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MOSAIC

MOSAIC. Randomize. Stage ll+lll. FOLFOX4. LV5FU2. DFS. 3-year. FOLFOX (n=1123) 77.9% LV5FU2 (n=1123) 72.8%. Hazard ratio: 0.77 [0.65 – 0.92] p < 0.01. DFS (months). 23 % risk reduction in the FOLFOX arm. On November 4, 2004, the FDA

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MOSAIC

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  1. MOSAIC Randomize Stage ll+lll FOLFOX4 LV5FU2

  2. DFS 3-year FOLFOX (n=1123) 77.9% LV5FU2 (n=1123) 72.8% Hazard ratio: 0.77 [0.65 – 0.92] p < 0.01 DFS (months) 23 % risk reduction in the FOLFOX arm

  3. On November 4, 2004, the FDA approved oxaliplatin in combination with infusional FULV for adjuvant stage III colon cancer. The approval was based on improvement in DFS…

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

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

  6. NSABP C-07 Opened: 02-00 Closed: 11-02 Accrual: 2407 MTS: 34 mo.

  7. NSABP C-07 Endpoint: 3 yr DFS Event: first recurrence, second primary, death (any cause)

  8. NSABP C-07 89% power to detect: 5.4% ↑ DFS.

  9. C-07Accrual FULV FLOX Randomized Inelig/Lost Analysis 1245 38 1207 1247 47 1200

  10. C-07Patient Characteristics Age FULV % FLOX % < 60 60-69 70+ 50.4 33.0 16.6 52.431.9 15.7

  11. C-07Patient Characteristics Location FULV % FLOX % Left Colon Right Colon Sigmoid Multiple + Unk 20.8 41.5 36.8 1.9 19.8 45.7 32.6 1.9

  12. C-07Patient Characteristics Pos Nodes FULV % FLOX % 28.8 45.7 25.3 0 1-3 ≥4 28.9 44.8 25.6

  13. C-07Overall Toxicity (%) 0-2 3 4 5 Grade FULV FLOX 49 41 9 1 38 50 10 1

  14. C-07 Sanofi-NCI Neurotoxicity Gr 1. P/D that do not interfere with function Gr 2. P/D interfering with function, but not ADL Gr 3. P/D with pain or interference with ADL Gr 4. Persistent PD that are disabling or life-threatening

  15. Gr >1 (All) Neurotoxicity (%)

  16. Gr 3 Neurotoxicity (%)

  17. OxaliplatinProtocol-stipulated cumulative dose C-07 765 mg/m2 Mosaic 1020 mg/m2

  18. % of full dose oxaliplatin /cycle 73% received protocol-stipulated cumulative dose

  19. C-07Bowel wall injury 34 (2.7%) 56 (4.5%) N FULV FLOX Smith R ASCO GI #195,2004

  20. C-07Deaths during treatment 14 (1.1%) 15 (1.2%) N FULV FLOX

  21. C-07 DFS Ev # 3yr DFS FLOX 272 76.5% FULV 332 71.6% p < 0.004 HR: 0.79 [0.67 – 0.93] 21 % risk reduction

  22. The global test for interaction between treatment and tumor stage (II+III) was not significant (p=0.70)

  23. C-07 and Mosaic OXA benefit

  24. Conclusions The addition of oxaliplatin to weekly bolus FULV significantly improves 3-year DFS in patients with Stage II and III colon cancer The data confirm and extend the results of the Mosaic trial

  25. Conclusions The benefit of oxaliplatin does not appear to be dependent on the schedule of FULV administration The data support the use of weekly bolus FULV in combination with oxaliplatin in adjuvant colon cancer

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