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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 : 002D82 ( PubMed/Curation ); précédent : 002D81; suivant : 002D83

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 ; 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 [États-Unis] ; S P Iyer [États-Unis] ; A. Shustov [États-Unis] ; J. Nichols ; J. Balser ; B. Balser ; B. Pro [États-Unis]

Source :

RBID : pubmed:25605745

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English descriptors

Abstract

For patients with peripheral T-cell lymphoma (PTCL), the value of (18)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.

DOI: 10.1093/annonc/mdv010
PubMed: 25605745

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S. Horwitz
<affiliation>
<nlm:affiliation>Lymphoma Division, Memorial Sloan-Kettering Cancer Center, New York, USA horwitzs@mskcc.org.</nlm:affiliation>
<wicri:noCountry code="subField">USA horwitzs@mskcc.org.</wicri:noCountry>
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J. Nichols
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<nlm:affiliation>JNichols LLC, Swampscott.</nlm:affiliation>
<wicri:noCountry code="subField">Swampscott</wicri:noCountry>
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J. Balser
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<nlm:affiliation>Veristat, LLC, Holliston.</nlm:affiliation>
<wicri:noCountry code="subField">Holliston</wicri:noCountry>
</affiliation>
B. Balser
<affiliation>
<nlm:affiliation>Veristat, LLC, Holliston.</nlm:affiliation>
<wicri:noCountry code="subField">Holliston</wicri:noCountry>
</affiliation>

Le document en format XML

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<div type="abstract" xml:lang="en">For patients with peripheral T-cell lymphoma (PTCL), the value of (18)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.</div>
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<ELocationID EIdType="doi" ValidYN="Y">10.1093/annonc/mdv010</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">For patients with peripheral T-cell lymphoma (PTCL), the value of (18)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.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">Patients received romidepsin at a dose of 14 mg/m(2) 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.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">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), P = 0.0001] and PET status (negative versus positive, P < 0.0001). Patients who achieved CR/CRu had prolonged progression-free survival (PFS, median 25.9 months) compared with other response groups (P = 0.0007). Patients who achieved PR or stable disease (SD) had similar PFS (median 7.2 and 6.3 months, respectively, P = 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 (P = 0.0923).</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">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.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">NCT00426764.</AbstractText>
<CopyrightInformation>© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Horwitz</LastName>
<ForeName>S</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Lymphoma Division, Memorial Sloan-Kettering Cancer Center, New York, USA horwitzs@mskcc.org.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Coiffier</LastName>
<ForeName>B</ForeName>
<Initials>B</Initials>
<AffiliationInfo>
<Affiliation>Department of Hematology, Hospices Civils de Lyon, Lyon, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Foss</LastName>
<ForeName>F</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Hematology Department, Yale Cancer Center, New Haven, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Prince</LastName>
<ForeName>H M</ForeName>
<Initials>HM</Initials>
<AffiliationInfo>
<Affiliation>Division of Cancer Medicine, Department of Haematology, Peter MacCallum Cancer Centre and University of Melbourne, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sokol</LastName>
<ForeName>L</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Department of Malignant Hematology, Moffitt Cancer Center, Tampa, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Greenwood</LastName>
<ForeName>M</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Department of Haematology, Royal North Shore Hospital, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Caballero</LastName>
<ForeName>D</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Hematology Department, Hospital Universitario de Salamanca, Salamanca, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Morschhauser</LastName>
<ForeName>F</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Department of Hematology, Hôpital Claude Huriez, CHU de Lille, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Pinter-Brown</LastName>
<ForeName>L</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Division of Hematology-Oncology, UCLA Medical Center, Los Angeles.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Iyer</LastName>
<ForeName>S P</ForeName>
<Initials>SP</Initials>
<AffiliationInfo>
<Affiliation>Malignant Hematology, Houston Methodist Cancer Center, Houston.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Shustov</LastName>
<ForeName>A</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Division of Hematology, University of Washington, Seattle.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Nichols</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>JNichols LLC, Swampscott.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Balser</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Veristat, LLC, Holliston.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Balser</LastName>
<ForeName>B</ForeName>
<Initials>B</Initials>
<AffiliationInfo>
<Affiliation>Veristat, LLC, Holliston.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Pro</LastName>
<ForeName>B</ForeName>
<Initials>B</Initials>
<AffiliationInfo>
<Affiliation>Division of Hematology, Thomas Jefferson University, Philadelphia, USA.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y">
<DataBank>
<DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList>
<AccessionNumber>NCT00426764</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<GrantList CompleteYN="Y">
<Grant>
<GrantID>UL1 TR000371</GrantID>
<Acronym>TR</Acronym>
<Agency>NCATS NIH HHS</Agency>
<Country>United States</Country>
</Grant>
</GrantList>
<PublicationTypeList>
<PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic">
<Year>2015</Year>
<Month>01</Month>
<Day>20</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo>
<Country>England</Country>
<MedlineTA>Ann Oncol</MedlineTA>
<NlmUniqueID>9007735</NlmUniqueID>
<ISSNLinking>0923-7534</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000903">Antibiotics, Antineoplastic</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D047630">Depsipeptides</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D019275">Radiopharmaceuticals</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0Z5B2CJX4D</RegistryNumber>
<NameOfSubstance UI="D019788">Fluorodeoxyglucose F18</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>CX3T89XQBK</RegistryNumber>
<NameOfSubstance UI="C087123">romidepsin</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
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<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D000903" MajorTopicYN="N">Antibiotics, Antineoplastic</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D047630" MajorTopicYN="N">Depsipeptides</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D019008" MajorTopicYN="N">Drug Resistance, Neoplasm</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D019788" MajorTopicYN="N">Fluorodeoxyglucose F18</DescriptorName>
<QualifierName UI="Q000493" MajorTopicYN="Y">pharmacokinetics</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005500" MajorTopicYN="N">Follow-Up Studies</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D016411" MajorTopicYN="N">Lymphoma, T-Cell, Peripheral</DescriptorName>
<QualifierName UI="Q000000981" MajorTopicYN="Y">diagnostic imaging</QualifierName>
<QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName>
<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
<QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D009367" MajorTopicYN="N">Neoplasm Staging</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D049268" MajorTopicYN="N">Positron-Emission Tomography</DescriptorName>
<QualifierName UI="Q000656" MajorTopicYN="Y">utilization</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011379" MajorTopicYN="N">Prognosis</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D019275" MajorTopicYN="N">Radiopharmaceuticals</DescriptorName>
<QualifierName UI="Q000493" MajorTopicYN="N">pharmacokinetics</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012074" MajorTopicYN="N">Remission Induction</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015996" MajorTopicYN="N">Survival Rate</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D014018" MajorTopicYN="N">Tissue Distribution</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<OtherID Source="NLM">PMC4374388</OtherID>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">histone deacetylase inhibitor</Keyword>
<Keyword MajorTopicYN="N">peripheral T-cell lymphoma</Keyword>
<Keyword MajorTopicYN="N">positron emission tomography</Keyword>
<Keyword MajorTopicYN="N">radiology</Keyword>
<Keyword MajorTopicYN="N">romidepsin</Keyword>
</KeywordList>
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<Month>1</Month>
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<Hour>6</Hour>
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