First UK patients recruited in international immunotherapy trial for bladder cancer
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The first UK patients have been recruited into an international trial looking at whether an immunotherapy treatment could improve the long-term outcomes following radiotherapy for patients with bladder cancer.
The BL-13 trial is being led in the UK by Dr Simon Crabb at the CRUK Southampton Clinical Trials Unit, based within the University of Southampton’s Centre for Cancer Immunology.
Around 10,000 people are diagnosed with bladder cancer each year in the UK. If the cancer has invaded the muscle wall of the bladder, patients require treatment with chemotherapy followed by either a course of radiotherapy to the bladder or a cystectomy (surgery to remove the bladder), a procedure which may impact on their quality of life.
The aim of these treatments is to cure the cancer. However, a proportion of patients will relapse, and the cancer will return, at which point treatment options are limited and patients will generally die from the disease.
The BL-13 trial is being carried out in patients with muscle-invasive bladder cancer that have opted for the radiotherapy approach to treatment. Half are then given an immunotherapy called Durvalumab, in order to boost their immune system to fight the cancer.
Dr Simon Crabb, Associate Clinical Director of the CRUK Southampton Clinical Trials Unit, said:
“Immunotherapy has already been shown to be an effective treatment in people who have advanced, incurable bladder cancer. What this trial will do is test whether patients with disease at an earlier stage may benefit from having immunotherapy added as part of their curative treatment process following chemotherapy and radiotherapy.”
Durvalumab works by binding to a protein on the surface of cancer cells meaning the body’s own immune cells are able to recognise and destroy them. It’s already used in the treatment of some lung cancers and is currently being tested in several clinical trials for other cancers such as breast and kidney cancers.
Dr Crabb continues: “The hope is that by priming the body’s own immune system to spot cancer cells, this immunotherapy will help it fight the disease and hopefully reduce the risk of cancer relapse in these patients.”
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Immunotherapy has been a “life-saver”
When Mark Harrigan was diagnosed with advanced bladder cancer at the age of 54, he was given just 10 months to live.
But four years later, the former police officer is living with his cancer thanks to an immunotherapy treatment which he calls a “life-saver”.
Mark first noticed something was wrong in early 2016 when he kept having to get up at night to go to the toilet.
“The doctor diagnosed me with a urine infection and put me on antibiotics,” says Mark. “But after several months of suspected infections and more courses of antibiotics, blood began appearing in my urine and I was sent for a cystoscopy to examine my bladder.”
“I actually saw the inside of my bladder on the screen while the procedure was happening, and I saw what looked like a growth. At that point I knew myself that it was cancer, even though the official diagnosis had not been made.”
Less than a month later Mark went to A&E when he was unable to pass urine and became ill. He underwent a TURBT operation, a procedure to remove early cancer from the bladder. He was then given the news that not only was the cancer in his bladder, but it had also spread to the prostate and he was started on chemotherapy.
“At 54, I was quite young to be diagnosed with bladder cancer. I remember the doctor who carried out the TURBT operation saying it was fairly rare for someone my age to be having the procedure. I was working as a driver at the time, having retired from the police force, but I had to give that up. The chemotherapy made me extremely sick, so it did impact on my life.”
In March 2017, after only four rounds of chemotherapy, Mark became very poorly and went back to hospital where he was told the cancer had spread to the base of his spine.
“By this stage, surgery to remove the bladder was not an option, and I was told my treatment would be palliative. I didn’t want to know my prognosis, but I later found out that the doctors thought I had around 10 months to live.”
“Then the following week, Dr Crabb called and asked me how I felt about trying an immunotherapy treatment called atezolizumab. I’d never heard of immunotherapy; the word didn’t mean anything to me. Dr Crabb explained that the treatment was fairly new and was still in some trials but was being offered to some patients on the NHS.”
Mark, who is now 58 and lives in Lyndhurst in the New Forest with his husband Lee, has a monthly infusion of atezolizumab at home and scans every three months to keep an eye on his tumour. He says the treatment has kept him alive.
“For me, immunotherapy has been a pure life-saver and I’m still here over four years later. I do have side-effects, some stomach upsets and serious fatigue, but without this treatment I probably wouldn’t be here. Although my cancer isn’t curable, it’s still being treated. The tumour will always be there because it’s in the bones, but the immunotherapy stabilises everything.”
“Sadly though, we know that immunotherapy doesn’t work for everyone or for all tumours. Therefore, it’s vital that trials like the BL-13 trial continue to happen, as the more research we can do to find new immunotherapies, the more people like me will be able to benefit.”
The BL-13 study originated from the Canadian Clinical Trials Group and the trial has already opened in Canada and Spain. The CRUK Southampton Clinical Trials Unit is running the UK part of the study with the first patients recruited at University Hospital Southampton, the Royal Marsden Hospital and the Royal Cornwall Hospital. The trial is also open at the Christie in Manchester, with several more sites due to open in the coming months.
The trial is being funded by therapeutics company AstraZeneca who make Durvalumab and has been endorsed by Cancer Research UK, which allows the trial team access to NHS resources to assist in running the study.
Watch a video on the BL-13 trial:
Notes for editors
BL-13 is a randomised phase II trial assessing trimodality therapy with or without adjuvant durvalumab to treat patients with muscle-invasive bladder cancer.
The Southampton Clinical Trials Unit (CTU) is a Cancer Research UK funded CTU with expertise in the design, conduct and analysis of interventional, multi-centre clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. For more information, visit the SCTU website.
Bladder cancer statistics from Cancer Research UK. For more information on bladder cancer and more statistics on the disease, visit the CRUK website.
The Canadian Cancer Trials Group (CCTG) is a cooperative oncology group that designs and administers clinical trials in cancer therapy, supportive care and prevention. For more information visit the CCTG website.