Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis

Palazon-Carrion, N; Garcia-Sancho, AM; Nogales-Fernandez, E; Jimenez-Cortegana, C; Carnicero-Gonzalez, F; Rios-Herranz, E; de la Cruz-Vicente, F; Rodriguez-Garcia, G; Fernandez-Alvarez, R; Martinez-Banaclocha, N; Guma-Padro, J; Gomez-Codina, J; Salar-Silvestre, A; Rodriguez-Abreu, D; Galvez-Carvajal, L; Labrador, J; Guirado-Risueno, M; Garcia-Dominguez, DJ; Hontecillas-Prieto, L; Espejo-Garcia, P; Fernandez-Roman, I; Provencio-Pulla, M; Sanchez-Beato, M; Navarro, M; Marylene, L; Alvaro-Naranjo, T; Casanova-Espinosa, M; Sanchez-Margalet, V; Rueda-Dominguez, A; de la Cruz-Merino, L

Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis

Purpose: New therapeutic options are needed in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Lenalidomide-based schedules can reverse rituximab refractoriness in lymphoma. Patients and Methods: In the phase II R2-GDP trial, 78 patients unsuitable for autologous stem cell transplant...

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Autores:	Palazon-Carrion, N, Garcia-Sancho, AM, Nogales-Fernandez, E, Jimenez-Cortegana, C, Carnicero-Gonzalez, F, Rios-Herranz, E, de la Cruz-Vicente, F, Rodriguez-Garcia, G, Fernandez-Alvarez, R, Martinez-Banaclocha, N, Guma-Padro, J, Gomez-Codina, J, Salar-Silvestre, A, Rodriguez-Abreu, D, Galvez-Carvajal, L, Labrador, J, Guirado-Risueno, M, Garcia-Dominguez, DJ, Hontecillas-Prieto, L, Espejo-Garcia, P, Fernandez-Roman, I, Provencio-Pulla, M, Sanchez-Beato, M, Navarro, M, Marylene, L, Alvaro-Naranjo, T, Casanova-Espinosa, M, Sanchez-Margalet, V, Rueda-Dominguez, A, de la Cruz-Merino, L
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2022
País:	España
Institución:	Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:	r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:	oai:fisabio.fundanetsuite.com:p14890
Acceso en línea:	https://fisabio.portalinvestigacion.com/publicaciones/14890
Access Level:	acceso abierto

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spelling	Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker SubanalysisPalazon-Carrion, NGarcia-Sancho, AMNogales-Fernandez, EJimenez-Cortegana, CCarnicero-Gonzalez, FRios-Herranz, Ede la Cruz-Vicente, FRodriguez-Garcia, GFernandez-Alvarez, RMartinez-Banaclocha, NGuma-Padro, JGomez-Codina, JSalar-Silvestre, ARodriguez-Abreu, DGalvez-Carvajal, LLabrador, JGuirado-Risueno, MGarcia-Dominguez, DJHontecillas-Prieto, LEspejo-Garcia, PFernandez-Roman, IProvencio-Pulla, MSanchez-Beato, MNavarro, MMarylene, LAlvaro-Naranjo, TCasanova-Espinosa, MSanchez-Margalet, VRueda-Dominguez, Ade la Cruz-Merino, LPurpose: New therapeutic options are needed in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Lenalidomide-based schedules can reverse rituximab refractoriness in lymphoma. Patients and Methods: In the phase II R2-GDP trial, 78 patients unsuitable for autologous stem cell transplant received treatment with the following schedule: lenalidomide 10 mg Days (D)1-14, rituximab 375 mg/m(2) D1, cisplatin 60 mg/m(2) D1, gemcitabine 750 mg/m(2) D1 and D8, and dexamethasone 20 mg D1-3, up to 6 cycles (induction phase), followed by lenalidomide 10 mg (or last lenalidomide dose received) D1-21 every 28 days (maintenance phase). Primary endpoint was overall response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and monitorization of key circulating immune biomarkers (EU Clinical Trials Register number: EudraCT 2014-001620-29). Results: After a median follow-up of 37 months, ORR was 60.2% [37.1% complete responses (CR) and 23.1% partial responses (PR)]. Median OS was 12 months (47 vs. 6 months in CR vs. no CR); median PFS was 9 months (34 vs. 5 months in CR vs. no CR). In the primary refractory population, ORR was 45.5% (21.2% CR and 24.3% PR). Most common grade 3-4 adverse events were thrombocytopenia (60.2%), neutropenia (60.2%), anemia (26.9%), infections (15.3%), and febrile neutropenia (14.1%). Complete responses were associated with a sharp decrease in circulating myeloid-derived suppressor cells and regulatory T cells. Conclusions: R2-GDP schedule is feasible and highly active in R/R DLBCL, including the primary refractory population. Immune biomarkers showed differences in responders versus progressors.AMER ASSOC CANCER RESEARCH2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/14890CLINICAL CANCER RESEARCHISSN: 10780432ISSNe: 15573265reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Consejo Superior de Investigaciones Científicas (CSIC)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p148902026-06-11T12:45:17Z
dc.title.none.fl_str_mv	Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis
title	Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis
spellingShingle	Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis Palazon-Carrion, N
title_short	Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis
title_full	Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis
title_fullStr	Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis
title_full_unstemmed	Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis
title_sort	Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis
dc.creator.none.fl_str_mv	Palazon-Carrion, N Garcia-Sancho, AM Nogales-Fernandez, E Jimenez-Cortegana, C Carnicero-Gonzalez, F Rios-Herranz, E de la Cruz-Vicente, F Rodriguez-Garcia, G Fernandez-Alvarez, R Martinez-Banaclocha, N Guma-Padro, J Gomez-Codina, J Salar-Silvestre, A Rodriguez-Abreu, D Galvez-Carvajal, L Labrador, J Guirado-Risueno, M Garcia-Dominguez, DJ Hontecillas-Prieto, L Espejo-Garcia, P Fernandez-Roman, I Provencio-Pulla, M Sanchez-Beato, M Navarro, M Marylene, L Alvaro-Naranjo, T Casanova-Espinosa, M Sanchez-Margalet, V Rueda-Dominguez, A de la Cruz-Merino, L
author	Palazon-Carrion, N
author_facet	Palazon-Carrion, N Garcia-Sancho, AM Nogales-Fernandez, E Jimenez-Cortegana, C Carnicero-Gonzalez, F Rios-Herranz, E de la Cruz-Vicente, F Rodriguez-Garcia, G Fernandez-Alvarez, R Martinez-Banaclocha, N Guma-Padro, J Gomez-Codina, J Salar-Silvestre, A Rodriguez-Abreu, D Galvez-Carvajal, L Labrador, J Guirado-Risueno, M Garcia-Dominguez, DJ Hontecillas-Prieto, L Espejo-Garcia, P Fernandez-Roman, I Provencio-Pulla, M Sanchez-Beato, M Navarro, M Marylene, L Alvaro-Naranjo, T Casanova-Espinosa, M Sanchez-Margalet, V Rueda-Dominguez, A de la Cruz-Merino, L
author_role	author
author2	Garcia-Sancho, AM Nogales-Fernandez, E Jimenez-Cortegana, C Carnicero-Gonzalez, F Rios-Herranz, E de la Cruz-Vicente, F Rodriguez-Garcia, G Fernandez-Alvarez, R Martinez-Banaclocha, N Guma-Padro, J Gomez-Codina, J Salar-Silvestre, A Rodriguez-Abreu, D Galvez-Carvajal, L Labrador, J Guirado-Risueno, M Garcia-Dominguez, DJ Hontecillas-Prieto, L Espejo-Garcia, P Fernandez-Roman, I Provencio-Pulla, M Sanchez-Beato, M Navarro, M Marylene, L Alvaro-Naranjo, T Casanova-Espinosa, M Sanchez-Margalet, V Rueda-Dominguez, A de la Cruz-Merino, L
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author author author author author
description	Purpose: New therapeutic options are needed in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Lenalidomide-based schedules can reverse rituximab refractoriness in lymphoma. Patients and Methods: In the phase II R2-GDP trial, 78 patients unsuitable for autologous stem cell transplant received treatment with the following schedule: lenalidomide 10 mg Days (D)1-14, rituximab 375 mg/m(2) D1, cisplatin 60 mg/m(2) D1, gemcitabine 750 mg/m(2) D1 and D8, and dexamethasone 20 mg D1-3, up to 6 cycles (induction phase), followed by lenalidomide 10 mg (or last lenalidomide dose received) D1-21 every 28 days (maintenance phase). Primary endpoint was overall response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and monitorization of key circulating immune biomarkers (EU Clinical Trials Register number: EudraCT 2014-001620-29). Results: After a median follow-up of 37 months, ORR was 60.2% [37.1% complete responses (CR) and 23.1% partial responses (PR)]. Median OS was 12 months (47 vs. 6 months in CR vs. no CR); median PFS was 9 months (34 vs. 5 months in CR vs. no CR). In the primary refractory population, ORR was 45.5% (21.2% CR and 24.3% PR). Most common grade 3-4 adverse events were thrombocytopenia (60.2%), neutropenia (60.2%), anemia (26.9%), infections (15.3%), and febrile neutropenia (14.1%). Complete responses were associated with a sharp decrease in circulating myeloid-derived suppressor cells and regulatory T cells. Conclusions: R2-GDP schedule is feasible and highly active in R/R DLBCL, including the primary refractory population. Immune biomarkers showed differences in responders versus progressors.
publishDate	2022
dc.date.none.fl_str_mv	2022
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://fisabio.portalinvestigacion.com/publicaciones/14890
url	https://fisabio.portalinvestigacion.com/publicaciones/14890
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.rights.none.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	AMER ASSOC CANCER RESEARCH
publisher.none.fl_str_mv	AMER ASSOC CANCER RESEARCH
dc.source.none.fl_str_mv	CLINICAL CANCER RESEARCH ISSN: 10780432 ISSNe: 15573265 reponame:r-FISABIO. Repositorio Institucional de Producción Científica instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str	Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str	r-FISABIO. Repositorio Institucional de Producción Científica
collection	r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score	15.812429

Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis

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