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Serveur d'exploration sur les relations entre la France et l'Australie

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Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy

Identifieur interne : 005949 ( Main/Exploration ); précédent : 005948; suivant : 005950

Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy

Auteurs : Bertrand Coiffier [France] ; Barbara Pro [États-Unis] ; H. Miles Prince [Australie] ; Francine Foss [États-Unis] ; Lubomir Sokol [États-Unis] ; Matthew Greenwood [Australie] ; Dolores Caballero [Espagne] ; Peter Borchmann [Allemagne] ; Franck Morschhauser [France, États-Unis] ; Martin Wilhelm [Allemagne] ; Lauren Pinter-Brown [États-Unis] ; Swaminathan Padmanabhan [États-Unis] ; Andrei Shustov [France, États-Unis] ; Jean Nichols [États-Unis] ; Susan Carroll [États-Unis] ; John Balser [États-Unis] ; Barbara Balser [États-Unis] ; Steven Horwitz [États-Unis]

Source :

RBID : Pascal:12-0120481

Descripteurs français

English descriptors

Abstract

Purpose Romidepsin is a structurally unique, potent class 1 selective histone deacetylase inhibitor. The primary objective of this international, pivotal, single-arm, phase II trial was to confirm the efficacy of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Patients and Methods Patients who were refractory to at least one prior systemic therapy or for whom at least one prior systemic therapy failed received romidepsin at 14 mg/m2 as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days. The primary end point was the rate of complete response/unconfirmed complete response (CR/CRu) as assessed by an independent review committee. Results Of the 131 patients enrolled, 130 had histologically confirmed PTCL by central review. The median number of prior systemic therapies was two (range, one to eight). The objective response rate was 25% (33 of 130), including 15% (19 of 130) with CR/CRu. Patient characteristics, prior stem-cell transplantation, number or type of prior therapies, or response to last prior therapy did not have an impact on response rate. The median duration of response was 17 months, with the longest response ongoing at 34+ months. Of the 19 patients who achieved CR/CRu, 17 (89%) had not experienced disease progression at a median follow-up of 13.4 months. The most common grade ≥ 3 adverse events were thrombocytopenia (24%), neutropenia (20%), and infections (all types, 19%). Conclusion Single-agent romidepsin induced complete and durable responses with manageable toxicity in patients with relapsed or refractory PTCL across all major PTCL subtypes, regardless of the number or type of prior therapies. Results led to US Food and Drug Administration approval of romidepsin in this indication.


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Le document en format XML

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<title xml:lang="en" level="a">Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy</title>
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<name sortKey="Greenwood, Matthew" sort="Greenwood, Matthew" uniqKey="Greenwood M" first="Matthew" last="Greenwood">Matthew Greenwood</name>
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<name sortKey="Caballero, Dolores" sort="Caballero, Dolores" uniqKey="Caballero D" first="Dolores" last="Caballero">Dolores Caballero</name>
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<s1>Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille</s1>
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<name sortKey="Wilhelm, Martin" sort="Wilhelm, Martin" uniqKey="Wilhelm M" first="Martin" last="Wilhelm">Martin Wilhelm</name>
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</author>
<author>
<name sortKey="Pinter Brown, Lauren" sort="Pinter Brown, Lauren" uniqKey="Pinter Brown L" first="Lauren" last="Pinter-Brown">Lauren Pinter-Brown</name>
<affiliation wicri:level="1">
<inist:fA14 i1="12">
<s1>University of California at Los Angeles Medical Center</s1>
<s2>Los Angeles, CA</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>University of California at Los Angeles Medical Center</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Padmanabhan, Swaminathan" sort="Padmanabhan, Swaminathan" uniqKey="Padmanabhan S" first="Swaminathan" last="Padmanabhan">Swaminathan Padmanabhan</name>
<affiliation wicri:level="1">
<inist:fA14 i1="13">
<s1>The University of Texas Health Science Center at San Antonio</s1>
<s2>San Antonio, TX</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>The University of Texas Health Science Center at San Antonio</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Shustov, Andrei" sort="Shustov, Andrei" uniqKey="Shustov A" first="Andrei" last="Shustov">Andrei Shustov</name>
<affiliation wicri:level="3">
<inist:fA14 i1="02">
<s1>Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille</s1>
<s2>Lille</s2>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<region type="region">Hauts-de-France</region>
<region type="old region">Nord-Pas-de-Calais</region>
<settlement type="city">Lille</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="4">
<inist:fA14 i1="14">
<s1>University of Washington</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<settlement type="city">Seattle</settlement>
<region type="state">Washington (État)</region>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
</author>
<author>
<name sortKey="Nichols, Jean" sort="Nichols, Jean" uniqKey="Nichols J" first="Jean" last="Nichols">Jean Nichols</name>
<affiliation wicri:level="1">
<inist:fA14 i1="15">
<s1>Celgene</s1>
<s2>Cambridge, MA</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Celgene</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Carroll, Susan" sort="Carroll, Susan" uniqKey="Carroll S" first="Susan" last="Carroll">Susan Carroll</name>
<affiliation wicri:level="1">
<inist:fA14 i1="15">
<s1>Celgene</s1>
<s2>Cambridge, MA</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Celgene</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Balser, John" sort="Balser, John" uniqKey="Balser J" first="John" last="Balser">John Balser</name>
<affiliation wicri:level="1">
<inist:fA14 i1="16">
<s1>Veristat</s1>
<s2>Holliston, MA</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Veristat</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name>
<affiliation wicri:level="1">
<inist:fA14 i1="16">
<s1>Veristat</s1>
<s2>Holliston, MA</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Veristat</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name>
<affiliation wicri:level="1">
<inist:fA14 i1="17">
<s1>Memorial Sloan-Kettering Cancer Center</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Memorial Sloan-Kettering Cancer Center</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
<imprint>
<date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Cancerology</term>
<term>Peripheral T cell lymphoma</term>
<term>Phase II trial</term>
<term>Relapse</term>
<term>Romidepsin</term>
<term>Treatment</term>
<term>Treatment resistance</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Essai clinique phase II</term>
<term>Traitement</term>
<term>Récidive</term>
<term>Romidepsine</term>
<term>Résistance traitement</term>
<term>Cancérologie</term>
<term>Lymphome périphérique à cellules T</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Purpose Romidepsin is a structurally unique, potent class 1 selective histone deacetylase inhibitor. The primary objective of this international, pivotal, single-arm, phase II trial was to confirm the efficacy of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Patients and Methods Patients who were refractory to at least one prior systemic therapy or for whom at least one prior systemic therapy failed received romidepsin at 14 mg/m
<sup>2</sup>
as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days. The primary end point was the rate of complete response/unconfirmed complete response (CR/CRu) as assessed by an independent review committee. Results Of the 131 patients enrolled, 130 had histologically confirmed PTCL by central review. The median number of prior systemic therapies was two (range, one to eight). The objective response rate was 25% (33 of 130), including 15% (19 of 130) with CR/CRu. Patient characteristics, prior stem-cell transplantation, number or type of prior therapies, or response to last prior therapy did not have an impact on response rate. The median duration of response was 17 months, with the longest response ongoing at 34+ months. Of the 19 patients who achieved CR/CRu, 17 (89%) had not experienced disease progression at a median follow-up of 13.4 months. The most common grade ≥ 3 adverse events were thrombocytopenia (24%), neutropenia (20%), and infections (all types, 19%). Conclusion Single-agent romidepsin induced complete and durable responses with manageable toxicity in patients with relapsed or refractory PTCL across all major PTCL subtypes, regardless of the number or type of prior therapies. Results led to US Food and Drug Administration approval of romidepsin in this indication.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>États-Unis</li>
</country>
<region>
<li>Auvergne-Rhône-Alpes</li>
<li>District de Cologne</li>
<li>Hauts-de-France</li>
<li>Nord-Pas-de-Calais</li>
<li>Nouvelle-Galles du Sud</li>
<li>Rhénanie-du-Nord-Westphalie</li>
<li>Rhône-Alpes</li>
<li>Victoria (État)</li>
<li>Washington (État)</li>
</region>
<settlement>
<li>Cologne</li>
<li>Lille</li>
<li>Lyon</li>
<li>Melbourne</li>
<li>Seattle</li>
<li>Sydney</li>
</settlement>
<orgName>
<li>Université de Cologne</li>
<li>Université de Melbourne</li>
<li>Université de Washington</li>
</orgName>
</list>
<tree>
<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>
<name sortKey="Morschhauser, Franck" sort="Morschhauser, Franck" uniqKey="Morschhauser F" first="Franck" last="Morschhauser">Franck Morschhauser</name>
<name sortKey="Shustov, Andrei" sort="Shustov, Andrei" uniqKey="Shustov A" first="Andrei" last="Shustov">Andrei Shustov</name>
</country>
<country name="États-Unis">
<noRegion>
<name sortKey="Pro, Barbara" sort="Pro, Barbara" uniqKey="Pro B" first="Barbara" last="Pro">Barbara Pro</name>
</noRegion>
<name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name>
<name sortKey="Balser, John" sort="Balser, John" uniqKey="Balser J" first="John" last="Balser">John Balser</name>
<name sortKey="Carroll, Susan" sort="Carroll, Susan" uniqKey="Carroll S" first="Susan" last="Carroll">Susan Carroll</name>
<name sortKey="Foss, Francine" sort="Foss, Francine" uniqKey="Foss F" first="Francine" last="Foss">Francine Foss</name>
<name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name>
<name sortKey="Morschhauser, Franck" sort="Morschhauser, Franck" uniqKey="Morschhauser F" first="Franck" last="Morschhauser">Franck Morschhauser</name>
<name sortKey="Nichols, Jean" sort="Nichols, Jean" uniqKey="Nichols J" first="Jean" last="Nichols">Jean Nichols</name>
<name sortKey="Padmanabhan, Swaminathan" sort="Padmanabhan, Swaminathan" uniqKey="Padmanabhan S" first="Swaminathan" last="Padmanabhan">Swaminathan Padmanabhan</name>
<name sortKey="Pinter Brown, Lauren" sort="Pinter Brown, Lauren" uniqKey="Pinter Brown L" first="Lauren" last="Pinter-Brown">Lauren Pinter-Brown</name>
<name sortKey="Shustov, Andrei" sort="Shustov, Andrei" uniqKey="Shustov A" first="Andrei" last="Shustov">Andrei Shustov</name>
<name sortKey="Sokol, Lubomir" sort="Sokol, Lubomir" uniqKey="Sokol L" first="Lubomir" last="Sokol">Lubomir Sokol</name>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Prince, H Miles" sort="Prince, H Miles" uniqKey="Prince H" first="H. Miles" last="Prince">H. Miles Prince</name>
</noRegion>
<name sortKey="Greenwood, Matthew" sort="Greenwood, Matthew" uniqKey="Greenwood M" first="Matthew" last="Greenwood">Matthew Greenwood</name>
<name sortKey="Prince, H Miles" sort="Prince, H Miles" uniqKey="Prince H" first="H. Miles" last="Prince">H. Miles Prince</name>
</country>
<country name="Espagne">
<noRegion>
<name sortKey="Caballero, Dolores" sort="Caballero, Dolores" uniqKey="Caballero D" first="Dolores" last="Caballero">Dolores Caballero</name>
</noRegion>
</country>
<country name="Allemagne">
<region name="Rhénanie-du-Nord-Westphalie">
<name sortKey="Borchmann, Peter" sort="Borchmann, Peter" uniqKey="Borchmann P" first="Peter" last="Borchmann">Peter Borchmann</name>
</region>
<name sortKey="Wilhelm, Martin" sort="Wilhelm, Martin" uniqKey="Wilhelm M" first="Martin" last="Wilhelm">Martin Wilhelm</name>
</country>
</tree>
</affiliations>
</record>

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