Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma
Identifieur interne : 000841 ( Main/Exploration ); précédent : 000840; suivant : 000842Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma
Auteurs : Shaji Kumar ; Philippe Moreau ; Parameswaran Hari ; Maria-Victoria Mateos ; Heinz Ludwig ; Chaim Shustik ; Tamas Masszi ; Andrew Spencer ; Roman Hájek ; Kenneth Romeril ; Irit Avivi ; Anna M. Liberati ; Monique C. Minnema ; Hermann Einsele ; Sagar Lonial ; Deborah Berg ; Jianchang Lin ; Neeraj Gupta ; Dixie-Lee Esseltine ; Paul G. RichardsonSource :
- British Journal of Haematology [ 0007-1048 ] ; 2017.
Descripteurs français
- KwdFr :
- Administration par voie orale, Adulte, Adulte d'âge moyen, Calendrier d'administration des médicaments, Composés du bore (administration et posologie), Composés du bore (effets indésirables), Dexaméthasone (administration et posologie), Dexaméthasone (effets indésirables), Glycine (administration et posologie), Glycine (analogues et dérivés), Glycine (effets indésirables), Humains, Hémopathies (), Myélome multiple (traitement médicamenteux), Mâle, Méthode en double aveugle, Nausée (), Neuropathies périphériques (), Numération des leucocytes, Numération des plaquettes, Protocoles de polychimiothérapie antinéoplasique (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Relation dose-effet des médicaments, Sujet âgé, Sujet âgé de 80 ans ou plus, Thalidomide (administration et posologie), Thalidomide (analogues et dérivés), Thalidomide (effets indésirables), Toxidermies (), Toxidermies (étiologie), Vomissement (), Études de suivi.
- MESH :
- administration et posologie : Composés du bore, Dexaméthasone, Glycine, Thalidomide.
- analogues et dérivés : Glycine, Thalidomide.
- effets indésirables : Composés du bore, Dexaméthasone, Glycine, Protocoles de polychimiothérapie antinéoplasique, Thalidomide.
- traitement médicamenteux : Myélome multiple.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- étiologie : Toxidermies.
- Administration par voie orale, Adulte, Adulte d'âge moyen, Calendrier d'administration des médicaments, Humains, Hémopathies, Mâle, Méthode en double aveugle, Nausée, Neuropathies périphériques, Numération des leucocytes, Numération des plaquettes, Relation dose-effet des médicaments, Sujet âgé, Sujet âgé de 80 ans ou plus, Toxidermies, Vomissement, Études de suivi.
English descriptors
- KwdEn :
- Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Boron Compounds (administration & dosage), Boron Compounds (adverse effects), Dexamethasone (administration & dosage), Dexamethasone (adverse effects), Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Drug Eruptions (etiology), Drug Eruptions (therapy), Follow-Up Studies, Glycine (administration & dosage), Glycine (adverse effects), Glycine (analogs & derivatives), Hematologic Diseases (chemically induced), Hematologic Diseases (therapy), Humans, Leukocyte Count, Male, Middle Aged, Multiple Myeloma (drug therapy), Nausea (chemically induced), Nausea (therapy), Peripheral Nervous System Diseases (chemically induced), Peripheral Nervous System Diseases (therapy), Platelet Count, Thalidomide (administration & dosage), Thalidomide (adverse effects), Thalidomide (analogs & derivatives), Vomiting (chemically induced), Vomiting (therapy).
- MESH :
- chemical , administration & dosage : Boron Compounds, Dexamethasone, Glycine, Thalidomide.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols, Boron Compounds, Dexamethasone, Glycine, Thalidomide.
- chemical , analogs & derivatives : Glycine, Thalidomide.
- chemically induced : Hematologic Diseases, Nausea, Peripheral Nervous System Diseases, Vomiting.
- drug therapy : Multiple Myeloma.
- etiology : Drug Eruptions.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- therapy : Drug Eruptions, Hematologic Diseases, Nausea, Peripheral Nervous System Diseases, Vomiting.
- Administration, Oral, Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Follow-Up Studies, Humans, Leukocyte Count, Male, Middle Aged, Platelet Count.
Abstract
The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double‐blind, placebo‐controlled Phase
Url:
DOI: 10.1111/bjh.14733
PubMed: 28485007
PubMed Central: 5574012
Affiliations:
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Le document en format XML
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Liberati</name><affiliation><nlm:aff id="bjh14733-aff-0012"></nlm:aff></affiliation></author><author><name sortKey="Minnema, Monique C" sort="Minnema, Monique C" uniqKey="Minnema M" first="Monique C." last="Minnema">Monique C. Minnema</name><affiliation><nlm:aff id="bjh14733-aff-0013"></nlm:aff></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation><nlm:aff id="bjh14733-aff-0014"></nlm:aff></affiliation></author><author><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name><affiliation><nlm:aff id="bjh14733-aff-0015"></nlm:aff></affiliation></author><author><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Esseltine, Dixie Ee" sort="Esseltine, Dixie Ee" uniqKey="Esseltine D" first="Dixie-Lee" last="Esseltine">Dixie-Lee Esseltine</name><affiliation><nlm:aff id="bjh14733-aff-0016"></nlm:aff></affiliation></author><author><name sortKey="Richardson, Paul G" sort="Richardson, Paul G" uniqKey="Richardson P" first="Paul G." last="Richardson">Paul G. Richardson</name><affiliation><nlm:aff id="bjh14733-aff-0017"></nlm:aff></affiliation></author></analytic><series><title level="j">British Journal of Haematology</title><idno type="ISSN">0007-1048</idno><idno type="eISSN">1365-2141</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Boron Compounds (administration & dosage)</term><term>Boron Compounds (adverse effects)</term><term>Dexamethasone (administration & dosage)</term><term>Dexamethasone (adverse effects)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Eruptions (etiology)</term><term>Drug Eruptions (therapy)</term><term>Follow-Up Studies</term><term>Glycine (administration & dosage)</term><term>Glycine (adverse effects)</term><term>Glycine (analogs & derivatives)</term><term>Hematologic Diseases (chemically induced)</term><term>Hematologic Diseases (therapy)</term><term>Humans</term><term>Leukocyte Count</term><term>Male</term><term>Middle Aged</term><term>Multiple Myeloma (drug therapy)</term><term>Nausea (chemically induced)</term><term>Nausea (therapy)</term><term>Peripheral Nervous System Diseases (chemically induced)</term><term>Peripheral Nervous System Diseases (therapy)</term><term>Platelet Count</term><term>Thalidomide (administration & dosage)</term><term>Thalidomide (adverse effects)</term><term>Thalidomide (analogs & derivatives)</term><term>Vomiting (chemically induced)</term><term>Vomiting (therapy)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Administration par voie orale</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Calendrier d'administration des médicaments</term><term>Composés du bore (administration et posologie)</term><term>Composés du bore (effets indésirables)</term><term>Dexaméthasone (administration et posologie)</term><term>Dexaméthasone (effets indésirables)</term><term>Glycine (administration et posologie)</term><term>Glycine (analogues et dérivés)</term><term>Glycine (effets indésirables)</term><term>Humains</term><term>Hémopathies ()</term><term>Myélome multiple (traitement médicamenteux)</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Nausée ()</term><term>Neuropathies périphériques ()</term><term>Numération des leucocytes</term><term>Numération des plaquettes</term><term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Relation dose-effet des médicaments</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Thalidomide (administration et posologie)</term><term>Thalidomide (analogues et dérivés)</term><term>Thalidomide (effets indésirables)</term><term>Toxidermies ()</term><term>Toxidermies (étiologie)</term><term>Vomissement ()</term><term>Études de suivi</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Boron Compounds</term><term>Dexamethasone</term><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Composés du bore</term><term>Dexaméthasone</term><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Boron Compounds</term><term>Dexamethasone</term><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Glycine</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Hematologic Diseases</term><term>Nausea</term><term>Peripheral Nervous System Diseases</term><term>Vomiting</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Multiple Myeloma</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Composés du bore</term><term>Dexaméthasone</term><term>Glycine</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Thalidomide</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Drug Eruptions</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Drug Eruptions</term><term>Hematologic Diseases</term><term>Nausea</term><term>Peripheral Nervous System Diseases</term><term>Vomiting</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Myélome multiple</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Toxidermies</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Follow-Up Studies</term><term>Humans</term><term>Leukocyte Count</term><term>Male</term><term>Middle Aged</term><term>Platelet Count</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Administration par voie orale</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Calendrier d'administration des médicaments</term><term>Humains</term><term>Hémopathies</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Nausée</term><term>Neuropathies périphériques</term><term>Numération des leucocytes</term><term>Numération des plaquettes</term><term>Relation dose-effet des médicaments</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Toxidermies</term><term>Vomissement</term><term>Études de suivi</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Summary</title><p>The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double‐blind, placebo‐controlled Phase <styled-content style="fixed-case">III TOURMALINE</styled-content>‐<styled-content style="fixed-case">MM</styled-content>1 study of ixazomib‐Rd (<styled-content style="fixed-case">IR</styled-content>d) versus placebo‐Rd in patients with relapsed/refractory multiple myeloma. <styled-content style="fixed-case">IR</styled-content>d resulted in a significant improvement in progression‐free survival versus placebo‐Rd (median: 20·6 vs. 14·7 months; hazard ratio 0·74). Common toxicities observed more commonly with <styled-content style="fixed-case">IR</styled-content>d versus placebo‐Rd were thrombocytopenia, nausea, vomiting, diarrhoea, constipation, rash, peripheral neuropathy, peripheral oedema and back pain; these were generally grade 1/2 in severity except for thrombocytopenia (19% vs. 9% grade 3/4), which appeared manageable and reversible, with no differences between arms in significant bleeding or dose discontinuations. No cumulative toxicities were observed, indicating the potential feasibility of long‐term <styled-content style="fixed-case">IR</styled-content>d treatment. Safety data from <styled-content style="fixed-case">TOURMALINE</styled-content>‐<styled-content style="fixed-case">MM</styled-content>1 are reviewed and guidance for managing clinically relevant adverse events associated with <styled-content style="fixed-case">IR</styled-content>d is provided. Most toxicities were manageable with supportive care and dose delays or reductions as needed. Clinicians should be aware of and understand these potential side effects to optimise and prolong patient benefit.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list></list><tree><noCountry><name sortKey="Avivi, Irit" sort="Avivi, Irit" uniqKey="Avivi I" first="Irit" last="Avivi">Irit Avivi</name><name sortKey="Berg, Deborah" sort="Berg, Deborah" uniqKey="Berg D" first="Deborah" last="Berg">Deborah Berg</name><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><name sortKey="Esseltine, Dixie Ee" sort="Esseltine, Dixie Ee" uniqKey="Esseltine D" first="Dixie-Lee" last="Esseltine">Dixie-Lee Esseltine</name><name sortKey="Gupta, Neeraj" sort="Gupta, Neeraj" uniqKey="Gupta N" first="Neeraj" last="Gupta">Neeraj Gupta</name><name sortKey="Hajek, Roman" sort="Hajek, Roman" uniqKey="Hajek R" first="Roman" last="Hájek">Roman Hájek</name><name sortKey="Hari, Parameswaran" sort="Hari, Parameswaran" uniqKey="Hari P" first="Parameswaran" last="Hari">Parameswaran Hari</name><name sortKey="Kumar, Shaji" sort="Kumar, Shaji" uniqKey="Kumar S" first="Shaji" last="Kumar">Shaji Kumar</name><name sortKey="Liberati, Anna M" sort="Liberati, Anna M" uniqKey="Liberati A" first="Anna M." last="Liberati">Anna M. Liberati</name><name sortKey="Lin, Jianchang" sort="Lin, Jianchang" uniqKey="Lin J" first="Jianchang" last="Lin">Jianchang Lin</name><name sortKey="Lonial, Sagar" sort="Lonial, Sagar" uniqKey="Lonial S" first="Sagar" last="Lonial">Sagar Lonial</name><name sortKey="Ludwig, Heinz" sort="Ludwig, Heinz" uniqKey="Ludwig H" first="Heinz" last="Ludwig">Heinz Ludwig</name><name sortKey="Masszi, Tamas" sort="Masszi, Tamas" uniqKey="Masszi T" first="Tamas" last="Masszi">Tamas Masszi</name><name sortKey="Mateos, Maria Ictoria" sort="Mateos, Maria Ictoria" uniqKey="Mateos M" first="Maria-Victoria" last="Mateos">Maria-Victoria Mateos</name><name sortKey="Minnema, Monique C" sort="Minnema, Monique C" uniqKey="Minnema M" first="Monique C." last="Minnema">Monique C. Minnema</name><name sortKey="Moreau, Philippe" sort="Moreau, Philippe" uniqKey="Moreau P" first="Philippe" last="Moreau">Philippe Moreau</name><name sortKey="Richardson, Paul G" sort="Richardson, Paul G" uniqKey="Richardson P" first="Paul G." last="Richardson">Paul G. Richardson</name><name sortKey="Romeril, Kenneth" sort="Romeril, Kenneth" uniqKey="Romeril K" first="Kenneth" last="Romeril">Kenneth Romeril</name><name sortKey="Shustik, Chaim" sort="Shustik, Chaim" uniqKey="Shustik C" first="Chaim" last="Shustik">Chaim Shustik</name><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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