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 : 000C13 ( Pmc/Curation ); précédent : 000C12; suivant : 000C14Romidepsin 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.
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.
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DOI: 10.1186/s13045-016-0243-8
PubMed: 26965915
PubMed Central: 4785666
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: 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. 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Miles Prince</name><affiliation wicri:level="1"><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></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="1"><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></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26965915</idno><idno type="pmc">4785666</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4785666</idno><idno type="RBID">PMC:4785666</idno><idno type="doi">10.1186/s13045-016-0243-8</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000D52</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000D52</idno><idno type="wicri:Area/Pmc/Curation">000C13</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000C13</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: 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="1"><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></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="1"><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></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></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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<front><journal-meta><journal-id journal-id-type="nlm-ta">J Hematol Oncol</journal-id><journal-id journal-id-type="iso-abbrev">J Hematol Oncol</journal-id><journal-title-group><journal-title>Journal of Hematology & Oncology</journal-title></journal-title-group><issn pub-type="epub">1756-8722</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26965915</article-id><article-id pub-id-type="pmc">4785666</article-id><article-id pub-id-type="publisher-id">243</article-id><article-id pub-id-type="doi">10.1186/s13045-016-0243-8</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research</subject></subj-group></article-categories><title-group><article-title>Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Foss</surname><given-names>Francine</given-names></name><address><phone>209.785.4095</phone><email>francine.foss@yale.edu</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Horwitz</surname><given-names>Steven</given-names></name><address><email>horwitzs@mskcc.org</email></address><xref ref-type="aff" rid="Aff2"></xref></contrib><contrib contrib-type="author"><name><surname>Pro</surname><given-names>Barbara</given-names></name><address><email>barbara.pro@jefferson.edu</email></address><xref ref-type="aff" rid="Aff3"></xref></contrib><contrib contrib-type="author"><name><surname>Prince</surname><given-names>H. Miles</given-names></name><address><email>miles.prince@petermac.org</email></address><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Sokol</surname><given-names>Lubomir</given-names></name><address><email>lubomir.sokol@moffitt.org</email></address><xref ref-type="aff" rid="Aff5"></xref></contrib><contrib contrib-type="author"><name><surname>Balser</surname><given-names>Barbara</given-names></name><address><email>barbara.balser@veristat.com</email></address><xref ref-type="aff" rid="Aff6"></xref></contrib><contrib contrib-type="author"><name><surname>Wolfson</surname><given-names>Julie</given-names></name><address><email>julie.wolfson@veristat.com</email></address><xref ref-type="aff" rid="Aff6"></xref></contrib><contrib contrib-type="author"><name><surname>Coiffier</surname><given-names>Bertrand</given-names></name><address><email>bertrand.coiffier@univ-lyon1.fr</email></address><xref ref-type="aff" rid="Aff7"></xref></contrib><aff id="Aff1"><label></label>Yale Cancer Center, PO Box 208028, 333 Cedar St, TMP 3, New Haven, CT 06520-8028 USA</aff><aff id="Aff2"><label></label>Memorial Sloan-Kettering Cancer Center, New York, NY USA</aff><aff id="Aff3"><label></label>Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA USA</aff><aff id="Aff4"><label></label>Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia</aff><aff id="Aff5"><label></label>Moffitt Cancer Center, Tampa, FL USA</aff><aff id="Aff6"><label></label>Veristat, LLC, Southborough, MA USA</aff><aff id="Aff7"><label></label>Hospices Civils de Lyon, Lyon, France</aff></contrib-group><pub-date pub-type="epub"><day>10</day><month>3</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>10</day><month>3</month><year>2016</year></pub-date><pub-date pub-type="collection"><year>2016</year></pub-date><volume>9</volume><elocation-id>22</elocation-id><history><date date-type="received"><day>30</day><month>11</month><year>2015</year></date><date date-type="accepted"><day>11</day><month>2</month><year>2016</year></date></history><permissions><copyright-statement>© Foss et al. 2016</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold>This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><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></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Romidepsin</kwd><kwd>Peripheral T cell lymphoma</kwd><kwd>Stable disease</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2016</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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