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Therapeutic Drug Monitoring of Asparaginase Activity-Method Comparison of MAAT and AHA Test Used in the International AIEOP-BFM ALL 2009 Trial

C. Lanvers-Kaminsky, A. Rüffer, G. Würthwein, J. Gerss, M. Zucchetti, A. Ballerini, A. Attarbaschi, P. Smisek, C. Nath, S. Lee, S. Elitzur, M. Zimmermann, A. Möricke, M. Schrappe, C. Rizzari, J. Boos,

. 2018 ; 40 (1) : 93-102.

Language English Country United States

Document type Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc19001052

BACKGROUND: In the international AIEOP-BFM ALL 2009 trial, asparaginase (ASE) activity was monitored after each dose of pegylated Escherichia coli ASE (PEG-ASE). Two methods were used: the aspartic acid β-hydroxamate (AHA) test and medac asparaginase activity test (MAAT). As the latter method overestimates PEG-ASE activity because it calibrates using E. coli ASE, method comparison was performed using samples from the AIEOP-BFM ALL 2009 trial. METHODS: PEG-ASE activities were determined using MAAT and AHA test in 2 sets of samples (first set: 630 samples and second set: 91 samples). Bland-Altman analysis was performed on ratios between MAAT and AHA tests. The mean difference between both methods, limits of agreement, and 95% confidence intervals were calculated and compared for all samples and samples grouped according to the calibration ranges of the MAAT and the AHA test. RESULTS: PEG-ASE activity determined using the MAAT was significantly higher than when determined using the AHA test (P < 0.001; Wilcoxon signed-rank test). Within the calibration range of the MAAT (30-600 U/L), PEG-ASE activities determined using the MAAT were on average 23% higher than PEG-ASE activities determined using the AHA test. This complies with the mean difference reported in the MAAT manual. With PEG-ASE activities >600 U/L, the discrepancies between MAAT and AHA test increased. Above the calibration range of the MAAT (>600 U/L) and the AHA test (>1000 U/L), a mean difference of 42% was determined. Because more than 70% of samples had PEG-ASE activities >600 U/L and required additional sample dilution, an overall mean difference of 37% was calculated for all samples (37% for the first and 34% for the second set). CONCLUSIONS: Comparison of the MAAT and AHA test for PEG-ASE activity confirmed a mean difference of 23% between MAAT and AHA test for PEG-ASE activities between 30 and 600 U/L. The discrepancy increased in samples with >600 U/L PEG-ASE activity, which will be especially relevant when evaluating high PEG-ASE activities in relation to toxicity, efficacy, and population pharmacokinetics.

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$a BACKGROUND: In the international AIEOP-BFM ALL 2009 trial, asparaginase (ASE) activity was monitored after each dose of pegylated Escherichia coli ASE (PEG-ASE). Two methods were used: the aspartic acid β-hydroxamate (AHA) test and medac asparaginase activity test (MAAT). As the latter method overestimates PEG-ASE activity because it calibrates using E. coli ASE, method comparison was performed using samples from the AIEOP-BFM ALL 2009 trial. METHODS: PEG-ASE activities were determined using MAAT and AHA test in 2 sets of samples (first set: 630 samples and second set: 91 samples). Bland-Altman analysis was performed on ratios between MAAT and AHA tests. The mean difference between both methods, limits of agreement, and 95% confidence intervals were calculated and compared for all samples and samples grouped according to the calibration ranges of the MAAT and the AHA test. RESULTS: PEG-ASE activity determined using the MAAT was significantly higher than when determined using the AHA test (P < 0.001; Wilcoxon signed-rank test). Within the calibration range of the MAAT (30-600 U/L), PEG-ASE activities determined using the MAAT were on average 23% higher than PEG-ASE activities determined using the AHA test. This complies with the mean difference reported in the MAAT manual. With PEG-ASE activities >600 U/L, the discrepancies between MAAT and AHA test increased. Above the calibration range of the MAAT (>600 U/L) and the AHA test (>1000 U/L), a mean difference of 42% was determined. Because more than 70% of samples had PEG-ASE activities >600 U/L and required additional sample dilution, an overall mean difference of 37% was calculated for all samples (37% for the first and 34% for the second set). CONCLUSIONS: Comparison of the MAAT and AHA test for PEG-ASE activity confirmed a mean difference of 23% between MAAT and AHA test for PEG-ASE activities between 30 and 600 U/L. The discrepancy increased in samples with >600 U/L PEG-ASE activity, which will be especially relevant when evaluating high PEG-ASE activities in relation to toxicity, efficacy, and population pharmacokinetics.
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$a Rüffer, Andrea $u Department of Pediatric Hematology and Oncology, University Children's Hospital of Muenster.
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$a Würthwein, Gudrun $u Department of Pediatric Hematology and Oncology, University Children's Hospital of Muenster.
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$a Gerss, Joachim $u Institute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany.
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$a Zucchetti, Massimo $u Laboratory of Cancer Pharmacology, Department of Oncology, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri.
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$a Ballerini, Andrea $u Department of Oncology and Onco-Hematology, University of Milan, Milan, Italy.
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$a Elitzur, Sara $u Pediatric Hematology-Oncology, Schneider Children's Medical Center, Petah-Tikva. Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
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$a Zimmermann, Martin $u Department of Paediatric Haematology and Oncology, Hannover Medical School, Hannover.
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$a Möricke, Anja $u Klinik für Allgemeine Pädiatrie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.
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$a Schrappe, Martin $u Klinik für Allgemeine Pädiatrie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.
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$a Rizzari, Carmelo $u Clinica Pediatrica, Ospedale S. Gerardo, Università di Milano-Bicocca, Monza, Italy.
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$a Boos, Joachim $u Department of Pediatric Hematology and Oncology, University Children's Hospital of Muenster.
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