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Authors: Presented by Alberts and Goldberg Analysis By Scott Berry Date posted: June 21 2010

Phase III Clinical Trial of FOLFOX with or without Cetuximab in Resected Stage 3 Colon Cancer: Cooperative Group Trial N0147 (NCCTG*, CALGB, ECOG, NCIC, NSABP, SWOG). Authors: Presented by Alberts and Goldberg Analysis By Scott Berry Date posted: June 21 2010.

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Authors: Presented by Alberts and Goldberg Analysis By Scott Berry Date posted: June 21 2010

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  1. Phase III Clinical Trial of FOLFOX with or without Cetuximab in Resected Stage 3 Colon Cancer:Cooperative Group Trial N0147(NCCTG*, CALGB, ECOG, NCIC, NSABP, SWOG) Authors: Presented by Alberts and Goldberg Analysis By Scott Berry Date posted: June 21 2010

  2. Thank you for downloading this update. Please feel free to use it for educational purposes. Please acknowledge OncologyEducation.ca and Dr. Berry when using these slides.

  3. Initial Study Design N=2300 Primary Outcome: DFS Treatment A: mFOLFOX6 (12 cycles) R Treatment B: mFOLFOX6 + Cetux (12 cycles)

  4. Revised Study Design KRAS WT ONLY N=3768 Primary Outcome: DFS Treatment A: mFOLFOX6 (12 cycles) R Treatment B: mFOLFOX6 + Cetux (12 cycles)

  5. Trial Closed Early • 1864 randomized to A (FOLFOX) or D (FOLFOX + cetuximab) • Trial halted on findings of planned interim analysis • 90% of planned accrual • Median follow-up 23 months

  6. RESULTS : KRAS-WT

  7. Gr 3/4 TOXICITY

  8. Reasons for Discontinuation

  9. Conclusions • No benefit to adding cetuximab in patients with resected stage 3 K-ras WT expressing colon cancer • ? Explanation • Decreased tolerance with cetuximab • Differences in dose intensity • Interaction with age: • Worse outcomes in older patients receiving cetuximab • Lessened ability to complete therapy

  10. Was adverse impact of Cetuximab due to dosing issues? In post-hoc analysis, attempted to identify ‘ideal’ patients First 6 cycles with > 80% dose intensity for all drugs Consider only patients aged < 70 If no benefit in these pts (young, > 80% dose rec’d), then adverse impact not likely due to reduced dosing

  11. Was adverse impact of Cetuximab due to dosing issues? Comparison based on dosing not protected by randomization, thus possibly confounded with other reasons for stopping treatment Alternative Use Time to Recurrence endpoint Most sensitive Least confounded

  12. Dose Intensity (% with > 80%) K-ras WT Cycle 6 Cycle 10

  13. “Idealized” Patient Comparison: Time to Recurrence – K-Ras WT All Patients “Ideal” Patients

  14. Was adverse impact of Cetuximab due to dosing issues? GOLDBERG: While they had lower drug exposure, we don’t believe that is the key reason based on the idealized patient analysis We believe that the explanation is related to tumor biology

  15. STUDY COMMENTARY • Adding Cetuximab to adjuvant FOLFOX for resected Stage III colon cancer patients does not improve outcome • Results do not appear to be explained by attendant increased toxicity / decreased dose intensity with combination • ? Tumour Biology

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