Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial
Identifieur interne : 002F62 ( Ncbi/Checkpoint ); précédent : 002F61; suivant : 002F63Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial
Auteurs : N. Raje ; S. Vadhan-Raj [États-Unis] ; W. Willenbacher [Autriche] ; E. Terpos [Grèce] ; V. Hungria [Brésil] ; A. Spencer [Australie] ; Y. Alexeeva [Russie] ; T. Facon [France] ; A K Stewart [États-Unis] ; A. Feng [États-Unis] ; A. Braun [États-Unis] ; A. Balakumaran [États-Unis] ; G D Roodman [États-Unis]Source :
- Blood Cancer Journal [ 2044-5385 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Agents de maintien de la densité osseuse (usage thérapeutique), Diphosphonates (administration et posologie), Diphosphonates (effets indésirables), Diphosphonates (usage thérapeutique), Dénosumab (administration et posologie), Dénosumab (effets indésirables), Dénosumab (usage thérapeutique), Femelle, Humains, Imidazoles (administration et posologie), Imidazoles (effets indésirables), Imidazoles (usage thérapeutique), Myélome multiple (diagnostic), Myélome multiple (mortalité), Myélome multiple (traitement médicamenteux), Mâle, Métastase tumorale, Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Transplantation autologue, Transplantation de cellules souches hématopoïétiques, Tumeurs (anatomopathologie), Tumeurs osseuses (secondaire), Tumeurs osseuses (traitement médicamenteux).
- MESH :
- administration et posologie : Diphosphonates, Dénosumab, Imidazoles.
- anatomopathologie : Tumeurs.
- diagnostic : Myélome multiple.
- effets indésirables : Diphosphonates, Dénosumab, Imidazoles.
- mortalité : Myélome multiple.
- secondaire : Tumeurs osseuses.
- traitement médicamenteux : Myélome multiple, Tumeurs osseuses.
- usage thérapeutique : Agents de maintien de la densité osseuse, Diphosphonates, Dénosumab, Imidazoles, Protocoles de polychimiothérapie antinéoplasique.
- Adulte d'âge moyen, Femelle, Humains, Mâle, Métastase tumorale, Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Transplantation autologue, Transplantation de cellules souches hématopoïétiques.
English descriptors
- KwdEn :
- Aged, Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Bone Density Conservation Agents (therapeutic use), Bone Neoplasms (drug therapy), Bone Neoplasms (secondary), Denosumab (administration & dosage), Denosumab (adverse effects), Denosumab (therapeutic use), Diphosphonates (administration & dosage), Diphosphonates (adverse effects), Diphosphonates (therapeutic use), Female, Hematopoietic Stem Cell Transplantation, Humans, Imidazoles (administration & dosage), Imidazoles (adverse effects), Imidazoles (therapeutic use), Male, Middle Aged, Multiple Myeloma (diagnosis), Multiple Myeloma (drug therapy), Multiple Myeloma (mortality), Neoplasm Metastasis, Neoplasm Staging, Neoplasms (pathology), Transplantation, Autologous, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Denosumab, Diphosphonates, Imidazoles.
- chemical , adverse effects : Denosumab, Diphosphonates, Imidazoles.
- chemical , therapeutic use : Bone Density Conservation Agents, Denosumab, Diphosphonates, Imidazoles.
- diagnosis : Multiple Myeloma.
- drug therapy : Bone Neoplasms, Multiple Myeloma.
- mortality : Multiple Myeloma.
- pathology : Neoplasms.
- secondary : Bone Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Aged, Female, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Transplantation, Autologous, Treatment Outcome.
Abstract
In a phase 3 trial of denosumab vs zoledronic acid in patients (
Url:
DOI: 10.1038/bcj.2015.96
PubMed: 26745852
PubMed Central: 4742634
Affiliations:
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PMC:4742634Le document en format XML
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<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Bone Density Conservation Agents (therapeutic use)</term>
<term>Bone Neoplasms (drug therapy)</term>
<term>Bone Neoplasms (secondary)</term>
<term>Denosumab (administration & dosage)</term>
<term>Denosumab (adverse effects)</term>
<term>Denosumab (therapeutic use)</term>
<term>Diphosphonates (administration & dosage)</term>
<term>Diphosphonates (adverse effects)</term>
<term>Diphosphonates (therapeutic use)</term>
<term>Female</term>
<term>Hematopoietic Stem Cell Transplantation</term>
<term>Humans</term>
<term>Imidazoles (administration & dosage)</term>
<term>Imidazoles (adverse effects)</term>
<term>Imidazoles (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Multiple Myeloma (diagnosis)</term>
<term>Multiple Myeloma (drug therapy)</term>
<term>Multiple Myeloma (mortality)</term>
<term>Neoplasm Metastasis</term>
<term>Neoplasm Staging</term>
<term>Neoplasms (pathology)</term>
<term>Transplantation, Autologous</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Agents de maintien de la densité osseuse (usage thérapeutique)</term>
<term>Diphosphonates (administration et posologie)</term>
<term>Diphosphonates (effets indésirables)</term>
<term>Diphosphonates (usage thérapeutique)</term>
<term>Dénosumab (administration et posologie)</term>
<term>Dénosumab (effets indésirables)</term>
<term>Dénosumab (usage thérapeutique)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Imidazoles (administration et posologie)</term>
<term>Imidazoles (effets indésirables)</term>
<term>Imidazoles (usage thérapeutique)</term>
<term>Myélome multiple (diagnostic)</term>
<term>Myélome multiple (mortalité)</term>
<term>Myélome multiple (traitement médicamenteux)</term>
<term>Mâle</term>
<term>Métastase tumorale</term>
<term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term>
<term>Résultat thérapeutique</term>
<term>Stade de la tumeur</term>
<term>Sujet âgé</term>
<term>Transplantation autologue</term>
<term>Transplantation de cellules souches hématopoïétiques</term>
<term>Tumeurs (anatomopathologie)</term>
<term>Tumeurs osseuses (secondaire)</term>
<term>Tumeurs osseuses (traitement médicamenteux)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Denosumab</term>
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<term>Imidazoles</term>
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</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Bone Density Conservation Agents</term>
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<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Diphosphonates</term>
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<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Multiple Myeloma</term>
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<term>Imidazoles</term>
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</keywords>
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</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Neoplasms</term>
</keywords>
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</keywords>
<keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
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<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Agents de maintien de la densité osseuse</term>
<term>Diphosphonates</term>
<term>Dénosumab</term>
<term>Imidazoles</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Female</term>
<term>Hematopoietic Stem Cell Transplantation</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neoplasm Metastasis</term>
<term>Neoplasm Staging</term>
<term>Transplantation, Autologous</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Métastase tumorale</term>
<term>Résultat thérapeutique</term>
<term>Stade de la tumeur</term>
<term>Sujet âgé</term>
<term>Transplantation autologue</term>
<term>Transplantation de cellules souches hématopoïétiques</term>
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<front><div type="abstract" xml:lang="en"><p>In a phase 3 trial of denosumab vs zoledronic acid in patients (<italic>n</italic>
=1776) with bone metastases and solid tumors or multiple myeloma, denosumab was superior to zoledronic acid for the primary end point of prevention of skeletal-related events. There was no difference in overall survival between the two groups; however, an <italic>ad hoc</italic>
overall survival analysis in the multiple myeloma subset of patients (<italic>n</italic>
=180) favored zoledronic acid (hazard ratio (HR) 2.26; 95% confidence interval (CI) 1.13–4.50; <italic>P</italic>
=0.014). In the present analysis, we found imbalances between the groups with respect to baseline risk characteristics. HRs with two-sided 95% CIs were estimated using the Cox model. After adjustment in a covariate analysis, the CI crossed unity (HR 1.86; 95% CI 0.90–3.84; <italic>P</italic>
=0.0954). Furthermore, we found a higher rate of early withdrawals for the reasons of lost to follow-up and withdrawal of consent in the zoledronic acid group; after accounting for these, the HR was 1.31 (95% CI 0.80–2.15; <italic>P</italic>
=0.278). In conclusion, the survival results in multiple myeloma patients in this trial were confounded and will eventually be resolved by an ongoing phase 3 trial.</p>
</div>
</front>
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<affiliations><list><country><li>Australie</li>
<li>Autriche</li>
<li>Brésil</li>
<li>France</li>
<li>Grèce</li>
<li>Russie</li>
<li>États-Unis</li>
</country>
</list>
<tree><noCountry><name sortKey="Raje, N" sort="Raje, N" uniqKey="Raje N" first="N" last="Raje">N. Raje</name>
</noCountry>
<country name="États-Unis"><noRegion><name sortKey="Vadhan Raj, S" sort="Vadhan Raj, S" uniqKey="Vadhan Raj S" first="S" last="Vadhan-Raj">S. Vadhan-Raj</name>
</noRegion>
<name sortKey="Balakumaran, A" sort="Balakumaran, A" uniqKey="Balakumaran A" first="A" last="Balakumaran">A. Balakumaran</name>
<name sortKey="Braun, A" sort="Braun, A" uniqKey="Braun A" first="A" last="Braun">A. Braun</name>
<name sortKey="Feng, A" sort="Feng, A" uniqKey="Feng A" first="A" last="Feng">A. Feng</name>
<name sortKey="Roodman, G D" sort="Roodman, G D" uniqKey="Roodman G" first="G D" last="Roodman">G D Roodman</name>
<name sortKey="Stewart, A K" sort="Stewart, A K" uniqKey="Stewart A" first="A K" last="Stewart">A K Stewart</name>
</country>
<country name="Autriche"><noRegion><name sortKey="Willenbacher, W" sort="Willenbacher, W" uniqKey="Willenbacher W" first="W" last="Willenbacher">W. Willenbacher</name>
</noRegion>
</country>
<country name="Grèce"><noRegion><name sortKey="Terpos, E" sort="Terpos, E" uniqKey="Terpos E" first="E" last="Terpos">E. Terpos</name>
</noRegion>
</country>
<country name="Brésil"><noRegion><name sortKey="Hungria, V" sort="Hungria, V" uniqKey="Hungria V" first="V" last="Hungria">V. Hungria</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Spencer, A" sort="Spencer, A" uniqKey="Spencer A" first="A" last="Spencer">A. Spencer</name>
</noRegion>
</country>
<country name="Russie"><noRegion><name sortKey="Alexeeva, Y" sort="Alexeeva, Y" uniqKey="Alexeeva Y" first="Y" last="Alexeeva">Y. Alexeeva</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="Facon, T" sort="Facon, T" uniqKey="Facon T" first="T" last="Facon">T. Facon</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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