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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Association for Cancer Research
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9433956/ https://www.ncbi.nlm.nih.gov/pubmed/35727601 http://dx.doi.org/10.1158/1078-0432.CCR-22-0588 |
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author | Palazón-Carrión, Natalia Martín García-Sancho, Alejandro Nogales-Fernández, Esteban Jiménez-Cortegana, Carlos Carnicero-González, Fernando Ríos-Herranz, Eduardo de la Cruz-Vicente, Fátima Rodríguez-García, Guillermo Fernández-Álvarez, Rubén Martínez-Banaclocha, Natividad Gumà-Padrò, Josep Gómez-Codina, José Salar-Silvestre, Antonio Rodríguez-Abreu, Delvys Gálvez-Carvajal, Laura Labrador, Jorge Guirado-Risueño, María García-Domínguez, Daniel J. Hontecillas-Prieto, Lourdes Espejo-García, Pablo Fernández-Román, Isabel Provencio-Pulla, Mariano Sánchez-Beato, Margarita Navarro, Marta Marylene, Lejeune Álvaro-Naranjo, Tomás Casanova-Espinosa, Maria Sánchez-Margalet, Victor Rueda-Domínguez, Antonio de la Cruz-Merino, Luis |
author_facet | Palazón-Carrión, Natalia Martín García-Sancho, Alejandro Nogales-Fernández, Esteban Jiménez-Cortegana, Carlos Carnicero-González, Fernando Ríos-Herranz, Eduardo de la Cruz-Vicente, Fátima Rodríguez-García, Guillermo Fernández-Álvarez, Rubén Martínez-Banaclocha, Natividad Gumà-Padrò, Josep Gómez-Codina, José Salar-Silvestre, Antonio Rodríguez-Abreu, Delvys Gálvez-Carvajal, Laura Labrador, Jorge Guirado-Risueño, María García-Domínguez, Daniel J. Hontecillas-Prieto, Lourdes Espejo-García, Pablo Fernández-Román, Isabel Provencio-Pulla, Mariano Sánchez-Beato, Margarita Navarro, Marta Marylene, Lejeune Álvaro-Naranjo, Tomás Casanova-Espinosa, Maria Sánchez-Margalet, Victor Rueda-Domínguez, Antonio de la Cruz-Merino, Luis |
author_sort | Palazón-Carrión, Natalia |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-9433956 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | American Association for Cancer Research |
record_format | MEDLINE/PubMed |
spelling | pubmed-94339562023-01-05 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 Palazón-Carrión, Natalia Martín García-Sancho, Alejandro Nogales-Fernández, Esteban Jiménez-Cortegana, Carlos Carnicero-González, Fernando Ríos-Herranz, Eduardo de la Cruz-Vicente, Fátima Rodríguez-García, Guillermo Fernández-Álvarez, Rubén Martínez-Banaclocha, Natividad Gumà-Padrò, Josep Gómez-Codina, José Salar-Silvestre, Antonio Rodríguez-Abreu, Delvys Gálvez-Carvajal, Laura Labrador, Jorge Guirado-Risueño, María García-Domínguez, Daniel J. Hontecillas-Prieto, Lourdes Espejo-García, Pablo Fernández-Román, Isabel Provencio-Pulla, Mariano Sánchez-Beato, Margarita Navarro, Marta Marylene, Lejeune Álvaro-Naranjo, Tomás Casanova-Espinosa, Maria Sánchez-Margalet, Victor Rueda-Domínguez, Antonio de la Cruz-Merino, Luis Clin Cancer Res Research Briefs: Clinical Trial Brief Reports 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. American Association for Cancer Research 2022-09-01 2022-06-21 /pmc/articles/PMC9433956/ /pubmed/35727601 http://dx.doi.org/10.1158/1078-0432.CCR-22-0588 Text en ©2022 The Authors; Published by the American Association for Cancer Research https://creativecommons.org/licenses/by-nc-nd/4.0/This open access article is distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) license. |
spellingShingle | Research Briefs: Clinical Trial Brief Reports Palazón-Carrión, Natalia Martín García-Sancho, Alejandro Nogales-Fernández, Esteban Jiménez-Cortegana, Carlos Carnicero-González, Fernando Ríos-Herranz, Eduardo de la Cruz-Vicente, Fátima Rodríguez-García, Guillermo Fernández-Álvarez, Rubén Martínez-Banaclocha, Natividad Gumà-Padrò, Josep Gómez-Codina, José Salar-Silvestre, Antonio Rodríguez-Abreu, Delvys Gálvez-Carvajal, Laura Labrador, Jorge Guirado-Risueño, María García-Domínguez, Daniel J. Hontecillas-Prieto, Lourdes Espejo-García, Pablo Fernández-Román, Isabel Provencio-Pulla, Mariano Sánchez-Beato, Margarita Navarro, Marta Marylene, Lejeune Álvaro-Naranjo, Tomás Casanova-Espinosa, Maria Sánchez-Margalet, Victor Rueda-Domínguez, Antonio de la Cruz-Merino, Luis 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 |
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_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_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 |
topic | Research Briefs: Clinical Trial Brief Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9433956/ https://www.ncbi.nlm.nih.gov/pubmed/35727601 http://dx.doi.org/10.1158/1078-0432.CCR-22-0588 |
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