Appendix C. Detail on criteria for audit of the use of capecitabine and oxaliplatin in the adjuvant treatment of stage III (Dukes' C) colon cancer

Appendix C. Detail on criteria for audit of the use of capecitabine and oxaliplatin in the adjuvant treatment of stage III (Dukes' C) colon cancer

Possible objectives for an audit

An audit on the adjuvant treatment of people with stage III (Dukes' C) colon cancer could be carried out to ensure that capecitabine and oxaliplatin are being used appropriately.

Possible patients to be included in the audit

An audit could be carried out on people with stage III (Dukes' C) colon cancer seen over a suitable time period for audit; for example, 6 months or a year.

Measures that could be used as a basis for an audit

The measures that could be used in an audit of capecitabine and oxaliplatin in the adjuvant treatment of stage III (Dukes' C) colon cancer are as follows.

Criterion

Standard

Exception

Definition of terms

1. A person with stage III (Dukes' C) colon cancer is offered the following as options for adjuvant treatment following surgery for the condition:

a. capecitabine monotherapy and

b. oxaliplatin in combination with 5-FU/FA

100% of people who have stage III (Dukes' C) colon cancer and to whom adjuvant treatment is offered

A. The person has a contraindication to capecitabine

B. The person has a contraindication to oxaliplatin, 5-FU, or folinic acid

Clinicians will need to agree locally on how the offer of the treatment options is documented for audit purposes.

Contraindications for capecitabine include severe leucopenia, neutropenia, thrombocytopenia, severe hepatic impairment or severe renal impairment.

Contraindications for oxaliplatin include myelosuppression before the patient starts the first course of adjuvant treatment, as evidenced by a baseline neutrophil count of less than 2 x 109 per litre and/or a platelet count of less than 100 x 109 per litre, or peripheral neuropathy with functional impairment prior to the first course of adjuvant treatment.

See the Summary of Product Characteristics for contraindications to 5‑FU/FA.

2. The individual and the clinician(s) responsible for treatment decide jointly on the choice of adjuvant treatment after an informed discussion

100% of people who have stage III (Dukes' C) colon cancer and to whom adjuvant treatment is offered

None

Clinicians will need to agree locally on how the discussion and decision are documented for audit purposes. The discussion should take into account contraindications and the side-effect profile of the agent(s), the method of administration, and the clinical condition and preferences of the individual.

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.