Zucker School of Medicine at Hofstra/Northwell, Lake Success, NY and Mount Sinai Comprehensive Cancer Center, Miami, FL, USA.
Cancer Specialists of North Florida, Jacksonville, FL, USA.
Target Oncol. 2023 Sep;18(5):727-734. doi: 10.1007/s11523-023-00988-0. Epub 2023 Sep 20.
Despite recent approvals of lifesaving treatments for chronic lymphocytic leukemia (CLL), real-world data on the tolerability of the Bruton tyrosine kinase inhibitor ibrutinib for CLL treatment are lacking, especially in Black patients.
To expand upon a previously reported retrospective chart review of ibrutinib-treated patients with CLL to increase the number of sites and the enrollment period in first-line (1L) and relapsed/refractory (R/R) settings with a subanalysis based on ethnicity.
Adults with CLL who initiated ibrutinib treatment from five centers were followed for ≥ 6 months.
We identified 482 patients with CLL [405 White (153 1L, 252 R/R), 37 Black (17 1L, 20 R/R), 40 other/unidentified]. At baseline, 58.5% of all patients (68.8% of Black patients) had hypertension. At a median follow-up of 28.2 months, 31.1% of patients overall discontinued ibrutinib, 16.2% due to adverse events (12.2% 1L, 18.8% R/R). Overall, 46.0% of patients experienced ≥ 1 dose hold (40.2% 1L, 49.8% R/R), and 28.8% of patients experienced ≥ 1 dose reduction (24.9% 1L, 31.4% R/R). Among Black patients, ibrutinib was discontinued in 24.3% of patients (17.6% 1L, 30.0% R/R), 8.1% due to disease progression and 5.4% due to adverse events; 40.5% of patients experienced ≥ 1 dose hold (35.3% 1L, 45.0% R/R), and 32.4% of patients experienced ≥ 1 dose reduction (23.5% 1L, 40.0% R/R).
Toxicity and disease progression were the most common reasons for ibrutinib discontinuations in the overall population and among Black patients, respectively. Encouraging research participation of underrepresented patient groups will help clinicians better understand treatment outcomes.
尽管最近批准了治疗慢性淋巴细胞白血病 (CLL) 的救命疗法,但缺乏伊布替尼治疗 CLL 的耐受性的真实世界数据,尤其是在黑人患者中。
扩展之前报道的伊布替尼治疗 CLL 患者的回顾性图表审查,以增加一线(1L)和复发/难治性(R/R)环境中的站点数量和入组时间,并基于种族进行亚分析。
来自五个中心的开始接受伊布替尼治疗的 CLL 成年患者接受了至少 6 个月的随访。
我们确定了 482 例 CLL 患者[405 例白人(153 例 1L,252 例 R/R),37 例黑人(17 例 1L,20 例 R/R),40 例其他/未识别]。基线时,所有患者中有 58.5%(黑人患者中有 68.8%)患有高血压。在中位随访 28.2 个月时,总体上有 31.1%的患者停止了伊布替尼治疗,16.2%是由于不良反应(12.2% 1L,18.8% R/R)。总体而言,46.0%的患者经历了≥1 次剂量中断(40.2% 1L,49.8% R/R),28.8%的患者经历了≥1 次剂量减少(24.9% 1L,31.4% R/R)。在黑人患者中,24.3%的患者停止了伊布替尼治疗(17.6% 1L,30.0% R/R),8.1%是由于疾病进展,5.4%是由于不良反应;40.5%的患者经历了≥1 次剂量中断(35.3% 1L,45.0% R/R),32.4%的患者经历了≥1 次剂量减少(23.5% 1L,40.0% R/R)。
毒性和疾病进展分别是总体人群和黑人患者中伊布替尼停药的最常见原因。鼓励代表性不足的患者群体参与研究将有助于临床医生更好地了解治疗结果。