Real-world data in clinical practice are needed to confirm the efficacy and safety that ibrutinib has demonstrated in clinical trials of patients with chronic lymphocytic leukemia (CLL). We described the real-world persistence rate, patterns of use, and clinical outcomes in 309 patients with CLL receiving single-agent ibrutinib in first line (1L,n= 118), 2L (n= 127) and ≥3L (n= 64) in the prospective, real-world, Italian EVIdeNCE study. After a median follow-up of 23.9 months, 29.8% of patients discontinued ibrutinib (1L: 24.6%, 2L: 29.9%, ≥3L: 39.1%), mainly owing to adverse events (AEs)/toxicity (14.2%). The most common AEs leading to discontinuation were infections (1L, ≥3L) and cardiac events (2L). The 2-year retention rate was 70.2% in the whole cohort (1L: 75.4%, 2L: 70.1%, ≥3L: 60.9%). The 2-year PFS and OS were, respectively, 85.4% and 91.7% in 1L, 80.0% and 86.2% in 2L, and 70.1% and 80.0% in ≥3L. Cardiovascular conditions did not impact patients’ clinical outcomes. The most common AEs were infections (30.7%), bleeding (12.9%), fatigue (10.0%), and neutropenia (9.7%), while grade 3–4 atrial fibrillation occurred in 3.9% of patients. No new safety signals were detected. These results strongly support ibrutinib as a valuable treatment option for CLL.
为确认依鲁替尼在慢性淋巴细胞白血病（CLL）临床试验中展现的疗效与安全性，需在临床实践中获取真实世界数据。本研究基于意大利前瞻性真实世界研究EVIdeNCE，描述了309例接受单药依鲁替尼治疗的CLL患者的实际持续用药率、用药模式及临床结局，其中一线治疗（1L）118例、二线治疗（2L）127例、三线及以上治疗（≥3L）64例。中位随访23.9个月后，29.8%的患者停用依鲁替尼（1L：24.6%，2L：29.9%，≥3L：39.1%），主要原因为不良事件/毒性反应（14.2%）。导致停药的最常见不良事件为感染（1L及≥3L组）和心脏事件（2L组）。全队列2年药物保留率为70.2%（1L：75.4%，2L：70.1%，≥3L：60.9%）。2年无进展生存率与总生存率分别为：1L组85.4%与91.7%，2L组80.0%与86.2%，≥3L组70.1%与80.0%。心血管基础疾病未影响患者临床结局。最常见不良事件包括感染（30.7%）、出血（12.9%）、乏力（10.0%）和中性粒细胞减少（9.7%），3-4级心房颤动发生率为3.9%。未发现新的安全性信号。这些结果有力支持依鲁替尼作为CLL的重要治疗选择。
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