Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial
Identifieur interne : 001780 ( Main/Exploration ); précédent : 001779; suivant : 001781Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial
Auteurs : Francine Foss [États-Unis] ; Steven Horwitz [États-Unis] ; Barbara Pro [États-Unis] ; H. Miles Prince [Australie] ; Lubomir Sokol [États-Unis] ; Barbara Balser [États-Unis] ; Julie Wolfson [États-Unis] ; Bertrand Coiffier [France]Source :
- Journal of Hematology & Oncology [ 1756-8722 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antibiotiques antinéoplasiques (effets indésirables), Antibiotiques antinéoplasiques (usage thérapeutique), Calendrier d'administration des médicaments, Depsipeptides (effets indésirables), Depsipeptides (usage thérapeutique), Facteurs temps, Fatigue (), Femelle, Humains, Induction de rémission, Inhibiteurs de désacétylase d'histone (effets indésirables), Inhibiteurs de désacétylase d'histone (usage thérapeutique), Jeune adulte, Lymphome T périphérique (anatomopathologie), Lymphome T périphérique (traitement médicamenteux), Mâle, Nausée (), Neutropénie (), Récidive tumorale locale, Résistance aux médicaments antinéoplasiques (), Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Évolution de la maladie.
- MESH :
- anatomopathologie : Lymphome T périphérique.
- effets indésirables : Antibiotiques antinéoplasiques, Depsipeptides, Inhibiteurs de désacétylase d'histone.
- traitement médicamenteux : Lymphome T périphérique.
- usage thérapeutique : Antibiotiques antinéoplasiques, Depsipeptides, Inhibiteurs de désacétylase d'histone.
- Adulte, Adulte d'âge moyen, Calendrier d'administration des médicaments, Facteurs temps, Fatigue, Femelle, Humains, Induction de rémission, Jeune adulte, Mâle, Nausée, Neutropénie, Récidive tumorale locale, Résistance aux médicaments antinéoplasiques, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Évolution de la maladie.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antibiotics, Antineoplastic (adverse effects), Antibiotics, Antineoplastic (therapeutic use), Depsipeptides (adverse effects), Depsipeptides (therapeutic use), Disease Progression, Disease-Free Survival, Drug Administration Schedule, Drug Resistance, Neoplasm (drug effects), Fatigue (chemically induced), Female, Histone Deacetylase Inhibitors (adverse effects), Histone Deacetylase Inhibitors (therapeutic use), Humans, Lymphoma, T-Cell, Peripheral (drug therapy), Lymphoma, T-Cell, Peripheral (pathology), Male, Middle Aged, Nausea (chemically induced), Neoplasm Recurrence, Local, Neutropenia (chemically induced), Remission Induction, Time Factors, Treatment Outcome, Young Adult.
- MESH :
- chemical , adverse effects : Antibiotics, Antineoplastic, Depsipeptides, Histone Deacetylase Inhibitors.
- chemical , therapeutic use : Antibiotics, Antineoplastic, Depsipeptides, Histone Deacetylase Inhibitors.
- chemically induced : Fatigue, Nausea, Neutropenia.
- drug effects : Drug Resistance, Neoplasm.
- drug therapy : Lymphoma, T-Cell, Peripheral.
- pathology : Lymphoma, T-Cell, Peripheral.
- Adult, Aged, Aged, 80 and over, Disease Progression, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Remission Induction, Time Factors, Treatment Outcome, Young Adult.
Abstract
Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD). Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25 % (33/130), including 15 % with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD.
Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m2 romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months.
Of the 32 patients (25 %) with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment). The longest SD was >3 years in a patient who received maintenance dosing of 14 mg/m2 on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated.
We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses.
Url:
DOI: 10.1186/s13045-016-0243-8
PubMed: 26965915
PubMed Central: 4785666
Affiliations:
- Australie, France, États-Unis
- Auvergne-Rhône-Alpes, Connecticut, Floride, Massachusetts, Pennsylvanie, Rhône-Alpes, Victoria (État), État de New York
- Lyon, Melbourne
- Université de Melbourne
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Le document en format XML
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prolonged stable disease provides clinical benefits for patients in the pivotal trial</title><author><name sortKey="Foss, Francine" sort="Foss, Francine" uniqKey="Foss F" first="Francine" last="Foss">Francine Foss</name><affiliation wicri:level="2"><nlm:aff id="Aff1">Yale Cancer Center, PO Box 208028, 333 Cedar St, TMP 3, New Haven, CT 06520-8028 USA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Yale Cancer Center, PO Box 208028, 333 Cedar St, TMP 3, New Haven</wicri:cityArea></affiliation></author><author><name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name><affiliation wicri:level="2"><nlm:aff id="Aff2">Memorial Sloan-Kettering Cancer Center, New York, NY USA</nlm:aff><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Memorial Sloan-Kettering Cancer Center, New York</wicri:cityArea></affiliation></author><author><name sortKey="Pro, Barbara" sort="Pro, Barbara" uniqKey="Pro B" first="Barbara" last="Pro">Barbara Pro</name><affiliation wicri:level="2"><nlm:aff id="Aff3">Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>Kimmel Cancer Center, Thomas Jefferson University, Philadelphia</wicri:cityArea></affiliation></author><author><name sortKey="Prince, H Miles" sort="Prince, H Miles" uniqKey="Prince H" first="H. Miles" last="Prince">H. Miles Prince</name><affiliation wicri:level="4"><nlm:aff id="Aff4">Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Peter MacCallum Cancer Centre, University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region><settlement type="city">Melbourne</settlement></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Sokol, Lubomir" sort="Sokol, Lubomir" uniqKey="Sokol L" first="Lubomir" last="Sokol">Lubomir Sokol</name><affiliation wicri:level="2"><nlm:aff id="Aff5">Moffitt Cancer Center, Tampa, FL USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Moffitt Cancer Center, Tampa</wicri:cityArea></affiliation></author><author><name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name><affiliation wicri:level="2"><nlm:aff id="Aff6">Veristat, LLC, Southborough, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Veristat, LLC, Southborough</wicri:cityArea></affiliation></author><author><name sortKey="Wolfson, Julie" sort="Wolfson, Julie" uniqKey="Wolfson J" first="Julie" last="Wolfson">Julie Wolfson</name><affiliation wicri:level="2"><nlm:aff id="Aff6">Veristat, LLC, Southborough, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Veristat, LLC, Southborough</wicri:cityArea></affiliation></author><author><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><affiliation wicri:level="3"><nlm:aff id="Aff7">Hospices Civils de Lyon, Lyon, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hospices Civils de Lyon, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author></analytic><series><title level="j">Journal of Hematology & Oncology</title><idno type="eISSN">1756-8722</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antibiotics, Antineoplastic (adverse effects)</term><term>Antibiotics, Antineoplastic (therapeutic use)</term><term>Depsipeptides (adverse effects)</term><term>Depsipeptides (therapeutic use)</term><term>Disease Progression</term><term>Disease-Free Survival</term><term>Drug Administration Schedule</term><term>Drug Resistance, Neoplasm (drug effects)</term><term>Fatigue (chemically induced)</term><term>Female</term><term>Histone Deacetylase Inhibitors (adverse effects)</term><term>Histone Deacetylase Inhibitors (therapeutic use)</term><term>Humans</term><term>Lymphoma, T-Cell, Peripheral (drug therapy)</term><term>Lymphoma, T-Cell, Peripheral (pathology)</term><term>Male</term><term>Middle Aged</term><term>Nausea (chemically induced)</term><term>Neoplasm Recurrence, Local</term><term>Neutropenia (chemically induced)</term><term>Remission Induction</term><term>Time Factors</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Antibiotiques antinéoplasiques (effets indésirables)</term><term>Antibiotiques antinéoplasiques (usage thérapeutique)</term><term>Calendrier d'administration des médicaments</term><term>Depsipeptides (effets indésirables)</term><term>Depsipeptides (usage thérapeutique)</term><term>Facteurs temps</term><term>Fatigue ()</term><term>Femelle</term><term>Humains</term><term>Induction de rémission</term><term>Inhibiteurs de désacétylase d'histone (effets indésirables)</term><term>Inhibiteurs de désacétylase d'histone (usage thérapeutique)</term><term>Jeune adulte</term><term>Lymphome T périphérique (anatomopathologie)</term><term>Lymphome T périphérique (traitement médicamenteux)</term><term>Mâle</term><term>Nausée ()</term><term>Neutropénie ()</term><term>Récidive tumorale locale</term><term>Résistance aux médicaments antinéoplasiques ()</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Survie sans rechute</term><term>Évolution de la maladie</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibiotics, Antineoplastic</term><term>Depsipeptides</term><term>Histone Deacetylase Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibiotics, Antineoplastic</term><term>Depsipeptides</term><term>Histone Deacetylase Inhibitors</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Lymphome T périphérique</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Fatigue</term><term>Nausea</term><term>Neutropenia</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Drug Resistance, Neoplasm</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Lymphoma, T-Cell, Peripheral</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antibiotiques antinéoplasiques</term><term>Depsipeptides</term><term>Inhibiteurs de désacétylase d'histone</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Lymphoma, T-Cell, Peripheral</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Lymphome T périphérique</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antibiotiques antinéoplasiques</term><term>Depsipeptides</term><term>Inhibiteurs de désacétylase d'histone</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Disease Progression</term><term>Disease-Free Survival</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Neoplasm Recurrence, Local</term><term>Remission Induction</term><term>Time Factors</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Calendrier d'administration des médicaments</term><term>Facteurs temps</term><term>Fatigue</term><term>Femelle</term><term>Humains</term><term>Induction de rémission</term><term>Jeune adulte</term><term>Mâle</term><term>Nausée</term><term>Neutropénie</term><term>Récidive tumorale locale</term><term>Résistance aux médicaments antinéoplasiques</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Survie sans rechute</term><term>Évolution de la maladie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD). Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25 % (33/130), including 15 % with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD.</p></sec><sec><title>Methods</title><p>Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m<sup>2</sup> romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months.</p></sec><sec><title>Results</title><p>Of the 32 patients (25 %) with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment). The longest SD was >3 years in a patient who received maintenance dosing of 14 mg/m<sup>2</sup> on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated.</p></sec><sec><title>Conclusions</title><p>We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">NCT00426764</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Foss, Fm" uniqKey="Foss F">FM Foss</name></author><author><name sortKey="Zinzani, Pl" uniqKey="Zinzani P">PL Zinzani</name></author><author><name sortKey="Vose, Jm" uniqKey="Vose J">JM Vose</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Horwitz, Sm" uniqKey="Horwitz S">SM Horwitz</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Vose, J" uniqKey="Vose J">J Vose</name></author><author><name 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uniqKey="Coiffier B">B Coiffier</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Morgan, M" uniqKey="Morgan M">M Morgan</name></author><author><name sortKey="Maloney, D" uniqKey="Maloney D">D Maloney</name></author><author><name sortKey="Duvic, M" uniqKey="Duvic M">M Duvic</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Peacock, Jm" uniqKey="Peacock J">JM Peacock</name></author><author><name sortKey="Ohira, T" uniqKey="Ohira T">T Ohira</name></author><author><name sortKey="Post, W" uniqKey="Post W">W Post</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Del Gobbo, Lc" uniqKey="Del Gobbo L">LC Del Gobbo</name></author><author><name sortKey="Imamura, F" uniqKey="Imamura F">F Imamura</name></author><author><name sortKey="Wu, Jh" uniqKey="Wu J">JH Wu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Santoro, A" uniqKey="Santoro A">A Santoro</name></author><author><name sortKey="Mancini, E" uniqKey="Mancini E">E Mancini</name></author><author><name sortKey="London, G" uniqKey="London G">G London</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Osadchii, Oe" uniqKey="Osadchii O">OE Osadchii</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="El Sherif, N" uniqKey="El Sherif N">N El-Sherif</name></author><author><name sortKey="Turitto, G" uniqKey="Turitto G">G Turitto</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Piekarz, Rl" uniqKey="Piekarz R">RL Piekarz</name></author><author><name sortKey="Frye, Ar" uniqKey="Frye A">AR Frye</name></author><author><name sortKey="Wright, Jj" uniqKey="Wright J">JJ Wright</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Juweid, Me" uniqKey="Juweid M">ME Juweid</name></author><author><name sortKey="Wiseman, Ga" uniqKey="Wiseman G">GA Wiseman</name></author><author><name sortKey="Vose, Jm" uniqKey="Vose J">JM Vose</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Horwitz, S" uniqKey="Horwitz S">S Horwitz</name></author><author><name sortKey="Coiffier, B" uniqKey="Coiffier B">B Coiffier</name></author><author><name sortKey="Foss, F" uniqKey="Foss F">F Foss</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Australie</li><li>France</li><li>États-Unis</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Connecticut</li><li>Floride</li><li>Massachusetts</li><li>Pennsylvanie</li><li>Rhône-Alpes</li><li>Victoria (État)</li><li>État de New York</li></region><settlement><li>Lyon</li><li>Melbourne</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="États-Unis"><region name="Connecticut"><name sortKey="Foss, Francine" sort="Foss, Francine" uniqKey="Foss F" first="Francine" last="Foss">Francine Foss</name></region><name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name><name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name><name sortKey="Pro, Barbara" sort="Pro, Barbara" uniqKey="Pro B" first="Barbara" last="Pro">Barbara Pro</name><name sortKey="Sokol, Lubomir" sort="Sokol, Lubomir" uniqKey="Sokol L" first="Lubomir" last="Sokol">Lubomir Sokol</name><name sortKey="Wolfson, Julie" sort="Wolfson, Julie" uniqKey="Wolfson J" first="Julie" last="Wolfson">Julie Wolfson</name></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Prince, H Miles" sort="Prince, H Miles" uniqKey="Prince H" first="H. Miles" last="Prince">H. Miles Prince</name></region></country><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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