January 27, 2010 (FinancialWire) — Myriad Genetics, Inc. (NASDAQ: MYGN) announced that a presentation entitled: “Extensive 5-FU Inter-Patient Pharmacokinetic Variability May Result in Suboptimal 5-FU Dosing of Metastatic and Adjuvant Colon Cancer Patients on FOLFOX Regimens,” was presented at the Seventh Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology in Orlando, Florida.

The study investigated the chemotherapic dosing of 150 colon cancer patients in the United States, including 102 patients who received FOLFOX6 and 48 patients who received FOLFOX6 plus Avastin. The results showed that when 5-FU is administered in combination with oxaliplatin according to current standard-of-care body surface area dosing, 81.3% of the colon cancer patients had 5-FU exposure levels outside the optimal therapeutic range (Gamelin, et al., Journal of Clinical Oncology). Additionally, 28.7% of the patients showed elevated exposure to the drug, from too high of a dose of 5-FU and resulting in increased risk of toxicity, including diarrhea, oral mucositis, and hand and foot syndrome, and 52.6% of the patients exhibited a suboptimal 5-FU exposure, receiving too little drug and potentially resulting in the inadequate treatment of their cancer. These data are particularly important because they are based on measurements of drug exposure in actual community practice settings and they represent the largest data set of its kind in monitoring the treatment of colon cancer patients.

“This work demonstrates the large variability in 5-FU exposure that exists among colon cancer patients in the U.S. receiving 5-FU when dosed according to conventional protocols,” stated Edward Chu, M.D., Deputy director of the Yale Cancer Center. “This variability in exposure puts patients at risk of receiving too much or too little drug and highlights the importance of a laboratory test such as OnDose™ to monitor patient exposure to 5-FU in order to individualize dosing.”

Studies conducted during the last two decades show that there is tremendous pharmacokinetic variability in the way that patients metabolize 5-FU, with as much as a 30-fold difference in clearance of and resulting exposure to 5-FU during the course of treatment. Colon cancer patients in this U.S.-based study also exhibited substantial variability in their drug exposure as determined by OnDose™. A consequence of this variability among patients is the difficultly for physicians using conventional BSA dosing methods to strike an optimum balance between achieving maximum efficacy in treating the cancer, and, at the same time, avoiding serious toxicity in a particular patient.

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