A Phase III Trial Comparing FULV to A Phase III Trial Comparing FULV to FULV + Oxaliplatin in Stage II or FULV + Oxaliplatin in Stage II or III Carcinoma of the Colon: Results III Carcinoma of the Colon: Results of NSABP-C-07 of NSABP-C-07 Norman Wolmark, MD Colorectal Cancer Update Think Tank Meeting June 24, 2005
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Norman Wolmark, MD Colorectal Cancer Update Think Tank Meeting June 24, 2005
A Phase III Trial Comparing FULV to FULV + Oxaliplatin in Stage II or III Carcinoma of the Colon: Results of NSABP-C-07. Norman Wolmark, MD Colorectal Cancer Update Think Tank Meeting June 24, 2005. MOSAIC. Stage ll+lll. â. Randomize. å. æ. LV5FU2. FOLFOX4. DFS. 1.0 0.9 0.8 0.7 0.6 - PowerPoint PPT Presentation
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A Phase III Trial Comparing FULV to FULV + A Phase III Trial Comparing FULV to FULV + Oxaliplatin in Stage II or III Carcinoma of the Oxaliplatin in Stage II or III Carcinoma of the
Colon: Results of NSABP-C-07Colon: Results of NSABP-C-07
Norman Wolmark, MDColorectal Cancer Update Think Tank Meeting
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…
RandomizeRandomize
FULVBolus 5-FU/leucovorin
Stratification: Number of positive nodes
FLOXBolus 5-FU/leucovorin
+ oxaliplatin
Stage ll+lll
NSABP-C-07NSABP-C-07
NSABP-C-07: 5-FU/LV versus 5-FU/LV plus NSABP-C-07: 5-FU/LV versus 5-FU/LV plus Oxaliplatin in Stage II/III Colon CancerOxaliplatin in Stage II/III Colon Cancer
x 3
LV
R
Week 1 2 3 4 5 6 7 8
FU
LV
FU
500
500
500
500
OHP 85 2hr
Re
st
Re
st
Source: Wolmark N. Presentation. ASCO 2005.
NSABP-C-07NSABP-C-07
Opened: 02-00
Closed: 11-02
Accrual: 2,407
MTS: 34 mo.
Endpoint: 3 yr DFS
Event: first recurrence, second primary, death (any cause)