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A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon:

A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: Survival results of NSABP Protocol C-07. N. Wolmark, S. Wieand, P. J. Kuebler, L. Colangelo, M. J. O'Connell, G. Yothers. 50 YEARS. Protocol C-07. Disclosure:

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A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon:

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  1. A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: Survival results of NSABP Protocol C-07 N. Wolmark, S. Wieand, P. J. Kuebler, L. Colangelo, M. J. O'Connell, G. Yothers

  2. 50 YEARS Protocol C-07 Disclosure: Norman Wolmark is an unpaid member of Sanofi-Aventis advisory boards

  3. NSABP C-07 Stage ll + lll Strat: # Pos. N Randomize FULV FLOX

  4. NSABP C-07 FU B Rest 500 LV 500 2hr x3 R FU 500 B Rest LV 500 2hr OHP 85 2hr Week 1 2 3 4 5 6 7 8

  5. NSABP C-07 Opened: 02-00 Closed: 11-02 Accrual: 2492 MFU: 34 mo 5’05 MFU: 42.5 mo 6’07 MFU: 67 mo

  6. FULV FLOX Randomized Inelig/No F-U Analysis 1245 36 1209 1247 47 1200 C-07Accrual

  7. NSABP C-07 Primary Endpoint: DFS Event: first recurrence, second primary, death (any cause)

  8. NSABP C-07 Secondary Endpoint: Overall Survival Formal analysis of survival: 5 years after the last patient was entered(11’02)

  9. Expected # deaths: 700 Actual # deaths: 560 Consequently the power to detect the protocol specified 0.214 reduction in the annual death rate was decreased from 0.89 to 0.81.

  10. C-07Patient Characteristics Pos Nodes FULV % FLOX % 0 1-3 ≥4 28.9 45.8 25.3 28.8 45.3 25.8

  11. DFS Update

  12. C-07 DFS p = 0.002 HR: 0.81 [0.70 – 0.93] 3y 5y FLOX 76.1% 69.4% FULV 71.5% 64.2%Δ 4.6% 5.2% 19% risk reduction

  13. Overall < 65 yr ≥ 65 yr N 0 1-3 >3 DFS Hazard Ratio FLOX Better FULV Better

  14. Overall Survival

  15. C-07 Survival D(n) 5y 6y FLOX 259 80.3% 77.7% FULV 301 78.3% 73.5%Δ 42 2.0% 4.2% p = 0.06 HR: 0.85 [0.72 – 1.01] 15% risk reduction

  16. Overall < 65 yr ≥ 65 yr Stage II Stage III S Hazard Ratio FLOX Better FULV Better

  17. C-07 and Mosaic oxaliplatin benefit

  18. Is 5 years the appropriate time to assess overall survival?

  19. ACCENT Survival After Recurrence P<0.0001 O’Connell JCO May 2008

  20. C-04 - C-07 Survival after Recurrence Median C-04 ‘89 12.7 C-05 ’91 12.6 C-06 ’97 16.4 C-07 ’00 19.6 P < 0.0001 N~8000

  21. C-07 Survival after Recurrence Median FLOX 17.6 FULV 22.2 P = 0.02 HR: 1.24

  22. Conclusions There is a trend toward improved survival (p=0.06) with the addition of oxaliplatin to weekly FULV at 67m MFU The benefit of oxaliplatin (S and DFS) is independent of the schedule of FULV administration

  23. Conclusions The durable consistency between the results of C-07 and Mosaic validates the benefit of oxaliplatin Longer follow-up (>5 yrs) in future colon adjuvant trials appears to be appropriate to reliably detect survival benefit

  24. H. Samuel Wieand February 19, 1944 - June 10, 2006

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