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Tri-fold brochure explaining how measuring 5-FU can improve treatment of colorectal cancer - reducing toxicities and increasing survival
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MY5-FU ASSAY PROTOCOL
• One blood sample collected towards end of infusion.
• Sample injected with supplied stabilizer and sent to a clinical lab for analysis.
• Assay results used to adjust subsequent dose based upon published dose adjustment algorithm.
• Average of 3 adjustment cycles to reach optimal range. Periodic monitoring to ensure sustained optimal drug level.
The My5-FU Assay
REFERENCES
A: Adapted from Gamelin., J Clin Oncol, May 2008.
B: Gamelin, et al., J Clin Oncol 26:2099-2105, 2008.
C: Wilhelm, et al., CESAR Annual Meeting 2010.
D: Wenstrup, et al., Clin Colorectal Cancer, in press.
E: (1) de Gramont, et al., J Clin Oncol 18:2938-2947, 2000; (2) Saltz, et al.,
J Clin Oncol 26: 2013-2019, 2008; Cassidy, et al., J Clin Oncol 26:2006-
2012,2008; (3) Gamelin et al., ASCO GI, Abstract #356, 2009. Cost estimates
from Meropol, N.J. et al., J Clin Oncol 25:180-186, 2007; Wong, et al., ASCO
Annual Meeting, Abstract #3515, 2006 and internal estimates.
F: Gamelin, et al., J Clin Oncol 26:2099-2105, 2008; Gamelin, et al., ASCO
GI, Abstract #356, 2009; Capitain et al., ASCO GI, Abstract #429, 2008;
Eloxatin™ package insert: [Sanofi-Aventis, August 2002]; Camptosar® pack-
age insert: [Pfizer, March 2005].
116 Research Drive, Bethlehem, PA 18015 U.S.A.Tel:+610.419.6731 Fax:+610.849.5001
www.saladax.com
© 2011 Saladax Biomedical, Inc. My5-FU is a registeredtrademark of Saladax Biomedical Inc. All rights reserved. LIT 728-FNP-003, rev01 BECAUSE NO TWO PATIENTS ARE ALIKE.
BETTER EFFICACY
WITH FEWERSIDE EFFECTS
AT LOWER COSTS.
PERSONALIZEYOUR PATIENTS’
CAREWITH ONE
SIMPLE BLOOD TEST.
MY5-FU. APPLYING SCIENCE TO THE ART OF 5-FU DOSING.
IMPROVES OUTCOMES. REDUCES SIDE EFFECTS. LOWERS COSTS.
5-FU BSA-based dosing often results in inter-patient drug plasma
variability as high as 10-fold.
My5-FU reduces inter-patient pharmacokinetic
variability.
My5-FU reduces toxicity andimproves colorectal cancer treatment
at lower cost.
FIG. C
FIG.D
FIG. E
FIG. F
FIG. A
17%
68%
15% OPTIMAL THERAPEUTIC RANGE
TOO HIGH
TOO LOW5-FU
PLA
SMA
CO
NC
ENT
RA
TIO
N
FIG. B
• Toxicity • Premature treatment
termination• Compromised immunity• Higher treatment costs
• Lack of therapeutic response• Continued growth of cancer• Higher cost of recurrence
High Inter-Patient Variability ObservedConsistently in Evaluation Sites
5-FU Dose Management Improves FOLFOX Treatment Efficacy at a Lower Cost
5-FU Dose Management Substantially ReducesGrade 3/4 Toxicities*
Dose IntensityArm A (Fixed Dose) vs. Arm B (Adj Dose)
60
50
40
30
20-
10
0
AU
C m
g•h/
L
0 1 2 3 4
Cycle
50
40
30
20-
10
0
AU
C m
g•h/
L
0 1 2 3 4
Cycle
Num
ber
Of P
atie
nts
5-FU Weekly Dose (mg/m2)
Optimal AUC Range
Dose Adjustment Leads toMore Patients Within Target Levels
Optimal AUC Range