4.7 Article

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

Journal

CLINICAL CANCER RESEARCH
Volume 28, Issue 17, Pages 3658-3668

Publisher

AMER ASSOC CANCER RESEARCH
DOI: 10.1158/1078-0432.CCR-22-0588

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Funding

  1. ISCIII [PT20/00069]
  2. FEDER funds [PT20/00069]
  3. Spanish Lymphoma Oncology Group (GOTEL)
  4. Celgene (Investigator Initiated Trials Program)
  5. Consejeria de Salud y Familias, Junta de Andalucia [RH-0047-2021]

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The R2-GDP schedule demonstrates feasibility and high activity in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). The regimen is able to reverse refractoriness to rituximab and shows significant efficacy in the primary refractory population. Additionally, monitoring immune biomarkers showed differences between responders and progressors.
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/m(2) D1, cisplatin 60 mg/m(2) D1, gemcitabine 750 mg/m(2) 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.

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