A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer

Cabozantinib; Medullary thyroid cancer; Tyrosine kinase inhibitor

Detalles Bibliográficos
Autores: Klochikhin, Arkadiy, Isaev, Pavel, Badiu, Corin, Robinson, Bruce, Capdevila Castillon, Jaume, Leboulleux, Sophie
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
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:11351/9667
Acceso en línea:https://hdl.handle.net/11351/9667
Access Level:acceso abierto
Palabra clave:Tiroide - Càncer - Tractament
Proteïnes quinases - Inhibidors - Ús terapèutic
DISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Thyroid Neoplasms
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::/therapeutic use
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias de la tiroides
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::/uso terapéutico
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oai_identifier_str oai:recercat.cat:11351/9667
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer
title A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer
spellingShingle A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer
Klochikhin, Arkadiy
Tiroide - Càncer - Tractament
Proteïnes quinases - Inhibidors - Ús terapèutic
DISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Thyroid Neoplasms
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::/therapeutic use
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias de la tiroides
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::/uso terapéutico
title_short A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer
title_full A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer
title_fullStr A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer
title_full_unstemmed A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer
title_sort A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer
dc.creator.none.fl_str_mv Klochikhin, Arkadiy
Isaev, Pavel
Badiu, Corin
Robinson, Bruce
Capdevila Castillon, Jaume
Leboulleux, Sophie
author Klochikhin, Arkadiy
author_facet Klochikhin, Arkadiy
Isaev, Pavel
Badiu, Corin
Robinson, Bruce
Capdevila Castillon, Jaume
Leboulleux, Sophie
author_role author
author2 Isaev, Pavel
Badiu, Corin
Robinson, Bruce
Capdevila Castillon, Jaume
Leboulleux, Sophie
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Capdevila J] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. IOB-Quiron-Teknon, Barcelona, Spain. [Klochikhin A] Regional Clinical Oncology Hospital, Yaroslavl, Russian Federation. [Leboulleux S] Gustave Roussy and University Paris Saclay, Villejuif, France. [Isaev P] Federal State Institution Medical Radiology Research Center, Obninsk, Russian Federation. [Badiu C] ‘‘C. I. Parhon,’’ National Institute of Endocrinology and ‘‘C. Davila’’ University of Medicine and Pharmacy, Bucharest, Romania. [Robinson B] Royal North Shore Hospital, St Leonards, Australia
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Tiroide - Càncer - Tractament
Proteïnes quinases - Inhibidors - Ús terapèutic
DISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Thyroid Neoplasms
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::/therapeutic use
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias de la tiroides
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::/uso terapéutico
topic Tiroide - Càncer - Tractament
Proteïnes quinases - Inhibidors - Ús terapèutic
DISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Thyroid Neoplasms
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::/therapeutic use
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias de la tiroides
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::/uso terapéutico
description Cabozantinib; Medullary thyroid cancer; Tyrosine kinase inhibitor
publishDate 2022
dc.date.none.fl_str_mv 2022
2023
2023
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/11351/9667
url https://hdl.handle.net/11351/9667
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Thyroid;32(5)
https://doi.org/10.1089/thy.2022.0027
dc.rights.none.fl_str_mv Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Mary Ann Liebert
publisher.none.fl_str_mv Mary Ann Liebert
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)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869425803744247808
spelling A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid CancerKlochikhin, ArkadiyIsaev, PavelBadiu, CorinRobinson, BruceCapdevila Castillon, JaumeLeboulleux, SophieTiroide - Càncer - TractamentProteïnes quinases - Inhibidors - Ús terapèuticDISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Thyroid NeoplasmsOther 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::/therapeutic useENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias de la tiroidesOtros 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::/uso terapéuticoCabozantinib; Medullary thyroid cancer; Tyrosine kinase inhibitorCabozantinib; Càncer medul·lar de tiroides; Inhibidor de la tirosina cinasaCabozantinib; Cáncer medular de tiroides; Inhibidor de la tirosina cinasaBackground: Cabozantinib inhibits pathways involved in medullary thyroid cancer (MTC). Cabozantinib is approved as 140 mg/day in capsules for MTC and 60 mg/day in tablets for other solid tumors. This study compared the two doses in progressive metastatic MTC. Methods: In this Phase 4, randomized, double-blind noninferiority (NI) trial (NCT01896479), patients with progressive metastatic MTC were randomized 1:1 to cabozantinib 60 mg/day tablet or 140 mg/day capsules. The primary end point was progression-free survival (PFS) by blinded independent radiology committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. NI would be concluded if the upper 95% confidence interval [CI] for the PFS hazard ratio (HR) was less than the NI margin, 1.58. The secondary end point was objective response rate (ORR) by BIRC per RECIST v1.1; additional end points included safety and pharmacokinetics. Results: At data cutoff (July 15, 2020), 247 patients were randomized to the 60 mg/day tablet arm (n = 123) and the 140 mg/day capsules arm (n = 124). NI was not met (median PFS 11.0 months vs. 13.9 months in the 60 and 140 mg/day arms [HR 1.24; CI 0.90–1.70; p = 0.19]). The ORR was 33% in both arms. Generally, adverse event (AE) incidence was lower in the 60 mg/day arm (Grade 3/4, 63% vs. 72%), as were dose reductions (69% vs. 81%) and treatment discontinuations due to AEs (23% vs. 36%). Initially, cabozantinib plasma concentrations were higher in the 140 mg/day arm but became similar between arms at later time points. Conclusions: PFS NI of the cabozantinib 60 mg/day tablet vs. 140 mg/day capsules was not met. The 60 mg/day tablet had the same ORR and lower rates of AEs.This work was supported by Exelixis, Inc., Alameda, CA, USA (no grant number). Exelixis was involved in the study design, the collection, analysis, and interpretation of data, the writing of the report, and the decision to submit for publication.Mary Ann LiebertInstitut Català de la Salut[Capdevila J] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. IOB-Quiron-Teknon, Barcelona, Spain. [Klochikhin A] Regional Clinical Oncology Hospital, Yaroslavl, Russian Federation. [Leboulleux S] Gustave Roussy and University Paris Saclay, Villejuif, France. [Isaev P] Federal State Institution Medical Radiology Research Center, Obninsk, Russian Federation. [Badiu C] ‘‘C. I. Parhon,’’ National Institute of Endocrinology and ‘‘C. Davila’’ University of Medicine and Pharmacy, Bucharest, Romania. [Robinson B] Royal North Shore Hospital, St Leonards, AustraliaVall d'Hebron Barcelona Hospital Campus202320232022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/9667Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésThyroid;32(5)https://doi.org/10.1089/thy.2022.0027Attribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/96672026-05-29T05:05:01Z
score 15,812455

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