9/7/17. Implementing the ARK Immunoassay for Therapeutic Drug Monitoring of High-Dose Methotrexate. Disclosure. Learning Objectives

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1 Implementing the ARK Immunoassay for Therapeutic Drug Monitoring of High-Dose Methotrexate Kristine R. Crews, PharmD, FCCP, BCPS St. Jude Children s Research Hospital September 14, 2017 Disclosure I declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program. Learning Objectives Describe differences in assay performance with the ARK immunoassay compared to the previously marketed TDx assay for therapeutic drug monitoring of high-dose methotrexate. List possible changes to clinical care that may result from differences in assay performance with the ARK immunoassay compared to the previously marketed TDx assay. 1

2 Therapeutic Drug Monitoring of Methotrexate (MTX) Plasma Concentrations is Essential after High-Dose MTX Toxicity includes severe myelosuppression and mucositis Routine monitoring of MTX concentrations predicts early detection of patients at high risk of toxicity Goal of monitoring: To ensure that all patients receive adequate leucovorin rescue and IV hydration to prevent severe toxicity This is precision medicine in practice! Stoller, NEJM, 1977 Relling, J Clin Oncol FDA Approved MTX Assays Fluorescence polarization immunoassay Abbott TDxFLx Marketed Competitive homogeneous enzyme immunoassay ARK Diagnostics What about HPLC or LC-MS? Lab-developed assays a possibility 2

3 What is the ARK Immunoassay? ARK Diagnostics competitive homogeneous enzyme immunoassay 1 Gained FDA approval in 2011 Can be placed in service using multiple platforms Roche Cobas c502 Abbott Architect Beckman AU ARK MTX results show a positive bias compared to TDx MTX results Godefroid et al., 2013 Multicenter method comparison: Roche Cobas, Abbott Architect, Beckman AU, and Siemens Dimension Vista Accuracy (only for Roche and Abbott): Positive bias at the very low end (24.7%) Gunther et al., 2016 Comparison among Abbott TDx, ARK Diagnostics (on Roche Cobas), and LC-MS/MS Positive bias between the TDx MTX and the ARK MTX is particularly pronounced near the Limit of Quantitation. Godefroid MJ et al. Clin Chem Lab Med Feb;52(2):e13-6. doi: /cclm PubMed PMID: Günther V et al. Clin Chem Lab Med May;54(5): doi: /cclm PubMed PMID: St. Jude Clinical Pharmacokinetics Lab performed extensive validation testing CLIA requires a that lab verify the performance characteristics of an assay (e.g. accuracy, precision, limit of quantification, etc.) Manufacturer established Limit of Quantitation (LOQ): 0.04 µm St. Jude established ARK LOQ: 0.06 µm (LOQ of TDx was 0.03 µm) At 0.06 µm the total error of the assay was ~25% 0.04 µm 0.05 µm 0.1 µm 0.15 µm Bias (%) 36% 31% 18% 8.2% CV% 4.8% 3.8% 2.7% 1.0% 3

4 ARK assay exhibits a significant positive bias at low MTX concentrations compared to TDx assay in pt samples assayed with both methods N=115 Across the assay range of 0.03 to 150 um bias is 21% for the ARK vs. the TDx *in patient samples assayed with both methods um 11% higher by the ARK vs. the TDx *in patient samples assayed with both methods 4

5 *in patient samples assayed with both methods *in patient samples assayed with both methods 5

6 Bias in assay results could affect clinical actions Patient 1: MTX 12 g/m2 over 4 hr MTX plasma conc. (um) Hours TDx ARK ARK MTX TDx MTX Sample Type (um) (um) Mtx 66hr Mtx 66hr Mtx 66hr Mtx Pre Mtx 72hr Mtx 90hr Mtx IT Mtx 66hr Mtx 90hr Mtx 66hr Mtx 90hr Mtx 48hr Mtx Pre 0.15 µm In our validation dataset, of 13 samples that were between 0.1 and 0.15 um is by ARK, the 11 (85%) newwere below 0.1 um by TDx 0.1 µm! Section 4.12: Section 5.7.1: 6

7 St. Jude Response: Revised MTX Monitoring Guidelines Patients on St. Jude clinical trials will be followed until MTX <0.15 um if clinically stable, without toxicity. Threshold was 0.1 um by TDx assay now 0.15 um by ARK assay. Patients on COG clinical trials will be followed until MTX < 0.10 um if clinically stable, without toxicity (unless thresholds change for COG studies) Patients with any evidence of a fluid collection or third space will have plasma concentrations monitored until < 0.06 um (ARK assay) for 2 consecutive results at least 24 hours apart. If clinical toxicity is present, continue leucovorin until no toxicity regardless of plasma MTX level. Educated clinicians: absolute values may be difficult to interpret with the ARK assay at levels <0.15 um. LOQ was 0.03 um by TDx assay now 0.06 um by ARK assay Conclusions When a lab switches from the TDx to the ARK assay: Overestimation of MTX concentrations at low concentrations may lead to increased dose or duration of leucovorin rescue with new ARK assay compared to courses monitored when old TDx assay was in place. It is crucial for a clinician to understand an assay s performance characteristics when using results to individualize a patient s regimen. Communication between the clinical lab and clinical pharmacists is essential when placing a new assay into service. The Team Alejandro Molinelli, PhD Jennifer Pauley, PharmD John McCormick, PharmD Sherree Johns, BS, MLS (ASCP) J. Carl Panetta, PhD Hiroto Inaba, MD, PhD Michael Bishop, MD Mary Relling, PharmD Clinical Pharmacokinetics Lab Clinical Pharmacy Specialists 7

8 Assessment Question The ARK assay exhibits a significant positive bias at methotrexate concentrations compared to the TDx assay. a. Low b. High c. Mid-range 8

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