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MOSAIC Stage ll+lll FOLFOX4 LV5FU2 Randomize. DFS DFS (months) Hazard ratio: 0.77 [0.65 – 0.92] p < 0.01 FOLFOX (n=1123) 77.9% LV5FU2 (n=1123) 72.8% FOLFOX.

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Presentation on theme: "MOSAIC Stage ll+lll FOLFOX4 LV5FU2 Randomize. DFS DFS (months) Hazard ratio: 0.77 [0.65 – 0.92] p < 0.01 FOLFOX (n=1123) 77.9% LV5FU2 (n=1123) 72.8% FOLFOX."— Presentation transcript:

1 MOSAIC Stage ll+lll FOLFOX4 LV5FU2 Randomize

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

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 FLOXFULV Randomize Strat: # Pos. N

5 FU Rest LV500 FU500 Rest LV500 OHP 852hr 500 Week R NSABP C-07 x3

6 NSABP C-07 Opened: Closed: 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-07 Accrual FULVFLOX Randomized Inelig/Lost Analysis

10 C-07 Patient Characteristics FULV %FLOX % < Age

11 C-07 Patient Characteristics FULV %FLOX % Left Colon Right Colon Sigmoid Multiple + Unk Location

12 C-07 Patient Characteristics Pos NodesFULV %FLOX % ≥

13 C-07 Overall Toxicity (%) FULVFLOX Grade

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 Oxaliplatin Protocol-stipulated cumulative dose C mg/m 2 Mosaic 1020 mg/m 2

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

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

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

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

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

23 3y DFS Δ HR C % 4.9 % 0.79 Mosaic 77.9 % 5.1 % 0.77 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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