Population Pharmacokinetic Analysis of Lanreotide Autogel®/Depot in the Treatment of Neuroendocrine Tumors: Pooled Analysis of Four Clinical Trials
Background and Objectives Lanreotide Autogel ® (lanreotide Depot in the USA) has demonstrated anti-tumor activity and control of the symptoms associated with hormone hypersecretion in patients with neuroendocrine tumors. The objectives of this study were to describe the pharmacokinetics of lanreotid...
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Published in | Clinical pharmacokinetics Vol. 55; no. 4; pp. 461 - 473 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
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01.04.2016
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Abstract | Background and Objectives
Lanreotide Autogel
®
(lanreotide Depot in the USA) has demonstrated anti-tumor activity and control of the symptoms associated with hormone hypersecretion in patients with neuroendocrine tumors. The objectives of this study were to describe the pharmacokinetics of lanreotide Autogel
®
administered 4-weekly by deep subcutaneous injections of 60, 90, or 120 mg in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), to quantify the magnitude of inter-patient variability (IPV), and to identify those patient characteristics that impact on pharmacokinetics.
Methods
Analyses were based on pooled data from clinical trials. A total of 1541 serum concentrations from 290 patients were analyzed simultaneously by the population approach using NONMEM
®
version 7.2. Covariates evaluated included demographics, renal and hepatic function markers, and disease-related parameters.
Results
Serum profiles were described by a one-compartment disposition model in which the absorption process was characterized by two parallel pathways following first- and zero-order kinetics. The estimated apparent volume of distribution was 18.3 L. The estimated apparent total serum clearance for a typical 74 kg patient was 513 L/day, representing a substantial difference in clearance in this population of patients with respect to healthy volunteers that could not be explained by any of the covariates tested. Body weight was the only covariate to show a statistically significant effect on the pharmacokinetic profile, but due to the overlap between the pharmacokinetic profiles of patients with lower or higher body weights the effect of body weight on clearance was not considered clinically relevant. The IPV was low for clearance (27 %) and moderate to high for volume of distribution (150 %) and the absorption constant (61 %).
Conclusions
Using two mechanisms of absorption, the pharmacokinetics of lanreotide Autogel
®
were well-described in patients with GEP-NET. None of the patient characteristics tested were of clinical relevance to potential dose adjustment in clinical practice. |
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AbstractList | Background and Objectives
Lanreotide Autogel
®
(lanreotide Depot in the USA) has demonstrated anti-tumor activity and control of the symptoms associated with hormone hypersecretion in patients with neuroendocrine tumors. The objectives of this study were to describe the pharmacokinetics of lanreotide Autogel
®
administered 4-weekly by deep subcutaneous injections of 60, 90, or 120 mg in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), to quantify the magnitude of inter-patient variability (IPV), and to identify those patient characteristics that impact on pharmacokinetics.
Methods
Analyses were based on pooled data from clinical trials. A total of 1541 serum concentrations from 290 patients were analyzed simultaneously by the population approach using NONMEM
®
version 7.2. Covariates evaluated included demographics, renal and hepatic function markers, and disease-related parameters.
Results
Serum profiles were described by a one-compartment disposition model in which the absorption process was characterized by two parallel pathways following first- and zero-order kinetics. The estimated apparent volume of distribution was 18.3 L. The estimated apparent total serum clearance for a typical 74 kg patient was 513 L/day, representing a substantial difference in clearance in this population of patients with respect to healthy volunteers that could not be explained by any of the covariates tested. Body weight was the only covariate to show a statistically significant effect on the pharmacokinetic profile, but due to the overlap between the pharmacokinetic profiles of patients with lower or higher body weights the effect of body weight on clearance was not considered clinically relevant. The IPV was low for clearance (27 %) and moderate to high for volume of distribution (150 %) and the absorption constant (61 %).
Conclusions
Using two mechanisms of absorption, the pharmacokinetics of lanreotide Autogel
®
were well-described in patients with GEP-NET. None of the patient characteristics tested were of clinical relevance to potential dose adjustment in clinical practice. BACKGROUND AND OBJECTIVESLanreotide Autogel (lanreotide Depot in the USA) has demonstrated anti-tumor activity and control of the symptoms associated with hormone hypersecretion in patients with neuroendocrine tumors. The objectives of this study were to describe the pharmacokinetics of lanreotide Autogel administered 4-weekly by deep subcutaneous injections of 60, 90, or 120 mg in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), to quantify the magnitude of inter-patient variability (IPV), and to identify those patient characteristics that impact on pharmacokinetics.METHODSAnalyses were based on pooled data from clinical trials. A total of 1541 serum concentrations from 290 patients were analyzed simultaneously by the population approach using NONMEM version 7.2. Covariates evaluated included demographics, renal and hepatic function markers, and disease-related parameters.RESULTSSerum profiles were described by a one-compartment disposition model in which the absorption process was characterized by two parallel pathways following first- and zero-order kinetics. The estimated apparent volume of distribution was 18.3 L. The estimated apparent total serum clearance for a typical 74 kg patient was 513 L/day, representing a substantial difference in clearance in this population of patients with respect to healthy volunteers that could not be explained by any of the covariates tested. Body weight was the only covariate to show a statistically significant effect on the pharmacokinetic profile, but due to the overlap between the pharmacokinetic profiles of patients with lower or higher body weights the effect of body weight on clearance was not considered clinically relevant. The IPV was low for clearance (27%) and moderate to high for volume of distribution (150%) and the absorption constant (61%).CONCLUSIONSUsing two mechanisms of absorption, the pharmacokinetics of lanreotide Autogel were well-described in patients with GEP-NET. None of the patient characteristics tested were of clinical relevance to potential dose adjustment in clinical practice. Lanreotide Autogel (lanreotide Depot in the USA) has demonstrated anti-tumor activity and control of the symptoms associated with hormone hypersecretion in patients with neuroendocrine tumors. The objectives of this study were to describe the pharmacokinetics of lanreotide Autogel administered 4-weekly by deep subcutaneous injections of 60, 90, or 120 mg in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), to quantify the magnitude of inter-patient variability (IPV), and to identify those patient characteristics that impact on pharmacokinetics. Analyses were based on pooled data from clinical trials. A total of 1541 serum concentrations from 290 patients were analyzed simultaneously by the population approach using NONMEM version 7.2. Covariates evaluated included demographics, renal and hepatic function markers, and disease-related parameters. Serum profiles were described by a one-compartment disposition model in which the absorption process was characterized by two parallel pathways following first- and zero-order kinetics. The estimated apparent volume of distribution was 18.3 L. The estimated apparent total serum clearance for a typical 74 kg patient was 513 L/day, representing a substantial difference in clearance in this population of patients with respect to healthy volunteers that could not be explained by any of the covariates tested. Body weight was the only covariate to show a statistically significant effect on the pharmacokinetic profile, but due to the overlap between the pharmacokinetic profiles of patients with lower or higher body weights the effect of body weight on clearance was not considered clinically relevant. The IPV was low for clearance (27%) and moderate to high for volume of distribution (150%) and the absorption constant (61%). Using two mechanisms of absorption, the pharmacokinetics of lanreotide Autogel were well-described in patients with GEP-NET. None of the patient characteristics tested were of clinical relevance to potential dose adjustment in clinical practice. |
Author | Dehez, Marion Manon, Amandine Garrido, María Jesús Trocóniz, Iñaki F. Nguyen, Thi Xuan Quyen Gomez-Panzani, Edda L. Buil-Bruna, Núria |
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Cites_doi | 10.1038/sj.clpt.6100241 10.1111/j.1365-2125.2004.02170.x 10.2165/0003088-200948010-00004 10.1056/NEJMoa1316158 10.1159/000082875 10.1016/S0169-2607(98)00067-4 10.1124/jpet.112.195560 10.1186/1471-2407-13-427 10.1111/j.1365-2125.2006.02820.x 10.1016/S0009-9236(99)70011-1 10.1517/13543784.2014.942728 10.1016/j.cmpb.2005.04.005 10.1007/BF02353864 10.1200/jco.2014.32.3_suppl.268 |
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Snippet | Background and Objectives
Lanreotide Autogel
®
(lanreotide Depot in the USA) has demonstrated anti-tumor activity and control of the symptoms associated with... Lanreotide Autogel (lanreotide Depot in the USA) has demonstrated anti-tumor activity and control of the symptoms associated with hormone hypersecretion in... BACKGROUND AND OBJECTIVESLanreotide Autogel (lanreotide Depot in the USA) has demonstrated anti-tumor activity and control of the symptoms associated with... |
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SubjectTerms | Adult Aged Antineoplastic Agents - administration & dosage Antineoplastic Agents - blood Antineoplastic Agents - pharmacokinetics Body Weight Clinical Trials, Phase III as Topic Female Humans Internal Medicine Intestinal Neoplasms - blood Intestinal Neoplasms - drug therapy Intestinal Neoplasms - metabolism Male Medicine Medicine & Public Health Metabolic Clearance Rate Middle Aged Models, Biological Neuroendocrine Tumors - blood Neuroendocrine Tumors - drug therapy Neuroendocrine Tumors - metabolism Original Research Article Pancreatic Neoplasms - blood Pancreatic Neoplasms - drug therapy Pancreatic Neoplasms - metabolism Peptides, Cyclic - administration & dosage Peptides, Cyclic - blood Peptides, Cyclic - pharmacokinetics Pharmacology/Toxicology Pharmacotherapy Randomized Controlled Trials as Topic Somatostatin - administration & dosage Somatostatin - analogs & derivatives Somatostatin - blood Somatostatin - pharmacokinetics Stomach Neoplasms - blood Stomach Neoplasms - drug therapy Stomach Neoplasms - metabolism |
Title | Population Pharmacokinetic Analysis of Lanreotide Autogel®/Depot in the Treatment of Neuroendocrine Tumors: Pooled Analysis of Four Clinical Trials |
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