New Data Demonstrates 5-FU Personalized Chemotherapy Management Assay Provides Similar Performance to More Complicated LC-MS/MS
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A new blood test may make it easier for oncologists to accurately measure and personalize 5-fluorouracil (5-FU) dosing for patients undergoing continuous infusion chemotherapy regimens.
Data from a multicenter trial showed that a nanoparticle-based immunoassay from Saladax Biomedical, called 5-FU Personalized Chemotherapy Management (PCM®), performed as well as high performance liquid chromatography (HPLC) or LC-MS/MS, but was easier to use, more rapid and more amenable to widespread clinical use.
The data was presented at the 2008 Hematology/Oncology Pharmacy Association and the International Society of Oncology Pharmacy Practitioners' (HOPA/ISOPP) annual meeting in Anaheim, Calif.
5-FU is a cornerstone treatment regimen for colorectal cancer; the third leading cause of cancer deaths in the United States.
"This evidence-based tool for monitoring the actual drug concentrations of 5-FU in the blood will enable simplified, personalized dose management with the goal of minimizing toxicity and maximizing the therapeutic benefit of 5-FU treatment," said Salvatore Salamone, Ph.D., CEO of Saladax Biomedical.
"This is important because a significant amount of scientific evidence over the last decade demonstrates that the effectiveness of the 5-FU regimen is burdened by potentially severe and life-threatening side effects."
To date, analysis of 5-FU blood plasma levels could only be performed by complex, labor-intensive, expensive, and physical analytical methods such as HPLC that have insufficient capacity to be used in high volume clinical settings.
The 5-FU PCM assay could provide the same HPLC or LC-MS/MS-like performance, while offering advantages of automation, small sample size, and improved turn-around time for oncologists.
The multicenter study evaluated 5-FU blood plasma levels at three sites, according to the Clinical and Laboratory Standards Institute (CLSI) protocol. 5-FU blood plasma levels were evaluated using the 5-FU PCM assay and cross- analyzed using LC-MS/MS cross-reactivity, precision, and stability to ensure accuracy. Researchers found that the PCM assay was precise and analytical results correlated well with those obtained from the validated HPLC method.
A recent study demonstrated that monitoring patients' 5-FU blood plasma levels and adjusting chemotherapy doses to achieve optimal levels of 5-FU can improve response rates and minimize toxicity when compared to standard-of-care dosing based on height and weight (known as body surface area or BSA).
The May issue of the Journal of Clinical Oncology (JCO) featured results of a Phase III randomized study of colorectal cancer patients who were dosed with 5-FU based on the current standard, BSA compared with patients who had doses personalized according to 5-FU blood plasma levels.
The study concluded that only 25 percent of patients were in target range, while 17 percent were found to be over-dosed and 58 percent of patients were found to be under-dosed.
Additionally, this study demonstrated that after 5-FU doses was adjusted to achieve appropriate plasma levels, patients experienced improved response rates and nearly doubled overall survival, in addition to significantly lower toxicity.
