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Southampton Clinical Trials UnitNews

Major breakthrough could help patients with mesothelioma

Published: 1 February 2021
Professors Griffiths and Fennell
Professors Gareth Griffiths and Dean Fennell

Researchers at the Southampton Clinical Trials Unit (SCTU) have made a major breakthrough that could help patients with mesothelioma survive for longer.

People diagnosed with the aggressive form of cancer, linked to breathing in asbestos fibres, could have more time with their loved ones when prescribed an immunotherapy drug currently used to treat several other types of cancer, new research has found.

The CONFIRM* trial was led by Professor Gareth Griffiths at the CRUK Southampton Clinical Trials Unit, based at the University of Southampton’s Centre for Cancer Immunology, and Professor Dean Fennell at the University of Leicester.

Funded by Cancer Research UK's Stand Up To Cancer campaign, the trial found that an immunotherapy called nivolumab** increased survival and made the disease more stable for patients who relapsed following standard treatment.

A total of 332 patients whose tumours were still growing after receiving chemotherapy and who were not able to have surgery, took part in the randomised trial.

A total of 221 of those patients were given nivolumab and the remaining 111 given a placebo once every fortnight for up to 12 months. Twenty-one of the patients who took part in the trial were treated at University Hospital Southampton.

It’s the first study to show that a treatment has been able to improve survival in patients with mesothelioma that has come back after chemotherapy*** Until now, no treatment had been found that could significantly improve outcomes for patients.

The impressive findings, which saw those who had nivolumab survive an average of 9.2 months compared to those in the placebo group who survived 6.6 months,  were presented to oncologists and researchers around the world at the World Conference on Lung Cancer**** at the weekend.

Patients who received nivolumab also had more stable disease. The risk of their cancer progressing was reduced by 39%, with people not seeing their cancer worsening for 3.0 months compared with 1.8 months in the placebo group.

Mesothelioma develops in the lining of the lungs or abdomen, with most cases caused by exposure to the now outlawed industrial material, asbestos*****. Currently seven per cent of people survive their disease for five years or more.

Each year, around 90 people are diagnosed with mesothelioma in Hampshire******. Cases of mesothelioma in the UK have increased by 61% since the early 1990s. It is particularly high in areas where shipping and mining industries formerly thrived.

Patients are usually treated with chemotherapy, surgery or radiotherapy. But treatment options start to become limited once people stop responding to their treatment.

During the COVID-19 pandemic, NHS England endorsed nivolumab for use in some people with malignant mesothelioma as an alternative to chemotherapy because it has less of a suppressive effect on the immune system and may reduce the risk of someone becoming seriously ill during the pandemic******. This decision is currently in place until the end of March but the data from the CONFIRM trial could help to make this option permanently available to patients.

Professor Gareth Griffiths, Director of the Cancer Research UK Southampton Clinical Trials Unit at the University of Southampton, said: “This trial shows clear evidence of benefit and marks a major breakthrough in the treatment of mesothelioma, a disease where there are currently very few options for patients when first-line chemotherapy has stopped working and prognosis is often very poor.

“This is the first study ever to show improved survival and we therefore believe that nivolumab could be a game-changer for treating mesothelioma patients in the future.”

Michelle Mitchell, Cancer Research UK’s chief executive, said:  “Nearly half a century ago, Cancer Research UK scientists added to the understanding of just how dangerous asbestos could be. This research helped change regulations, reducing workers exposure to this deadly substance. But mesothelioma can take over 40 years to develop, and the long and painful legacy of asbestos use is still sadly being felt today.

“It’s wonderful news to hear that we may have found a new treatment for people with mesothelioma who have run out of options, when there has been so little progress over the years. We hope that NICE considers nivolumab as a treatment option, which will give people with mesothelioma precious extra time with their loved ones.”

"It's wonderful knowing you are helping to improve treatments"

Carol Wesson, 73, from Wimborne in Dorset, was one of the people who took part in the CONFIRM trial. Carol developed mesothelioma after years working for a company that used asbestos rope as a door seal in the manufacture of stoves.

“I didn’t work on the factory floor,” says Carol. “I was in the sales team and worked mainly in the office. But sometimes when things were busy, or a customer needed a replacement seal, I would help out by going into the factory and cutting a piece of the asbestos rope. I just used a pair of big scissors and you could see the fibres coming off the rope as I cut.”

In late 2016, Carol began to notice changes to how she was feeling. “I would be out walking my dogs and I would start to feel breathless going up hills. Then I developed a cough so in the New Year I went to see the doctor and was referred to hospital where I was diagnosed with cancer.”

“The day I was diagnosed I was told the prognosis was about a year. I was completely shocked, stunned. There was no cancer in my family. I had never been ill in my life.  I had worked for years without a day’s sickness."

After being diagnosed with Mesothelioma in January 2017, Carol was treated with chemotherapy. But she was then given the chance to take part in an early-phase clinical trial called VIM, and later went on to participate in CONFIRM.

She said: “I think it is so important for patients to be involved in research. When I was offered the chance to be part of the CONFIRM trial at Bournemouth Hospital, I jumped at it. It’s wonderful knowing that you are not only potentially helping yourself, but also helping improve treatment for more patients in the future.”

Carol Wesson is one of the patients who has been able to receive nivolumab through the NHS eight months after she finished on the CONFIRM trial.

She added: “It’s made a huge difference to my life. I can go out and walk my dogs, I split logs for my wood burner, and I do my garden. I can’t do everything exactly as I used to but then I am 73. I don’t take much notice of my age any more than I do of my tumour. I just get on with enjoying my life.”



Notes for editors

* CONFIRM: Checkpoint Blockade for Inhibition of Relapsed Mesothelioma (NCT03063450)

** Stand Up To Cancer, a joint national fundraising campaign from Cancer Research UK and Channel 4

*** Nivolumab (brand name OPDIVO) is a human immunoglobulin G4 monoclonal antibody which binds to the programmed death-1 (PD-1) receptor thereby potentiating an immune response to tumour cells

**** Presented at the International Association for the Study of Lung Cancer World Conference on Lung Cancer by Professor Dean Fennell, Chair of Thoracic Medical Oncology at the University of Leicester in collaboration with Professor Gareth Griffiths and his team at Southampton Clinical Trials Unit, University of Southampton.

****** Mesothelioma is quite a rare cancer, and it is estimated that in the UK, more than 9 out of 10 men with mesothelioma, and more than 8 out of 10 women with this type of cancer have been in contact with asbestos.

******* Based on the average annual number of new causes of mesothelioma (ICD10 C45) diagnosed in Hampshire (upper tier local authority) between 2015 and 2017.

Source: These data were extracted from the Public Health England’s Cancer Analysis System, snapshot CAS1902. Accessed 11/01/2021. This work is only possible because of data from the cancer registry, which is routinely collected by the NHS as part of patient care.

******During the COVID-19 pandemic, NHS England endorsed a range of interim treatment options including the use of nivolumab for people with malignant mesothelioma to protect those with cancer and make the best use of NHS resources during the pandemic, already available drugs like nivolumab were approved for use in a wider pool of cancer types. This approval is temporary however, and the team behind CONFIRM are dedicated to getting nivolumab permanently included into NICE guidelines where it could become a standard treatment for mesothelioma on the NHS. 

******** Nivolumab is currently licensed for: melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), classical hodgkin lymphoma (cHL), squamous cell cancer of the head and neck (SCCHN), urothelial carcinoma and oesophageal squamous cell carcinoma (OSCC)

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