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Studies Point to Benefits of Personalized Chemotherapy Dose Management in Colorectal Cancer
Date:5/2/2008

ses adjusted based on blood tests that measured the actual concentration of chemotherapy in the patients' blood plasma. The primary endpoint was tumor response; the secondary endpoint was treatment tolerance.

The JCO study concluded that:

-- Response rates were nearly doubled in the dose adjusted group versus

the BSA group (33.6 percent versus 18.3 percent) with statistical

significance

-- Overall survival at two years among patients with personalized 5-FU

dose management improved by 48 percent with an improved median

survival of 22 months versus 16 months in the BSA arm. The survival

data was leaning towards significance

-- Grade III/IV 5-FU related toxicities were found to be significantly

lower in patients with personalized dose adjustment

-- 58 percent of patients were found to be under-dosed (sub-therapeutic

and less effective drug levels) and had their doses adjusted upwards

-- 17 percent were found to be over-dosed (increasing the risk of severe

side effects) and had their doses adjusted downward

Dr. Gamelin, director of the Paul Papin Cancer Center in Angers, France, stated, "Pharmacokinetically-guided or personalized 5-FU dose management is the standard-of-care at our cancer center. We routinely test the level of 5-FU in the blood of our colorectal cancer patients and adjust their doses to achieve optimal drug concentration. Clinical studies conducted over the past 20 years have demonstrated that there is significant variability in 5-FU blood levels when patients are dosed by BSA, the prevailing practice."

"Our Phase III study demonstrates that the majority of patients are either over-dosed or in most cases, under-dosed. Personalized 5-FU dosing allows us to substantially reduce severe toxicity while improving patient quality of life and treatment outcomes," said Dr. Gamelin.

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SOURCE Saladax Biomedical
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