Novel Assay Allows Individualized Chemotherapy Management Monitoring

The 5-FU Personalized Chemotherapy Management (PCM) assay, intended for use on the Olympus AU400 clinical chemistry analyzer, allows oncologists who prescribe 5-fluorouracil (5-FU) continuous infusion regimens (alone or in combination for colorectal, stomach, breast, and pancreatic cancers) to control and fine-tune individualized dosing. Recent results from a Phase III randomized study compared colorectal cancer patients who were dosed with 5-FU based on body surface area (BSA, the current standard dosing method) with patients whose dose was adjusted based on the actual concentration of 5-FU in blood plasma. The study results showed that response rates among monitored patients doubled; two-year overall survival improved by 48%; and toxic side effects were significantly lower. Additionally, only 25% of BSA dosed patients were found to be in the target range to receive the optimal therapeutic benefit; 58% of patients were found to be under-dosed and had doses adjusted upward, while 17% were found to be over-dosed, increasing the risk of severe side effects. The study was published in the May 2008 issue of the Journal of Clinical Oncology.

"The availability of the 5-FU PCM assay will give oncologists in the European Union a powerful, cost-effective tool in the battle against colorectal cancer,” said lead author Erick Gamelin, M.D., Ph.D., director of the Paul Papin Cancer Center (Angers, France). "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.”

The 5-FU Personalized Chemotherapy Management assay system is a product of Saladax Biomedical (Bethlehem, PA, USA), and has received CE marking registration in the European Union (EU).

"Until now, a simple, rapid, and cost-effective 5-FU measurement tool that can be easily integrated into day-to-day practice has not been readily available. As a result, colorectal cancer patients receive chemotherapy based on their height and weight, with no monitoring system in place to allow oncologists to correlate dose with clinical patient response on an ongoing basis,” said Salvatore Salamone, Ph.D., CEO of Saladax Biomedical. "Access to this simple blood test will arm oncologists with the ability to individualize 5-FU dosing to ensure patients receive the optimal benefit from their treatment.”

Colorectal cancer is a worldwide public health problem, with more than 940,000 new cases diagnosed each year, resulting in approximately 500,000 deaths annually, according to data from the World Health Organization (WHO, Geneva, Switzerland). In the United States, colorectal cancer is the third leading cause of cancer mortality, and in 2008, nearly 50,000 deaths will be attributed to this disease. Data from industrialized countries demonstrate that incidence rates are strongly correlated with age, rising three-fold between the ages of 60 and 80 years.


Related Links:
Paul Papin Cancer Center
Saladax Biomedical