OnDose®: Personalized Medicine for Customized Chemotherapy

OnDose® testing evaluates 5-FU exposure for patients undergoing continuous infusion 5-FU chemotherapy. OnDose allows physicians to make a pharmacokinetic determination of the Area Under the Curve (AUC) for each infusion cycle and provides insight to help the physician proactively adjust and optimize dosing to optimize efficacy and reduce toxicity.

PK-Guided Dosing of 5-FU for Patients With Colorectal Cancer

OnDose is a simple blood test that helps oncologists to optimize infusional 5-FU therapy. OnDose provides the data for PK-guided dose adjustments of infusional 5-FU to help optimize dosing for patients with colorectal cancer.

  • OnDose can be offered to CRC patients with an early- or late-stage disease receiving 5-FU-based chemotherapy
  • OnDose is a diagnostic assay for the quantitative determination of 5-FU levels in human plasma
  • The assay relies on the quantification of plasma 5-FU area under the curve (AUC) levels by antibody detection and has >99% correlation with high-performance liquid chromatography (HPLC) methodology1

1. Saam J, Critchfield GC, Hamilton SA, et al. Body Surface Area–based dosing of 5-Fluorouracil results in extensive interindividual variability in 5-Fluorouracil expo- sure in colorectal cancer patients on FOLFOX regimens [published online ahead of print May 30, 2011]. Clin Colorectal Cancer. doi:10.1016/j.clcc.2011.03.015.

PK-Based Dosing Shows Improved Outcomes vs. BSA-Based Dosing

PK-based dosing allows you to personalize the 5-FU dose to obtain optimal drug exposure and increase the overall response rate.1

  • Overall response rate seen in PK group was 2-fold higher than in the BSA group1
  • There was a relationship between 5-FU plasma levels and objective response rate (P=0.004)2
  • 38% increase in overall survival seen in PK-guided group, trending toward statistical significance (P=0.08)2

     

    —Overall survival was not a primary endpoint

A Phase III, multicenter, randomized trial of 208 patients with metastatic colorectal cancer. Initial regimen was 1500 mg/m2 5-FU plus 200 mg/m2 folinic acid infusion during a continuous 8-hour period administered once weekly. 5-FU doses were adjusted weekly in the PK-guided arm based on a single-point measurement of 5-FU plasma concentrations at steady state until the therapeutic range was reached.2

1. Saif MW, Choma A, Salamone SJ, et al. Pharmacokinetically guided dose adjustment of 5-Fluorouracil: a rational approach to improving therapeutic outcomes. J Natl Cancer Inst. 2009;101:1543-1552.

2. Gamelin E, Delva R, Jacob J, 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;26:2099-2105.

 

OnDose Case Studies

OnDose Adjustments Ft. Dr Brian Abbott

Variability Case Study Ft. Dr Brian Abbott

For more information visit the OnDose website.