Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma
Identifieur interne : 003405 ( Main/Exploration ); précédent : 003404; suivant : 003406Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma
Auteurs : Francine Foss [États-Unis] ; Bertrand Coiffier [France] ; Steven Horwitz [États-Unis] ; Barbara Pro [États-Unis] ; H Miles Prince [Australie] ; Lubomir Sokol [États-Unis] ; Matthew Greenwood [Australie] ; Adam Lerner [États-Unis] ; Dolores Caballero [Espagne] ; Eugeniusz Baran [Pologne] ; Ellen Kim [États-Unis] ; Jean Nichols [États-Unis] ; Barbara Balser [États-Unis] ; Julie Wolfson [États-Unis] ; Sean Whittaker [Royaume-Uni]Source :
- Biomarker Research [ 2050-7771 ] ; 2014.
Abstract
Histone deacetylase inhibitor romidepsin has demonstrated durable clinical responses and tolerability in patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Selection of novel drug therapies for patients with relapsed/refractory aggressive lymphoma requires not only considerations regarding efficacy but also careful evaluation of toxicities as well as overall clinical benefit. The purpose of this analysis was to examine common adverse events (AEs) reported in pivotal trials of romidepsin in relapsed/refractory PTCL or CTCL and to more clearly define the overall AE profile in these populations.
Patients with relapsed/refractory PTCL or CTCL were treated with romidepsin at 14 mg/m2 as a 4-hour intravenous infusion on days 1, 8, and 15 of 28-day cycles for up to 6 cycles; patients with at least stable disease could extend therapy until progressive disease or another withdrawal criterion was met. All enrolled patients who received ≥ 1 dose of romidepsin were included in the AE analyses.
Overall, safety profiles of common AEs were similar, although patients with relapsed/refractory PTCL had more frequent hematologic toxicities and grade ≥ 3 infections. In both patient populations, the greatest incidence of grade ≥ 3 AEs and the majority of discontinuations due to AEs occurred during cycles 1–2. Early discontinuations were primarily related to infection, thrombocytopenia, or electrocardiogram abnormalities, confirming the need to closely monitor patients with poor bone marrow reserve or other comorbidities. Despite this, 28% of patients with relapsed/refractory PTCL and 36% of patients with relapsed/refractory CTCL continued on romidepsin treatment for ≥ 6 cycles.
This study demonstrates that patients with relapsed/refractory PTCL or CTCL have similar AE profiles with romidepsin treatment, although patients with PTCL experienced more frequent and more severe hematologic toxicities and more frequent grade ≥ 3 infections. The greatest incidence of grade ≥ 3 AEs and the majority of discontinuations due to AEs occurred during treatment cycles 1–2. Extended dosing of romidepsin can be tolerated in responding patients.
Url:
DOI: 10.1186/2050-7771-2-16
PubMed: 25279222
PubMed Central: 4181623
Affiliations:
- Australie, Espagne, France, Pologne, Royaume-Uni, États-Unis
- Auvergne-Rhône-Alpes, Connecticut, Floride, Massachusetts, Pennsylvanie, Rhône-Alpes, Victoria (État), État de New York
- Lyon, Melbourne
- Université de Melbourne
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Box 208028, 333 Cedar Street, TMP 3, New Haven, CT 06520-8028, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Yale Cancer Center, PO Box 208028, 333 Cedar Street, TMP 3, New Haven, CT 06520-8028</wicri:regionArea><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><affiliation wicri:level="3"><nlm:aff id="I2">Hospices Civils de Lyon, Lyon, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hospices Civils de Lyon, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name><affiliation wicri:level="2"><nlm:aff id="I3">Memorial Sloan Kettering Cancer Center, New York, NY, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Memorial Sloan Kettering Cancer Center, New York, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Pro, Barbara" sort="Pro, Barbara" uniqKey="Pro B" first="Barbara" last="Pro">Barbara Pro</name><affiliation wicri:level="2"><nlm:aff id="I4">Thomas Jefferson University, Philadelphia, PA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Thomas Jefferson University, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></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 wicri:level="4"><nlm:aff id="I5">Peter MacCallum Cancer Centre and University of Melbourne, East Melbourne, Victoria, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Peter MacCallum Cancer Centre and University of Melbourne, East Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Sokol, Lubomir" sort="Sokol, Lubomir" uniqKey="Sokol L" first="Lubomir" last="Sokol">Lubomir Sokol</name><affiliation wicri:level="2"><nlm:aff id="I6">Moffitt Cancer Center, Tampa, FL, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Moffitt Cancer Center, Tampa, FL</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Greenwood, Matthew" sort="Greenwood, Matthew" uniqKey="Greenwood M" first="Matthew" last="Greenwood">Matthew Greenwood</name><affiliation wicri:level="1"><nlm:aff id="I7">Royal North Shore Hospital, Sydney, New South Wales, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Royal North Shore Hospital, Sydney, New South Wales</wicri:regionArea><wicri:noRegion>New South Wales</wicri:noRegion></affiliation></author><author><name sortKey="Lerner, Adam" sort="Lerner, Adam" uniqKey="Lerner A" first="Adam" last="Lerner">Adam Lerner</name><affiliation wicri:level="2"><nlm:aff id="I8">Boston Medical Center, Boston, MA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Boston Medical Center, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Caballero, Dolores" sort="Caballero, Dolores" uniqKey="Caballero D" first="Dolores" last="Caballero">Dolores Caballero</name><affiliation wicri:level="1"><nlm:aff id="I9">Hospital Universitario de Salamanca, Salamanca, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Universitario de Salamanca, Salamanca</wicri:regionArea><wicri:noRegion>Salamanca</wicri:noRegion></affiliation></author><author><name sortKey="Baran, Eugeniusz" sort="Baran, Eugeniusz" uniqKey="Baran E" first="Eugeniusz" last="Baran">Eugeniusz Baran</name><affiliation wicri:level="1"><nlm:aff id="I10">Wroclaw Medical University, Wroclaw, Poland</nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea>Wroclaw Medical University, Wroclaw</wicri:regionArea><wicri:noRegion>Wroclaw</wicri:noRegion></affiliation></author><author><name sortKey="Kim, Ellen" sort="Kim, Ellen" uniqKey="Kim E" first="Ellen" last="Kim">Ellen Kim</name><affiliation wicri:level="2"><nlm:aff id="I11">University of Pennsylvania, Philadelphia, PA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Pennsylvania, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Nichols, Jean" sort="Nichols, Jean" uniqKey="Nichols J" first="Jean" last="Nichols">Jean Nichols</name><affiliation wicri:level="2"><nlm:aff id="I12">J Nichols LLC, Swampscott, MA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>J Nichols LLC, Swampscott, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name><affiliation wicri:level="2"><nlm:aff id="I13">Veristat, LLC, Holliston, MA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Veristat, LLC, Holliston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Wolfson, Julie" sort="Wolfson, Julie" uniqKey="Wolfson J" first="Julie" last="Wolfson">Julie Wolfson</name><affiliation wicri:level="2"><nlm:aff id="I13">Veristat, LLC, Holliston, MA, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Veristat, LLC, Holliston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Whittaker, Sean" sort="Whittaker, Sean" uniqKey="Whittaker S" first="Sean" last="Whittaker">Sean Whittaker</name><affiliation wicri:level="1"><nlm:aff id="I14">Guy’s and St Thomas’ Hospital, London, England, United Kingdom</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Guy’s and St Thomas’ Hospital, London, England</wicri:regionArea><wicri:noRegion>England</wicri:noRegion></affiliation></author></analytic><series><title level="j">Biomarker Research</title><idno type="eISSN">2050-7771</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Histone deacetylase inhibitor romidepsin has demonstrated durable clinical responses and tolerability in patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Selection of novel drug therapies for patients with relapsed/refractory aggressive lymphoma requires not only considerations regarding efficacy but also careful evaluation of toxicities as well as overall clinical benefit. The purpose of this analysis was to examine common adverse events (AEs) reported in pivotal trials of romidepsin in relapsed/refractory PTCL or CTCL and to more clearly define the overall AE profile in these populations.</p></sec><sec><title>Methods</title><p>Patients with relapsed/refractory PTCL or CTCL were treated with romidepsin at 14 mg/m<sup>2</sup> as a 4-hour intravenous infusion on days 1, 8, and 15 of 28-day cycles for up to 6 cycles; patients with at least stable disease could extend therapy until progressive disease or another withdrawal criterion was met. All enrolled patients who received ≥ 1 dose of romidepsin were included in the AE analyses.</p></sec><sec><title>Results</title><p>Overall, safety profiles of common AEs were similar, although patients with relapsed/refractory PTCL had more frequent hematologic toxicities and grade ≥ 3 infections. In both patient populations, the greatest incidence of grade ≥ 3 AEs and the majority of discontinuations due to AEs occurred during cycles 1–2. Early discontinuations were primarily related to infection, thrombocytopenia, or electrocardiogram abnormalities, confirming the need to closely monitor patients with poor bone marrow reserve or other comorbidities. Despite this, 28% of patients with relapsed/refractory PTCL and 36% of patients with relapsed/refractory CTCL continued on romidepsin treatment for ≥ 6 cycles.</p></sec><sec><title>Conclusions</title><p>This study demonstrates that patients with relapsed/refractory PTCL or CTCL have similar AE profiles with romidepsin treatment, although patients with PTCL experienced more frequent and more severe hematologic toxicities and more frequent grade ≥ 3 infections. The greatest incidence of grade ≥ 3 AEs and the majority of discontinuations due to AEs occurred during treatment cycles 1–2. Extended dosing of romidepsin can be tolerated in responding patients.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00426764?term=NCT00426764&rank=1">NCT00426764,</ext-link><ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/ct2/show/NCT00106431?term=NCT00106431&rank=1">NCT00106431</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Tan, J" uniqKey="Tan J">J Tan</name></author><author><name sortKey="Cang, S" uniqKey="Cang S">S Cang</name></author><author><name sortKey="Ma, Y" uniqKey="Ma Y">Y Ma</name></author><author><name sortKey="Petrillo, Rl" uniqKey="Petrillo R">RL Petrillo</name></author><author><name sortKey="Liu, D" uniqKey="Liu D">D Liu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bolden, Je" uniqKey="Bolden J">JE Bolden</name></author><author><name sortKey="Peart, Mj" 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Bates</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cabell, C" uniqKey="Cabell C">C Cabell</name></author><author><name sortKey="Bates, S" uniqKey="Bates S">S Bates</name></author><author><name sortKey="Piekarz, R" uniqKey="Piekarz R">R Piekarz</name></author><author><name sortKey="Whittaker, Yk" uniqKey="Whittaker Y">YK Whittaker</name></author><author><name sortKey="Godfrey, C" uniqKey="Godfrey C">C Godfrey</name></author><author><name sortKey="Schoonmaker, C" uniqKey="Schoonmaker C">C Schoonmaker</name></author><author><name sortKey="Mcculloch, W" uniqKey="Mcculloch W">W McCulloch</name></author><author><name sortKey="Nichols, J" uniqKey="Nichols J">J Nichols</name></author><author><name sortKey="Burris, Ha" uniqKey="Burris H">HA Burris</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Navari, Rm" uniqKey="Navari R">RM Navari</name></author><author><name sortKey="Koeller, Jm" uniqKey="Koeller J">JM Koeller</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Keefe, Dl" uniqKey="Keefe D">DL Keefe</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Australie</li><li>Espagne</li><li>France</li><li>Pologne</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Connecticut</li><li>Floride</li><li>Massachusetts</li><li>Pennsylvanie</li><li>Rhône-Alpes</li><li>Victoria (État)</li><li>État de New York</li></region><settlement><li>Lyon</li><li>Melbourne</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="États-Unis"><region name="Connecticut"><name sortKey="Foss, Francine" sort="Foss, Francine" uniqKey="Foss F" first="Francine" last="Foss">Francine Foss</name></region><name sortKey="Balser, Barbara" sort="Balser, Barbara" uniqKey="Balser B" first="Barbara" last="Balser">Barbara Balser</name><name sortKey="Horwitz, Steven" sort="Horwitz, Steven" uniqKey="Horwitz S" first="Steven" last="Horwitz">Steven Horwitz</name><name sortKey="Kim, Ellen" sort="Kim, Ellen" uniqKey="Kim E" first="Ellen" last="Kim">Ellen Kim</name><name sortKey="Lerner, Adam" sort="Lerner, Adam" uniqKey="Lerner A" first="Adam" last="Lerner">Adam Lerner</name><name sortKey="Nichols, Jean" sort="Nichols, Jean" uniqKey="Nichols J" first="Jean" last="Nichols">Jean Nichols</name><name sortKey="Pro, Barbara" sort="Pro, Barbara" uniqKey="Pro B" first="Barbara" last="Pro">Barbara Pro</name><name sortKey="Sokol, Lubomir" sort="Sokol, Lubomir" uniqKey="Sokol L" first="Lubomir" last="Sokol">Lubomir Sokol</name><name sortKey="Wolfson, Julie" sort="Wolfson, Julie" uniqKey="Wolfson J" first="Julie" last="Wolfson">Julie Wolfson</name></country><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></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Prince, H Miles" sort="Prince, H Miles" uniqKey="Prince H" first="H Miles" last="Prince">H Miles Prince</name></region><name sortKey="Greenwood, Matthew" sort="Greenwood, Matthew" uniqKey="Greenwood M" first="Matthew" last="Greenwood">Matthew Greenwood</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="Pologne"><noRegion><name sortKey="Baran, Eugeniusz" sort="Baran, Eugeniusz" uniqKey="Baran E" first="Eugeniusz" last="Baran">Eugeniusz Baran</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Whittaker, Sean" sort="Whittaker, Sean" uniqKey="Whittaker S" first="Sean" last="Whittaker">Sean Whittaker</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document 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