Professor Niall Corcoran, Professorial Fellow – Surgery, Royal Melbourne Hospital
10 in Victoria
The saying goes that “knowledge is power”, and in the field of medicine the resulting power is a very positive one - the ability to improve outcomes and quality of life for patients.
A recent project commenced by BioGrid Australia and led by the Royal Melbourne Hospital illustrates this power for surgeons in grappling with a common cancer that is still under-examined in terms of treatment options and outcomes.
Bladder cancer is a relatively common cancer in Australia, with around 3100 new cases diagnosed each year, the vast majority in the public health system.
According to Professor Niall Corcoran, “In many patients bladder cancer is not an aggressive cancer, it's more of a ‘nuisance’ tumour. However it is a very costly tumour to treat because patients require ongoing surveillance, involving hospital admissions and procedures over potentially an extended period of time.”
Most bladder cancer happens in older people, with the most common risk factor being smoking. These tumours tend to recur with a very low progression rate of around 5-10%.
However these slow-moving tumours are expensive to manage due to the long-term surveillance required. Initially patients will undergo surveillance scopes for the first three months, then at nine months, then annually. However it's not clear how long the surveillance is required, so a conservative approach is used. Currently the surveillance is carried out for about five years in older patients, but may continue for up to ten years in younger patients.
A more serious version of bladder cancer is ‘muscle invasive’, where the cancer is actually invading the bladder wall. These are always high grade tumours that can’t be controlled endoscopically and the patients usually require chemotherapy in combination with surgery to remove their bladder.
These occur in about 15-20% of patients, and then there's 10-15% of patients that suffer tumours that are not muscle invasive but are high grade or they have multiple low grade tumours, or there are other factors that put them at higher risk of progression. These cases require treatment into the bladder with various approaches including immunotherapy chemotherapy and more stringent surveillance. These patients will receive an endoscopy every three months for two years and every six months thereafter. They may also be receiving intravesical treatments [directly administered into the bladder], requiring an admission to hospital, 18 to 20 times over a 24 month period.
Another aspect of bladder cancer that makes the condition complex to manage is that there are limited treatment options for high grade disease.
At one end of the spectrum, there is BCG, or Bacillus Calmette-Guerin, which is a form of Mycobacterium bovis used as an immunotherapy that is directly applied into the bladder. This treatment is generally used for ‘non-muscle invasive’ bladder cancer and has been used for almost 50 years.
At the other end of the spectrum is surgery, which usually involves removal of the bladder.
Over the few years, shortages of BCG have occurred for a variety of reasons, and when that happens surgeons don’t have many other treatment options, other than surgically removing the bladder. This is a significant operation, and not one embarked upon lightly.
“What became clear last time there was a shortage of BCG is that we didn't have good data on how many patients were going to need the medication," says Professor Corcoran.
“We didn't have good statistics about incidence and prevalence and treatment patterns or occurrences. If somebody came up with an idea for an alternative treatment, we had no way to rapidly assess it in a coordinated fashion to determine if it had feasibility as an alternative therapy.”
Data about many non-muscle invasive bladder cancers are not collected by Cancer Council Victoria for the Victorian Cancer Registry, as it’s not a notifiable cancer. As a result, there are few really good statistics on elements such as incidence, recurrence rates, and health service utilisation costs.
The impact of the lack of data is exacerbated by the high cost of treatment. It was an obvious step to look at how to collect the required data to inform decisions regarding how bladder cancer is currently treated, and so the Australian Bladder Cancer (ABC) Registry was born as a Victorian Comprehensive Cancer Centre (VCCC) Alliance project. It later expanded beyond the VCCC Alliance members to include Monash Health.
“The purpose of the registry is twofold. One is to get some data on how we are treating bladder cancer in Victoria," says Professor Corcoran.
“Secondly we can use that data to benchmark practice against established quality indicators. This will enable us to confirm that we're doing as well as we can to maximise patient treatment to minimise patient recurrence and morbidity.”
There’s a bonus third use for the data in the registry – providing a platform for health service cluster randomised trials, providing more data about aspects such as optimal surveillance timelines.
The first challenge for the project is to import and harmonise all retrospective data from the variety of sources where they currently exist and then, going forward, collect prospective data.
“A lot of units have put together Excel or REDCap databases to keep track of patients on a surveillance protocol. Some of that data is even in specific endoscopy software. It's all around the place,” says Professor Corcoran.
The ABC Registry will reside in a REDCap database that has been built by BioGrid Australia and approved by the participating hospitals, whose staff will enter prospective data into it. In the meantime, the project team is sourcing funding for entry of the retrospective data.
“We would hope that because it's such an expensive cancer to treat, hospitals would be doing their own quality assurance around bladder cancer management, at least on a hospital level, if not on a state level,” says Professor Corcoran. “And we would be hopeful that we could secure some funding ongoing to keep it funded because it won't be that expensive to run once we get it going.”
In designing the registry, the project team reached out to the consortium running the Canadian National Bladder Cancer database with the objective of ensuring that the ABC Registry would be set up for future international collaboration.
“We got their database and their data dictionary and aligned our data framework with theirs, so that going forward we can collaborate with North American sites for multi institutional multinational studies,” says Professor Corcoran.
This means that some data curation will be required for the retrospective data, to ensure that the data items match up and are relevant. BioGrid Australia will be providing this data curation expertise, honed on previous registry work.
For Professor Corcoran there were obvious advantages of working with BioGrid Australia on the ABC Registry.
Professor Corcoran
Data security was another strength that BioGrid Australia offers, based on an in-depth knowledge of the needs of the clinical research community.
“They've got a data protection plan in place and they meet all of the data privacy or data protection aspects. From an ethics point of view, it's much easier if you're getting multi-institutional, multi-site ethics to use an established organisation [like BioGrid] because people are familiar with them and ethics committees are used to dealing with them.”
The benefits of tracking bladder cancer surgical quality go further than the immediate benefits of improved treatment outcomes and more cost effective patient management for the public health system.
With the potential for using the registry as a platform for research, participating surgical departments can be involved in that research, supporting their academic career and helping them to meet their Continuing Professional Development (CPD) requirements.
Professor Corcoran also hopes it will also provide junior hospital staff who are interested in a surgical career the opportunity to be involved in doing research, supporting their career progression.
It’s also positive for public hospital governance – an easy way to demonstrate that they are auditing their bladder surgery outcomes and improving their processes to improve outcomes. Ultimately this type of procedural improvement has the potential to minimise the number of times a patient is admitted to hospital, saving a lot of money at both hospital and State levels.