Real-world outcomes for 205 patients with chronic lymphocytic leukemia treated with ibrutinib

Kathrine Aarup*, Emelie Curovic Rotbain, Lisbeth Enggaard, Robert Schou Pedersen, Olav Jonas Bergmann, Rasmus Heje Thomsen, Mikael Frederiksen, Henrik Frederiksen, Tine Nielsen, Ilse Christiansen, Michael Asger Andersen, Carsten Utoft Niemann

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Abstrakt

Ibrutinib has now been approved for treatment of chronic lymphocytic leukemia (CLL) in both front-line setting and as later-line treatment. However, knowledge about the outcomes and adverse events (AE) among patients at a population-based level is still limited. Objectives: To report outcomes and AEs in a population-based cohort treated with ibrutinib outside clinical trials. Methods: We conducted a multicenter, retrospective cohort study including all patients with CLL treated with ibrutinib. Results: In total, 205 patients were included of whom 39 (19%) were treatment-naïve. The median follow-up was 21.4 months (interquartile range (IQR), 11.9,32.8), the estimated overall survival at 12 months was 88.8% (95% confidence interval (CI); 84.3%, 93.3%), and the estimated progression-free survival at 12 months was 86.3% (95% CI; 81.3%, 91.2%). During follow-up, 200 (97.6%) patients had at least one AE and 100 (48.8%) patients had at least one grade ≥3 AE. Eighty-six patients (42.0%) discontinued ibrutinib, hereof 47 (54.7%) due to AEs and 19 (22.1%) had progression of CLL or Richter transformation. Conclusions: In our study, we find comparable, though slightly inferior, overall, and progression-free survival, and discontinuation due to toxicity was higher compared with clinical trials. Patient training and information may improve treatment adherence outside clinical trials.

OriginalsprogEngelsk
TidsskriftEuropean journal of haematology
Vol/bind105
Udgave nummer5
Sider (fra-til)646-654
ISSN0902-4441
DOI
StatusUdgivet - 1. nov. 2020

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  • Citationsformater

    Aarup, K., Rotbain, E. C., Enggaard, L., Pedersen, R. S., Bergmann, O. J., Thomsen, R. H., Frederiksen, M., Frederiksen, H., Nielsen, T., Christiansen, I., Andersen, M. A., & Niemann, C. U. (2020). Real-world outcomes for 205 patients with chronic lymphocytic leukemia treated with ibrutinib. European journal of haematology, 105(5), 646-654. https://doi.org/10.1111/ejh.13499