An immunotherapy helps bladder cancer patients remain cancer free and enables them to avoid surgery, a phase II trial has found.
Adding durvalumab to chemotherapy and radiotherapy (chemoradiation) – without surgically removing the bladder – kept cancer at bay, according to the 12-month results of the trial presented at the American Society of Clinical Oncology (ASCO) annual meeting.
Bladder cancer is the ninth most common cancer in the world, and there are nearly 11,000 cases of bladder cancer in the UK each year.
Muscle-invasive bladder cancer is an advanced form of the disease, where the tumour has grown into the muscle wall of the bladder. It affects around 25 per cent of bladder cancer patients and has a high risk of cancer returning, with only 50 per cent of patients surviving beyond five years. It is most often treated with surgery to remove the bladder.
Surgical removal of the bladder is a big operation, and patients will need an alternative way to pass urine for the rest of their life, such as a bag outside the body.
Previous trials have shown that chemoradiation can reduce the risk of bladder cancer coming back, compared with radiotherapy alone. However, some cancers do return, and surgery is still the preferred treatment option by many clinicians, particularly outside of the UK.
The RAD-IO trial tested the addition of the immunotherapy durvalumab to the chemoradiation, without the use of surgery.
Without surgery, 85 per cent of patients saw no cancer return
The trial, led by Professor Nick James at The Institute of Cancer Research, London and Royal Marsden NHS Foundation Trust, and funded by AstraZeneca and the University of Birmingham, tested the treatment in 54 patients.
Of the 54 patients, 46 (85 per cent) had no return of cancer – either locally in the bladder or in another part of the body – after one year. In previous trials, chemoradiation, without immunotherapy, prevented cancer returning after one year in 60 per cent of patients.
Although chemotherapy and radiotherapy kill cancer cells, some residual disease survives and can adapt to hide from the immune system.
Durvalumab targets the PD-L1 protein on the surface of tumour and immune cells. PD-L1 is an immune checkpoint – it usually works as an ‘off switch’ to stop the body’s immune system from attacking healthy cells – but cancer cells can hijack this process to hide.
By blocking PD-L1, durvalumab switches the immune system on, enabling it to kill any remaining cancer cells after the chemoradiation.
Durvalumab was recently approved to treat NHS patients with muscle-invasive bladder cancer, in combination with surgery and chemotherapy. These early results from the RAD-IO trial show that the drug – with chemoradiation – works well to treat cancer and prevent its return, whilst sparing patients from bladder removal surgery.
'I expect this approach to be practice-changing'
Professor Nick James, Professor of Prostate and Bladder Cancer Research at The Institute of Cancer Research, London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, said:
“In 2012, my team showed that adding a low-cost chemotherapy drug to radiation provides good long-term benefit to bladder cancer patients. Now, we’ve shown that with the addition of immunotherapy, the combination of treatments has an even bigger improvement in outcomes – fewer cancers come back.
“Importantly, we’ve shown that it’s possible to achieve these outcomes without surgically removing the bladder. Keeping the bladder means people can avoid major, life-changing surgery and maintain more of their normal daily function and independence.
“I expect this approach to be practice-changing – offering bladder cancer patients improved outcomes whilst preserving their quality of life.”
'Spare patients the physical and psychological burden'
Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said:
“Identifying smarter, kinder treatments is a key priority in cancer research – approaches that not only control the disease effectively, but that also reduce the life-changing impact of treatment on patients.
“These results are a significant step forward for people with aggressive bladder cancer. By adding immunotherapy to chemotherapy and radiotherapy, we may be able to spare patients the physical and psychological burden of having their bladder removed entirely - and after one year, we're already seeing a meaningful reduction in the risk of the cancer returning. This builds on the recent NHS approval of this immunotherapy alongside chemotherapy and surgery and suggests that surgery itself could one day become avoidable for some patients.
“I look forward to seeing the next stages of this research as patients in the trial continue to be monitored, to find out whether this combination can deliver a long-term benefit and change standard of care for this disease.”
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Banner image: Immunofluorescence staining of bladder tumour tissue. Credit: Rose Foster, The Institute of Cancer Research, London.