RT Journal Article
T1 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.
A1 Palazón-Carrión, Natalia
A1 Martín García-Sancho, Alejandro
A1 Nogales-Fernández, Esteban
A1 Jiménez-Cortegana, Carlos
A1 Carnicero-González, Fernando
A1 Ríos-Herranz, Eduardo
A1 de la Cruz-Vicente, Fátima
A1 Rodríguez-García, Guillermo
A1 Fernández-Álvarez, Rubén
A1 Martínez-Banaclocha, Natividad
A1 Gumà-Padrò, Josep
A1 Gómez-Codina, José
A1 Salar-Silvestre, Antonio
A1 Rodríguez-Abreu, Delvys
A1 Gálvez-Carvajal, Laura
A1 Labrador, Jorge
A1 Guirado-Risueño, María
A1 García-Domínguez, Daniel J
A1 Hontecillas-Prieto, Lourdes
A1 Espejo-García, Pablo
A1 Fernández-Román, Isabel
A1 Provencio-Pulla, Mariano
A1 Sánchez-Beato, Margarita
A1 Navarro, Marta
A1 Marylene, Lejeune
A1 Álvaro-Naranjo, Tomás
A1 Casanova-Espinosa, Maria
A1 Sánchez-Margalet, Victor
A1 Rueda-Domínguez, Antonio
A1 de la Cruz-Merino, Luis
AB 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.
YR 2022
FD 2022
LK http://hdl.handle.net/10668/20187
UL http://hdl.handle.net/10668/20187
LA en
DS RISalud
RD Apr 6, 2025