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00925njm 22002777a 4500 dc Palazón-Carrión, Natalia author Martín García-Sancho, Alejandro author Nogales-Fernández, Esteban author Jiménez-Cortegana, Carlos author Carnicero-González, Fernando author Ríos-Herranz, Eduardo author de la Cruz-Vicente, Fátima author Rodríguez-García, Guillermo author Fernández-Álvarez, Rubén author Martínez-Banaclocha, Natividad author Gumà-Padrò, Josep author Gómez-Codina, José author Salar-Silvestre, Antonio author Rodríguez-Abreu, Delvys author Gálvez-Carvajal, Laura author Labrador, Jorge author Guirado-Risueño, María author García-Domínguez, Daniel J author Hontecillas-Prieto, Lourdes author Espejo-García, Pablo author Fernández-Román, Isabel author Provencio-Pulla, Mariano author Sánchez-Beato, Margarita author Navarro, Marta author Marylene, Lejeune author Álvaro-Naranjo, Tomás author Casanova-Espinosa, Maria author Sánchez-Margalet, Victor author Rueda-Domínguez, Antonio author de la Cruz-Merino, Luis author 2022 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. 10.1158/1078-0432.CCR-22-0588 1557-3265 Clinical cancer research : an official journal of the American Association for Cancer Research http://hdl.handle.net/10668/20187 35727601 http://hdl.handle.net/20.500.12105/18562 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.