Audit of Abiraterone Acetate in Clinical Practice

To establish if the results achieved in the phase-3 trial are transferable to local clinical practice [1].

Abiraterone acetate (abiraterone) is a potent antagonist of cytochrome P450 c17 which is critical in the synthesis of testosterone. Extragonadal synthesis of androgens is thought to influence progression of castrate-resistant prostate cancer. In the Greater Midlands, abiraterone has been used in patients with metastatic prostate cancer via the Cancer Drug Fund (CDF). These patients must be Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1 and have progressed after, or are intolerant to, first line chemotherapy.

The standard: 

The standard to which this audit is being compared is a phase-3 multinational randomised double-blind placebo-controlled trial involving 1195 patients.

Target: 

• Median duration of treatment - 8 months

• Death rate - 29%

• Median overall survival - 14.8 months

• PSA response - 10.2 months

• Median time to 25% of patients having a skeletal event - 9.9. months

• Improvement in pain control

• Toxicity profile

Indicators: 

The data will show no significant difference from the standard.

Data items to be collected: 

• Patient demographics

• PSA response and toxicity data from paper (free-text) and electronic records (Clinical Web Portal, Version 3)

Suggested number: 

29 patients identified through CDF application records.

The collection of further data involving other hospitals within the West Midlands and re- audit.

• Personnel: clinical oncologist, statistician

• Time for data collection

1. http://www.nejm.org/doi/full/10.1056/nejmoa1014618#t=articletop

K Marshall