour cells and DNA in a patient’s blood to guide early diagnosis and treatments for women with metastatic breast cancer. Meanwhile ASSURE is looking at ways to tailor breast cancer screening to an individual’s needs, and is developing alternatives to mammography – unsuitable for cancer detection in women with dense breasts.

Another project, RATHER, is identifying novel treatments, along with personalised diagnostic techniques, for women with triple-negative and invasive lobular breast cancer. These are difficult-to-treat cancers for which no targeted therapies are currently available. Finally, the MERIT project is developing a way to treat triple-negative breast cancers with personalised RNA vaccines that are unique to each patient.

Background

Breast cancer remains the second most common cancer in the world, and kills more women than any other cancer type. In the EU, a record 364 449 women found out they had the disease in 2012. The EU invested €160 million in breast cancer research from 2007 to 2013 and that support will continue through Horizon 2020, the new research and innovation programme for 2014-2020.

On 1 January 2014, the European Union launched a new research and innovation funding programme called Horizon 2020. Over the next seven years almost €80 billion will be invested in research and innovation projects to support Europe’s economic competitiveness and extend the frontiers of human knowledge. The EU research budget is focused mainly on improving everyday life in areas like health, the environment, transport, food and energy.

More information

BIG and TRANSBIG
EPIC
CareMore
CTCTRAP
ASSURE
RATHER
MERIT
Horizon 2020 website

Breast cancer

#EAPM - Climate change is one thing, Mr President - changes in cancer treatments are another…

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Love them or loath them, politicians from left, right and centre are an essential part of the landscape in every important arena affecting citizens, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Whatever one may make of the recent news that US President Donald Trump no longer believes that climate change is a ‘hoax’, in the wake of scientists issuing a final call to halt rising temperatures, he still says the experts have a ‘political agenda’.

Well, doesn’t everyone? And that includes in the vast arena of healthcare, although all parties are pushing for ways to imbed innovation and personalised medicine into healthcare systems as they all have a stake in making it work.

Each aspect of related regulation may not always suit everyone, but all are agreed that it is necessary, alongside cooperation, if we are to make the best of the fast-moving science for the benefit of patients.

Against this backdrop, many stakeholders in the field of cancer will come together at the ESMO Congress, which this year takes place in Munich (19-23 October). The European Alliance for Personalised Medicine (EAPM) will once again be on board, and the keynote annual oncology conference comes just a few weeks ahead of EAPM’s own event in Milan in late November. (Please see link to programme.)

The two gatherings will happen at a time when health technology assessment (HTA) is filling everyone’s minds. Indeed, last week, EAPM and its associate the Bulgarian Alliance for Precision and Personalised Medicine (BAPPM), held a key event on the future of HTA.

The conference presented and discussed the specifics of HTA in respect of personalised medicine products as well as target therapies, companion diagnostics, and innovative pharmaceutical products for personalised treatment.

Real-world data and date sharing 

One of the many important topics set to be discussed by ESMO in Munich will be the use of real-world data to complement the traditional evidence from randomised clinical trials, and EAPM has already moved forward in this regard when scoring an important victory with its MEGA initiative.     MEGA stands for Million European Genomes Alliance, and was adopted by 16 countries in a joint declaration in April 2018. It zooms in on the key goal of engaging EU and national policy makers now, in order that they understand and shape the landscape for the successful implementation of genomics and related technologies throughout healthcare.

MEGA constituted a major commitment on behalf of a coalition of willing Member States, alongside the European Commission, to join genomic databanks at an EU level for medical research.

The signatories agreed to work together “towards building a research cohort of at least one million genomes accessible in the EU by 2022”.

But although genome sequencing is starting to be introduced to clinical care, improving diagnosis and care of patients with rare genetic diseases and starting to impact on cancer diagnosis and stratification of therapies, there remain a number of key challenges to ensure genomics and related technologies are applied such that over the next few years we can fully realise the potential of personalised medicine. These will be discussed at ESMO as well as at the EAPM event a few weeks later.

Real-world data promises to substantially increase the effectiveness and efficiency of all processes in the development and utilization of medicines, from research and development, to regulatory decision-making, pricing and reimbursement decisions to use in medical practice.

However, to realize the full potential of real-world data requires a ‘learning healthcare system’, based on electronic health records and other collected healthcare data.  This would allow real-world data to be continuously fed into the system,and would complement the traditional evidence from randomised clinical trials.

However, health-care systems must be ready in terms of technology to collect data, using a methodology that analyses information taking into account aspects such as protection of personal data, consent, ethics and data access.

On immunotherapy… 

The Nobel Assembly at Karolinska Institutet this month awarded the 2018 Nobel Prize in Physiology or Medicine jointly to James P. Allison and Tasuku Honjo. The award was given “for their discovery of cancer therapy by inhibition of negative immune regulation”.

By stimulating the inherent ability of immune system to attack tumour cells the pair have established a new principle for cancer therapy.

For more than 100 years scientists attempted to engage the immune system in the fight against cancer, but progress into clinical development was modest.

Immune checkpoint therapy has now revolutionized cancer treatment and fundamentally changed the way cancer can be managed. Allison and Honjo have inspired efforts to combine different strategies to release the brakes on the immune system with the aim of eliminating tumour cells even more efficiently.

A large number of checkpoint therapy trials are currently under way against most types of cancer, and new checkpoint proteins are being tested as targets.

Targeted drugs moving house 

Targeted drugs for advanced cancer are moving from specialist units to a more-community setting these days. Almost 25% of patients with advanced cancer, treated at Comprehensive Cancer Care Network centres in the United States, are receiving innovative drugs matched to DNA mutations in their tumours.

This achievement will be reported at the ESMO Congress and will show that “cutting-edge precision medicine is spreading from highly specialist cancer units to other healthcare facilities so more patients can benefit, wherever they are treated”, say the event’s organizers.

EAPM is watching matters closely, and will follow up at its own Congress on the many important developments emerging from ESMO 2018 in Germany.  One thing is already clear, the climate is certainly changing in cancer treatment.

To register for the EAPM Congress, please click here and to see the programme click here.

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Breast cancer

Serious failure in English #BreastCancerScreening may have shortened lives - minister

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As many as 270 lives might have been shortened after errors in the breast cancer screening programme in England meant 450,000 patients were not notified for appointments, Britain’s health minister said on Wednesday (2 May), write Alistair Smout and Michael Holden.

Health Secretary Jeremy Hunt apologized for the “serious failure,” which he said was the result of a mistake in the computer system’s algorithm, and ordered an independent inquiry.

“Our current best estimate which comes with caveats ... is that there may be between 135 and 270 women who had their lives shortened as a result,” he told parliament.

“Tragically there are likely to be some people in this group who would have been alive today if the failure had not happened.”

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Breast cancer

#WorldCancerDay European cancer groups urged to take action against glyphosate

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T lymphocyte and cancer cell, SEMThe Health and Environment Alliance (HEAL) is calling on Europe’s most influential cancer societies to urge governments to put an immediate ban on glyphosate, a chemical used as a herbicide. In a letter sent on World Cancer Day 4 February from HEAL’s President, Dr Peter van den Hazel, he reminds leading national cancer groups that a ban on glyphosate represents a significant opportunity in cancer prevention.

Glyphosate was classified as a 'probable carcinogen' on the basis of currently available data by the World Health’s Organization’s (WHO) International Agency for Research on Cancer (IARC) in March 2015.

Dr Peter van den Hazel says: “Defining glyphosate as a ‘probable carcinogen’ means that scientists have been able to show that glyphosate causes cancer in mammals. Policy makers in Europe and at national level should listen to the expertise of the leading WHO scientists and now urgently reduce exposure to this herbicide. We must assume that if exposure can produce cancer in animals, it can do the same in people.”

Glyphosate is in widespread use in Europe. It is the active ingredient in most herbicides sold for use in the agricultural sector. It is also sold to consumers as a weed killer for private garden use and to public authorities to keep school grounds, hospitals grounds, public parks, pavements and railway lines clear of unwanted vegetation.

Surveys monitoring the body fluids of Europeans suggest exposure to glyphosate is increasing. Germany’s federal environment agency (UBA) recently published the results of its regular testing of glyphosate in the urine of German residents. It showed that whereas only 10 percent of 400 urine samples taken in the survey in 2001 were contaminated with glyphosate, the percentage had increased to just under 60 percent in 2013 and to 40% in 2015. Biomonitoring by Friends of the Earth Europe (FoEE) in 18 European countries in 2013 showed levels varied widely.

Existing national initiatives

Some national cancer societies in Europe have already taken the action that HEAL is promoting. Last year, the French cancer league (la Ligue contre le cancer with a membership of 700,000) issued a statement calling on the French government to ban glyphosate and four other pesticides included in the IARC classification as soon as possible. A few months later, they launched a petition to prevent renewal of the licence for glyphosate by the European Union authorities. It seems their voice was heard as a few months after the first call, the French Environment Minister required French garden centres to stop sales of glyphosate to individuals unless a qualified vendor provides advice.

In the Netherlands, private sales of herbicides containing glyphosate were banned in 2014. German state consumer protection ministries have called for a ban, and some retailers in Germany have voluntarily taken glyphosate products off their shelves. The Danish Working Environment Authority, which is under the Danish Ministry of Employment, has followed the WHO/IARC decision by declaring glyphosate as a carcinogen. This will imply changes in application practices, including recommendations to use alternative, less toxic chemicals.

Genon Jensen, HEAL’s Executive Director says that she believes national cancer societies could be highly effective in bringing about a policy change that would reduce cancer risk.  “We are asking influential cancer organisations to encourage their national authorities to ban this probable carcinogen. Now is the time to do it because the EU is reviewing whether to renew the European licence on glyphosate. So alongside taking national action at home, we are asking national governments to oppose the renewal of glyphosate’s authorisation at the EU level. Cancer leadership within the countries are well-placed to be heard and, in this way, can contribute to avoiding unnecessary cancer diagnoses from this exposure in the future.”

HEAL is a signatory to a petition to the EU Commission, the Food Safety and Health Commissioner Vytenis Andriukaitis, and responsible Ministers of the Member States calling on them not to renew the licence for glyphosate.

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