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Determination of serum levels of imatinib mesylate in patients with chronic myeloid leukemia: validation and application of a new analytical method to monitor treatment compliance.

Rezende VM, Rivellis AJ, Gomes MM, Dörr FA, Novaes MM, Nardinelli L, Costa AL, Chamone DA, Bendit I - Rev Bras Hematol Hemoter (2013)

Bottom Line: This study includes results (imatinib serum concentrations) for 308 samples from patients being treated with imatinib mesylate.The imatinib serum levels of patients achieving a major molecular response were significantly higher than those of patients who did not achieve this result.These results are thus consistent with published reports concerning other populations.

View Article: PubMed Central - HTML - PubMed

Affiliation: Faculdade de Medicina, Universidade de São Paulo - USP, São Paulo, SP, Brazil.

ABSTRACT

Objective: The goal of this study was to monitor imatinib mesylate therapeutically in the Tumor Biology Laboratory, Department of Hematology and Hemotherapy, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP). A simple and sensitive method to quantify imatinib and its metabolite (CGP74588) in human serum was developed and fully validated in order to monitor treatment compliance.

Methods: The method used to quantify these compounds in serum included protein precipitation extraction followed by instrumental analysis using high performance liquid chromatography coupled with mass spectrometry. The method was validated for several parameters, including selectivity, precision, accuracy, recovery and linearity.

Results: The parameters evaluated during the validation stage exhibited satisfactory results based on the Food and Drug Administration and the Brazilian Health Surveillance Agency (ANVISA) guidelines for validating bioanalytical methods. These parameters also showed a linear correlation greater than 0.99 for the concentration range between 0.500 µg/mL and 10.0 µg/mL and a total analysis time of 13 minutes per sample. This study includes results (imatinib serum concentrations) for 308 samples from patients being treated with imatinib mesylate.

Conclusion: The method developed in this study was successfully validated and is being efficiently used to measure imatinib concentrations in samples from chronic myeloid leukemia patients to check treatment compliance. The imatinib serum levels of patients achieving a major molecular response were significantly higher than those of patients who did not achieve this result. These results are thus consistent with published reports concerning other populations.

No MeSH data available.


Related in: MedlinePlus

Serum concentrations of imatinib observed in the samples (Set 1: Total - n = 308;Set 2: MMR only - n = 223; Set 3: non-MMR - n = 85).There is a significant difference in the distribution of values between sets,especially in relation to the median and amplitude of the values.The horizontal line at the concentration of 1344 µg/mL corresponds to themedian of better treatment response set, which is significantly higher than thenon-MMR group. Values are in µg/mL
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f02: Serum concentrations of imatinib observed in the samples (Set 1: Total - n = 308;Set 2: MMR only - n = 223; Set 3: non-MMR - n = 85).There is a significant difference in the distribution of values between sets,especially in relation to the median and amplitude of the values.The horizontal line at the concentration of 1344 µg/mL corresponds to themedian of better treatment response set, which is significantly higher than thenon-MMR group. Values are in µg/mL

Mentions: Figure 1 shows a histogram of the distribution ofimatinib concentrations in the MMR samples. The ranges defined by quartiles andfrequencies are indicated on the histogram. Figure2 shows the results of three sets of data in a box-plot, as well as theparameters used to calculate these data.


Determination of serum levels of imatinib mesylate in patients with chronic myeloid leukemia: validation and application of a new analytical method to monitor treatment compliance.

Rezende VM, Rivellis AJ, Gomes MM, Dörr FA, Novaes MM, Nardinelli L, Costa AL, Chamone DA, Bendit I - Rev Bras Hematol Hemoter (2013)

Serum concentrations of imatinib observed in the samples (Set 1: Total - n = 308;Set 2: MMR only - n = 223; Set 3: non-MMR - n = 85).There is a significant difference in the distribution of values between sets,especially in relation to the median and amplitude of the values.The horizontal line at the concentration of 1344 µg/mL corresponds to themedian of better treatment response set, which is significantly higher than thenon-MMR group. Values are in µg/mL
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3672119&req=5

f02: Serum concentrations of imatinib observed in the samples (Set 1: Total - n = 308;Set 2: MMR only - n = 223; Set 3: non-MMR - n = 85).There is a significant difference in the distribution of values between sets,especially in relation to the median and amplitude of the values.The horizontal line at the concentration of 1344 µg/mL corresponds to themedian of better treatment response set, which is significantly higher than thenon-MMR group. Values are in µg/mL
Mentions: Figure 1 shows a histogram of the distribution ofimatinib concentrations in the MMR samples. The ranges defined by quartiles andfrequencies are indicated on the histogram. Figure2 shows the results of three sets of data in a box-plot, as well as theparameters used to calculate these data.

Bottom Line: This study includes results (imatinib serum concentrations) for 308 samples from patients being treated with imatinib mesylate.The imatinib serum levels of patients achieving a major molecular response were significantly higher than those of patients who did not achieve this result.These results are thus consistent with published reports concerning other populations.

View Article: PubMed Central - HTML - PubMed

Affiliation: Faculdade de Medicina, Universidade de São Paulo - USP, São Paulo, SP, Brazil.

ABSTRACT

Objective: The goal of this study was to monitor imatinib mesylate therapeutically in the Tumor Biology Laboratory, Department of Hematology and Hemotherapy, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP). A simple and sensitive method to quantify imatinib and its metabolite (CGP74588) in human serum was developed and fully validated in order to monitor treatment compliance.

Methods: The method used to quantify these compounds in serum included protein precipitation extraction followed by instrumental analysis using high performance liquid chromatography coupled with mass spectrometry. The method was validated for several parameters, including selectivity, precision, accuracy, recovery and linearity.

Results: The parameters evaluated during the validation stage exhibited satisfactory results based on the Food and Drug Administration and the Brazilian Health Surveillance Agency (ANVISA) guidelines for validating bioanalytical methods. These parameters also showed a linear correlation greater than 0.99 for the concentration range between 0.500 µg/mL and 10.0 µg/mL and a total analysis time of 13 minutes per sample. This study includes results (imatinib serum concentrations) for 308 samples from patients being treated with imatinib mesylate.

Conclusion: The method developed in this study was successfully validated and is being efficiently used to measure imatinib concentrations in samples from chronic myeloid leukemia patients to check treatment compliance. The imatinib serum levels of patients achieving a major molecular response were significantly higher than those of patients who did not achieve this result. These results are thus consistent with published reports concerning other populations.

No MeSH data available.


Related in: MedlinePlus