1. 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
- Author
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Universitat Rovira i Virgili, 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, Universitat Rovira i Virgili, and 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
- 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.
- Published
- 2022