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5-Fluorouracil

Drug Level Testing

The International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) strongly recommends TDM for the management of 5-FU therapy.1

Personalized Chemotherapy Dose Optimization with a Simple Blood Test

  • The majority of patients on 5-FU infusion regimens are underdosed2-6
    • It is well-recognized that dosing by body surface area is inadequate73,7-9
    • A German Registry Study of patients and 36 unique centers confirms 5-FU under dosing issue10
    • A wide range of doses is needed for optimal exposure2,6
  • Dose adjustment is effective at reducing variability in exposure; patients can be adjusted into target range4,8
    • Published dosing algorithms can be used to personalize 5-FU dosing3
  • Adjusting patients into target range can reduces toxicities and improves outcomes2,4,6,11,12
  • Implementing testing into practice has been demonstrated4,5

View References

  1. Beumer JH, Chu E, Allegra C, et al. Therapeutic drug monitoring in oncology: International Association of Therapeutic Drug Monitoring and Clinical Toxicology recommendations for 5-fluorouracil therapy. Clin Pharmacol Ther. 2019; 105(3):598-613.
  2. Capitain O, et al. Individual Fluorouracil Dose Adjustment in FOLFOX Based on Pharmacokinetic Follow-Up Compared With Conventional Body-Area-Surface Dosing: A Phase II, Proof-of-Concept Study. Clin Colorectal Cancer. 2012;11(4):263-267.
  3. Kaldate RR, et al. Modeling the 5-fluorouracil area under the curve versus dose relationship to develop a pharmacokinetic dosing algorithm for colorectal cancer patients receiving FOLFOX6. 2012;17(3):296-302.
  4. Wilhelm M, et al. Prospective, multi-center study of 5-fluorouracil (5-FU) therapeutic drug management (TDM) in metastatic colorectal cancer (mCRC) patients treated in routine clinical practice. Clin Colorectal Cancer. 2016; 15(4):381-388.
  5. Braiteh FS, et al. Pharmacokinetic (PK)-guided optimization of 5-fluorouracil (5FU) exposure in colorectal cancer (CRC) patients: U.S.-based clinical practices experience. J Clin. Oncol. 2014;32(5s):(suppl; abstr 3574).
  6. Gamelin E, et al. Individual fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: results of a multicenter randomized trial of patients with metastatic colorectal cancer. J Clin Oncol. 2008;26(13):2099-2105.
  7. Baker SD, et al. Role of body surface area in dosing of investigational anticancer agents in adults, 1991-2001. J Natl Cancer Inst. 2002;94(24):1883-1888.
  8. Saam J, et al. Body surface area-based dosing of 5-fluoruracil results in extensive interindividual variability in 5-fluorouracil exposure in colorectal cancer patients on FOLFOX regimens. Clin Colorectal Cancer. 2011;10(3):203-206.
  9. Felici A, et al. Dosing strategies for anticancer drugs: the good, the bad and body-surface area. Eur J Cancer. 2002;38(13):1677-1684.
  10. Hofheinz R-D. Kolorektale Tumore. Oral presentation at: Onko Update; February, 2018; Berlin, Germany.
  11. Kline CL, et al. Personalized dosing via pharmacokinetic monitoring of 5-fluorouracil might reduce toxicity in early- or late-stage colorectal cancer patients treated with infusional 5-fluorouracil- based chemotherapy regimens. Clin Colorectal Cancer. 2014;13(2):119-126.
  12. Zhou X, Chang Y, Qian J, Shen C, Han J, Zhao H, Chang R. Clinical Benefit of Therapeutic Drug Monitoring in Colorectal Cancer Patients Who Received Fluorouracil-Based Chemotherapy. Med Sci Monit. 2021 Jul 31;27:e929474.

Fast. Simple. Accurate.

Rapid, accurate, easy to perform diagnostic test

Parameters available for a wide range of clinical chemistry analysers

CE Marked

Cost Effective

Only commercially available assay

No reagent preparation or sample pretreatment

ISO 13485 and FDA cGMP compliant manufacturing process

Patented 5-FU sample stabilizer for improved workflow

Real Caregivers. Real Results.

“My wife was diagnosed with cancer. Of course, I was devastated. I did what everyone else does, I spent hours on the internet researching everything. I didn’t like what I was reading. Doctors prescribe what they call maximum tolerated dose. Do you know what that means? They give as much as the body can tolerate. Even though studies show that after a certain point there is no additional benefit, and most certainly only increased adverse effects. Several studies point to a dosing method using TDM, it sounds reasonable. Give the patient an optimum dose, not too high, not too low. Why don’t all doctors use TDM instead of maximum tolerated dose?”

RickardoHusband & Caregiver

“Through Saladax's empathy and direct help, combined with a lot of leg work and persistence myself, we were able to determine if my wife was receiving the proper dose of 5-FU. Saladax connected us to a laboratory that could provide us 5-FU blood level testing.”

TimHusband & Caregiver

My5-FU Assay Performance

Precision Data

Sample Type Assigned Value (ng/mL) N Mean (ng/mL) Repeatability %CV Within-Laboratory %CV
Controls Low 225 80 223 2.5 5.2
Medium 450 80 450 1.4 2.1
High 900 80 910 1.1 1.6
Plasma Spike 1 240 80 238 4.9 5.5
Spike 2 470 80 475 1.8 2.6
Spike 3 700 80 705 1.9 2.1
Spike 4 1300 80 1341 1.4 2.0

Method Comparison

Slope = 1.017; Y-Intercept = 6.78;
Correlation Coefficient (r) = 0.9925

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