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Patients were included according to the French marketing authorization in 2016 (i.e. patients with relapsed or refractory CLL or to previously untreated CLL patients with deletion 17p and\/or tumor protein p53 mutations unsuitable for chemoimmunotherapy) and could have initiated ibrutinib more than 30\u00a0days prior their enrolment in the study (i.e. retrospective patients) or between 30\u00a0days before and 14\u00a0days after their enrolment (i.e. prospective patients). The results showed that in the effectiveness population (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u2009388), the median progression-free survival (PFS) was 53.1 (95% CI: 44.5\u201360.5) months for retrospective patients and 52.9 (95% CI: 40.3\u201360.6) months for prospective patients and no difference was shown between the PFS of patients who had at least one dose reduction versus the PFS of patients without dose reduction (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.7971 for retrospective and\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.3163 for prospective patients). For both retrospective and prospective patients, the median overall survival was not reached. The most frequent treatment-emergent adverse event of interest was infections (57.6% retrospective; 71.4% prospective). A total of 14.6% of the retrospective patients and 22.4% of the prospective patients had an adverse event leading to death. Our findings on effectiveness were consistent with other studies and the fact that patients with dose reductions had similar PFS than patients without dose reduction is reassuring. No additional safety concerns than those already mentioned in previous studies could be noticed.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial registration\u00a0<\/jats:bold>\n                    ClinicalTrials.gov, NCT03425591. Registered 1 February 2018 \u2013 Retrospectively registered.\n                  <\/jats:p>","DOI":"10.1007\/s00277-024-05666-3","type":"journal-article","created":{"date-parts":[[2024,3,5]],"date-time":"2024-03-05T23:35:04Z","timestamp":1709681704000},"page":"1079-1093","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Final results on effectiveness and safety of Ibrutinib in patients with chronic lymphocytic leukemia from the non-interventional FIRE 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However, the study was conducted in accordance with the principles stated in the Declaration of Helsinki and an Informed Consent Form was obtained from all patients prior their participation in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"CD has received honoraria from Abbvie, AstraZeneca, Beigene, Janssen and Lilly. AQ has received honoraria from Abbvie, AstraZeneca, Beigene and Janssen. LY has received honoraria from Abbvie, AstraZeneca, Beigene, BMS\/Celgene, Gilead\/Kite, Janssen and Roche. MSD has received honoraria from Abbvie, Astra Zeneca, Beigene and Janssen. KLD has received honoraria from Janssen, Abbvie, AstraZeneca, Roche, Incyte and Takeda. ET has received honoraria from Abbvie, AstraZeneca, Beigene and Janssen. PF has received honoraria from Abbvie, Amgen, AstraZeneca, Beigene, Gilead, Janssen and LoxoLilly. VL has received honoraria from Abbvie, Astra Zeneca, Amgen, MSD, Janssen, Beigene and Lilly. SD is an employee of Janssen and reports stock ownership of Johnson & Johnson. MD is an employee of Janssen. BA, BS, ST, HO, LV, SG, and JVM have nothing to declare.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}