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News

New PCM assay enables oncologists to personalize 5-FU dosing

Saladax Biomedical : 24 June, 2008  (New Product)
A new blood test has been developed to make it easier for oncologists to accurately measure and personalise 5-fluorouracil (5-FU) dosing for patients undergoing continuous infusion chemotherapy treatment.
Data from a multicentre 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, California, USA.

5-FU is a cornerstone treatment regimen for colorectal cancer; the third leading cause of cancer deaths in the USA.

'This evidence-based tool for monitoring the actual drug concentrations of 5-FU in the blood will enable simplified, personalised dose management with the goal of minimising toxicity and maximising the therapeutic benefit of 5-FU treatment,' said Salvatore Salamone, PhD, chief executive officer 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 multicentre 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-analysed 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 a patient’s 5-FU blood plasma levels and adjusting chemotherapy doses to achieve optimal levels of 5-FU can improve response rates and minimise 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 personalised 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.
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