Outcome of Abiraterone in metastatic prostate cancer: An audit to assess real life experience in Northern Ireland

It is likely that previous exposure to other therapies such as corticosteroids may influence the ‘real world’ response rates to Abiraterone and hence we wished to assess the biochemical response rates and toxicities of Abiraterone at our institution.

The combination of Abiraterone and prednisolone has phase 3 evidence (COU -AA -301 trial) of a survival benefit over prednisolone alone in men with castration resistant metastatic prostate cancer (mCRPC) previously treated with Docetaxel chemotherapy, with median survival of 15.8 months compared to 11.2 months.

The standard: 

COU-AA-301 trial (median duration of treatment 8 months, median survival 15.8 months, PSA response in 29.5% and median time to PSA progression 8.5 months).

Target: 

• Docetaxel-containing chemotherapy regimen before - 100%

• Reasons for commencing abiraterone

• Radiological, biochemical and symptomatic progression -100%

• Performance status of patients between 0-2 -100%

• Average no of cycles of abiraterone - 8

• Were patients seen 2 weekly for LFTs and BP check in the first 3 cycles - 100%

• Median overall survival - 15.8 months

• Toxicities profile

• Death in 1st 30 days of last dose - 11%

Indicators: 

The data will show no significant difference from the standard.

Data items to be collected: 

• Patients demographics

• Time to PSA progression

• Biochemical and radiological response

• Toxicities

• Date of death

Suggested number: 

Between 60-70.

• Establish clear guidelines for departmental initiation of abiraterone to unify practise

• Establish clear guidelines for discontinuation of treatment

Personnel:

- Clinical oncologist

- Radiologist

- Specialist Nurse

- Hospital audit department

- Electronic data service manager

- Estimated time: 20-30 hours to review patients records and data collection and then data analysis

1. D e Bono et al.COU-AA-301 trial: Abiraterone and Increased Survival in Metastatic Prostate Cancer. N Engl J 2011; 364:1995-2005May 26, 2011DOI: 10.1056/NEJMoa1014618.

2. Fizazi K et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92.

Prantik Das