医学
化学免疫疗法
回顾性队列研究
伊布替尼
不利影响
前瞻性队列研究
内科学
慢性淋巴细胞白血病
人口
外科
白血病
环境卫生
作者
Caroline Dartigeas,Anne Quinquenel,Loïc Ysebaert,Marie-Sarah Dilhuydy,Bruno Annibale,Borhane Slama,Katell Le Dû,Stéphanie Tardy,Emmanuelle Tchernonog,Hubert ORFEUVRE,Laurent Voillat,Stéphanie Guidez,Jean-Valère Malfuson,Sandrine Dupuis,Marine Deslandes,Pierre Feugier,Véronique Leblond
出处
期刊:Research Square - Research Square
日期:2024-01-03
标识
DOI:10.21203/rs.3.rs-3809070/v1
摘要
Abstract We conducted an observational study (FIRE) to understand the effectiveness and safety outcomes of ibrutinib in patients with chronic lymphocytic leukemia (CLL) in France, after a maximum follow-up of five years. Patients were included according to the French marketing authorization in 2016 (i.e. patients with relapsed or refractoryCLL or to previously untreated CLL patients with deletion 17p and/or TP53 mutations unsuitable for chemoimmunotherapy) and could have initiated ibrutinib more than 30 days prior their enrolment in the study (i.e. retrospective patients) or between 30 days before and 14 days after their enrolment (i.e. prospective patients). The results showed that in the effectiveness population (N=388), the median progression-free survival (PFS) was 53.1 (95% CI: 44.5-60.5) months for retrospective patients and 52.9 (95% CI: 40.3-60.6) 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 (p=0.7971 for retrospective and p=0.3163 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. Trial registration ClinicalTrials.gov, NCT03425591. Registered 1 February 2018 – Retrospectively registered.
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