Until recently, people with advanced bladder cancer routinely received between four to six cycles of intensive chemotherapy, followed by avelumab, a type of immunotherapy, as standard NHS care. While effective, this treatment can often cause severe side effects, including extreme fatigue, nausea, infections and long-term impacts on daily life.
The international, investigator-led, randomised phase II DISCUS trial, published today in Annals of Oncology, sought to find out if giving patients fewer rounds of chemotherapy could help them survive just as long as current standard care, while causing fewer side effects and making treatment easier to cope with.
The study included 267 people with advanced bladder cancer. Participants were allocated to receive either three cycles of chemotherapy, or the previous standard of six chemotherapy cycles, followed by avelumab. The study found that:
- those who received three-cycles of chemotherapy reported their quality of life remained the same, while those in the six-cycle group reported a poorer quality of life.
- the median overall survival was the same for those undergoing three cycles and those undergoing six cycles.
- severe side effects were less common in those who received fewer cycles of chemotherapy.
As a result of this research, NHS guidelines have been updated, offering eligible patients a choice between three and six cycles of chemotherapy followed by maintenance avelumab. By halving the number of chemotherapy cycles, treatment and quality of life is expected to improve for hundreds of patients each year, reducing unnecessary side effects while maintaining the chance of controlling the disease.
Lead author Thomas Powles, Professor of Genitourinary Oncology at Queen Mary University of London and Director of the Barts Cancer Centre at Barts Health NHS Trust, said: "Fewer cycles of chemotherapy appear to improve quality of life without significantly compromising activity. This is particularly attractive for those patients who struggle with side effects."
Second author, Syed A Hussain, Professor of Medical Oncology and Honorary consultant, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust said: "This update to NHS England guidance has the potential to benefit a significant proportion of patients, particularly those who discontinue chemotherapy after three cycles because of treatment-related toxicity.
"It is exciting to see that the DISCUS results have helped to change NHS England guidelines and patients can now be offered maintenance Avelumab treatment after three cycles of platinum-based chemotherapy."
Cynthia's story
Cynthia Haywood, 79, from Bakewell, was diagnosed with advanced bladder cancer two years ago and was told she would likely only survive another nine to twelve months due to its aggressive nature.
Following surgery, she was referred to Weston Park Cancer Centre in Sheffield where her consultant, Professor Hussain, told her about the DISCUS trial.
"I had been diagnosed with quite an advanced bladder cancer so it was a bit scary and at that stage I felt like I should grab anything to help."
She was randomised into the previous six-cycle group of standard care, but on the fourth chemotherapy cycle she was stricken by a "horrible rash". Although she was promptly put on a drip for a few days to treat the severe allergic reaction, owing to the toxic effect of the treatment doctors decided it was no longer safe for her to continue with chemotherapy, and she was offered the maintenance avelumab treatment.
"I started on the immunotherapy two years ago in April and I've been great on that. I've not felt ill, and I feel my usual self on it," Cynthia said.
"When I was on the chemo, I felt quite weary and was wanting to get into bed but now my energy levels are normal, and I can lead a normal sort of life and go out and do something every day."
Cynthia, who turns 80 next week, now visits Weston Park Cancer Centre every fortnight to have her maintenance treatment.
"I've been extremely lucky to be on the trial. It's certainly improved my standard of life. The cancer's still there but it's not got worse over the last few scans so that's the main thing. I can't praise the team at Weston Park Cancer Centre enough for their constant care and support. Without the trial I would not be here now. If it has helped others too, that's a nice feeling as well."
