News & Updates

by Simon Rodwell | 1 November 2018 14:14

News stories on this page
December 2018: Melanoma Focus launches Sentinel Node Biopsy Guideline
October 2018: NHS England changes stopping and retreatment rules for immunotherapy patients
October 2018: Leading immunologist recommends melanoma immunotherapy patients should still receive flu jab
September 2018: First safe and effective adjuvant therapy for melanoma is now available on the NHS
July 2018: ‘How Much Is Enough’ awareness campaign launches
May 2018: Mucosal Melanoma Guidelines completed
April 2018: Acral/Mucosal Melanoma Trial seeks participants
March 2018: Development group being formed for next phase of mucosal melanoma guidelines
August 2017: Melanoma working group rejects NHS drug retreatment rules
June 2017: AVAST-M Clinical Trial final results announced
May 2017: Patient Decision Aid launched
March 2017: Melanoma treatments: new drug combo restrictions lifted
January 2017: Melanoma World Society Newsletters
June 2016: NICE approves combination immunotherapy treatment for melanoma
June 2015: Patient Impact Programme award to Newcastle University for melanoma ulceration study
June 2015: Survey finds the public are confused by sunscreen labelling
January 2015: Review of smartphone melanoma apps recommends caution
January 2015: Melanoma Focus guidelines for uveal melanoma accredited by NICE
January 2015: Encouraging results announced for new immunotherapy drug pembrolizumab
November 2013: Follow-up of high risk cutaneous melanoma cases: key paper released
October 2013: Sunbeds: an ASA Ruling

The sentinel node biopsy (SNB) surgical procedure has been used in the staging of melanoma patients for the many years. However, in the light of fundamental changes in the management of melanoma and the findings of recent clinical trials, it had become clear that there needed to be scrutiny of the role of SNB in patient prognosis and treatment, as well as the benefits or otherwise of completion lymph node dissection (CLND) following a positive biopsy of sentinel lymph nodes.

A group of clinicians, nurses and patient representatives met at the Melanoma Focus office in Cambridge earlier this year to debate the issues and reach a consensus on SNB and related issues. Their report has now been released, summarised by ten recommendations in the form of a Consensus Statement.

On CLND, the group says this ‘should not be recommended routinely for patients who have a positive sentinel node biopsy. Patients deemed at high risk should be considered for adjuvant therapy. A lymph node dissection should be considered for those patients who subsequently present with node ONLY recurrence having failed first line systemic treatment’.

Follow this link to see further details and download the guideline document.

NHS England has agreed to revise its ruling covering the stopping and re-starting of treatment for patients with melanoma who are receiving the anti PD-1 inhibitors pembrolizumab and nivolumab. This means clinicians will be able to halt treatment after two years, provided they and their patients consider this to be the correct course of action, with the assurance that funding for the drugs will continue to be available if the disease progresses and the treatment needs to be resumed.

Under the previous ruling – that once stopped, no further funding was available should treatment need to be re-started – clinicians and patients tended to adopt the understandably cautious approach of continuing treatment beyond the two-year point.

The decision is in response to an initiative by Melanoma Focus to persuade the NHS to alter its stance on this issue. There is evidence from recent clinical trials showing that for many patients the drugs have a beneficial effect within the first two years, with no additional gain in continuing the treatment for longer once a response has been confirmed. Indeed, given the severe side-effects some patients experience, ceasing treatment can often lead to significant quality of life improvements. A further advantage is the financial savings if these costly drugs can be suspended once their effect on a patient has become established.

NHS England has set a number of conditions, for example the requirement to submit a special request for retreatment, together with the collection of some additional basic data about patients. The NHS is expected to finalise the necessary procedures and documentation shortly.

Professor Paul Lorigan, chairman of Melanoma Focus, comments: ‘NHS England has responded to the evidence presented in a very positive way, recognising the advantages for patients. Clinicians and patients are completely supportive and the collection of extra data will allow a better understanding of the benefits of retreatment.

‘This is a win-win situation. Patients won’t need to be treated for longer than is necessary, while they can be confident that the drugs will still be available if needed; and there will be substantial savings for the NHS by reducing unnecessary drug treatments as well as the costs of dealing with the side-effects’.

Click here for a .pdf document giving further information for clinicians and nurses.

With the change of seasons the subject of flu vaccinations arises, specifically in relation to melanoma patients who are receiving immunotherapy treatment. Some clinicians have asked whether they should sanction this injection for such patients since, in theory, an immune adjunct might increase immune-related toxicities.

Medical oncologist Professor Christian Ottensmeier, an expert on immunology from the University of Southampton, was asked for his opinion. ‘My personal view is that there is more harm in NOT vaccinating against flu than there is in vaccinating against it,’ Professor Ottensmeier said. ‘So for inactivated vaccines such as the flu, I tell my patients to continue to have this form of protection. I expect that the worst that could happen is mildly increased flu-like symptoms if the immunotherapy makes the immune system more effective overall.

‘The adjuvant in the vaccine, which is given to make the vaccine more effective, will make antibody responses better. I think it is unlikely to have much effect on the kind of cells we aim to release with immunotherapy against the cancer (CD8 T cells). It is already reported that anti CTLA4 (for example, ipilimumab) does not alter antibody responses after non-live vaccines. There are few data for anti PD-1 – for example, nivolumab or pembrolizumab.

‘In the last flu season we noticed no extra toxicity. I think it is unlikely that either the benefit from vaccination or immunotherapy, or immune-related side effects, would be changed meaningfully after a flu vaccine.

‘The advice for live vaccines (such as the live flu vaccine, or other live vaccines such as yellow fever) is to defer or avoid vaccination in parallel with combination. I think this is because of the vaccine itself and a reflection of caution, rather than specific concerns about the combination. Consistent with this, patients who develop flu-like illnesses do not seem to be more ill if they catch these while on immunotherapy.

‘I would like to make it clear that this is based on my personal opinion and experience rather than on formal evidence from clinical studies or trials. Nonetheless, it appears to be in line with the views other clinicians in the UK and other EU countries.’

The international pharmaceutical company Novartis has made the following announcement:

‘The first BRAF-targeted treatment for post-surgery stage III melanoma patients, the most aggressive type of skin-cancer, is to be made available for NHS patients in England and Wales following appraisal by NICE (National Institute for Health and Care Excellence). Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) has been recommended as a cost-effective treatment option for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following surgery’.

Paul Lorigan, Professor of Medical Oncology at The Christie, Manchester and Chairman of Melanoma Focus, commented:

‘Across the UK we continue to see an increase in cases of melanoma. Whilst the majority of patients are cured by surgery, this is not always the case. The dabrafenib/trametinib combination is the first treatment to be made available on the NHS that shows a significant reduction in the risk of dying from the recurrence of melanoma after surgery. It will transform outcomes for many patients in England and Wales.

‘We have made huge advances in the treatment of advanced melanoma in the past ten years, but this is the first approval of a safe and effective adjuvant therapy. Such treatments are a standard of care in other cancers – including breast, lung and colorectal – but we’ve never had an effective adjuvant therapy for melanoma. Melanoma oncologists and patients have worked tirelessly for the past 20 years to find an effective adjuvant treatment. In the UK alone, we ran two big randomised studies, AVAST-M and Aim High, with more than 2,000 patients agreeing to participate. Internationally, more than 12,000 patients were enrolled in randomised interferon studies, 1,300 in the DERMA trial and many more in chemotherapy, vaccine studies and others. None of these trials showed a convincing survival benefit.

‘The situation is transformed by this milestone announcement. And it’s very likely that adjuvant immunotherapy will also be approved, further increasing the options for patients.’

Speaking on the BBC’s Victoria Derbyshire programme, Dr Pippa Corrie, Consultant and Associate Lecturer in Medical Oncology at Addenbrooke’s Hospital, Cambridge and a Trustee of Melanoma Focus, explained the need for adjuvant therapy:

‘In about half of all melanomas there is a fault in a gene called BRAF and that abnormal gene drives the cancer process. The new drugs, dabrafenib and trametinib, are given orally and they work to block the signals from the mutant BRAF gene and therefore stop the cancers growing.

‘We have been using these drugs to treat metastatic melanoma – disease that we can’t remove – but it is much better to use them up-front, because at that stage you are preventing the cancer coming back. It’s a one-year course of treatment and hopefully it will make a big difference and be more cost-effective, using it to prevent the melanoma returning rather than trying to control the disease long term.

‘This is the first time we will have an effective treatment to offer after surgery for this group of patients. It really is a major step forward’.

NEW Skin Cancer Campaign #howmuchisenough

Altruist Sunscreen and Melanoma Focus unite to raise awareness of the dangers of sun damage and tanning.

What price a tan? As the summer holidays kick in, the UK’s unhealthy obsession with getting a tan continues to claim more skin cancer cases every year – and with the heatwave showing no sign of easing up, we are deeply concerned about the lasting impact that overdoing it in the sun will have on our health.

The campaign hits back with a new series of ‘scars and all’ content shorts to tell the human stories behind three common skin cancer cases.  They reveal both the physical scars left by the disease and the psychological impact that can live on long after treatment has been completed.

Altruist and Melanoma Focus commissioned the films as a warning to the nation to take care in the sun, whether at home or abroad. 

The campaign aims to encourage people to think before they tan, asking ‘How much is enough?’ as it delivers key facts including:

Please view and share the videos to help us raise awareness and visit our websites for more information on taking care in the sun. Join the conversation at #howmuchisenough on YouTube and our social media channels  

Facebook: melanomafundraising

Twitter: @focusonmelanoma

Instagram: MelanomaFocus

Phase I of the mucosal melanoma guidelines, covering ano-uro-genital disease, has now been completed. The Guideline Development Group has released its findings, consisting of a full guideline document, care pathways for each of the disease subsets, an executive summary, a slide set and supporting documents. A summary for patients will be published shortly.

Click here for more information about the project, the GDG and links to the documents.

Melanoma Focus is pleased to support a study named PIANO, which is now open at eight UK cancer centres. PIANO will assess a treatment for patients with advanced acral and mucosal melanoma. Acral melanoma affects the palms of the hands or the soles of the feet, while mucosal melanoma occurs in the mucous membrane in the sino-nasal/head & neck or ano-uro-genital regions.

This is a small trial that aims to recruit up to 24 eligible patients with the KIT mutation. As with all trials for rare forms of melanoma, finding sufficient suitable participants is a challenge. Anyone who is interested in learning more about this study should contact Richard Hutson, Clinical Trials Project Manager, at the Manchester Academic Science Centre: 0161 918 2496 or richard.hutson@christie.nhs.uk.

Melanoma Focus is now inviting applications to join the Guideline Development Group (GDG) for the second phase of its Mucosal Melanoma Guidelines initiative. This work, which will be led by Professor Kevin Harrington of the Institute of Cancer Research on behalf of the charity, will address sino-nasal/head & neck mucosal melanoma.

This follows the success of the first phase, led by Professor Martin Gore, which is currently being completed and is expected to be published shortly.

For more information about this initiative, including details of the disease and how to apply to be considered for membership of the phase II GDG, please click here.

In a letter to NHS England by Dr Pippa Corrie, the NHSE Melanoma Working Group gives its reasons for not approving new NHS rules on funding melanoma drugs when therapy is re-started after a break in treatment.

The rules have ‘caused great concern and unhappiness across the oncology community’, Dr Corrie comments. Later in the letter she points out: ‘An unintended consequence of these new rules… may well be that patients are denied access to efficacious treatments, with consequent reduction in their survival’.

To see the letter in full – and also a link for registering as a stakeholder in consultation on this issue – click here.

The AVAST-M Trial was one of the largest melanoma trials ever undertaken, involving 1,343 patients at 48 UK hospitals between between 2007 and 2012. Final results were released at the 2017 American Society of Clinical Oncology conference.

Click here to see the patient newsletter summarising the findings, together with comments by the Trial Chief Investigator, Dr Pippa Corrie.

After eight months’ work, Melanoma Focus has launched its Patient Decision Aid (PDA), which is designed to inform people about melanoma and guide patients through the decisions they will need to take during their treatment.  By helping people to understand their options, this new online tool will improve the effectiveness of conversations between melanoma specialists and their patients. A smartphone app version is planned in due course.

More than 30 clinicians, nurses and patient representatives contributed to the project, which was chaired by the charity’s CEO, Simon Rodwell, with Melanoma Focus Trustee Dr Mark Harries as lead clinician. ‘We are extremely grateful to the steering group for all their hard work’, Simon commented. ‘The PDA marks a significant improvement in the information available to melanoma patients about their choices and treatments and will help them, their families and their carers’.

Click here to go to the PDA page on this website, or click here to go direct to the dedicated PDA website.

NHS England has now removed restrictions on access for patients to certain therapies used in combination following a consultation process involving specialist melanoma oncologists led by Melanoma Focus Trustee Dr Pippa Corrie. The combinations are dabrafenib + trametinib, which is suitable for patients with a BRAF mutation, and the immunotherapy drugs ipilimumab + nivolumab. Click here for a full description of what has changed.

We now provide links and contents lists for this new series of excellent newsletters that review recently-published papers on all aspects of melanoma medicine. Click here to visit our Library page.

The National Institute for Health and Care Excellence (NICE) has approved a combination therapy for melanoma patients in England and Wales. This means they will be the first in Europe who can be prescribed this treatment. The decision was made in record time and is expected to apply in due course throughout the United Kingdom.

Dr Paul Nathan, a consultant medical oncologist and Melanoma Focus Trustee, commented: ‘Immunotherapy is genuinely exciting, it is starting to have a profound effect on many cancers and I’m in no doubt there will be patients that have long-term durable control of their disease. It really is a game-changer.’

The drugs, nivolumab and ipilimumab, will be combined in a new therapy for people with metastatic melanoma (or disease that has spread to organs of the body beyond the skin).

Professor Peter Johnson, Cancer Research UK’s chief clinician, said: ‘These results give new hope to melanoma patients. But it’s important to remember that more powerful treatment comes with an increased chance of severe side effects. Our research now needs to identify which patients are most likely to benefit from this combination and who is most likely to experience the side effects, so doctors can make sure we get the balance right.’

NICE’s Professor Carole Longson said: ‘After one of the fastest drug appraisals NICE has carried out, these promising new immunotherapy treatments for advanced melanoma look set to significantly extend the life of people with the condition. The evidence we examined was very promising and I know further trials are ongoing which have also released encouraging data.’

Click here to read more.

Melanoma Focus has awarded funds to a scientific group based at Newcastle University to investigate the phenomenon of the ulceration of skin above a melanoma and the associated greater risk of the disease spreading to other parts of the body. The project, Validation of Ambra-1 and Loricrin as prognostic biomarkers for the early detection of high risk melanomas, will be conducted over 18 months under the direction of Dr Rob Ellis and Professor Penny Lovat and will concentrate on the role of two proteins found in the layer of skin overlying melanomas. The findings will help to predict which patients are at a higher risk of metastatic melanoma and therefore require closer follow-up, as well as investigating more effective therapies to reduce the rate of metastasis and overall mortality.

Click here for more information about the award… and here for a technical overview.

A survey by The Royal Pharmaceutical Society (RPS) has found that the public is confused about the labelling of sun creams, calling for a standardised rating method by all manufacturers.

Professor Jayne Lawrence, Chief Scientist of the RPS, said: ‘This survey indicates that there is a huge amount of confusion around sunscreen labelling that is a barrier to effective sun protection. Clearly many consumers do not realise the SPF rating applies only to the amount of protection offered against UVB rays, not UVA rays – both of which can damage the skin and cause skin cancer.

‘People should not have to pick their way through complicated dual ratings information to understand how sunscreen works and the amount of protection it potentially provides. We think it’s time for sunscreen manufacturers to provide one easy to understand rating, based on a simple description of the total amount of sun protection offered: low, medium, high and very high protection.

‘People now have largely got the message that they must protect their skin from the sun using sunscreen, along with other precautions such as covering up and keeping out of the sun during the hottest part of the day. What the RPS is calling for now is one uniform measure for all sun protection products, so pharmacists can provide easy to understand advice on the effectiveness of products and how they should be used’.

Of the 2,000 UK adults who were surveyed only one in five was aware that the SPF rating relates to protection against UVB rays, rather than against UVA radiation. There is the possibility that overexposure to UVA or UVB radiation may lead to melanoma.

A recent study of smartphone applications (‘apps’) designed to be used by non-specialists in the detection or prevention of melanoma has urged users to be cautious. The review, published in the July 2015 edition of The British Journal of Dermatology, was the work of a team led by Dr Fiona Walter from the University of Cambridge’s Department of Public Health and Primary Care. It is the most comprehensive research finding of its type.

Dr Walter said: ‘Although smartphone apps are recognized as having potentially wide use in detecting melanoma, experts have expressed caution concerning their usefulness, accuracy and safety. We identified almost 40 apps available to detect or prevent melanoma by non-specialist users – patients and GPs.

‘Most apps gave advice or education about melanoma, ultraviolet radiation exposure preventive advice and skin self-examination strategies. Only half of them enabled patients to capture and store images of their skin lesions, either for review by a dermatologist or for self-monitoring to identify change – an important predictor of melanoma. A small minority (4) provided a risk assessment about a skin lesion.

‘In summary, there was little evidence of any evaluation of their usefulness or accuracy, so clinicians and patients alike should be cautious about using these apps to detect melanoma’.

Click here to see the article.

Melanoma Focus has announced that its recently-completed national guidelines for uveal (ocular) melanoma have been awarded formal accreditation by The National Institute for Health and Care Excellence (NICE).

Melanoma Focus has funded the project. The guidelines were developed over the past three years by the group of experts, aided by patient representatives. The result is a comprehensive set of recommendations, based on the best available scientific evidence. It is expected to enhance patient care and improve counselling and informed decision-making, while helping clinicians gain a better understanding of outcomes.

For further details click here

A highly anticipated new immunotherapy from Merck & Co Inc proved effective in patients with advanced melanoma as well as some with lung cancer or head and neck cancer, according to early-stage studies presented on Monday… a Phase I study in 411 patients with melanoma that had spread to other parts of the body found that 69 percent were alive after a year of treatment. At 18 months, researchers estimated that overall survival was 62 percent, with some patients on the drug for more than two years. The findings were presented at the American Society of Clinical Oncology meeting in Chicago. (Reuters)

Click here to see the report in full

Following the recent remarkable progress in improving the treatments available for those suffering from advanced melanoma, almost 50 of the UK’s leading melanoma clinicians have reached a consensus view on the how to follow up patients believed to be at a high risk of the disease recurring.

The report’s lead author, Dr James Larkin of The Royal Marsden, said: ‘Our findings represent a significant departure from the previous guidelines, which were published in 2010. They are intended as a framework for clinical teams treating patients with melanoma. But this is a dynamic field of medicine and we expect there to be some debate over these recommendations.’

Read more about this story via this link

Incensed by the extraordinary claims in a sunbed salon’s advertising about the potential health benefits of tanning, John Rouse (an adviser to Melanoma Focus) entered battle. He anticipated having to use expert witnesses to counter the salon’s assertions but in the event the Advertising Standards Authority ruled they contravened the regulation that only products licensed for medicinal purposes may claim such benefits.

Follow this link to read John’s account in full.

Have you seen a salon near you making exorbitant claims about the ‘benefits’ of sunbeds? If so, let us know: info@melanomafocus.com

 

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