伊布替尼治疗复发/难治性慢性淋巴细胞白血病的长期疗效：波兰成人白血病研究组观察性研究结果。
Long-term Efficacy of Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia: Results of the Polish Adult Leukemia Study Group Observational Study.
机构信息
Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland
Department of Hematology, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
出版信息
Anticancer Res. 2020 Jul;40(7):4059-4066. doi: 10.21873/anticanres.14403.
BACKGROUND/AIM: To study the long-term clinical efficacy and tolerability of ibrutinib monotherapy in real-world relapsed and refractory chronic lymphocytic leukemia (RR-CLL) patients outside clinical trials.
PATIENTS AND METHODS
Clinical data of 171 RR-CLL patients treated with ibrutinib were collected within the observational study of the Polish Adult Leukemia Study Group.
RESULTS
Median patient age was 64 years. Patients were pretreated with 3 (1-10) median lines of therapy, while 42 (24.6%) had 17p deletion. The median observation time was 40 months (range=1-59 months), while median ibrutinib monotherapy reached 37.5 months (range=0.4-59.2 months). Response was noted in 132 (77.2%) patients. The estimated 5-year progression-free survival (PFS) and overall survival (OS) rates were 61.1% (95%CI=49.3-70.9%) and 56.8% (95%CI=45.6-66.6%), respectively. At the time of analysis 97 (56.7%) remained under ibrutinib monotherapy.
CONCLUSION
Ibrutinib is clinically effective and tolerable as a monotherapy in real-world RR-CLL patients.
背景/目的：研究伊布替尼单药治疗真实世界中复发/难治性慢性淋巴细胞白血病（RR-CLL）患者的长期临床疗效和耐受性。
患者和方法
在波兰成人白血病研究组的观察性研究中，收集了 171 例接受伊布替尼治疗的 RR-CLL 患者的临床数据。
结果
中位患者年龄为 64 岁。患者接受了 3（1-10）线中位治疗，42 例（24.6%）存在 17p 缺失。中位观察时间为 40 个月（范围=1-59 个月），而伊布替尼单药治疗的中位时间达到 37.5 个月（范围=0.4-59.2 个月）。132 例（77.2%）患者有缓解。估计 5 年无进展生存（PFS）和总生存（OS）率分别为 61.1%（95%CI=49.3-70.9%）和 56.8%（95%CI=45.6-66.6%）。在分析时，97 例（56.7%）仍在接受伊布替尼单药治疗。
结论
伊布替尼作为单药治疗真实世界中的 RR-CLL 患者是临床有效且耐受良好的。
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