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Lynn M. Schuchter, M.D. Associate Professor of Medicine University of Pennsylvania Cancer Center

Lynn M. Schuchter, M.D. Associate Professor of Medicine University of Pennsylvania Cancer Center. Why is there so much controversy regarding the role of IFN in patients with high risk melanoma?.

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Lynn M. Schuchter, M.D. Associate Professor of Medicine University of Pennsylvania Cancer Center

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  1. Lynn M. Schuchter, M.D.Associate Professor of MedicineUniversity of Pennsylvania Cancer Center

  2. Why is there so much controversy regarding the role of IFN in patients with high risk melanoma? Reasonable people disagree about the results from clinical trials and draw different conclusions from the data.

  3. Does IFN improve overall survival in patients with melanoma?

  4. If IFN does improve overall survival in patients with melanoma, is the 10% difference worth the substantial toxicity associated with therapy?

  5. Does IFN improve overall survival? • E1684: HD dose IFN vs observation • 10% difference in OS • One sided log rank test used p=.0237 • When two sided log rank test used p=.07 • E 1684:Patients not stratified for the most important predictor of relapse and survival: the number of positive nodes. Therefore, possible imbalance between the two arms

  6. Does IFN improve overall survival? • E1690 High dose IFN vs low dose IFN vs observation • Intended as a confirmatory study to 1684 • No differences in OS • 5 year OS IFN 52% • 5 year OS observation 55% • These efficacy results need to be considered in light of the substantial toxicity associated with one year of HDIFN.

  7. IFN and Melanoma • High dose IFN improves RFS by 10%. • Unclear whether HD IFN improves OS • Patients and physicians must consider making treatment decisions on RFS data and measures of quality of life. Many patients refuse to take IFN. • The majority of patient with Stage III melanoma die from their disease, despite high dose IFN • Critical to continue evaluating new agents in patients with high risk melanoma.

  8. COLON CANCERAdjuvant Therapy of Stage II Disease • Conclusion: therapy for stage II patients is controversial • In US, patients with stage II colon cancer may be randomized to: • CALGB trial: surgery alone vs MoAb 17-1a • NSABP trial: FU/LV vs FU/LV/oxaliplatin

  9. Treatment options for a patients with high risk melanoma should remain: • Observation • High dose IFN • Participation in a clinical trial- Vaccine- Biochemotherapy- Alternative IFN doses/schedule

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