a Department of Medicine , State University of New York at Buffalo , Buffalo , NY , USA.
b Department of Biostatistics and Bioinformatics , Roswell Park Comprehensive Cancer Center , Buffalo , NY , USA.
Leuk Lymphoma. 2019 Jul;60(7):1650-1655. doi: 10.1080/10428194.2018.1554862. Epub 2019 Jan 2.
Ibrutinib is a first-in-class small molecule inhibitor that has shown remarkable efficacy in the treatment of CLL. Current guidelines recommend lifelong administration at a fixed daily dose of 420 mg. Data from real-world studies indicate up to 17.5% of patients discontinue ibrutinib due to toxicity. Hypothetically, judicious dose reductions could result in improved tolerance. Our objective was to study the impact of dose reductions on outcomes in CLL patients treated with ibrutinib in a real-world setting. We identified 70 CLL patients treated with ibrutinib at Roswell Park Comprehensive Cancer Center between January 2014 and June 2017. Twenty-three (31.3%) patients required dose reductions. There was no statistically significant difference in overall response rate (ORR), clinical benefit rate (CBR), median progression-free survival, and overall survival (OS) between the dose-reduced and standard-dose groups (SDGs). These results extended to all patients, irrespective of whether the modification was made within three months of treatment initiation, or later.
伊布替尼是一种首创的小分子抑制剂，在治疗 CLL 方面显示出了显著的疗效。目前的指南建议以固定的每日 420mg 剂量终身给药。来自真实世界研究的数据表明，多达 17.5%的患者因毒性而停止使用伊布替尼。理论上，谨慎地减少剂量可能会提高耐受性。我们的目的是研究在真实环境中使用伊布替尼治疗 CLL 患者时，剂量减少对结局的影响。我们确定了 2014 年 1 月至 2017 年 6 月在罗斯韦尔公园综合癌症中心接受伊布替尼治疗的 70 例 CLL 患者。23 例（31.3%）患者需要减少剂量。剂量减少组和标准剂量组（SDG）之间的总缓解率（ORR）、临床获益率（CBR）、中位无进展生存期和总生存期（OS）没有统计学上的显著差异。这些结果扩展到了所有患者，无论治疗开始后三个月内是否进行了调整，或之后进行了调整。
