Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials.
Identifieur interne : 000327 ( PubMed/Corpus ); précédent : 000326; suivant : 000328Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials.
Auteurs : Andrei Shustov ; Bertrand Coiffier ; Steven Horwitz ; Lubomir Sokol ; Barbara Pro ; Julie Wolfson ; Barbara Balser ; Robin Eisch ; Leslie Popplewell ; H Miles Prince ; Steven L. Allen ; Richard Piekarz ; Susan BatesSource :
- Leukemia & lymphoma [ 1029-2403 ] ; 2017.
Abstract
Peripheral T-cell lymphomas (PTCLs) are a rare group of lymphoid neoplasms with high relapse rates after initial therapy and poor prognosis. Most patients are aged ≥60 years and are often not candidates for aggressive salvage therapies. Romidepsin, a potent class I histone deacetylase inhibitor, has shown significant single-agent activity in relapsed/refractory PTCL. We evaluated the efficacy and tolerability of romidepsin in elderly patients in this setting. Ninety-five patients aged ≥60 years were identified from 2 prospective phase 2 registration trials of romidepsin, and comparative analyses were performed with younger patients from these trials. Response rates, progression-free survival, and overall survival were not statistically different for younger vs older patients. The toxicity profile in older and younger patients was similar in both trials. Romidepsin demonstrated similar efficacy and tolerability in younger and older patients and presents an attractive treatment option for relapsed/refractory PTCL regardless of age.
DOI: 10.1080/10428194.2017.1295143
PubMed: 28264616
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Allen</name><affiliation><nlm:affiliation>j Department of Hematology , Hofstra North Shore-LIJ School of Medicine and Monter Cancer Center , Lake Success , NY , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Piekarz, Richard" sort="Piekarz, Richard" uniqKey="Piekarz R" first="Richard" last="Piekarz">Richard Piekarz</name><affiliation><nlm:affiliation>g Department of Investigational Therapeutics , National Cancer Institute , Bethesda , MD , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Bates, Susan" sort="Bates, Susan" uniqKey="Bates S" first="Susan" last="Bates">Susan Bates</name><affiliation><nlm:affiliation>k Department of Hematology/Oncology , Columbia University Medical Center , New York , NY , USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28264616</idno><idno type="pmid">28264616</idno><idno type="doi">10.1080/10428194.2017.1295143</idno><idno type="wicri:Area/PubMed/Corpus">000327</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000327</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials.</title><author><name sortKey="Shustov, Andrei" sort="Shustov, Andrei" uniqKey="Shustov A" first="Andrei" last="Shustov">Andrei Shustov</name><affiliation><nlm:affiliation>a Department of Hematology , University of Washington Medical Center , Seattle , WA , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><affiliation><nlm:affiliation>b Department of Hematology , Hospices Civils de Lyon , Lyon , France.</nlm:affiliation></affiliation></author><author><name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name><affiliation><nlm:affiliation>c Department of Oncology , Memorial Sloan Kettering Cancer Center , New York , NY , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sokol, Lubomir" sort="Sokol, Lubomir" uniqKey="Sokol L" first="Lubomir" last="Sokol">Lubomir Sokol</name><affiliation><nlm:affiliation>d Department of Hematology , Moffitt Cancer Center , Tampa , FL , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pro, Barbara" sort="Pro, Barbara" uniqKey="Pro B" first="Barbara" last="Pro">Barbara Pro</name><affiliation><nlm:affiliation>e Department of Hematology/Oncology , Kimmel Cancer Center, Thomas Jefferson University , Philadelphia , PA , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Wolfson, Julie" sort="Wolfson, Julie" uniqKey="Wolfson J" first="Julie" last="Wolfson">Julie Wolfson</name><affiliation><nlm:affiliation>f Veristat, LLC , Southborough , MA , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name><affiliation><nlm:affiliation>f Veristat, LLC , Southborough , MA , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Eisch, Robin" sort="Eisch, Robin" uniqKey="Eisch R" first="Robin" last="Eisch">Robin Eisch</name><affiliation><nlm:affiliation>g Department of Investigational Therapeutics , National Cancer Institute , Bethesda , MD , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Popplewell, Leslie" sort="Popplewell, Leslie" uniqKey="Popplewell L" first="Leslie" last="Popplewell">Leslie Popplewell</name><affiliation><nlm:affiliation>h Department of Hematology/Oncology , City of Hope Medical Center-Oncology , Duarte , CA , USA.</nlm:affiliation></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><nlm:affiliation>i Department of Hematology , Peter MacCallum Cancer Centre and University of Melbourne , Melbourne , Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Allen, Steven L" sort="Allen, Steven L" uniqKey="Allen S" first="Steven L" last="Allen">Steven L. Allen</name><affiliation><nlm:affiliation>j Department of Hematology , Hofstra North Shore-LIJ School of Medicine and Monter Cancer Center , Lake Success , NY , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Piekarz, Richard" sort="Piekarz, Richard" uniqKey="Piekarz R" first="Richard" last="Piekarz">Richard Piekarz</name><affiliation><nlm:affiliation>g Department of Investigational Therapeutics , National Cancer Institute , Bethesda , MD , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Bates, Susan" sort="Bates, Susan" uniqKey="Bates S" first="Susan" last="Bates">Susan Bates</name><affiliation><nlm:affiliation>k Department of Hematology/Oncology , Columbia University Medical Center , New York , NY , USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Leukemia & lymphoma</title><idno type="eISSN">1029-2403</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Peripheral T-cell lymphomas (PTCLs) are a rare group of lymphoid neoplasms with high relapse rates after initial therapy and poor prognosis. Most patients are aged ≥60 years and are often not candidates for aggressive salvage therapies. Romidepsin, a potent class I histone deacetylase inhibitor, has shown significant single-agent activity in relapsed/refractory PTCL. We evaluated the efficacy and tolerability of romidepsin in elderly patients in this setting. Ninety-five patients aged ≥60 years were identified from 2 prospective phase 2 registration trials of romidepsin, and comparative analyses were performed with younger patients from these trials. Response rates, progression-free survival, and overall survival were not statistically different for younger vs older patients. The toxicity profile in older and younger patients was similar in both trials. Romidepsin demonstrated similar efficacy and tolerability in younger and older patients and presents an attractive treatment option for relapsed/refractory PTCL regardless of age.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28264616</PMID><DateCreated><Year>2017</Year><Month>03</Month><Day>07</Day></DateCreated><DateRevised><Year>2017</Year><Month>10</Month><Day>07</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1029-2403</ISSN><JournalIssue CitedMedium="Internet"><Volume>58</Volume><Issue>10</Issue><PubDate><Year>2017</Year><Month>Oct</Month></PubDate></JournalIssue><Title>Leukemia & lymphoma</Title><ISOAbbreviation>Leuk. Lymphoma</ISOAbbreviation></Journal><ArticleTitle>Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials.</ArticleTitle><Pagination><MedlinePgn>2335-2341</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1080/10428194.2017.1295143</ELocationID><Abstract><AbstractText>Peripheral T-cell lymphomas (PTCLs) are a rare group of lymphoid neoplasms with high relapse rates after initial therapy and poor prognosis. Most patients are aged ≥60 years and are often not candidates for aggressive salvage therapies. Romidepsin, a potent class I histone deacetylase inhibitor, has shown significant single-agent activity in relapsed/refractory PTCL. We evaluated the efficacy and tolerability of romidepsin in elderly patients in this setting. Ninety-five patients aged ≥60 years were identified from 2 prospective phase 2 registration trials of romidepsin, and comparative analyses were performed with younger patients from these trials. Response rates, progression-free survival, and overall survival were not statistically different for younger vs older patients. The toxicity profile in older and younger patients was similar in both trials. Romidepsin demonstrated similar efficacy and tolerability in younger and older patients and presents an attractive treatment option for relapsed/refractory PTCL regardless of age.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Clinicaltrials.gov identifiers: NCT00426764, NCT00007345.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Shustov</LastName><ForeName>Andrei</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>a Department of Hematology , University of Washington Medical Center , Seattle , WA , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coiffier</LastName><ForeName>Bertrand</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>b Department of Hematology , Hospices Civils de Lyon , Lyon , France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Horwitz</LastName><ForeName>Steven</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>c Department of Oncology , Memorial Sloan Kettering Cancer Center , New York , NY , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sokol</LastName><ForeName>Lubomir</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>d Department of Hematology , Moffitt Cancer Center , Tampa , FL , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pro</LastName><ForeName>Barbara</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>e Department of Hematology/Oncology , Kimmel Cancer Center, Thomas Jefferson University , Philadelphia , PA , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wolfson</LastName><ForeName>Julie</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>f Veristat, LLC , Southborough , MA , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Balser</LastName><ForeName>Barbara</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>f Veristat, LLC , Southborough , MA , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Eisch</LastName><ForeName>Robin</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>g Department of Investigational Therapeutics , National Cancer Institute , Bethesda , MD , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Popplewell</LastName><ForeName>Leslie</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>h Department of Hematology/Oncology , City of Hope Medical Center-Oncology , Duarte , CA , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Prince</LastName><ForeName>H Miles</ForeName><Initials>HM</Initials><AffiliationInfo><Affiliation>i Department of Hematology , Peter MacCallum Cancer Centre and University of Melbourne , Melbourne , Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Allen</LastName><ForeName>Steven L</ForeName><Initials>SL</Initials><AffiliationInfo><Affiliation>j Department of Hematology , Hofstra North Shore-LIJ School of Medicine and Monter Cancer Center , Lake Success , NY , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Piekarz</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>g Department of Investigational Therapeutics , National Cancer Institute , Bethesda , MD , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bates</LastName><ForeName>Susan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>k Department of Hematology/Oncology , Columbia University Medical Center , New York , NY , USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>03</Month><Day>07</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Leuk Lymphoma</MedlineTA><NlmUniqueID>9007422</NlmUniqueID><ISSNLinking>1026-8022</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Peripheral T-cell lymphoma</Keyword><Keyword MajorTopicYN="N">clinical trial</Keyword><Keyword MajorTopicYN="N">elderly</Keyword><Keyword MajorTopicYN="N">histone deacetylase inhibitor</Keyword><Keyword MajorTopicYN="N">romidepsin</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>3</Month><Day>8</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>3</Month><Day>8</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>3</Month><Day>8</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28264616</ArticleId><ArticleId 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