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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
MS. Czuczman, M. Trněný, A. Davies, S. Rule, KM. Linton, N. Wagner-Johnston, RD. Gascoyne, GW. Slack, P. Brousset, DA. Eberhard, FJ. Hernandez-Ilizaliturri, G. Salles, TE. Witzig, PL. Zinzani, GW. Wright, LM. Staudt, Y. Yang, PM. Williams, CJ....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze II, klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie
NLK
Free Medical Journals
od 1995 do Před 1 rokem
Freely Accessible Science Journals
od 1995
Open Access Digital Library
od 1995-01-01
Open Access Digital Library
od 1995-01-01
- MeSH
- deoxycytidin aplikace a dávkování analogy a deriváty MeSH
- difúzní velkobuněčný B-lymfom farmakoterapie patologie MeSH
- dospělí MeSH
- etoposid aplikace a dávkování MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- organoplatinové sloučeniny aplikace a dávkování MeSH
- přežití po terapii bez příznaků nemoci MeSH
- prognóza * MeSH
- proporcionální rizikové modely MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování škodlivé účinky MeSH
- rituximab aplikace a dávkování MeSH
- senioři MeSH
- thalidomid aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
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.
Cancer Sciences Unit Faculty of Medicine University of Southampton Southampton United Kingdom
Celgene Corporation Boudry Switzerland
Celgene Corporation Summit New Jersey
Centre for Lymphoid Cancers BC Cancer Agency Vancouver British Columbia Canada
Department of Haematology Derriford Hospital Plymouth United Kingdom
Department of Hematology Charles University Hospital Prague Czech Republic
Departments of Laboratory Medicine and Pathology and Hematology Mayo Clinic Rochester Minnesota
Division of Oncology Washington University School of Medicine St Louis Missouri
Divison of Haematology Royal Adelaide Hospital and University of Adelaide Adelaide Australia
Hematology Department Hospices Civils de Lyon Centre Hospitalier Lyon Sud Pierre Benite France
Institute of Hematology and Medical Oncology University of Bologna Bologna Italy
Laboratoire D'Anatomie Pathologique Centre Hospitalier Universitaire Purpan Toulouse France
Citace poskytuje Crossref.org
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