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Utility of 18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma

Identifieur interne : 000C50 ( Pmc/Checkpoint ); précédent : 000C49; suivant : 000C51

Utility of 18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma

Auteurs : S. Horwitz [États-Unis] ; B. Coiffier [France] ; F. Foss [États-Unis] ; H. M. Prince [Australie] ; L. Sokol [États-Unis] ; M. Greenwood [Australie] ; D. Caballero [Espagne] ; F. Morschhauser [France] ; L. Pinter-Brown ; S. P. Iyer ; A. Shustov ; J. Nichols ; J. Balser ; B. Balser ; B. Pro [États-Unis]

Source :

RBID : PMC:4374388

Abstract

This study examined the utility of PET scans for assessing prognosis and response to treatment in patients with relapsed/refractory PTCL receiving romidepsin. For patients with stable disease or partial response by conventional criteria, PET status better differentiated durability of response than conventional response category. Routine PET use may aid in treatment planning in patients with PTCL.


Url:
DOI: 10.1093/annonc/mdv010
PubMed: 25605745
PubMed Central: 4374388


Affiliations:


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PMC:4374388

Le document en format XML

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fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma</title>
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<addr-line>Lyon</addr-line>
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<nlm:aff id="mdv010_af8">
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<addr-line>CHU de Lille</addr-line>
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<country>France</country>
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<addr-line>Los Angeles</addr-line>
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fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma</title>
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<p>This study examined the utility of PET scans for assessing prognosis and response to treatment in patients with relapsed/refractory PTCL receiving romidepsin. For patients with stable disease or partial response by conventional criteria, PET status better differentiated durability of response than conventional response category. Routine PET use may aid in treatment planning in patients with PTCL.</p>
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<pmc article-type="research-article">
<pmc-dir>properties open_access</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Ann Oncol</journal-id>
<journal-id journal-id-type="iso-abbrev">Ann. Oncol</journal-id>
<journal-id journal-id-type="publisher-id">annonc</journal-id>
<journal-id journal-id-type="hwp">annonc</journal-id>
<journal-title-group>
<journal-title>Annals of Oncology</journal-title>
</journal-title-group>
<issn pub-type="ppub">0923-7534</issn>
<issn pub-type="epub">1569-8041</issn>
<publisher>
<publisher-name>Oxford University Press</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">25605745</article-id>
<article-id pub-id-type="pmc">4374388</article-id>
<article-id pub-id-type="doi">10.1093/annonc/mdv010</article-id>
<article-id pub-id-type="publisher-id">mdv010</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Original Articles</subject>
<subj-group subj-group-type="heading">
<subject>Hematologic Malignancies</subject>
</subj-group>
</subj-group>
</article-categories>
<title-group>
<article-title>Utility of
<sup>18</sup>
fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Horwitz</surname>
<given-names>S.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af1">1</xref>
<xref ref-type="corresp" rid="mdv010_cor1">*</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Coiffier</surname>
<given-names>B.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af2">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Foss</surname>
<given-names>F.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af3">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Prince</surname>
<given-names>H. M.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af4">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Sokol</surname>
<given-names>L.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af5">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Greenwood</surname>
<given-names>M.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af6">6</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Caballero</surname>
<given-names>D.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af7">7</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Morschhauser</surname>
<given-names>F.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af8">8</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Pinter-Brown</surname>
<given-names>L.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af9">9</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Iyer</surname>
<given-names>S. P.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af10">10</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Shustov</surname>
<given-names>A.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af11">11</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Nichols</surname>
<given-names>J.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af12">12</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Balser</surname>
<given-names>J.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af13">13</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Balser</surname>
<given-names>B.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af13">13</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Pro</surname>
<given-names>B.</given-names>
</name>
<xref ref-type="aff" rid="mdv010_af14">14</xref>
</contrib>
<aff id="mdv010_af1">
<label>1</label>
<addr-line>Lymphoma Division</addr-line>
,
<institution>Memorial Sloan-Kettering Cancer Center</institution>
,
<addr-line>New York</addr-line>
,
<country>USA</country>
</aff>
<aff id="mdv010_af2">
<label>2</label>
<addr-line>Department of Hematology</addr-line>
,
<institution>Hospices Civils de Lyon</institution>
,
<addr-line>Lyon</addr-line>
,
<country>France</country>
</aff>
<aff id="mdv010_af3">
<label>3</label>
<addr-line>Hematology Department</addr-line>
,
<institution>Yale Cancer Center</institution>
,
<addr-line>New Haven</addr-line>
,
<country>USA</country>
</aff>
<aff id="mdv010_af4">
<label>4</label>
<addr-line>Division of Cancer Medicine, Department of Haematology</addr-line>
,
<institution>Peter MacCallum Cancer Centre and University of Melbourne</institution>
,
<country>Australia</country>
</aff>
<aff id="mdv010_af5">
<label>5</label>
<addr-line>Department of Malignant Hematology</addr-line>
,
<institution>Moffitt Cancer Center</institution>
,
<addr-line>Tampa</addr-line>
,
<country>USA</country>
</aff>
<aff id="mdv010_af6">
<label>6</label>
<addr-line>Department of Haematology</addr-line>
,
<institution>Royal North Shore Hospital</institution>
,
<addr-line>Sydney</addr-line>
,
<country>Australia</country>
</aff>
<aff id="mdv010_af7">
<label>7</label>
<addr-line>Hematology Department</addr-line>
,
<institution>Hospital Universitario de Salamanca</institution>
,
<addr-line>Salamanca</addr-line>
,
<country>Spain</country>
</aff>
<aff id="mdv010_af8">
<label>8</label>
<addr-line>Department of Hematology</addr-line>
,
<institution>Hôpital Claude Huriez</institution>
,
<addr-line>CHU de Lille</addr-line>
,
<country>France</country>
</aff>
<aff id="mdv010_af9">
<label>9</label>
<addr-line>Division of Hematology-Oncology</addr-line>
,
<institution>UCLA Medical Center</institution>
,
<addr-line>Los Angeles</addr-line>
</aff>
<aff id="mdv010_af10">
<label>10</label>
<addr-line>Malignant Hematology</addr-line>
,
<institution>Houston Methodist Cancer Center</institution>
,
<addr-line>Houston</addr-line>
</aff>
<aff id="mdv010_af11">
<label>11</label>
<addr-line>Division of Hematology</addr-line>
,
<institution>University of Washington</institution>
,
<addr-line>Seattle</addr-line>
</aff>
<aff id="mdv010_af12">
<label>12</label>
<institution>JNichols LLC</institution>
,
<addr-line>Swampscott</addr-line>
</aff>
<aff id="mdv010_af13">
<label>13</label>
<institution>Veristat, LLC</institution>
,
<addr-line>Holliston</addr-line>
</aff>
<aff id="mdv010_af14">
<label>14</label>
<addr-line>Division of Hematology</addr-line>
,
<institution>Thomas Jefferson University</institution>
,
<addr-line>Philadelphia</addr-line>
,
<country>USA</country>
</aff>
</contrib-group>
<author-notes>
<corresp id="mdv010_cor1">
<label>*</label>
<italic>Correspondence to:</italic>
Dr Steven Horwitz, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA. Tel: +
<phone>1-212-639-3045</phone>
; E-mail:
<email>horwitzs@mskcc.org</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub">
<month>4</month>
<year>2015</year>
</pub-date>
<pub-date pub-type="epub">
<day>20</day>
<month>1</month>
<year>2015</year>
</pub-date>
<pub-date pub-type="pmc-release">
<day>20</day>
<month>1</month>
<year>2015</year>
</pub-date>
<pmc-comment> PMC Release delay is 0 months and 0 days and was based on the . </pmc-comment>
<volume>26</volume>
<issue>4</issue>
<fpage>774</fpage>
<lpage>779</lpage>
<history>
<date date-type="received">
<day>11</day>
<month>9</month>
<year>2014</year>
</date>
<date date-type="rev-recd">
<day>19</day>
<month>12</month>
<year>2014</year>
</date>
<date date-type="accepted">
<day>23</day>
<month>12</month>
<year>2014</year>
</date>
</history>
<permissions>
<copyright-statement>© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology.</copyright-statement>
<copyright-year>2015</copyright-year>
<license license-type="creative-commons" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/">
<license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (
<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/">http://creativecommons.org/licenses/by-nc/4.0/</ext-link>
), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com</license-p>
</license>
</permissions>
<self-uri content-type="pdf" xlink:type="simple" xlink:href="mdv010.pdf"></self-uri>
<abstract abstract-type="precis">
<p>This study examined the utility of PET scans for assessing prognosis and response to treatment in patients with relapsed/refractory PTCL receiving romidepsin. For patients with stable disease or partial response by conventional criteria, PET status better differentiated durability of response than conventional response category. Routine PET use may aid in treatment planning in patients with PTCL.</p>
</abstract>
<abstract>
<sec>
<title>Background</title>
<p>For patients with peripheral T-cell lymphoma (PTCL), the value of
<sup>18</sup>
fluoro-deoxyglucose positron emission tomography (FDG-PET) scans for assessing prognosis and response to treatment remains unclear. The utility of FDG-PET, in addition to conventional radiology, was examined as a planned exploratory end point in the pivotal phase 2 trial of romidepsin for the treatment of relapsed/refractory PTCL.</p>
</sec>
<sec>
<title>Patients and methods</title>
<p>Patients received romidepsin at a dose of 14 mg/m
<sup>2</sup>
on days 1, 8, and 15 of 28-day cycles. The primary end point was the rate of confirmed/unconfirmed complete response (CR/CRu) as assessed by International Workshop Criteria (IWC) using conventional radiology. For the exploratory PET end point, patients with at least baseline FDG-PET scans were assessed by IWC + PET criteria.</p>
</sec>
<sec>
<title>Results</title>
<p>Of 130 patients, 110 had baseline FDG-PET scans, and 105 were PET positive at baseline. The use of IWC + PET criteria increased the objective response rate to 30% compared with 26% by conventional radiology. Durations of response were well differentiated by both conventional radiology response criteria [CR/CRu versus partial response (PR),
<italic>P</italic>
= 0.0001] and PET status (negative versus positive,
<italic>P</italic>
< 0.0001). Patients who achieved CR/CRu had prolonged progression-free survival (PFS, median 25.9 months) compared with other response groups (
<italic>P</italic>
= 0.0007). Patients who achieved PR or stable disease (SD) had similar PFS (median 7.2 and 6.3 months, respectively,
<italic>P</italic>
= 0.6427). When grouping PR and SD patients by PET status, patients with PET-negative versus PET-positive disease had a median PFS of 18.2 versus 7.1 months (
<italic>P</italic>
= 0.0923).</p>
</sec>
<sec>
<title>Conclusion(s)</title>
<p>Routine use of FDG-PET does not obviate conventional staging, but may aid in determining prognosis and refine response assessments for patients with PTCL, particularly for those who do not achieve CR/CRu by conventional staging. The optimal way to incorporate FDG-PET scans for patients with PTCL remains to be determined.</p>
</sec>
<sec>
<title>Trial registration</title>
<p>NCT00426764.</p>
</sec>
</abstract>
<kwd-group>
<kwd>romidepsin</kwd>
<kwd>peripheral T-cell lymphoma</kwd>
<kwd>positron emission tomography</kwd>
<kwd>radiology</kwd>
<kwd>histone deacetylase inhibitor</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>États-Unis</li>
</country>
</list>
<tree>
<noCountry>
<name sortKey="Balser, B" sort="Balser, B" uniqKey="Balser B" first="B." last="Balser">B. Balser</name>
<name sortKey="Balser, J" sort="Balser, J" uniqKey="Balser J" first="J." last="Balser">J. Balser</name>
<name sortKey="Iyer, S P" sort="Iyer, S P" uniqKey="Iyer S" first="S. P." last="Iyer">S. P. Iyer</name>
<name sortKey="Nichols, J" sort="Nichols, J" uniqKey="Nichols J" first="J." last="Nichols">J. Nichols</name>
<name sortKey="Pinter Brown, L" sort="Pinter Brown, L" uniqKey="Pinter Brown L" first="L." last="Pinter-Brown">L. Pinter-Brown</name>
<name sortKey="Shustov, A" sort="Shustov, A" uniqKey="Shustov A" first="A." last="Shustov">A. Shustov</name>
</noCountry>
<country name="États-Unis">
<noRegion>
<name sortKey="Horwitz, S" sort="Horwitz, S" uniqKey="Horwitz S" first="S." last="Horwitz">S. Horwitz</name>
</noRegion>
<name sortKey="Foss, F" sort="Foss, F" uniqKey="Foss F" first="F." last="Foss">F. Foss</name>
<name sortKey="Pro, B" sort="Pro, B" uniqKey="Pro B" first="B." last="Pro">B. Pro</name>
<name sortKey="Sokol, L" sort="Sokol, L" uniqKey="Sokol L" first="L." last="Sokol">L. Sokol</name>
</country>
<country name="France">
<noRegion>
<name sortKey="Coiffier, B" sort="Coiffier, B" uniqKey="Coiffier B" first="B." last="Coiffier">B. Coiffier</name>
</noRegion>
<name sortKey="Morschhauser, F" sort="Morschhauser, F" uniqKey="Morschhauser F" first="F." last="Morschhauser">F. Morschhauser</name>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Prince, H M" sort="Prince, H M" uniqKey="Prince H" first="H. M." last="Prince">H. M. Prince</name>
</noRegion>
<name sortKey="Greenwood, M" sort="Greenwood, M" uniqKey="Greenwood M" first="M." last="Greenwood">M. Greenwood</name>
</country>
<country name="Espagne">
<noRegion>
<name sortKey="Caballero, D" sort="Caballero, D" uniqKey="Caballero D" first="D." last="Caballero">D. Caballero</name>
</noRegion>
</country>
</tree>
</affiliations>
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