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 : 001552 ( PascalFrancis/Corpus ); précédent : 001551; suivant : 001553Results 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 ; Barbara Pro ; H. Miles Prince ; Francine Foss ; Lubomir Sokol ; Matthew Greenwood ; Dolores Caballero ; Peter Borchmann ; Franck Morschhauser ; Martin Wilhelm ; Lauren Pinter-Brown ; Swaminathan Padmanabhan ; Andrei Shustov ; Jean Nichols ; Susan Carroll ; John Balser ; Barbara Balser ; Steven HorwitzSource :
- Journal of clinical oncology [ 0732-183X ] ; 2012.
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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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| NO : | PASCAL 12-0120481 INIST |
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| ET : | Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy |
| AU : | COIFFIER (Bertrand); PRO (Barbara); PRINCE (H. Miles); FOSS (Francine); SOKOL (Lubomir); GREENWOOD (Matthew); CABALLERO (Dolores); BORCHMANN (Peter); MORSCHHAUSER (Franck); WILHELM (Martin); PINTER-BROWN (Lauren); PADMANABHAN (Swaminathan); SHUSTOV (Andrei); NICHOLS (Jean); CARROLL (Susan); BALSER (John); BALSER (Barbara); HORWITZ (Steven) |
| AF : | Hospices Civils de Lyon/Lyon/France (1 aut.); Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille/Lille/France (9 aut., 13 aut.); Fox Chase Cancer Center/Philadelphia, PA/Etats-Unis (2 aut.); Peter MacCallum Cancer Centre, East Melbourne/Australie (3 aut.); University of Melbourne/Parkville, Melbourne/Australie (3 aut.); Royal North Shore Hospital/Sydney/Australie (6 aut.); Yale Cancer Center/New Haven, CT/Etats-Unis (4 aut.); Moffitt Cancer Center/Tampa, FL/Etats-Unis (5 aut.); Hospital Universitario de Salamanca/Salamanca/Espagne (7 aut.); Klinikum der Universität zu Köln/Köln/Allemagne (8 aut.); Klinikum Nürnberg Nord/Nürnberg/Allemagne (10 aut.); University of California at Los Angeles Medical Center/Los Angeles, CA/Etats-Unis (11 aut.); The University of Texas Health Science Center at San Antonio/San Antonio, TX/Etats-Unis (12 aut.); University of Washington/Seattle, WA/Etats-Unis (9 aut., 13 aut.); Celgene/Cambridge, MA/Etats-Unis (14 aut., 15 aut.); Veristat/Holliston, MA/Etats-Unis (16 aut., 17 aut.); Memorial Sloan-Kettering Cancer Center/New York, NY/Etats-Unis (18 aut.) |
| DT : | Publication en série; Niveau analytique |
| SO : | Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2012; Vol. 30; No. 6; Pp. 631-636; Bibl. 29 ref. |
| LA : | Anglais |
| EA : | 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. |
| CC : | 002B04; 002B19B |
| FD : | Essai clinique phase II; Traitement; Récidive; Romidepsine; Résistance traitement; Cancérologie; Lymphome périphérique à cellules T |
| FG : | Inhibiteur histone deacetylase; Hémopathie maligne; Cancer; Lymphome non hodgkinien; Syndrome lymphoprolifératif |
| ED : | Phase II trial; Treatment; Relapse; Romidepsin; Treatment resistance; Cancerology; Peripheral T cell lymphoma |
| EG : | Histone deacetylase inhibitor; Malignant hemopathy; Cancer; Non Hodgkin lymphoma; Lymphoproliferative syndrome |
| SD : | Ensayo clínico fase II; Tratamiento; Recaida; Romidepsina; Resistencia tratamiento; Cancerología; Linfoma célula T periférica |
| LO : | INIST-20094.354000502809250120 |
| ID : | 12-0120481 |
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S" first="Swaminathan" last="Padmanabhan">Swaminathan Padmanabhan</name><affiliation><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></affiliation></author><author><name sortKey="Shustov, Andrei" sort="Shustov, Andrei" uniqKey="Shustov A" first="Andrei" last="Shustov">Andrei Shustov</name><affiliation><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></affiliation><affiliation><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></affiliation></author><author><name sortKey="Nichols, Jean" sort="Nichols, Jean" uniqKey="Nichols J" first="Jean" last="Nichols">Jean Nichols</name><affiliation><inist:fA14 i1="15"><s1>Celgene</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Carroll, Susan" sort="Carroll, Susan" uniqKey="Carroll S" first="Susan" last="Carroll">Susan Carroll</name><affiliation><inist:fA14 i1="15"><s1>Celgene</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Balser, John" sort="Balser, John" uniqKey="Balser J" first="John" last="Balser">John Balser</name><affiliation><inist:fA14 i1="16"><s1>Veristat</s1><s2>Holliston, MA</s2><s3>USA</s3><sZ>16 aut.</sZ><sZ>17 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name><affiliation><inist:fA14 i1="16"><s1>Veristat</s1><s2>Holliston, MA</s2><s3>USA</s3><sZ>16 aut.</sZ><sZ>17 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name><affiliation><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></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">12-0120481</idno><date when="2012">2012</date><idno type="stanalyst">PASCAL 12-0120481 INIST</idno><idno type="RBID">Pascal:12-0120481</idno><idno type="wicri:Area/PascalFrancis/Corpus">001552</idno></publicationStmt><sourceDesc><biblStruct><analytic><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><author><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><affiliation><inist:fA14 i1="01"><s1>Hospices Civils de Lyon</s1><s2>Lyon</s2><s3>FRA</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Pro, Barbara" sort="Pro, Barbara" uniqKey="Pro B" first="Barbara" last="Pro">Barbara Pro</name><affiliation><inist:fA14 i1="03"><s1>Fox Chase Cancer Center</s1><s2>Philadelphia, PA</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14></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><inist:fA14 i1="04"><s1>Peter MacCallum Cancer Centre, East Melbourne</s1><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14></affiliation><affiliation><inist:fA14 i1="05"><s1>University of Melbourne</s1><s2>Parkville, Melbourne</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Foss, Francine" sort="Foss, Francine" uniqKey="Foss F" first="Francine" last="Foss">Francine Foss</name><affiliation><inist:fA14 i1="07"><s1>Yale Cancer Center</s1><s2>New Haven, CT</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Sokol, Lubomir" sort="Sokol, Lubomir" uniqKey="Sokol L" first="Lubomir" last="Sokol">Lubomir Sokol</name><affiliation><inist:fA14 i1="08"><s1>Moffitt Cancer Center</s1><s2>Tampa, FL</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Greenwood, Matthew" sort="Greenwood, Matthew" uniqKey="Greenwood M" first="Matthew" last="Greenwood">Matthew Greenwood</name><affiliation><inist:fA14 i1="06"><s1>Royal North Shore Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Caballero, Dolores" sort="Caballero, Dolores" uniqKey="Caballero D" first="Dolores" last="Caballero">Dolores Caballero</name><affiliation><inist:fA14 i1="09"><s1>Hospital Universitario de Salamanca</s1><s2>Salamanca</s2><s3>ESP</s3><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Borchmann, Peter" sort="Borchmann, Peter" uniqKey="Borchmann P" first="Peter" last="Borchmann">Peter Borchmann</name><affiliation><inist:fA14 i1="10"><s1>Klinikum der Universität zu Köln</s1><s2>Köln</s2><s3>DEU</s3><sZ>8 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Morschhauser, Franck" sort="Morschhauser, Franck" uniqKey="Morschhauser F" first="Franck" last="Morschhauser">Franck Morschhauser</name><affiliation><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></affiliation><affiliation><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></affiliation></author><author><name sortKey="Wilhelm, Martin" sort="Wilhelm, Martin" uniqKey="Wilhelm M" first="Martin" last="Wilhelm">Martin Wilhelm</name><affiliation><inist:fA14 i1="11"><s1>Klinikum Nürnberg Nord</s1><s2>Nürnberg</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14></affiliation></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><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></affiliation></author><author><name sortKey="Padmanabhan, Swaminathan" sort="Padmanabhan, Swaminathan" uniqKey="Padmanabhan S" first="Swaminathan" last="Padmanabhan">Swaminathan Padmanabhan</name><affiliation><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></affiliation></author><author><name sortKey="Shustov, Andrei" sort="Shustov, Andrei" uniqKey="Shustov A" first="Andrei" last="Shustov">Andrei Shustov</name><affiliation><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></affiliation><affiliation><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></affiliation></author><author><name sortKey="Nichols, Jean" sort="Nichols, Jean" uniqKey="Nichols J" first="Jean" last="Nichols">Jean Nichols</name><affiliation><inist:fA14 i1="15"><s1>Celgene</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Carroll, Susan" sort="Carroll, Susan" uniqKey="Carroll S" first="Susan" last="Carroll">Susan Carroll</name><affiliation><inist:fA14 i1="15"><s1>Celgene</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Balser, John" sort="Balser, John" uniqKey="Balser J" first="John" last="Balser">John Balser</name><affiliation><inist:fA14 i1="16"><s1>Veristat</s1><s2>Holliston, MA</s2><s3>USA</s3><sZ>16 aut.</sZ><sZ>17 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name><affiliation><inist:fA14 i1="16"><s1>Veristat</s1><s2>Holliston, MA</s2><s3>USA</s3><sZ>16 aut.</sZ><sZ>17 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name><affiliation><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></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><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0732-183X</s0></fA01><fA03 i2="1"><s0>J. clin. oncol.</s0></fA03><fA05><s2>30</s2></fA05><fA06><s2>6</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy</s1></fA08><fA11 i1="01" i2="1"><s1>COIFFIER (Bertrand)</s1></fA11><fA11 i1="02" i2="1"><s1>PRO (Barbara)</s1></fA11><fA11 i1="03" i2="1"><s1>PRINCE (H. Miles)</s1></fA11><fA11 i1="04" i2="1"><s1>FOSS (Francine)</s1></fA11><fA11 i1="05" i2="1"><s1>SOKOL (Lubomir)</s1></fA11><fA11 i1="06" i2="1"><s1>GREENWOOD (Matthew)</s1></fA11><fA11 i1="07" i2="1"><s1>CABALLERO (Dolores)</s1></fA11><fA11 i1="08" i2="1"><s1>BORCHMANN (Peter)</s1></fA11><fA11 i1="09" i2="1"><s1>MORSCHHAUSER (Franck)</s1></fA11><fA11 i1="10" i2="1"><s1>WILHELM (Martin)</s1></fA11><fA11 i1="11" i2="1"><s1>PINTER-BROWN (Lauren)</s1></fA11><fA11 i1="12" i2="1"><s1>PADMANABHAN (Swaminathan)</s1></fA11><fA11 i1="13" i2="1"><s1>SHUSTOV (Andrei)</s1></fA11><fA11 i1="14" i2="1"><s1>NICHOLS (Jean)</s1></fA11><fA11 i1="15" i2="1"><s1>CARROLL (Susan)</s1></fA11><fA11 i1="16" i2="1"><s1>BALSER (John)</s1></fA11><fA11 i1="17" i2="1"><s1>BALSER (Barbara)</s1></fA11><fA11 i1="18" i2="1"><s1>HORWITZ (Steven)</s1></fA11><fA14 i1="01"><s1>Hospices Civils de Lyon</s1><s2>Lyon</s2><s3>FRA</s3><sZ>1 aut.</sZ></fA14><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></fA14><fA14 i1="03"><s1>Fox Chase Cancer Center</s1><s2>Philadelphia, PA</s2><s3>USA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="04"><s1>Peter MacCallum Cancer Centre, East Melbourne</s1><s3>AUS</s3><sZ>3 aut.</sZ></fA14><fA14 i1="05"><s1>University of Melbourne</s1><s2>Parkville, Melbourne</s2><s3>AUS</s3><sZ>3 aut.</sZ></fA14><fA14 i1="06"><s1>Royal North Shore Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Yale Cancer Center</s1><s2>New Haven, CT</s2><s3>USA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="08"><s1>Moffitt Cancer Center</s1><s2>Tampa, FL</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="09"><s1>Hospital Universitario de Salamanca</s1><s2>Salamanca</s2><s3>ESP</s3><sZ>7 aut.</sZ></fA14><fA14 i1="10"><s1>Klinikum der Universität zu Köln</s1><s2>Köln</s2><s3>DEU</s3><sZ>8 aut.</sZ></fA14><fA14 i1="11"><s1>Klinikum Nürnberg Nord</s1><s2>Nürnberg</s2><s3>DEU</s3><sZ>10 aut.</sZ></fA14><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></fA14><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></fA14><fA14 i1="14"><s1>University of Washington</s1><s2>Seattle, WA</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>13 aut.</sZ></fA14><fA14 i1="15"><s1>Celgene</s1><s2>Cambridge, MA</s2><s3>USA</s3><sZ>14 aut.</sZ><sZ>15 aut.</sZ></fA14><fA14 i1="16"><s1>Veristat</s1><s2>Holliston, MA</s2><s3>USA</s3><sZ>16 aut.</sZ><sZ>17 aut.</sZ></fA14><fA14 i1="17"><s1>Memorial Sloan-Kettering Cancer Center</s1><s2>New York, NY</s2><s3>USA</s3><sZ>18 aut.</sZ></fA14><fA20><s1>631-636</s1></fA20><fA21><s1>2012</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20094</s2><s5>354000502809250120</s5></fA43><fA44><s0>0000</s0><s1>© 2012 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>29 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>12-0120481</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Journal of clinical oncology</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B04</s0></fC02><fC02 i1="02" i2="X"><s0>002B19B</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Essai clinique phase II</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Phase II trial</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Ensayo clínico fase II</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Traitement</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Treatment</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Tratamiento</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Récidive</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Relapse</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Recaida</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Romidepsine</s0><s2>FR</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Romidepsin</s0><s2>FR</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Romidepsina</s0><s2>FR</s2><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Résistance traitement</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Treatment resistance</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Resistencia tratamiento</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Cancérologie</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Cancerology</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Cancerología</s0><s5>06</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Lymphome périphérique à cellules T</s0><s5>07</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Peripheral T cell lymphoma</s0><s5>07</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Linfoma célula T periférica</s0><s5>07</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Inhibiteur histone deacetylase</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Histone deacetylase inhibitor</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Inhibidor histone deacetylase</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Hémopathie maligne</s0><s2>NM</s2><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Malignant hemopathy</s0><s2>NM</s2><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Hemopatía maligna</s0><s2>NM</s2><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Cáncer</s0><s2>NM</s2></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Lymphome non hodgkinien</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Non Hodgkin lymphoma</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Linfoma no Hodgkin</s0><s5>39</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Syndrome lymphoprolifératif</s0><s2>NM</s2><s5>40</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Lymphoproliferative syndrome</s0><s2>NM</s2><s5>40</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Linfoproliferativo síndrome</s0><s2>NM</s2><s5>40</s5></fC07><fN21><s1>093</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard><server><NO>PASCAL 12-0120481 INIST</NO><ET>Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy</ET><AU>COIFFIER (Bertrand); PRO (Barbara); PRINCE (H. Miles); FOSS (Francine); SOKOL (Lubomir); GREENWOOD (Matthew); CABALLERO (Dolores); BORCHMANN (Peter); MORSCHHAUSER (Franck); WILHELM (Martin); PINTER-BROWN (Lauren); PADMANABHAN (Swaminathan); SHUSTOV (Andrei); NICHOLS (Jean); CARROLL (Susan); BALSER (John); BALSER (Barbara); HORWITZ (Steven)</AU><AF>Hospices Civils de Lyon/Lyon/France (1 aut.); Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille/Lille/France (9 aut., 13 aut.); Fox Chase Cancer Center/Philadelphia, PA/Etats-Unis (2 aut.); Peter MacCallum Cancer Centre, East Melbourne/Australie (3 aut.); University of Melbourne/Parkville, Melbourne/Australie (3 aut.); Royal North Shore Hospital/Sydney/Australie (6 aut.); Yale Cancer Center/New Haven, CT/Etats-Unis (4 aut.); Moffitt Cancer Center/Tampa, FL/Etats-Unis (5 aut.); Hospital Universitario de Salamanca/Salamanca/Espagne (7 aut.); Klinikum der Universität zu Köln/Köln/Allemagne (8 aut.); Klinikum Nürnberg Nord/Nürnberg/Allemagne (10 aut.); University of California at Los Angeles Medical Center/Los Angeles, CA/Etats-Unis (11 aut.); The University of Texas Health Science Center at San Antonio/San Antonio, TX/Etats-Unis (12 aut.); University of Washington/Seattle, WA/Etats-Unis (9 aut., 13 aut.); Celgene/Cambridge, MA/Etats-Unis (14 aut., 15 aut.); Veristat/Holliston, MA/Etats-Unis (16 aut., 17 aut.); Memorial Sloan-Kettering Cancer Center/New York, NY/Etats-Unis (18 aut.)</AF><DT>Publication en série; Niveau analytique</DT><SO>Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2012; Vol. 30; No. 6; Pp. 631-636; Bibl. 29 ref.</SO><LA>Anglais</LA><EA>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.</EA><CC>002B04; 002B19B</CC><FD>Essai clinique phase II; Traitement; Récidive; Romidepsine; Résistance traitement; Cancérologie; Lymphome périphérique à cellules T</FD><FG>Inhibiteur histone deacetylase; Hémopathie maligne; Cancer; Lymphome non hodgkinien; Syndrome lymphoprolifératif</FG><ED>Phase II trial; Treatment; Relapse; Romidepsin; Treatment resistance; Cancerology; Peripheral T cell lymphoma</ED><EG>Histone deacetylase inhibitor; Malignant hemopathy; Cancer; Non Hodgkin lymphoma; Lymphoproliferative syndrome</EG><SD>Ensayo clínico fase II; Tratamiento; Recaida; Romidepsina; Resistencia tratamiento; Cancerología; Linfoma célula T periférica</SD><LO>INIST-20094.354000502809250120</LO><ID>12-0120481</ID></server></inist></record>Pour manipuler ce document sous Unix (Dilib)
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