Appendix C Detail on criteria for audit of the use of docetaxel for the treatment of hormone-refractory metastatic prostate cancer

Appendix C Detail on criteria for audit of the use of docetaxel for the treatment of hormone-refractory metastatic prostate cancer

Possible objectives for an audit

An audit could be carried out to ensure the appropriateness of use of docetaxel in men with hormone-refractory metastatic prostate cancer.

Possible patients to be included in the audit

An audit could be carried out on men with hormone-refractory metastatic prostate cancer who are seen in a reasonable time period for audit, for example, 6 months to 1 year. It may be useful to include men who were diagnosed and treated sufficiently long ago that the disease may have recurred after completion of the planned course of chemotherapy.

Measures that could be used as a basis for an audit

The measures that could be used in an audit of docetaxel for the treatment of hormone-refractory metastatic prostate cancer are as follows.

Criterion

Standard

Exception

Definition of terms

1. A man with hormone-refractory metastatic prostate cancer is offered docetaxel, within its licensed indications, as a treatment option only if his Karnofsky score is 60% or more

100% of men with hormone-refractory metastatic prostate cancer

A. The man has a contraindication to docetaxel

Hormone-refractory metastatic prostate cancer is defined either on the basis of biochemical testing (prostate-specific antigen, PSA), findings of imaging studies, or using clinical criteria of progressive metastatic disease despite castrate serum levels of testosterone. Clinicians will need to agree locally on how hormone-refractory metastatic prostate cancer is diagnosed and how the offer of docetaxel as a treatment option are documented, for audit purposes.

Karnofsky score of 60% or more means that at least the man is able to care for himself but requires occasional assistance. If the man is disabled in a manner unrelated to his likelihood of benefit or harm from docetaxel treatment of prostate cancer, the Karnofsky score should be interpreted on an individual basis at the discretion of the clinician. See appendix D for more information on the Karnofsky performance score.

For details of contraindications, see the summary of product characteristics.

2. For a man with hormone-refractory metastatic prostate cancer who has been treated with docetaxel, treatment with docetaxel is stopped when any of the following occur:

a. the planned treatment of up to 10 cycles is completed or

b. the man experiences a severe adverse event or

c. there is evidence of progression of disease

100% of men being treated with docetaxel for metastatic prostate cancer and for whom a or b or c occur

None

Adverse events are measured using the Common Toxicity Criteria of the US National Cancer Institute, version 2.

Evidence of progression of disease is by imaging studies or by clinical or laboratory criteria, which clinicians will need to agree locally, for audit purposes.

3. Repeat cycles of treatment with docetaxel are offered to a man with hormone-refractory metastatic prostate cancer if the disease recurs after completion of the planned course of chemotherapy

0% of men with hormone-refractory metastatic prostate cancer in whom the disease recurs after completion of the planned course of chemotherapy

None

Clinicians will need to agree locally how men in whom the disease recurs after completion of the planned course of chemotherapy are identified, for audit purposes.

Calculation of compliance

Compliance (%) with each measure described in the table above is calculated as follows.

Number of patients whose care is consistent with the criterion plus number of patients who meet any exception listed

x 100

Number of patients to whom the measure applies

Clinicians should review the findings of measurement, identify whether practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved.