8019 Background: Lenalidomide is an immunomodulatory drug that could reverse rituximab refractoriness in lymphoma patients (pts). We conducted an open label multicenter phase 2 trial testing the efficacy and toxicity of a combination of lenalidomide and rituximab (R2) plus GDP schedule (R2-GDP) in Relapsed/Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL) pts, not suitable for autologous stem cell transplant (ASCT). Methods: Patients with R/R DLBCL previously treated with at least 1 prior line of immunochemotherapy including rituximab, and not candidates for ASCT, were eligible. After a run-in phase period, treatment consisted of an induction phase with lenalidomide (LEN) 10 mg po d1-14, rituximab 375 mg/m2 iv d1, cisplatin 60 mg/m2 iv d1, gemcitabine 750 mg/m2 iv d1 and d8 and dexamethasone 20 mg d1-3, up to a maximum of 6 cycles. Pts without disease progression (DP) entered into a maintenance phase with LEN 10 mg, or last LEN dose received in the induction phase, d1-21 in cycles every 28 days. Primary endpoint was overall response rate (ORR) by investigator assessment. Secondary endpoints included disease free survival (DFS), event free survival (EFS), overall survival (OS), safety and response by cell of origin (COO), type of DLBCL (double-triple hit) and other microenvironment and genomic biomarkers. Results: 79 pts were enrolled between April 2015 and September 2018. Median age was 70 years (range 23-86), 48,7% women. 78 pts were considered for efficacy and safety in the intention to treat (ITT) analysis. With a median follow-up of 13 months at the time of cut-off (November 2019), ORRwas 59.0%, with 32.1% complete responses (CR) and 26.9% partial responses (PR). In the primary refractory population (n = 33), ORR was 45.5%, with 21.2% CR and 24.3% PR. There were no statistically significant differences in ORR with respect to COO. In Double-Hit R/R DLBCL (n = 16), ORR was 37.5% with 25% CR. Median OS was 12.0 months (6.9-17.0). Most common grade 3/4 (G3/4) adverse events were thrombocytopenia (60.2%), neutropenia (60.2%) and anemia (26.9%). Febrile neutropenia occurred in 14.1% pts. Most frequent non-hematologic G3/4 events were asthenia (19.2%), infection (15.3%) and renal insufficiency (6.4%). There were 4 toxic deaths related to the R2-GDP schedule. Conclusions: LEN with Rituximab and GDP (R2-GDP) is feasible and active in R/R DLBCL. Results in the primary refractory DLBCL population are particularly promising. Analysis of COO did not revealed differences in response rates. Immune biomarkers results will be showed at the meeting. Clinical trial information: EudraCT 2014-001620-29 .
Introducción: El riñón en herradura es la más común de las anomalías por fusión. Aparece en 1 de cada 400 nacimientos, el tumor de Wilms o Nefroblastoma es el segundo tumor abdominal más frecuente en la edad pediátrica y responde por más del 90 % de los tumores renales en pediatría. El TW es el primer ejemplo de cáncer en el que se alcanzaron significativas tasas de curación gracias a las terapias multimodales que incluyen quimioterapia, nefrectomía radical y radioterapia. Objetivo: Presentar el caso clínico de un paciente con diagnostico de Riñón en Herradura con presentación inusual de un Tumor de Wilms mediante Nefrectomía radical y quimioterapia pos operatoria mediante el protocolo NTWS 5. Métodos: El reporte de un paciente masculino de 10 años con Tumor de Wilms en un Riñón en Herradura, con revisión y comparación de los protocolos NTWS 5 y S.I.O.P. Resultado: Se logró realizar una Nefrectomía Radical con márgenes quirúrgicos libres de neoplasia sin encontrar metástasis a órganos vecinos. Se administra quimioterapia adyuvante durante 24 semanas con remisión completa de la enfermedad y adecuada función renal. Conclusiones: Los objetivos del tratamiento son lograr una curación completa con una baja toxicidad medicamentosa y conservar una adecuada función renal. La cirugía continúa siendo el pilar del tratamiento, la discusión está enfocada al uso de terapia neoadyuvante o adyuvante y cuáles deben ser los medicamentos y las dosis recomendadas. Todos los pacientes con TW deben recibir Quimioterapia Adyuvante. El uso de radioterapia es indispensable en la mayoría de los casos.
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