%0 Journal Article
%A Palazon-Carrion, Natalia
%A Martin-Garcia-Sancho, Alejandro
%A Nogales-Fernandez, Esteban
%A Jimenez-Cortegana, Carlos
%A Carnicero-Gonzalez, Fernando
%A Rios-Herranz, Eduardo
%A de-la Cruz-Vicente, Fatima
%A Rodriguez-Garcia, Guillermo
%A Fernandez-Alvarez, Ruben
%A Martinez-Banaclocha, Natividad
%A Guma-Padro, Josep
%A Gomez-Codina, Jose
%A Salar-Silvestre, Antonio
%A Rodriguez-Abreu, Delvys
%A Galvez-Carvajal, Laura
%A Labrador, Jorge
%A Guirado-Risueño, Maria
%A Garcia-Dominguez, Daniel J
%A Hontecillas-Prieto, Lourdes
%A Espejo-Garcia, Pablo
%A Fernandez-Roman, Isabel
%A Provencio-Pulla, Mariano
%A Sanchez-Beato, Margarita
%A Navarro, Marta
%A Marylene, Lejeune
%A Alvaro-Naranjo, Tomas
%A Casanova-Espinosa, Maria
%A Sanchez-Margalet, Victor
%A Rueda-Dominguez, Antonio
%A de-la-Cruz-Merino, Luis
%T 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.
%D 2022
%U http://hdl.handle.net/10668/20187
%X 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.
%K Recurrence
%K Drug Resistance, Neoplasm
%K Drug Therapy, Combination
%K Progression-Free Survival
%K Overall Survival
%K Tumor Biomarkers
%K Adverse Events
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