A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Identifieur interne : 001313 ( Main/Curation ); précédent : 001312; suivant : 001314A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Auteurs : Myron S. Czuczman [États-Unis] ; Marek Trn N [République tchèque] ; Andrew Davies [Royaume-Uni] ; Simon Rule [Royaume-Uni] ; Kim M. Linton [Royaume-Uni] ; Nina Wagner-Johnston [États-Unis] ; Randy D. Gascoyne [Canada] ; Graham W. Slack [Canada] ; Pierre Brousset [France] ; David A. Eberhard [États-Unis] ; Francisco J. Hernandez-Ilizaliturri [États-Unis] ; Gilles Salles [France] ; Thomas E. Witzig [États-Unis] ; Pier Luigi Zinzani [Italie] ; George W. Wright [États-Unis] ; Louis M. Staudt [États-Unis] ; Yandan Yang [États-Unis] ; P Mickey Williams [États-Unis] ; Chih-Jian Lih [États-Unis] ; Jacqueline Russo [États-Unis] ; Anjan Thakurta [États-Unis] ; Patrick Hagner [États-Unis] ; Pierre Fustier [Suisse] ; Dale Song [États-Unis] ; Ian D. Lewis [Australie]Source :
- Clinical cancer research : an official journal of the American Association for Cancer Research [ 1078-0432 ] ; 2017.
Abstract
Purpose: Randomized, multicenter, open-label, phase 2/3 trial investigating lenalidomide versus investigator's choice (IC) in relapsed/refractory diffuse large B-cell lymphoma (DLBCL).Experimental Design: Patients with DLBCL who received ≥2 prior therapies were stratified by DLBCL subtype [germinal center B-cell (GCB) vs. non-GCB; determined by immunohistochemistry (IHC)] and then randomized 1:1 to lenalidomide (25 mg/day, 21 days of 28-day cycle) or IC (gemcitabine, rituximab, etoposide, or oxaliplatin). Crossover to lenalidomide was permitted for IC-treated patients with radiologically confirmed progressive disease. The primary endpoint was overall response rate (ORR). Progression-free survival (PFS), overall survival, and subtype analysis [GCB vs. activated B-cell (ABC)] using gene expression profiling (GEP) were exploratory endpoints.Results: Stage 1: 102 DLBCL patients (by IHC: non-GCB, n = 54; GCB, n = 48) received ≥1 dose of lenalidomide or IC. Hematologic treatment-emergent adverse events with lenalidomide versus IC included neutropenia (42.6%; 36.4%), anemia (33.3%; 47.3%), thrombocytopenia (24.1%; 43.6%), and leukopenia (5.6%; 12.7%), respectively. Overall, lenalidomide-treated patients had an ORR of 27.5% versus 11.8% in IC (ORRs were similar regardless of IHC-defined DLBCL subtype). Median PFS was increased in patients receiving lenalidomide (13.6 weeks) versus IC (7.9 weeks; P = 0.041), with greater improvements in non-GCB patients (15.1 vs. 7.1 weeks, respectively; P = 0.021) compared with GCB (10.1 vs. 9.0 weeks, respectively; P = 0.550).Conclusions: The clinical benefit of lenalidomide monotherapy in DLBCL patients was more evident in the non-GCB subtype. Exploratory analyses suggest that this preferential benefit was more pronounced in the GEP-defined ABC population, demonstrating a need for additional studies of lenalidomide in DLBCL using GEP subtyping. Clin Cancer Res; 23(15); 4127-37. ©2017 AACR.
DOI: 10.1158/1078-0432.CCR-16-2818
PubMed: 28381416
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pubmed:28381416Le document en format XML
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<author><name sortKey="Zinzani, Pier Luigi" sort="Zinzani, Pier Luigi" uniqKey="Zinzani P" first="Pier Luigi" last="Zinzani">Pier Luigi Zinzani</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.</title>
<author><name sortKey="Czuczman, Myron S" sort="Czuczman, Myron S" uniqKey="Czuczman M" first="Myron S" last="Czuczman">Myron S. Czuczman</name>
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<author><name sortKey="Trn N, Marek" sort="Trn N, Marek" uniqKey="Trn N M" first="Marek" last="Trn N">Marek Trn N</name>
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<author><name sortKey="Davies, Andrew" sort="Davies, Andrew" uniqKey="Davies A" first="Andrew" last="Davies">Andrew Davies</name>
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<author><name sortKey="Rule, Simon" sort="Rule, Simon" uniqKey="Rule S" first="Simon" last="Rule">Simon Rule</name>
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<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Haematology, Derriford Hospital, Plymouth</wicri:regionArea>
<wicri:noRegion>Plymouth</wicri:noRegion>
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<author><name sortKey="Linton, Kim M" sort="Linton, Kim M" uniqKey="Linton K" first="Kim M" last="Linton">Kim M. Linton</name>
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<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Division of Molecular and Clinical Cancer Sciences, The Christie Foundation Trust, Manchester</wicri:regionArea>
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<author><name sortKey="Wagner Johnston, Nina" sort="Wagner Johnston, Nina" uniqKey="Wagner Johnston N" first="Nina" last="Wagner-Johnston">Nina Wagner-Johnston</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Missouri (État)</region>
</placeName>
<wicri:cityArea>Division of Oncology, Washington University School of Medicine, St. Louis</wicri:cityArea>
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</author>
<author><name sortKey="Gascoyne, Randy D" sort="Gascoyne, Randy D" uniqKey="Gascoyne R" first="Randy D" last="Gascoyne">Randy D. Gascoyne</name>
<affiliation wicri:level="1"><nlm:affiliation>Centre for Lymphoid Cancers, BC Cancer Agency, Vancouver, British Columbia, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Centre for Lymphoid Cancers, BC Cancer Agency, Vancouver, British Columbia</wicri:regionArea>
<wicri:noRegion>British Columbia</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Slack, Graham W" sort="Slack, Graham W" uniqKey="Slack G" first="Graham W" last="Slack">Graham W. Slack</name>
<affiliation wicri:level="1"><nlm:affiliation>Centre for Lymphoid Cancers, BC Cancer Agency, Vancouver, British Columbia, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Centre for Lymphoid Cancers, BC Cancer Agency, Vancouver, British Columbia</wicri:regionArea>
<wicri:noRegion>British Columbia</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Brousset, Pierre" sort="Brousset, Pierre" uniqKey="Brousset P" first="Pierre" last="Brousset">Pierre Brousset</name>
<affiliation wicri:level="3"><nlm:affiliation>Laboratoire D'Anatomie Pathologique, Centre Hospitalier Universitaire Purpan, Toulouse, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Laboratoire D'Anatomie Pathologique, Centre Hospitalier Universitaire Purpan, Toulouse</wicri:regionArea>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Midi-Pyrénées</region>
<settlement type="city">Toulouse</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Eberhard, David A" sort="Eberhard, David A" uniqKey="Eberhard D" first="David A" last="Eberhard">David A. Eberhard</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Pathology/Laboratory Medicine and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Department of Pathology/Laboratory Medicine and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Hernandez Ilizaliturri, Francisco J" sort="Hernandez Ilizaliturri, Francisco J" uniqKey="Hernandez Ilizaliturri F" first="Francisco J" last="Hernandez-Ilizaliturri">Francisco J. Hernandez-Ilizaliturri</name>
<affiliation wicri:level="2"><nlm:affiliation>Roswell Park Cancer Institute, Buffalo, New York.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
<wicri:cityArea>Roswell Park Cancer Institute, Buffalo</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Salles, Gilles" sort="Salles, Gilles" uniqKey="Salles G" first="Gilles" last="Salles">Gilles Salles</name>
<affiliation wicri:level="1"><nlm:affiliation>Hematology Department, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Benite, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Hematology Department, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Benite</wicri:regionArea>
<wicri:noRegion>Pierre-Benite</wicri:noRegion>
<wicri:noRegion>Pierre-Benite</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Witzig, Thomas E" sort="Witzig, Thomas E" uniqKey="Witzig T" first="Thomas E" last="Witzig">Thomas E. Witzig</name>
<affiliation wicri:level="2"><nlm:affiliation>Departments of Laboratory Medicine and Pathology and Hematology, Mayo Clinic, Rochester, Minnesota.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Departments of Laboratory Medicine and Pathology and Hematology, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Zinzani, Pier Luigi" sort="Zinzani, Pier Luigi" uniqKey="Zinzani P" first="Pier Luigi" last="Zinzani">Pier Luigi Zinzani</name>
<affiliation wicri:level="1"><nlm:affiliation>Institute of Hematology and Medical Oncology, University of Bologna, Bologna, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Institute of Hematology and Medical Oncology, University of Bologna, Bologna</wicri:regionArea>
<wicri:noRegion>Bologna</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wright, George W" sort="Wright, George W" uniqKey="Wright G" first="George W" last="Wright">George W. Wright</name>
<affiliation wicri:level="2"><nlm:affiliation>Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Staudt, Louis M" sort="Staudt, Louis M" uniqKey="Staudt L" first="Louis M" last="Staudt">Louis M. Staudt</name>
<affiliation wicri:level="2"><nlm:affiliation>Lymphoid Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Lymphoid Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Yang, Yandan" sort="Yang, Yandan" uniqKey="Yang Y" first="Yandan" last="Yang">Yandan Yang</name>
<affiliation wicri:level="2"><nlm:affiliation>Lymphoid Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Lymphoid Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Williams, P Mickey" sort="Williams, P Mickey" uniqKey="Williams P" first="P Mickey" last="Williams">P Mickey Williams</name>
<affiliation wicri:level="2"><nlm:affiliation>Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, National Cancer Institute, National Institutes of Health, Frederick, Maryland.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, National Cancer Institute, National Institutes of Health, Frederick</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Lih, Chih Jian" sort="Lih, Chih Jian" uniqKey="Lih C" first="Chih-Jian" last="Lih">Chih-Jian Lih</name>
<affiliation wicri:level="2"><nlm:affiliation>Molecular Characterization and Clinical Assay Development Laboratory, Leidos Biomedical Research Inc. and Frederick National Laboratory for Cancer Research, Frederick, Maryland.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Molecular Characterization and Clinical Assay Development Laboratory, Leidos Biomedical Research Inc. and Frederick National Laboratory for Cancer Research, Frederick</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Russo, Jacqueline" sort="Russo, Jacqueline" uniqKey="Russo J" first="Jacqueline" last="Russo">Jacqueline Russo</name>
<affiliation wicri:level="2"><nlm:affiliation>Celgene Corporation, Summit, New Jersey.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Celgene Corporation, Summit</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Thakurta, Anjan" sort="Thakurta, Anjan" uniqKey="Thakurta A" first="Anjan" last="Thakurta">Anjan Thakurta</name>
<affiliation wicri:level="2"><nlm:affiliation>Celgene Corporation, Summit, New Jersey.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Celgene Corporation, Summit</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Hagner, Patrick" sort="Hagner, Patrick" uniqKey="Hagner P" first="Patrick" last="Hagner">Patrick Hagner</name>
<affiliation wicri:level="2"><nlm:affiliation>Celgene Corporation, Summit, New Jersey.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Celgene Corporation, Summit</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Fustier, Pierre" sort="Fustier, Pierre" uniqKey="Fustier P" first="Pierre" last="Fustier">Pierre Fustier</name>
<affiliation wicri:level="1"><nlm:affiliation>Celgene Corporation, Boudry, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Celgene Corporation, Boudry</wicri:regionArea>
<wicri:noRegion>Boudry</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Song, Dale" sort="Song, Dale" uniqKey="Song D" first="Dale" last="Song">Dale Song</name>
<affiliation wicri:level="2"><nlm:affiliation>Celgene Corporation, Summit, New Jersey.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Jersey</region>
</placeName>
<wicri:cityArea>Celgene Corporation, Summit</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Lewis, Ian D" sort="Lewis, Ian D" uniqKey="Lewis I" first="Ian D" last="Lewis">Ian D. Lewis</name>
<affiliation wicri:level="1"><nlm:affiliation>Divison of Haematology, Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Divison of Haematology, Royal Adelaide Hospital and University of Adelaide, Adelaide</wicri:regionArea>
<wicri:noRegion>Adelaide</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j">Clinical cancer research : an official journal of the American Association for Cancer Research</title>
<idno type="ISSN">1078-0432</idno>
<imprint><date when="2017" type="published">2017</date>
</imprint>
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<front><div type="abstract" xml:lang="en">Purpose: Randomized, multicenter, open-label, phase 2/3 trial investigating lenalidomide versus investigator's choice (IC) in relapsed/refractory diffuse large B-cell lymphoma (DLBCL).Experimental Design: Patients with DLBCL who received ≥2 prior therapies were stratified by DLBCL subtype [germinal center B-cell (GCB) vs. non-GCB; determined by immunohistochemistry (IHC)] and then randomized 1:1 to lenalidomide (25 mg/day, 21 days of 28-day cycle) or IC (gemcitabine, rituximab, etoposide, or oxaliplatin). Crossover to lenalidomide was permitted for IC-treated patients with radiologically confirmed progressive disease. The primary endpoint was overall response rate (ORR). Progression-free survival (PFS), overall survival, and subtype analysis [GCB vs. activated B-cell (ABC)] using gene expression profiling (GEP) were exploratory endpoints.Results: Stage 1: 102 DLBCL patients (by IHC: non-GCB, n = 54; GCB, n = 48) received ≥1 dose of lenalidomide or IC. Hematologic treatment-emergent adverse events with lenalidomide versus IC included neutropenia (42.6%; 36.4%), anemia (33.3%; 47.3%), thrombocytopenia (24.1%; 43.6%), and leukopenia (5.6%; 12.7%), respectively. Overall, lenalidomide-treated patients had an ORR of 27.5% versus 11.8% in IC (ORRs were similar regardless of IHC-defined DLBCL subtype). Median PFS was increased in patients receiving lenalidomide (13.6 weeks) versus IC (7.9 weeks; P = 0.041), with greater improvements in non-GCB patients (15.1 vs. 7.1 weeks, respectively; P = 0.021) compared with GCB (10.1 vs. 9.0 weeks, respectively; P = 0.550).Conclusions: The clinical benefit of lenalidomide monotherapy in DLBCL patients was more evident in the non-GCB subtype. Exploratory analyses suggest that this preferential benefit was more pronounced in the GEP-defined ABC population, demonstrating a need for additional studies of lenalidomide in DLBCL using GEP subtyping. Clin Cancer Res; 23(15); 4127-37. ©2017 AACR.</div>
</front>
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