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5PSQ-038 Real-world safety of ibrutinib in clinical practice in patients with chronic lymphocytic leukaemia
  1. M Valera Rubio,
  2. J Cordero-Ramos,
  3. L Moñino Domínguez,
  4. A Aguado-Paredes
  1. Hospital Universitario Virgen Macarena, Hospital Pharmacy, Sevilla, Spain


Background and Importance Ibrutinib was well-tolerated in clinical trials. However, there is limited data on the safety of Ibrutinib-treated patients with chronic lymphocytic leukaemia (CLL) in routine clinical practice.

Aim and Objectives To describe the safety of ibrutinib in CLL patients in a real-world setting.

Material and Methods Retrospective study in a third-level hospital. All CLL patients treated with ibrutinib (July 2016 to June 2022) were included. Collected variables: age, sex, mutations, Binet stage at baseline, B symptoms at baseline, baseline ECOG, comorbidities, line of therapy, starting dose, discontinuation of treatment and reason. Presence of high-risk cytogenetics was determined: 17p deletion, TP53 mutation, 11q deletion, immunoglobulin heavy chain mutational status (IGHV). Safety variables: adverse events observed and their severity according to Common Terminology Criteria for Adverse Events v.5.0. Information was taken from medical records and the Outpatient Dispensing software. SPSS® was used for data analysis.

Results 47 patients were included, 68% male, mean(±SD) age of 69.2±11 years. 91.5% were >50 years old. 19.2% patients had TP53 alteration, 59.5% unmutated IGHV, 8.5% 11q deletion, and 8.5% 17p deletion. Binet staging classification was: A (42.6%), B (19.1%), C (21.3%) and undetermined in 17%. 42.6% of patients had B symptoms at baseline. 51% of patients presented ECOG 1 at initiation and 40.4% presented ECOG 0. 61.7% of patients had two or more comorbidities: hypertension (63.8% patients), diabetes mellitus (19.15%), dyslipidaemia (19.2%) and atrial fibrillation (12.8%). 66% of patients started as a first-line treatment. All received doses of 420 mg and four had dose reductions due to toxicity and one due to intolerance. In terms of safety, 14.9% patients had to discontinue due to the occurrence of adverse reactions. 80.8% patients experienced G1-type adverse reactions, the most frequent being asthenia (39.5%), arthralgias (26.6%) and haematomas (21.5%). 34% of patients had G2 reactions, most frequently haemorrhages and anaemia (18.7%), neutropenia (15.5%) and atrial fibrillation (12.5%).10.6% patients had G3 reactions, these being pneumonitis, neutropenia, uveitis, rectorrhagia and a cardiovascular event. Median follow-up until progression was 55.8±3.8 months. Median PFS was not reached.

Conclusion and Relevance Overall, results are consistent with those reported in clinical trials and other real-world studies. In addition, no increased risk of serious adverse events was observed. Further follow-up is needed to confirm long-term safety.

Conflict of Interest No conflict of interest.

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