Audit of the use of Sunitinib maleate in metastatic renal cell carcinoma in the North of England Cancer Network (NECN)

Audit of Sunitinib malaete in metastatic renal cell carcninoma carried out to compare use against NICE guidelines and to establish patient outcomes compared to published trial populations.

The standard: 

1) Patient selection:

   • mRCC

   • WHO performance status (PS) 0,1

2) Treatment schedule:

   • 4 weeks on 2 weeks off at 50 mg OD

   • Reduced to 37.5mg or 25mg OD to manage toxicity

3a) Trial median progression free survival (PFS):

   • 11 months [2]

3b)Trial overall survival (OS):

   • 26.4 months

Target: 

• 100 % Performance status 0-1

• 100 % Sunitinib given as described in the standard

• Comparable OS/PFS

Indicators: 

As part of early Sunitinib use at NECN, local agreement was to audit this patient population.

Data items to be collected: 

• Centre

• DOB

• Gender

• Performance status

• Diagnosis date,

• Nephrectomy?

• Mets identified date

• Pre-sunitinib treatment

• Sunitinib start date

• Best CT response

• Best CT response date

• Sunitinib Stop date

• Reason for stopping

• Haem Grade 3/4 toxicity

• Non-haem Grade 3/4 toxicity

• Hypothyroid date Dx

• New Hypertension date

• Interruption (Y/N)

• Interruption cycle

• Dose Modified (Y/N)

• Dose modifications (mg)

• Dose modified (cycle)

• Schedule change (Y/N)

• Schedule change (type)

• Progression

• Progression date

• Last seen/death date

• Current status (dead/alive)

• Post-sunitinib treatment

• Anything noteworthy?

Suggested number: 

~100 patients

This number should allow a multivariate analysis.

- Target 1 - performance status - significant determinant of outcome. If not met - explore reasons for treating poor performance status patients. Is PS an accurate representation of patient fitness?

- Target 2 - dose and scheduling. Aim to start all patients on full dose as modifications are easy to implement and lower starting doses associated with poorer outcomes

- Since completion of this audit Pazopanib has become available for first line treatment as an alternative to Sunitinib and this may be a suitable alternative to dose reductions or for patients which are considered less fit

- In addition Temsirolimus is available for high risk patients. Therefore, data collection could be adapted to include MSKCC risk factors

• Data collection was carried out using electronic records available at out cancer centres

• Two SpRs updated the patient information over an 8 month period

1. NICE Technology Appraisal 169, March 2009, http://guidance.nice.org.uk/TA169

2. Motzer RJ et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Aug 1;27(22):3584-90

Dr Bojidar B Goranov