Bladder cancer treatment can be better targeted and more effective, trials show

Testing for tumour DNA in the blood can successfully identify advanced bladder cancer patients who will not relapse following surgery, new phase 3 research presented at the 2024 European Association of Urology (EAU) Annual Congress showed.

This could allow doctors to target treatments more effectively to those who need it and spare those patients for whom further treatment is unnecessary, researchers say.

The findings from the screening phase of the IMvigor011 phase 3 trial show that just over 90 per cent of muscle invasive bladder cancer (MIBC) patients with a negative circulating DNA (ctDNA) test following surgery, which remained negative on follow-up, did not relapse. The findings mean that use of a ctDNA test could allow some patients to be spared further treatment with minimal risk.

Around half of MIBC patients experience cancer recurrence, often in the lungs and usually within two-to-three years. All patients are currently offered follow-up treatment such as chemotherapy or immunotherapy to prevent recurrence, for which the
side-effects can be serious and life-changing. Other phase 3 trial results, also presented at the EAU Congress, show that patients given immunotherapy, nivolumab, as a follow-up to surgery have an average survival of nearly six years, compared to four years for patients on placebo.

Prof Joost Boormans, Professor of Urology at Erasmus University Medical Centre in Rotterdam, Netherlands, and member of the EAU Scientific Congress Office, said: “Although we already knew that nivolumab improved disease-free survival in MIBC patients who received radical surgery, overall survival is what really matters following local treatment, such as radical surgery. These interim findings, which show that overall survival also improves, are very encouraging, particularly as this hasn’t been the case in other recent immunotherapy trials.

“The question for regulators and healthcare authorities is whether the improvement in overall survival is enough to justify licensing or prescribing the drug for all patients, in the knowledge that some of these patients would have been cured of their cancer by surgery alone. This is where the findings from the IMvigor011 trial could really make a difference, by allowing us to select patients at highest risk who will benefit the most from treatment while sparing others for whom it isn’t needed.”

Meanwhile, separate research presented at the EAU Congress showed how a simple urine test can more than halve the number of cystoscopies necessary to follow up high-risk bladder cancer patients.

Initial results from a two-year study suggest that there is also no increased risk of recurrence in patients who had a urine biomarker test rather than a standard flexible cystoscopy. Full results on this aspect of the trial are expected in the summer.

The study was carried out in Denmark, where post-surgical follow-up for high-risk bladder cancer recommends cystoscopies every four months for two years. The new research is the first time a urine biomarker test has been assessed in a randomised interventional controlled trial with high-risk patients. This trial design allowed the researchers to assess whether the test could reduce the number of cystoscopies patients had to undergo, as well as picking up any signs of returning cancer. Previous studies have only assessed biomarker tests observationally, adding the biomarker tests to existing standard of care.