The importance of data to improve patient outcomes with bladder cancer

Bladder cancer occurs when abnormal cells in the bladder grow and divide in an uncontrolled manner. It can take different forms. It is the fourth most common cancer in Australian men with the most common symptom of bladder cancer being blood in the urine, which can occur suddenly and is generally not painful. In 2020 an estimated 3098 people in Australia will be diagnosed with bladder cancer.

Radical cystectomy (bladder removal) surgery for bladder cancer is associated with significant risk of morbidity and mortality to patients. Currently there is a lack of good quality research carried out specifically in patients who underwent radical cystectomy to identify treatments or interventions that actually improve patient outcome.

The ACCEPT study is a secure online collaborative multicentre cystectomy database which acts as a portal for data collection. The data obtained will allow healthcare professionals to analyse the type of interventions currently used by participating urologists and the associated outcome and complications. Subsequently, this information will be used to formulate intervention and control arms for a future randomised controlled trial.

The study is led by ANZUP member Professor Dickon Hayne based at Fiona Stanley Hospital in Perth, Western Australia. To date there are 78 patients participating in the study with six other member sites and their patients in Queensland, Victoria and NSW preparing to join the study over the coming months. This is the first study of its type for bladder cancer. At ANZUP’s recent Annual Scientific Meeting, Prof Hayne presented an update on the progression of the ACCEPT study:

• First reported data from the database is being analysed;

• The range of data includes large contemporary and unselected Australian cases;

• Results compare favourably to national and international literature particularly in relation to major complications and mortality;

• Supports evidence based principles of high volume surgeons and centres and adoption of best practice to improve cystectomy outcomes;

• Widespread participation is encouraged to help improve patient outcomes across Australia, New

Zealand and globally.

“We are delighted to have data from the ACCEPT database to analyse. Working into the future we hope to galvanise additional multicentres to make this project a truly effective tool for cancer.” Professor Dickon Hayne.

The ACCEPT study has been funded by ANZUP’s Below the Belt Research Fund and more recently support has been received from the McCusker Foundation. ANZUP is extremely grateful to the McCusker Foundation for their support.

ANZUP are currently running a number of bladder cancer trials. For more details information about these trials, go to the ANZUP bladder cancer trials web page: http://bit.ly/ANZUPbladder

BCG+MM

Status: Open & recruiting

Location: Australia

Activated sites: 12

Patients recruited: 309

Patients required: Stage one: 130 / Stage two: 370

Non-muscle invasive bladder cancer is common and causes substantial suffering. It requires removal or irradiation of the bladder within five years in more than 30% of people with high-risk tumours, despite best current treatment.

Recent preliminary studies show promising results from adding mitomycin (MM), a chemotherapy drug, to current treatment with BCG (Bacillus Calmette-Guérin, a strain of modified bacteria which stimulates an immune response to early cancer cells).

This randomised trial will determine the effects of adding mitomycin on cure rates, survival, side effects and quality of life. This could potentially provide a simple and costeffective treatment for patients who suffer from this cancer.

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC). This ANZUP investigator-initiated study is being funded by Cancer Australia and the National Health and Medical Research Council. We acknowledge Omegapharm and Merck Sharp & Dohme for providing the study drugs.

Current site locations for the BCG + MM trial are:

NSW •Concord Repatriation General Hospital •John Hunter Hospital •Northern Cancer Institute, St Leonards •Southside Cancer Care Centre •The Tweed Hospital •Westmead Hospital

VIC •The Alfred Hospital •Austin Hospital •Epworth HealthCare (Richmond) •Frankston Hospital •Royal Melbourne Hospital

WA •Fiona Stanley Hospital

PCR-MIB

Status: Open & recruiting

Location: Australia wide

Activated sites: 6

Patients recruited: 24 • Patients required: 30

Opened in mid-2016, this trial is aimed at managing bladder cancer that has spread into the wall of the bladder. A combination of chemotherapy and radiotherapy is the current standard treatment. This study aims to assess if it is safe and effective to add an additional new drug called pembrolizumab to the standard therapy of chemotherapy and radiation therapy.

Pembrolizumab is a new treatment that “takes the brakes off” the immune system, allowing it to attack cancers more effectively. Studies of pembrolizumab in widespread bladder cancer have shown benefit, with cancer shrinkage observed in about two thirds of people, and in some cases long periods of disease control. At present, pembrolizumab, is approved for use in Australia for the treatment of advanced melanoma in adults.

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

We thank and acknowledge MSD for their funding and product support.

If a clinical trial proves that a treatment is more effective than existing options, it may become the new standard of care for patients in the future.

Current site locations for the PCR-MIB ANZUP clinical trial:

NSW •Chris O’Brien Lifehouse •Liverpool Hospital •Prince of Wales Hospital •Royal North Shore Hospital

VIC •Austin Hospital

WA •Sir Charles Gairdner Hospital