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/s||Palazón Carrión, Natalia
Martín García-Sancho, Alejandro
Jiménez Cortegana, Carlos
Ríos Herranz, Eduardo
Sánchez Margalet, Víctor
Rueda Domínguez, Antonio
Cruz Merino, Luis de la
|Department||Universidad de Sevilla. Departamento de Bioquímica Médica y Biología Molecular e Inmunología
Universidad de Sevilla. Departamento de Medicina
|Abstract||Purpose: New therapeutic options are needed in relapsed/refrac tory diffuse large B-cell lymphoma (R/R DLBCL). Lenalidomide based schedules can reverse rituximab refractoriness in lymphoma.
Patients and Methods: In the ...
Purpose: New therapeutic options are needed in relapsed/refrac tory diffuse large B-cell lymphoma (R/R DLBCL). Lenalidomide based schedules can reverse rituximab refractoriness in lymphoma. Patients and Methods: 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 Reg ister number: EudraCT 2014-001620-29). Results: 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 neutro penia (14.1%). Complete responses were associated with a sharp decrease in circulating myeloid-derived suppressor cells and regulatory T cells. Conclusions: 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.
|Funding agencies||Junta de Andalucía
European Commission (EC). Fondo Europeo de Desarrollo Regional (FEDER)
|Citation||Palazón-Carrión, N., Martín García-Sancho, A., Nogales-Fernández, E., Jiménez Cortegana, C., Carnicero-González, F., Ríos Herranz, E.,...,Cruz Merino, L.d.l. (2022). 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. CLINICAL CANCER RESEARCH, 28 (17), 3658-3668. https://doi.org/10.1158/1078-0432.CCR-22-0588.|