IBRORS-MCL study: a Spanish retrospective and observational study of relapsed/refractory mantle-cell lymphoma treated with ibrutinib in routine clinical practice.

This retrospective study evaluated 66 patients diagnosed with relapsed and/or refractory mantle cell lymphoma (R/R MCL) treated with ibrutinib in Spain in routine clinical practice. At diagnosis, patients had a median age of 64.5 years, 63.6% presented with intermediate/high sMIPI (simplified progno...

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Detalles Bibliográficos
Autores: Sancho, Juan-Manuel, Marin-Niebla, Ana, Fernandez, Silvia, Capote, Francisco-Javier, Canigral, Carolina, Grande, Carlos, Donato, Eva, Zeberio, Izaskun, Puerta, Jose-Manuel, Rivas, Alfredo, Perez-Ceballos, Elena, Vale, Ana, Martin Garcia-Sancho, Alejandro, Salar, Antonio, Gonzalez-Barca, Eva, Teruel, Anabel, Pastoriza, Carmen, Conde-Royo, Diego, Sanchez-Garcia, Joaquin, Barrenetxea, Cristina, Arranz, Reyes, Hernandez-Rivas, Jose-Angel, Ramirez, Maria-Jose, Jimenez, Aroa, Rubio-Azpeitia, Eva
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p16579
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/16579
Access Level:acceso abierto
Palabra clave:Clinical practice
Ibrutinib
Mantle-cell lymphoma
Real-world evidence
Relapsed/refractory
Descripción
Sumario:This retrospective study evaluated 66 patients diagnosed with relapsed and/or refractory mantle cell lymphoma (R/R MCL) treated with ibrutinib in Spain in routine clinical practice. At diagnosis, patients had a median age of 64.5 years, 63.6% presented with intermediate/high sMIPI (simplified prognostic index for advanced-stage mantle cell lymphoma), 24.5% had the blastoid variant, and 55.6% had a Ki67 > 30%. Patients had received a median of 2 prior lines of therapy (range 1-2; min-max 1-7). Overall response rate was 63.5%, with 38.1% of patients achieving complete response (CR). With a median duration of ibrutinib exposure of 10.7 months (range 5.2-19.6; min-max 0.3-36), the median progression-free survival (PFS) and overall survival (OS) were 20 months [95% confidence interval (CI) 8.8-31.1] and 32 months (95% CI 22.6-41.3), respectively, and were not reached in patients achieving CR. No grade = 3 cardiovascular toxicity or bleeding was reported. This study supports that treatment with ibrutinib leads to high response rates and favorable survival outcomes in patients with R/R MCL.

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