Articles producció científica> Medicina i Cirurgia

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

  • Identification data

    Identifier: imarina:9280994
    Authors:
    Palazón-Carrión NMartín García-Sancho ANogales-Fernández EJiménez-Cortegana CCarnicero-González FRíos-Herranz Ede la Cruz-Vicente FRodríguez-García GFernández-Álvarez RMartínez-Banaclocha NGumà-Padrò JGómez-Codina JSalar-Silvestre ARodríguez-Abreu DGálvez-Carvajal LLabrador JGuirado-Risueño MGarcía-Domínguez DJHontecillas-Prieto LEspejo-García PFernández-Román IProvencio-Pulla MSánchez-Beato MNavarro MMarylene LÁlvaro-Naranjo TCasanova-Espinosa MSánchez-Margalet VRueda-Domínguez Ade la Cruz-Merino L
    Abstract:
    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.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/m2 D1, cisplatin 60 mg/m2 D1, gemcitabine 750 mg/m2 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).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.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.©2022 The Authors; Published by the American Association for Cancer Research.
  • Others:

    Author, as appears in the article.: Palazón-Carrión N; Martín García-Sancho A; Nogales-Fernández E; Jiménez-Cortegana C; Carnicero-González F; Ríos-Herranz E; de la Cruz-Vicente F; Rodríguez-García G; Fernández-Álvarez R; Martínez-Banaclocha N; Gumà-Padrò J; Gómez-Codina J; Salar-Silvestre A; Rodríguez-Abreu D; Gálvez-Carvajal L; Labrador J; Guirado-Risueño M; García-Domínguez DJ; Hontecillas-Prieto L; Espejo-García P; Fernández-Román I; Provencio-Pulla M; Sánchez-Beato M; Navarro M; Marylene L; Álvaro-Naranjo T; Casanova-Espinosa M; Sánchez-Margalet V; Rueda-Domínguez A; de la Cruz-Merino L
    Department: Ciències Mèdiques Bàsiques Medicina i Cirurgia
    URV's Author/s: Gumà Padró, José / Lejeune, Marylène Marie
    Abstract: 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.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/m2 D1, cisplatin 60 mg/m2 D1, gemcitabine 750 mg/m2 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).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.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.©2022 The Authors; Published by the American Association for Cancer Research.
    Thematic Areas: Saúde coletiva Química Oncology Odontología Nutrição Medicine (all) Medicina iii Medicina ii Medicina i General medicine Ciências biológicas iii Ciências biológicas ii Ciências biológicas i Ciência da computação Cancer research Biotecnología
    licence for use: https://creativecommons.org/licenses/by/3.0/es/
    Author's mail: marylenemarie.lejeune@urv.cat jose.guma@urv.cat
    Author identifier: 0000-0001-8441-9404 0000-0001-7541-9832
    Record's date: 2024-09-07
    Papper version: info:eu-repo/semantics/publishedVersion
    Link to the original source: https://aacrjournals.org/clincancerres/article/28/17/3658/708080/Lenalidomide-plus-R-GDP-R2-GDP-in-Relapsed
    Licence document URL: https://repositori.urv.cat/ca/proteccio-de-dades/
    Papper original source: Clinical Cancer Research. 28 (17): 3658-3668
    APA: Palazón-Carrión N; Martín García-Sancho A; Nogales-Fernández E; Jiménez-Cortegana C; Carnicero-González F; Ríos-Herranz E; de la Cruz-Vicente F; Rodrí (2022). 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. Clinical Cancer Research, 28(17), 3658-3668. DOI: 10.1158/1078-0432.ccr-22-0588
    Article's DOI: 10.1158/1078-0432.ccr-22-0588
    Entity: Universitat Rovira i Virgili
    Journal publication year: 2022
    Publication Type: Journal Publications
  • Keywords:

    Cancer Research,Oncology
    Saúde coletiva
    Química
    Oncology
    Odontología
    Nutrição
    Medicine (all)
    Medicina iii
    Medicina ii
    Medicina i
    General medicine
    Ciências biológicas iii
    Ciências biológicas ii
    Ciências biológicas i
    Ciência da computação
    Cancer research
    Biotecnología
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