Real World Data on the Efficacy and Safety of Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma. Data collected from the Colombian Hematology Centers
Fecha
2019-09Autor
Resumen
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Abstract
Context
Ibrutinib has shown an overall response (OR) about 68% in relapsed/refractory mantle cell lymphoma (R/R-MCL).
Objective
To determine the efficacy and safety of Ibrutinib in R/R-MCL in Colombia.
Design
Descriptive and retrospective analysis as a case series. Quantitative variables were comparable by U Mann-Whitney test. The survival analysis was made by the Kaplan–Meier method.
Setting
Data from thirteen centers in five cities in Colombia.
Patients
Patients older than 18 years old with a diagnosis of R/R-MCL after one line of treatment.
Interventions
Data were taken from the medical records of each center.
Main Outcomes Measures
To establish Ibrutinib OR in the real world, evaluating its safety.
Results
38 patients were included. 78% were men. Median of age was 68.5 years old, without difference among gender (p=0.28; Mann-Whitney). 86% were diagnosed in stage IV of Ann Arbor. The most frequent histologic variant was classic 42.1% and blastoid 21.1%. A High MIPI score was documented in 71% in whole population. The median of treatment lines before Ibrutinib (including HSCT) was 2 (range 1-5). At the Ibrutinib beginning, 63.2% of patients had extra-nodal involvement: bone marrow 33.3% and CNS 26.6% the most frequent. 71.1% of patients was treated with Ibrutinib as monotherapy, and 26.3% received in combination with Rituximab. Ibrutinib had a 50% of OR, (34.2% of CR, 15.8% of PR). Nevertheless, among blastoid variant group, there was 75% of failure. Median of OS was 16.4 months form the Ibrutinib beginning. The mean of months of treatment received was 11 (range 1-67). There were 21% of grade III-IV toxicities identified. The most frequent toxicity was hematologic with 42% from the whole toxicities. At the moment of the last contact, 52.6% of patients still continue therapy with Ibrutinib. Discontinuations were mainly due to progression. There were no withdrawals for toxicities.
Conclusions
Ibrutinib alone or in combination with rituximab is a safe and highly active therapy for R/R-MCL, even in heavily treated patients and CNS involvement. Nevertheless, poor responses are seen in blastoid variant. Toxicities have a low incidence and most of the cases were not severe.
Keywords
URI
http://repositorio.mederi.com.co/handle/123456789/502https://www.sciencedirect.com/science/article/pii/S2152265019310535
Colecciones
- Investigación clínica [389]