Department of Medicine, Division of Hematology, Mayo Clinic, Rochester, MN, USA.
Department of Health Sciences Research, Division of Biomedical Statistics & Informatics, Mayo Clinic, Rochester, MN, USA.
Leuk Lymphoma. 2019 Nov;60(11):2712-2719. doi: 10.1080/10428194.2019.1602268. Epub 2019 Apr 24.
We identified all patients with chronic lymphocytic leukemia at Mayo Clinic treated with ibrutinib outside the context of a clinical trial; timing and reasons for discontinuation were ascertained, as were symptoms, exam and radiographic findings, and laboratory changes following discontinuation. Of 202 patients who received ibrutinib, 52 discontinued therapy (estimated 1- and 2-year risk of discontinuation 18% and 28%, respectively). The most common reasons for discontinuation were toxicity (56%) and progression of disease (32%, including Richter's transformation in 15%). Rapid progression of disease within 4 weeks after discontinuation was observed in 9/36 (25%) patients with adequate records for review, mostly in those stopping ibrutinib for disease progression ( = 8) rather than toxicity ( = 1). This was evident by sudden worsening of disease-related symptoms ( = 9), exam/radiographic changes ( = 7), and laboratory changes ( = 8). An estimated one in every three patients discontinued ibrutinib by 2 years, with 25% developing rapid disease progression afterwards.
我们确定了在临床试验之外接受伊布替尼治疗的梅奥诊所的所有慢性淋巴细胞白血病患者；确定了停药的时间和原因，以及停药后的症状、检查和影像学发现以及实验室变化。在接受伊布替尼治疗的 202 名患者中，有 52 名患者停止了治疗（估计停药的 1 年和 2 年风险分别为 18%和 28%）。停药的最常见原因是毒性（56%）和疾病进展（32%，包括 15%的里希特转化）。在有足够记录可供审查的 36 名患者中，有 9 名（25%）在停药后 4 周内观察到疾病快速进展，主要发生在因疾病进展而停止伊布替尼治疗的患者（ = 8 例）而不是因毒性（ = 1 例）。这表现为疾病相关症状突然恶化（ = 9 例）、检查/影像学变化（ = 7 例）和实验室变化（ = 8 例）。估计每三名患者中就有一名在两年内停止使用伊布替尼，其中 25%的患者随后出现疾病快速进展。
