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Supplementary Table from 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

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posted on 2023-03-31, 23:48 authored by Natalia Palazón-Carrión, Alejandro Martín García-Sancho, Esteban Nogales-Fernández, Carlos Jiménez-Cortegana, Fernando Carnicero-González, Eduardo Ríos-Herranz, Fátima de la Cruz-Vicente, Guillermo Rodríguez-García, Rubén Fernández-Álvarez, Natividad Martínez-Banaclocha, Josep Gumà-Padrò, José Gómez-Codina, Antonio Salar-Silvestre, Delvys Rodríguez-Abreu, Laura Gálvez-Carvajal, Jorge Labrador, María Guirado-Risueño, Daniel J. García-Domínguez, Lourdes Hontecillas-Prieto, Pablo Espejo-García, Isabel Fernández-Román, Mariano Provencio-Pulla, Margarita Sánchez-Beato, Marta Navarro, Lejeune Marylene, Tomás Álvaro-Naranjo, Maria Casanova-Espinosa, Victor Sánchez-Margalet, Antonio Rueda-Domínguez, Luis de la Cruz-Merino
Supplementary Table from 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

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ISCIII

FEDER

Consejería de Salud y Familias

Junta de Andalucía

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ARTICLE 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.

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