Saladax Biomedical, Inc. has signed an agreement with Karolinska University Hospital to supply the novel 5-fluorouracil (5-FU) Personalized Chemotherapy Management (PCM™) reagent kits. The test provides oncologists with a new tool for monitoring blood level of 5-FU in cancer patients undergoing chemotherapy. This rapid test is faster than currently available methods, enabling personalized dose management with the goal of minimizing toxicity and maximizing the therapeutic benefit of 5-FU treatment.
Karolinska is the first European institution to offer the novel, nanoparticle-based laboratory immunoassay suitable for determining 5-FU plasma levels (for continuous infusion regimens) with advantages of speed and small sample size. Automation and rapid turnaround time will enable efficient routine monitoring of 5-FU concentrations in clinical practice for the purpose of therapeutic drug monitoring.
Olof Beck, Laboratory Director at the Clinical Pharmacology Laboratory at the Karolinska University Hospital, said, "We look forward to bringing this test to market to provide oncologists with an evidence-based tool to monitor individual patient dosing based upon their plasma 5-FU concentration level. As a result, physicians will be better able to manage their patients and make more confident decisions in colorectal cancer treatment."
Dr. Hakan Gadler, Chief Medical Officer at Saladax, commented, "The ability to personalize chemotherapy is a significant advance in the treatment of cancer and one that will lead to improved efficacy and fewer side effects for patients. Individually adjusted chemotherapy dosing provides great benefits to patients, a meaningful new tool for oncologists, and cost savings to the health care system."
PERSONALIZING TREATMENT OF 5-FU IN COLORECTAL CANCER
Personalized medicine is the optimization of therapeutic decisions based upon individual patient profiles. It has long been recognized that patients respond differently to medication, but only recently have the scientific tools become available to enable accurate identification of individual patient differences. Such tools enable physicians to formulate individualized treatment plans more effectively.
Colorectal cancer is the third most commonly diagnosed cancer in the world. 5-FU used alone, or in combination with other drugs, is the mainstay of treatment. The therapeutic window between toxicity and efficacy of 5-FU is very narrow and therefore difficult to maintain through clinical examination alone. Current dosing based on BSA (Body Surface Area) results in up to a 50-fold variability in patient blood levels. While BSA is the standard, studies report there is no correlation between plasma clearance of the drug, exposure to the drug and BSA.
In the May 2008 issue of the Journal of Clinical Oncology, Dr. Erick Gamelin at the Paul Papin Cancer Center in Angers France reported a randomized multi-center study among metastatic colorectal cancer patients treated with continuous infusion 5-FU whose drug blood levels were monitored and dosing adjusted to achieve target concentrations. Dr. Gamelin demonstrated that dosing based on BSA resulted in 58% of patients having sub-therapeutic plasma levels; 17% of patients were over-dosed and only 25% were actually in the optimal therapeutic range. By practicing therapeutic dose management (TDM) to maintain the plasma level of 5-FU within the therapeutic window, patients did much better. They experienced significantly better objective tumor response and doubling of survival at two years, while experiencing significantly less toxicity.
"Access to a new laboratory tool to monitor the actual drug concentration in patients' blood and to adjust 5-FU dose to minimize toxicity and maximize the therapeutic benefit promises to improve outcomes," stated Professor Olof Beck.