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Reviewers: Drs. Daniel Heng and Lori Wood Date posted: June 18/2008

Overall Survival with Sunitinib vs. Interferon for Metastatic Renal Cell Carcinoma AUTHORS: RA Figlin, TE Hutson, P Tomczak, MD Michaelson, RM Bukowski, S Negrier, X Huang, ST Kim, I Chen, RJ Motzer ASCO 2008 Abs 5024. Reviewers: Drs. Daniel Heng and Lori Wood Date posted: June 18/2008.

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Reviewers: Drs. Daniel Heng and Lori Wood Date posted: June 18/2008

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  1. Overall Survival with Sunitinib vs. Interferon for Metastatic Renal Cell CarcinomaAUTHORS: RA Figlin, TE Hutson, P Tomczak, MD Michaelson, RM Bukowski,S Negrier, X Huang, ST Kim, I Chen, RJ MotzerASCO 2008 Abs 5024 Reviewers: Drs. Daniel Heng and Lori Wood Date posted: June 18/2008

  2. Sunitinib 50 mg PO OD (4/2wks on/off) N=375 R IFN-alfa 9 MU SC 3/wk N=375 750 patients Treatment naive Metastatic clear- cell renal cell carcinoma MSKCC Risk Profiles: Favorable 36% Intermediate 57% Poor 7% Prior Nephrectomy

  3. RESULTS

  4. Final Overall Survival Data

  5. STUDY COMMENTARY • 59% of patients in the interferon group had second-line treatment including: • 33% with sunitinib, 32% with another VEGF inhibitor • The traditional gold standard Log rank p value weights all patient events and time points equally throughout the study. p=0.051. • The secondary prespecified Wilcoxon p value places more weight on early rather than later patient events and time points. p=0.0128. • Calculating the p value while censoring patients with second-line treatment produced significant results but this introduced bias as there likely was a systematic difference in patients that were censored. • Poor risk patients only accounted for 7% of the patients. Thus, the subset analysis may not be powered sufficiently to detect a difference and the generalizability of these results to this subset may be limited.

  6. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Sunitinib produces a progression free survival benefit compared to IFN alpha in patients with mRCC treated first-line. PFS was the primary endpoint and this is a positive study. • There is a borderline overall survival benefit but this endpoint is clouded by second-line treatment of IFN patients with targeted agents. This may dilute the true OS benefit • Sunitinib remains a standard of care for the first-line treatment of mRCC in Canada • As of June 2008 in Canada: • Some provincial cancer programs cover the cost of sunitinib • Several private Canadian insurance plans include sunitinib

  7. Treatment of mRCC:Current Status *Bevacizumab and Everolimus are not yet FDA or Health Canada Approved for RCC Adapted with permission from Dr. Brian Rini

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