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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

MOSAIC

Randomize

Stage ll+lll

FOLFOX4

LV5FU2


Mosaic

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


Mosaic

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…


Mosaic

NSABP C-07

Stage ll + lll

Strat: # Pos. N

Randomize

FULV

FLOX


Mosaic

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


Mosaic

NSABP C-07

Opened: 02-00

Closed: 11-02

Accrual: 2407

MTS: 34 mo.


Mosaic

NSABP C-07

Endpoint: 3 yr DFS

Event: first recurrence,

second primary,

death (any cause)


Mosaic

NSABP C-07

89% power to detect:

5.4% ↑ DFS.


C 07 accrual

C-07Accrual

FULV

FLOX

Randomized

Inelig/Lost

Analysis

1245

38

1207

1247

47

1200


C 07 patient characteristics

C-07Patient Characteristics

Age

FULV %

FLOX %

< 60

60-69

70+

50.4

33.0

16.6

52.431.9

15.7


C 07 patient characteristics1

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


C 07 patient characteristics2

C-07Patient Characteristics

Pos Nodes

FULV %

FLOX %

28.8

45.7

25.3

0

1-3

≥4

28.9

44.8

25.6


C 07 overall toxicity

C-07Overall Toxicity (%)

0-2

3

4

5

Grade

FULV

FLOX

49

41

9

1

38

50

10

1


C 07 sanofi nci neurotoxicity

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


Mosaic

Gr >1 (All) Neurotoxicity (%)


Mosaic

Gr 3 Neurotoxicity (%)


Oxaliplatin protocol stipulated cumulative dose

OxaliplatinProtocol-stipulated cumulative dose

C-07 765 mg/m2

Mosaic 1020 mg/m2


Mosaic

% of full dose oxaliplatin /cycle

73% received protocol-stipulated cumulative dose


C 07 bowel wall injury

C-07Bowel wall injury

34 (2.7%)

56 (4.5%)

N

FULV

FLOX

Smith R ASCO GI #195,2004


C 07 deaths during treatment

C-07Deaths during treatment

14 (1.1%)

15 (1.2%)

N

FULV

FLOX


Mosaic

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


Mosaic

The global test for interaction

between treatment and

tumor stage (II+III)

was not significant (p=0.70)


Mosaic

C-07 and Mosaic

OXA benefit


Mosaic

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


Mosaic

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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