1 Recommendations

1.1

Synergo shows promise for high-risk non-muscle-invasive bladder cancer that has not responded to or has recurred after Bacillus Calmette-Guerin (BCG) treatment, or when people cannot or do not want to have BCG treatment. However there is not enough good-quality evidence to support the case for routine adoption. Synergo should only be used with special arrangements as outlined by NICE interventional procedures guidance on intravesical microwave hyperthermia and chemotherapy for non-muscle-invasive bladder cancer.

1.2

Research is recommended on the benefits and costs of Synergo for high-risk non-muscle-invasive bladder cancer. This is to address the uncertainty in the evidence base and to inform a revised cost analysis to assess the impact of Synergo on cystectomy rates or repeat cystoscopies in people who cannot have a cystectomy. Because randomised controlled trials are challenging in this patient population, further collection and analysis of observational and NHS audit data is recommended. Find out details of required research outcomes in the section on further research in this guidance.

Why the committee made these recommendations

Synergo delivers chemotherapy and microwave energy to the bladder. Clinical experts advise that chemotherapy using Synergo would be used in the NHS for high-risk non-muscle-invasive bladder cancer after BCG has not worked, or if someone cannot or does not want to have BCG.

Synergo offers an alternative treatment to the limited options available for these people, which include radical cystectomy (removal of the bladder) or regular cystoscopies (a procedure to look inside the bladder to check for tumours and remove them if necessary). The experts advise that using Synergo for intermediate-risk cancer is unlikely to be practical. Also, there are other effective treatments available for these people.

There is some evidence that chemotherapy using Synergo could reduce the chance of the cancer returning. But this observation comes from a trial that does not reflect how Synergo is likely to be used in the NHS.

Cost modelling for Synergo is uncertain and does not reflect how it is likely to be used in the NHS. Because of this and the limitations in the clinical evidence, further research is recommended into using Synergo in high-risk non-muscle-invasive bladder cancer.