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Reviewer: Dr Lori Wood Date posted: June 21, 2007

Sunitinib versus Interferon-alfa (IFN- ) as first-line treatment of metastatic renal cell carcinoma (mRCC): Updated results and analysis of prognostic factors Authors: Motzer et al, ASCO 2007. Abstract: 5024. Reviewer: Dr Lori Wood Date posted: June 21, 2007. Treatment A:

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Reviewer: Dr Lori Wood Date posted: June 21, 2007

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  1. Sunitinib versus Interferon-alfa (IFN-) as first-line treatment of metastatic renal cell carcinoma (mRCC): Updated results and analysis of prognostic factorsAuthors: Motzer et al, ASCO 2007.Abstract: 5024 Reviewer: Dr Lori Wood Date posted: June 21, 2007

  2. Treatment A: Sunitinib 50 mg d1-28 q6 wks R Treatment B: IFN- 9 MIU 3X/wk sc Metastatic clear- cell renal cell carcinoma (n=750)

  3. RESULTS Primary Endpoint = PFS.

  4. STUDY COMMENTARY • This is an update of the previously presented (ASCO 2006) and published (NEJM 2007) data from the first-line trial of Sunitinib vs Interferon in the first line setting. • The new data included PFS for the different Motzer risk criteria. • There were very few poor prognosis patients (6%) in this study. • It did not include an update on overall survival. • Prior Motzer prognostic factors were based on patients treated with cytokines and were predictive of overall survival. This analysis looked at patients treated with Sunitinib to determine if they were predictive of PFS. • The prior risk criteria, as well as new ones ( i.e. platelet count, prior nephrectomy, number of metastatic sites), were used to develop a nomogram to predict probability of no progression at 12 months. This data was described very quickly and will need to be reviewed in more detail once published.

  5. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • In the first-line setting, Sunitinib improves PFS (11m vs 5m) and OS data is still pending (although may be confounded by second and third-line therapy). • It should be considered first-line therapy for clear-cell mRCC. • As of June 25, 2007, funding will be a major issue for Sunitinib in Canada and only patients with specific private insurance will be covered. This will greatly impact patients, their caregivers, and the oncology team.

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