%0 Journal Article
%A Sancho, Juan-Manuel
%A Marin-Niebla, Ana
%A Fernandez, Silvia
%A Capote, Francisco-Javier
%A Cañigral, Carolina
%A Grande, Carlos
%A Donato, Eva
%A Zeberio, Izaskun
%A Puerta, Jose-Manuel
%A Rivas, Alfredo
%A Perez-Ceballos, Elena
%A Vale, Ana
%A Martin Garcia-Sancho, Alejandro
%A Salar, Antonio
%A Gonzalez-Barca, Eva
%A Teruel, Anabel
%A Pastoriza, Carmen
%A Conde-Royo, Diego
%A Sanchez-Garcia, Joaquin
%A Barrenetxea, Cristina
%A Arranz, Reyes
%A Hernandez-Rivas, Jose-Angel
%A Ramirez, Maria-Jose
%A Jimenez, Aroa
%A Rubio-Azpeitia, Eva
%T IBRORS-MCL study: a Spanish retrospective and observational study of relapsed/refractory mantle-cell lymphoma treated with ibrutinib in routine clinical practice.
%D 2022
%U http://hdl.handle.net/10668/21263
%X 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.
%K Clinical practice
%K Ibrutinib
%K Mantle-cell lymphoma
%K Real-world evidence
%K Relapsed/refractory
%K Área de Gestión Sanitaria de Jerez, Costa Noroeste y Sierra de Cádiz
%~