Personalized Cancer Care
The current standard of care for chemotherapy dosing is based on body surface area (BSA) which provides a "one size fits all" approach to determining drug dose. Scientific advances in the treatment of cancer and other diseases are enabling a new era in medicine aimed at more precise, individually "customized" care. Targeting drug selection by pharmacogenomics and other new technologies helps identify which drug will be most effective in battling the disease. Numerous studies, however, have shown that other factors may affect the metabolism of drugs leading to large variations in their effective blood levels. These factors can often result in systemic drug concentrations far above or below the optimal therapeutic range.
Clinical trials have demonstrated that optimizing the drug dose based on the patient's specific blood level can help overcome this variability and in doing so enhance the effectiveness of chemotherapy while improving the quality of the patient's life during and after treatment through reduced toxicity.
- How Can I get the My5-FU test?
- Common questions on personalized medicine
- A short video on My5-FU
- Helpful links
1. How Can I Get the My-5-FU Test?
In the United States, the My5-FU test is offered exclusively by Myriad Genetics under the trade name OnDose™. You can view Myriad's OnDose webpage here, or you can call Myriad at
1-800-469-7423, or email to: ondose@myriad.com.
In the United Kingdom, the My-5-FU test is offered by Lab21 under the tradename DoseCheck™. You can view Lab21's DoseCheck webpage here, or you can call Lab21 from the U.S. at 011 44 (0)1223 395450
The My5-FU test is approved for distribution in the European Union.If you are interested in learning how to get My5-FU in the EU, contact Mr. Keith Galloway at kgalloway@saladax.com.
In Japan, My5-FU will be made available by FALCO biosystems. More information coming shortly.
2. Commonly Asked Questions on Personalized Medicine
What Is Personalized Medicine & How Does It Relate to Optimal Dose Management?
Personalized medicine refers to the use of diagnostic tools that enable physicians to objectively identify how individual patients will respond to specific treatments. With this information, the doctor can tailor the dose to your individual needs to result in the highest therapeutic effects with minimized chances of excessive toxic side effects. Saladax's proprietary MyCare assays enable Personalized Medicine in oncology through optimized dosing of the most commonly prescribed chemotherapy drugs.
Read more about Personalized Medicine from The President's Council of Advisors on Science and Technology (PCAST) "Priorities for Personalized Medicine", September 2008, http://www.ostp.gov/galleries/PCAST/pcast_report_v2.pdf
What Is Therapeutic Drug Management?
Therapeutic Drug Management (TDM) is the measurement and adjustment of specific drugs at intervals in order to maintain a target range concentration of the medication in the bloodstream.
Drugs that are monitored and managed in this way tend to have a narrow "therapeutic range", meaning that - the quantity required to be effective is close to the quantity that causes significant side effects and/or toxicity.
Maintaining this optimal range is not as simple as giving a standard dose of medication to all patients. Each person will absorb, metabolize, utilize, and eliminate drugs at a different rate based upon their age, general state of health, genetic makeup, and the interference of other medications that they are taking. This rate may change over time and vary from day to day.
How Does TDM Work?
Through years of testing, the optimum therapeutic range for selected drug blood levels has been determined. Within this range, the optimal balance of efficacy and toxicity is achieved without excessive side effects or symptoms of toxicity. The drug dosage to reach this level must be individually determined using tests like the Saladax MyCare Assays.
How is the 5-FU dose management test administered?
My5-FU is a simple blood test that requires a single blood draw after the beginning of infusion of the 5-FU drug. The dose for your first infusion will be determined based upon your doctor's current practice. During your first infusion, the nurse will draw one small sample of your blood and send it to the laboratory for analysis. The test measures how much drug is in your bloodstream, which can vary significantly (ten-fold or more) from one patient to another when receiving the same dose. Based on the actual 5-FU drug concentration in your blood, as well as other signs and symptoms from clinical examinations, your physician will determine if dose adjustments are right for you. Your doctor will adjust subsequent doses of 5-FU based upon the information provided from the test results.
If your drug blood level is not within the optimal target range, on average, it will take three to four infusion cycles to bring the concentration into the target range. Thereafter, it is recommended that you have your levels checked at least every three cycles to ensure that the drug concentration remains in range.
How Will MyCare Blood Tests Help Me?
Personalized medicine makes it possible to give each individual patient "the appropriate dose at the appropriate time". The benefits of this approach are in its accuracy, efficacy, and safety. For example, clinical studies in patients treated with 5-fluorouracil (5-FU) for colorectal cancer have demonstrated that 67% of patients were not receiving sufficient drug dosing to optimally combat their disease when dosed by BSA, which is the current standard of care; and another 18% were overdosed. Only 15% of patients in this study received the optimal 5-FU dose to balance toxicities against best clinical outcomes. Among those patients whose 5-FU dosage was adjusted based upon blood drug levels, response rates and overall survival were doubled. In addition, severe 5-FU-attributed side effects were found to be significantly lower, resulting in improved quality of life.
4. Helpful Links
American Cancer Society
American College of Gastroenterology (Patient Information)
Cancer.Net
Colon Cancer Alliance
Colorectal Cancer Coalition
Colon Cancer Today
National Cancer Institute
National Comprehensive Cancer Network (For Patients)
Oncology Channel