Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921
Pediatric patients; Intolerant; Chronic myeloid leukemia
| Autores: | , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2024 |
| País: | España |
| Institución: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:11351/11158 |
| Acceso en línea: | https://hdl.handle.net/11351/11158 http://hdl.handle.net/11351/11158 |
| Access Level: | acceso abierto |
| Palabra clave: | Proteïnes quinases - Inhibidors - Ús terapèutic - Efectes secundaris Leucèmia mieloide crònica - Tractament DISEASES::Hemic and Lymphatic Diseases::Hematologic Diseases::Bone Marrow Diseases::Myeloproliferative Disorders::Leukemia, Myelogenous, Chronic, BCR-ABL Positive::Leukemia, Myeloid, Chronic-Phase Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase Inhibitors Other subheadings::Other subheadings::Other subheadings::/adverse effects ENFERMEDADES::enfermedades hematológicas y linfáticas::enfermedades hematológicas::enfermedades de la médula ósea::trastornos mieloproliferativos::leucemia mielogenosa crónica BCR-ABL positiva::leucemia mieloide de fase crónica Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos |
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Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921 |
| title |
Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921 |
| spellingShingle |
Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921 Brivio, Erica Proteïnes quinases - Inhibidors - Ús terapèutic - Efectes secundaris Leucèmia mieloide crònica - Tractament DISEASES::Hemic and Lymphatic Diseases::Hematologic Diseases::Bone Marrow Diseases::Myeloproliferative Disorders::Leukemia, Myelogenous, Chronic, BCR-ABL Positive::Leukemia, Myeloid, Chronic-Phase Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase Inhibitors Other subheadings::Other subheadings::Other subheadings::/adverse effects ENFERMEDADES::enfermedades hematológicas y linfáticas::enfermedades hematológicas::enfermedades de la médula ósea::trastornos mieloproliferativos::leucemia mielogenosa crónica BCR-ABL positiva::leucemia mieloide de fase crónica Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos |
| title_short |
Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921 |
| title_full |
Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921 |
| title_fullStr |
Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921 |
| title_full_unstemmed |
Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921 |
| title_sort |
Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921 |
| dc.creator.none.fl_str_mv |
Brivio, Erica Edoardo, Pennesi Willemse, Marieke E. Huitema, Alwin D. R. Jiang, Yilin van Tinteren, Harm Murillo-Sanjuán, Laura |
| author |
Brivio, Erica |
| author_facet |
Brivio, Erica Edoardo, Pennesi Willemse, Marieke E. Huitema, Alwin D. R. Jiang, Yilin van Tinteren, Harm Murillo-Sanjuán, Laura |
| author_role |
author |
| author2 |
Edoardo, Pennesi Willemse, Marieke E. Huitema, Alwin D. R. Jiang, Yilin van Tinteren, Harm Murillo-Sanjuán, Laura |
| author2_role |
author author author author author author |
| dc.contributor.none.fl_str_mv |
Institut Català de la Salut [Brivio E, Pennesi E, Willemse ME, Jiang Y] Department of Pediatric Oncology, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands. Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands. [Huitema ADR] Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands. The Netherlands Cancer Institute, Amsterdam, the Netherlands. University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. [van Tinteren HDR] Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands. [Murillo-Sanjuan L] Vall d’Hebron Hospital Universitari, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus |
| dc.subject.none.fl_str_mv |
Proteïnes quinases - Inhibidors - Ús terapèutic - Efectes secundaris Leucèmia mieloide crònica - Tractament DISEASES::Hemic and Lymphatic Diseases::Hematologic Diseases::Bone Marrow Diseases::Myeloproliferative Disorders::Leukemia, Myelogenous, Chronic, BCR-ABL Positive::Leukemia, Myeloid, Chronic-Phase Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase Inhibitors Other subheadings::Other subheadings::Other subheadings::/adverse effects ENFERMEDADES::enfermedades hematológicas y linfáticas::enfermedades hematológicas::enfermedades de la médula ósea::trastornos mieloproliferativos::leucemia mielogenosa crónica BCR-ABL positiva::leucemia mieloide de fase crónica Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos |
| topic |
Proteïnes quinases - Inhibidors - Ús terapèutic - Efectes secundaris Leucèmia mieloide crònica - Tractament DISEASES::Hemic and Lymphatic Diseases::Hematologic Diseases::Bone Marrow Diseases::Myeloproliferative Disorders::Leukemia, Myelogenous, Chronic, BCR-ABL Positive::Leukemia, Myeloid, Chronic-Phase Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase Inhibitors Other subheadings::Other subheadings::Other subheadings::/adverse effects ENFERMEDADES::enfermedades hematológicas y linfáticas::enfermedades hematológicas::enfermedades de la médula ósea::trastornos mieloproliferativos::leucemia mielogenosa crónica BCR-ABL positiva::leucemia mieloide de fase crónica Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos |
| description |
Pediatric patients; Intolerant; Chronic myeloid leukemia |
| publishDate |
2024 |
| dc.date.none.fl_str_mv |
2024 2024 2024 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/11351/11158 http://hdl.handle.net/11351/11158 |
| url |
https://hdl.handle.net/11351/11158 http://hdl.handle.net/11351/11158 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
Journal of Clinical Oncology;42(7) https://doi.org/10.1200/JCO.23.00897 |
| dc.rights.none.fl_str_mv |
Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess |
| rights_invalid_str_mv |
Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| eu_rights_str_mv |
openAccess |
| dc.format.none.fl_str_mv |
application/pdf |
| dc.publisher.none.fl_str_mv |
American Society of Clinical Oncology |
| publisher.none.fl_str_mv |
American Society of Clinical Oncology |
| dc.source.none.fl_str_mv |
Scientia reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| reponame_str |
Recercat. Dipósit de la Recerca de Catalunya |
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Recercat. Dipósit de la Recerca de Catalunya |
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1869424426335862784 |
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Bosutinib in Resistant and Intolerant Pediatric Patients With Chronic Phase Chronic Myeloid Leukemia: Results From the Phase I Part of Study ITCC054/COG AAML1921Brivio, EricaEdoardo, PennesiWillemse, Marieke E.Huitema, Alwin D. R.Jiang, Yilinvan Tinteren, HarmMurillo-Sanjuán, LauraProteïnes quinases - Inhibidors - Ús terapèutic - Efectes secundarisLeucèmia mieloide crònica - TractamentDISEASES::Hemic and Lymphatic Diseases::Hematologic Diseases::Bone Marrow Diseases::Myeloproliferative Disorders::Leukemia, Myelogenous, Chronic, BCR-ABL Positive::Leukemia, Myeloid, Chronic-PhaseOther subheadings::Other subheadings::Other subheadings::/drug therapyCHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase InhibitorsOther subheadings::Other subheadings::Other subheadings::/adverse effectsENFERMEDADES::enfermedades hematológicas y linfáticas::enfermedades hematológicas::enfermedades de la médula ósea::trastornos mieloproliferativos::leucemia mielogenosa crónica BCR-ABL positiva::leucemia mieloide de fase crónicaOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaCOMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasasOtros calificadores::Otros calificadores::Otros calificadores::/efectos adversosPediatric patients; Intolerant; Chronic myeloid leukemiaPacientes pediátricos; Intolerantes; Leucemia mieloide crónicaPacients pediàtrics; Intolerants; Leucèmia mieloide crònicaPurpose Bosutinib is approved for adults with chronic myeloid leukemia (CML): 400 mg once daily in newly diagnosed (ND); 500 mg once daily in resistant/intolerant (R/I) patients. Bosutinib has a different tolerability profile than other tyrosine kinase inhibitors (TKIs) and potentially less impact on growth (preclinical data). The primary objective of this first-in-child trial was to determine the recommended phase II dose (RP2D) for pediatric R/I and ND patients. Patients and Methods In the phase I part of this international, open-label trial (ClinicalTrials.gov identifier: NCT04258943), children age 1-18 years with R/I (per European LeukemiaNet 2013) Ph+ CML were enrolled using a 6 + 4 design, testing 300, 350, and 400 mg/m2 once daily with food. The RP2D was the dose resulting in 0/6 or 1/10 dose-limiting toxicities (DLTs) during the first cycle and achieving adult target AUC levels for the respective indication. As ND participants were only enrolled in phase II, the ND RP2D was selected based on data from R/I patients. Results Thirty patients were enrolled; 27 were evaluable for DLT: six at 300 mg/m2, 11 at 350 mg/m2 (one DLT), and 10 at 400 mg/m2 (one DLT). The mean AUCs at 300 mg/m2, 350 mg/m2, and 400 mg/m2 were 2.20 μg h/mL, 2.52 μg h/mL, and 2.66 μg h/mL, respectively. The most common adverse event was diarrhea (93%; ≥grade 3: 11%). Seven patients stopped because of intolerance and eight because of insufficient response. Complete cytogenetic and major molecular response to bosutinib appeared comparable with other published phase I/II trials with second-generation TKIs in children. Conclusion Bosutinib was safe and effective. The pediatric RP2D was 400 mg/m2 once daily (max 600 mg/d) with food in R/I patients and 300 mg/m2 once daily (max 500 mg/d) with food in ND patients, which achieved targeted exposures as per adult experience.Sponsorship for the study was provided by Erasmus MC/Sophia Children's Hospital, Department of Pediatrics, Rotterdam, the Netherlands.American Society of Clinical OncologyInstitut Català de la Salut[Brivio E, Pennesi E, Willemse ME, Jiang Y] Department of Pediatric Oncology, Erasmus MC Sophia Children’s Hospital, Rotterdam, the Netherlands. Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands. [Huitema ADR] Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands. The Netherlands Cancer Institute, Amsterdam, the Netherlands. University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. [van Tinteren HDR] Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands. [Murillo-Sanjuan L] Vall d’Hebron Hospital Universitari, Barcelona, SpainVall d'Hebron Barcelona Hospital Campus202420242024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/11158http://hdl.handle.net/11351/11158Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésJournal of Clinical Oncology;42(7)https://doi.org/10.1200/JCO.23.00897Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/111582026-05-29T05:05:01Z |
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15.812429 |