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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.
Palazón-Carrión, Natalia; Martín García-Sancho, Alejandro; Nogales-Fernández, Esteban; Jiménez-Cortegana, Carlos; Carnicero-González, Fernando; Ríos-Herranz, Eduardo; de la Cruz-Vicente, Fátima; Rodríguez-García, Guillermo; Fernández-Álvarez, Rubén; Martínez-Banaclocha, Natividad; Gumà-Padrò, Josep; Gómez-Codina, José; Salar-Silvestre, Antonio; Rodríguez-Abreu, Delvys; Gálvez-Carvajal, Laura; Labrador, Jorge; Guirado-Risueño, María; García-Domínguez, Daniel J; Hontecillas-Prieto, Lourdes; Espejo-García, Pablo; Fernández-Román, Isabel; Provencio-Pulla, Mariano; Sánchez-Beato, Margarita; Navarro, Marta; Marylene, Lejeune; Álvaro-Naranjo, Tomás; Casanova-Espinosa, Maria; Sánchez-Margalet, Victor; Rueda-Domínguez, Antonio; de la Cruz-Merino, Luis.
Afiliación
  • Palazón-Carrión N; Department of Clinical Oncology, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
  • Martín García-Sancho A; Department of Medicine, University of Seville, Seville, Spain.
  • Nogales-Fernández E; Department of Hematology, Hospital Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain.
  • Jiménez-Cortegana C; Department of Clinical Oncology, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
  • Carnicero-González F; Department of Medicine, University of Seville, Seville, Spain.
  • Ríos-Herranz E; Department of Medical Biochemistry and Molecular Biology and Immunology, Medical School, Hospital Universitario Virgen Macarena, Seville, Spain.
  • de la Cruz-Vicente F; Department of Hematology, Hospital San Pedro de Alcántara de Cáceres, Cáceres, Spain.
  • Rodríguez-García G; Department of Hematology, Hospital Universitario de Valme, Seville, Spain.
  • Fernández-Álvarez R; Department of Hematology, Hospital Universitario Virgen del Rocío, Seville, Spain.
  • Martínez-Banaclocha N; Department of Hematology, Hospital Universitario Virgen del Rocío, Seville, Spain.
  • Gumà-Padrò J; Department of Hematology, Cabueñes Hospital, Gijón, Spain.
  • Gómez-Codina J; Department of Clinical Oncology, Hospital General Universitario de Alicante, Alicante, Spain.
  • Salar-Silvestre A; Department of Clinical Oncology, Hospital Universitari Sant Joan de Reus URV, IISPV, Reus, Spain.
  • Rodríguez-Abreu D; Department of Clinical Oncology, Hospital Universitario La Fé, Valencia, Spain.
  • Gálvez-Carvajal L; Department of Hematology, Hospital del Mar, Barcelona, Spain.
  • Labrador J; Department of Clinical Oncology, Hospital Universitario Insular, Las Palmas de Gran Canaria, Spain.
  • Guirado-Risueño M; Department of Medical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, IBIMA, Málaga, Spain.
  • García-Domínguez DJ; Department of Hematology, Research Unit, Hospital Universitario de Burgos, Burgos, Spain.
  • Hontecillas-Prieto L; Department of Clinical Oncology, Hospital General Universitario de Elche, Elche, Spain.
  • Espejo-García P; Department of Clinical Oncology, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
  • Fernández-Román I; Department of Medicine, University of Seville, Seville, Spain.
  • Provencio-Pulla M; Department of Medical Biochemistry and Molecular Biology and Immunology, Medical School, Hospital Universitario Virgen Macarena, Seville, Spain.
  • Sánchez-Beato M; Department of Clinical Oncology, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
  • Navarro M; Department of Medicine, University of Seville, Seville, Spain.
  • Marylene L; Department of Medical Biochemistry and Molecular Biology and Immunology, Medical School, Hospital Universitario Virgen Macarena, Seville, Spain.
  • Álvaro-Naranjo T; Department of Clinical Oncology, Hospital Universitario Virgen Macarena, University of Seville, Seville, Spain.
  • Casanova-Espinosa M; Department of Medicine, University of Seville, Seville, Spain.
  • Sánchez-Margalet V; Department of Hematology, Hospital Universitario Virgen Macarena, Seville, Spain.
  • Rueda-Domínguez A; Department of Medical Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, Facultad de Medicina, Universidad Autónoma de Madrid, IDIPHISA, Madrid, Spain.
  • de la Cruz-Merino L; Department of Medical Oncology, Lymphoma Research Group, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHISA, CIBERONC, Madrid, Spain.
Clin Cancer Res ; 28(17): 3658-3668, 2022 09 01.
Article en En | MEDLINE | ID: mdl-35727601
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Linfoma no Hodgkin / Linfoma de Células B Grandes Difuso Límite: Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article País de afiliación: España Pais de publicación: Estados Unidos
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Linfoma no Hodgkin / Linfoma de Células B Grandes Difuso Límite: Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article País de afiliación: España Pais de publicación: Estados Unidos