Efficacy and pharmacokinetic/pharmacodynamic evaluation of the Aurora kinase A inhibitor MLN8237 against preclinical models of pediatric cancer
Purpose To gain a greater understanding of the potential of the Aurora kinase A inhibitor MLN8237 in the treatment of pediatric malignancies. Methods The activity of MLN8237 was evaluated against 28 neuroblastoma and Ewing sarcoma cell lines, and its in vivo efficacy was studied over a range of dose...
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Published in | Cancer chemotherapy and pharmacology Vol. 68; no. 5; pp. 1291 - 1304 |
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Main Authors | , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Berlin/Heidelberg
Springer-Verlag
01.11.2011
Springer Springer Nature B.V |
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Abstract | Purpose
To gain a greater understanding of the potential of the Aurora kinase A inhibitor MLN8237 in the treatment of pediatric malignancies.
Methods
The activity of MLN8237 was evaluated against 28 neuroblastoma and Ewing sarcoma cell lines, and its in vivo efficacy was studied over a range of doses against 12 pediatric tumor xenograft models. Pharmacokinetic, pharmacodynamic, and genomic studies were undertaken.
Results
In vitro neuroblastoma cell lines were generally more sensitive to MLN8237 than Ewing sarcoma lines. MLN8237 demonstrated significant activity in vivo against solid tumor models at the maximum tolerated dose (MTD); however, only 2 of 6 neuroblastoma models had objective responses at 0.25MTD. In contrast, MLN8237 induced objective responses at its MTD and at 0.5MTD in three ALL models and in two out of three at 0.25MTD. Pharmacokinetic studies at 0.5MTD demonstrated a
T
max
of 0.5 h,
C
max
of 24.8 μM, AUC
(0–24)
of 60.3 μM h, and 12 h trough level of 1.2 μM. Mitotic indices increased 6–12 h after MLN8237 administration. AURKA copy number variation was frequent in xenografts, and expression was highly correlated with copy number.
Conclusions
Objective responses were more frequent in tumors with decreased AURKA copy number (5/8) compared to those with increased gene copy number (2/14). This report confirms the significant activity against both solid tumor and ALL xenografts at the MTD, with a steep dose response. These data support clinical development of MLN8237 in childhood cancer. Because of the steep dose–response relationship, such studies should target achieving trough levels of 1 μM or higher for sustained periods of treatment. |
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AbstractList | To gain a greater understanding of the potential of the Aurora kinase A inhibitor MLN8237 in the treatment of pediatric malignancies.
The activity of MLN8237 was evaluated against 28 neuroblastoma and Ewing sarcoma cell lines, and its in vivo efficacy was studied over a range of doses against 12 pediatric tumor xenograft models. Pharmacokinetic, pharmacodynamic, and genomic studies were undertaken.
In vitro neuroblastoma cell lines were generally more sensitive to MLN8237 than Ewing sarcoma lines. MLN8237 demonstrated significant activity in vivo against solid tumor models at the maximum tolerated dose (MTD); however, only 2 of 6 neuroblastoma models had objective responses at 0.25MTD. In contrast, MLN8237 induced objective responses at its MTD and at 0.5MTD in three ALL models and in two out of three at 0.25MTD. Pharmacokinetic studies at 0.5MTD demonstrated a T (max) of 0.5 h, C (max) of 24.8 μM, AUC((0-24)) of 60.3 μM h, and 12 h trough level of 1.2 μM. Mitotic indices increased 6-12 h after MLN8237 administration. AURKA copy number variation was frequent in xenografts, and expression was highly correlated with copy number.
Objective responses were more frequent in tumors with decreased AURKA copy number (5/8) compared to those with increased gene copy number (2/14). This report confirms the significant activity against both solid tumor and ALL xenografts at the MTD, with a steep dose response. These data support clinical development of MLN8237 in childhood cancer. Because of the steep dose-response relationship, such studies should target achieving trough levels of 1 μM or higher for sustained periods of treatment. Purpose To gain a greater understanding of the potential of the Aurora kinase A inhibitor MLN8237 in the treatment of pediatric malignancies. Methods The activity of MLN8237 was evaluated against 28 neuroblastoma and Ewing sarcoma cell lines, and its in vivo efficacy was studied over a range of doses against 12 pediatric tumor xenograft models. Pharmacokinetic, pharmacodynamic, and genomic studies were undertaken. Results In vitro neuroblastoma cell lines were generally more sensitive to MLN8237 than Ewing sarcoma lines. MLN8237 demonstrated significant activity in vivo against solid tumor models at the maximum tolerated dose (MTD); however, only 2 of 6 neuroblastoma models had objective responses at 0.25MTD. In contrast, MLN8237 induced objective responses at its MTD and at 0.5MTD in three ALL models and in two out of three at 0.25MTD. Pharmacokinetic studies at 0.5MTD demonstrated a T max of 0.5 h, C max of 24.8 μM, AUC (0–24) of 60.3 μM h, and 12 h trough level of 1.2 μM. Mitotic indices increased 6–12 h after MLN8237 administration. AURKA copy number variation was frequent in xenografts, and expression was highly correlated with copy number. Conclusions Objective responses were more frequent in tumors with decreased AURKA copy number (5/8) compared to those with increased gene copy number (2/14). This report confirms the significant activity against both solid tumor and ALL xenografts at the MTD, with a steep dose response. These data support clinical development of MLN8237 in childhood cancer. Because of the steep dose–response relationship, such studies should target achieving trough levels of 1 μM or higher for sustained periods of treatment. To gain a greater understanding of the potential of the Aurora kinase A inhibitor MLN8237 in the treatment of pediatric malignancies. The activity of MLN8237 was evaluated against 28 neuroblastoma and Ewing sarcoma cell lines, and its in vivo efficacy was studied over a range of doses against 12 pediatric tumor xenograft models. Pharmacokinetic, pharmacodynamic, and genomic studies were undertaken. In vitro neuroblastoma cell lines were generally more sensitive to MLN8237 than Ewing sarcoma lines. MLN8237 demonstrated significant activity in vivo against solid tumor models at the maximum tolerated dose (MTD); however, only 2 of 6 neuroblastoma models had objective responses at 0.25MTD. In contrast, MLN8237 induced objective responses at its MTD and at 0.5MTD in three ALL models and in two out of three at 0.25MTD. Pharmacokinetic studies at 0.5MTD demonstrated a T ^sub max^ of 0.5 h, C ^sub max^ of 24.8 μM, AUC^sub (0-24)^ of 60.3 μM h, and 12 h trough level of 1.2 μM. Mitotic indices increased 6-12 h after MLN8237 administration. AURKA copy number variation was frequent in xenografts, and expression was highly correlated with copy number. Objective responses were more frequent in tumors with decreased AURKA copy number (5/8) compared to those with increased gene copy number (2/14). This report confirms the significant activity against both solid tumor and ALL xenografts at the MTD, with a steep dose response. These data support clinical development of MLN8237 in childhood cancer. Because of the steep dose-response relationship, such studies should target achieving trough levels of 1 μM or higher for sustained periods of treatment.[PUBLICATION ABSTRACT] |
Author | Manfredi, Mark Yang, Yu Houghton, Peter J. Wozniak, Amy E. Carol, Hernan Gorlick, Richard Boehm, Ingrid Ecsedy, Jeffrey Kang, Min H. Lock, Richard B. Morton, Christopher L. Keir, Stephen T. Wu, Jianrong Kolb, E. Anders Neale, Geoffrey Maris, John M. Wang, Jianmin Reynolds, C. Patrick Smith, Malcolm A. |
Author_xml | – sequence: 1 givenname: Hernan surname: Carol fullname: Carol, Hernan organization: Leukaemia Biology Program, Children’s Cancer Institute Australia for Medical Research, Lowy Cancer Research Centre, UNSW – sequence: 2 givenname: Ingrid surname: Boehm fullname: Boehm, Ingrid organization: Leukaemia Biology Program, Children’s Cancer Institute Australia for Medical Research, Lowy Cancer Research Centre, UNSW – sequence: 3 givenname: C. Patrick surname: Reynolds fullname: Reynolds, C. Patrick organization: Texas Tech University Health Sciences Center – sequence: 4 givenname: Min H. surname: Kang fullname: Kang, Min H. organization: Texas Tech University Health Sciences Center – sequence: 5 givenname: John M. surname: Maris fullname: Maris, John M. organization: Children’s Hospital of Philadelphia, University of Pennsylvania School of Medicine and Abramson Family Cancer Research Institute – sequence: 6 givenname: Christopher L. surname: Morton fullname: Morton, Christopher L. organization: St. Jude Children’s Research Hospital – sequence: 7 givenname: Richard surname: Gorlick fullname: Gorlick, Richard organization: The Children’s Hospital at Montefiore – sequence: 8 givenname: E. Anders surname: Kolb fullname: Kolb, E. Anders organization: A.I. DuPont Hospital for Children – sequence: 9 givenname: Stephen T. surname: Keir fullname: Keir, Stephen T. organization: Duke University Medical Center – sequence: 10 givenname: Jianrong surname: Wu fullname: Wu, Jianrong organization: St. Jude Children’s Research Hospital – sequence: 11 givenname: Amy E. surname: Wozniak fullname: Wozniak, Amy E. organization: St. Jude Children’s Research Hospital – sequence: 12 givenname: Yu surname: Yang fullname: Yang, Yu organization: Millennium Pharmaceuticals Inc – sequence: 13 givenname: Mark surname: Manfredi fullname: Manfredi, Mark organization: Millennium Pharmaceuticals Inc – sequence: 14 givenname: Jeffrey surname: Ecsedy fullname: Ecsedy, Jeffrey organization: Millennium Pharmaceuticals Inc – sequence: 15 givenname: Jianmin surname: Wang fullname: Wang, Jianmin organization: St. Jude Children’s Research Hospital – sequence: 16 givenname: Geoffrey surname: Neale fullname: Neale, Geoffrey organization: St. Jude Children’s Research Hospital – sequence: 17 givenname: Peter J. surname: Houghton fullname: Houghton, Peter J. organization: Nationwide Children’s Hospital – sequence: 18 givenname: Malcolm A. surname: Smith fullname: Smith, Malcolm A. organization: Cancer Therapy Evaluation Program, NCI – sequence: 19 givenname: Richard B. surname: Lock fullname: Lock, Richard B. email: rlock@ccia.unsw.edu.au organization: Leukaemia Biology Program, Children’s Cancer Institute Australia for Medical Research, Lowy Cancer Research Centre, UNSW |
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Keywords | MLN8237 Pediatric cancer Preclinical testing Developmental therapeutics Human Evaluation Pediatrics Pharmacokinetic pharmacodynamic relationship Treatment efficiency Preclinical trial Aurora kinase Malignant tumor Medical screening Serine/threonine-protein kinase 6 Treatment Development Inhibitor Models Child Cancer |
Language | English |
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SSID | ssj0004133 |
Score | 2.3453832 |
Snippet | Purpose
To gain a greater understanding of the potential of the Aurora kinase A inhibitor MLN8237 in the treatment of pediatric malignancies.
Methods
The... To gain a greater understanding of the potential of the Aurora kinase A inhibitor MLN8237 in the treatment of pediatric malignancies. The activity of MLN8237... To gain a greater understanding of the potential of the Aurora kinase A inhibitor MLN8237 in the treatment of pediatric malignancies. The activity of MLN8237... |
SourceID | pubmedcentral proquest crossref pubmed pascalfrancis springer |
SourceType | Open Access Repository Aggregation Database Index Database Publisher |
StartPage | 1291 |
SubjectTerms | Animals Antineoplastic agents Aurora Kinase A Aurora Kinases Azepines - pharmacokinetics Azepines - pharmacology Azepines - therapeutic use Biological and medical sciences Cancer Research Cell Line, Tumor Child Dose-Response Relationship, Drug Enzyme Inhibitors - pharmacokinetics Enzyme Inhibitors - pharmacology Enzyme Inhibitors - therapeutic use Female Gene Dosage Humans Medical sciences Medicine Medicine & Public Health Mice Mice, SCID Neoplasms - drug therapy Neoplasms - genetics Neoplasms - pathology Oncology Original Original Article Pharmacology. Drug treatments Pharmacology/Toxicology Protein-Serine-Threonine Kinases - antagonists & inhibitors Pyrimidines - pharmacokinetics Pyrimidines - pharmacology Pyrimidines - therapeutic use |
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Title | Efficacy and pharmacokinetic/pharmacodynamic evaluation of the Aurora kinase A inhibitor MLN8237 against preclinical models of pediatric cancer |
URI | https://link.springer.com/article/10.1007/s00280-011-1618-8 https://www.ncbi.nlm.nih.gov/pubmed/21448591 https://www.proquest.com/docview/903836064/abstract/ https://pubmed.ncbi.nlm.nih.gov/PMC3215888 |
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