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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- dc.contributor.author Palazón-Carrión, Natalia
- dc.contributor.author Salar Silvestre, Antonio
- dc.contributor.author de la Cruz-Merino, L.
- dc.date.accessioned 2022-10-19T06:29:59Z
- dc.date.available 2022-10-19T06:29:59Z
- dc.date.issued 2022
- dc.description.abstract Purpose: 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. 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 Register 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 neutropenia (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.
- dc.format.mimetype application/pdf
- dc.identifier.citation Palazón-Carrión N, Martín García-Sancho A, Nogales-Fernández E, Jiménez-Cortegana C, Carnicero-González F, Ríos-Herranz E, et al. 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. Clin Cancer Res. 2022 Sep 1; 28(17): 3658-68. DOI: 10.1158/1078-0432.CCR-22-0588
- dc.identifier.doi http://dx.doi.org/10.1158/1078-0432.CCR-22-0588
- dc.identifier.issn 1078-0432
- dc.identifier.uri http://hdl.handle.net/10230/54477
- dc.language.iso eng
- dc.publisher American Association for Cancer Research (AACR)
- dc.rights This open access article is distributed under the Creative Commons AttributionNonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) license. https://creativecommons.org/licenses/by-nc-nd/4.0/. c2022 The Authors; Published by the American Association for Cancer Research
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
- dc.subject.other Limfomes
- dc.subject.other Marcadors bioquímics
- dc.subject.other Tumors -- Tractament
- dc.title 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
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion