Real World Data on the Efficacy and Safety of Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma. Data collected from the Colombian Hematology Centers

Patiño-Escobar, Bonell; Enciso-Olivera, Leonardo; Acon-Solano, Cristina; Hoz, Diana Otero-de la; Martínez-Cordero, Humberto; Spirko, Paola; León-Basantes, Guillermo; Abello, Virginia; Bohorquez, Leonardo; Arévalo-Zambrano, Mónica; Contreras, Karen; Molina, Luisana; Bermúdez, Carlos Daniel; Quintero, Guillermo; Sossa, Claudia; Salazar-Montaña, Luis; Peña-Castellanos, Angela; Figueroa, Jair; Osuna, Mónica; Guerrero, Paola; Perilla, Oliver; Omaña, Paola; Gálvez, Kenny; Fonseca, Jaiver

doi:10.1016/j.clml.2019.07.294

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“…Although its efficacy in R/R MCL patients in clinical trials is clearly documented [ 22 – 24 ], real-world data on unselected patients are still insufficient. Patiño-Escobar et al offered insight into the performance of ibrutinib in unselected patients [ 25 ]. However, the studied population was relatively small, and heterogeneous treatment regimens were applied.…”

Section: Introductionmentioning

confidence: 99%

Ibrutinib in mantle cell lymphoma: a real-world retrospective multi-center analysis of 77 patients treated in the Czech Republic

et al. 2022

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Ibrutinib revolutionized therapy for relapsed/refractory (R/R) mantle cell lymphoma (MCL). Real-world data on the outcome of unselected patients are still limited. We analyzed 77 R/R MCL patients receiving ibrutinib with at least one prior systemic anti-lymphoma therapy. After a median follow-up of 14.0 months, 56 patients relapsed/progressed, and 45 died. The overall response rate was 66%, with 31% of complete metabolic remissions on PET/CT. The median progression-free and overall survival (OS) rates were 10.3 and 23.1 months, respectively. The median OS from ibrutinib failure was 3.7 months. High proliferation rate by Ki67 (≥ 30%) and two or more previous therapy lines both negatively correlated with outcome (HR = 2.2, p = 0.04, and HR = 2.06, p = 0.08, respectively). Female gender borderline correlated with better outcome (HR = 0.53, p = 0.08). In multivariate analysis, Ki67 and response to ibrutinib both correlated with OS (p < 0.05). Importantly, ibrutinib appeared to better control nodal and extranodal lymphoma than bone marrow (BM) involvement. From 20 patients with detectable BM infiltration (before ibrutinib initiation) achieving complete (n = 13) or partial (n = 7) metabolic remission, none achieved remission in BM. We confirmed good efficacy of ibrutinib in unselected heavily pre-treated MCL patients. Our findings support the use of a combination of ibrutinib and rituximab in patients with BM involvement.

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Section: Introductionmentioning

confidence: 99%