医学
中性粒细胞减少症
内科学
胃肠病学
套细胞淋巴瘤
中性粒细胞绝对计数
不利影响
临床研究阶段
发热性中性粒细胞减少症
临床终点
皮疹
伊布替尼
外科
淋巴瘤
临床试验
化疗
白血病
慢性淋巴细胞白血病
作者
Yuqin Song,Keshu Zhou,Dehui Zou,Jianfeng Zhou,Jianda Hu,Haiyan Yang,Huilai Zhang,Jing Jie,Wei Xu,Jie Jin,Fangfang Lv,Ru Feng,Sujun Gao,Haiyi Guo,Lei Zhou,Jane Huang,William Novotny,Pil Kim,Yanhao Yu,Binghao Wu,Jun Zhu
出处
期刊:Blood
[American Society of Hematology]
日期:2022-05-26
卷期号:139 (21): 3148-3158
被引量:48
标识
DOI:10.1182/blood.2021014162
摘要
Bruton tyrosine kinase (BTK) inhibitor is an established treatment for relapsed/refractory (R/R) mantle cell lymphoma (MCL). Zanubrutinib, a highly selective BTK inhibitor, is approved for patients with MCL who have received ≥1 prior therapy. We report the long-term safety and efficacy results from the multicenter, open-label, phase 2 registration trial of zanubrutinib. Patients (n = 86) received oral zanubrutinib 160 mg twice daily. The primary endpoint was the overall response rate (ORR), assessed per Lugano 2014. After a median follow-up of 35.3 months, the ORR was 83.7%, with 77.9% achieving complete response (CR); the median duration of response was not reached. Median progression-free survival (PFS) was 33.0 months (95% confidence interval [CI], 19.4-NE). The 36-month PFS and overall survival (OS) rates were 47.6% (95% CI, 36.2-58.1) and 74.8% (95% CI, 63.7-83.0), respectively. The safety profile was largely unchanged with extended follow-up. Most common (≥20%) all-grade adverse events (AEs) were neutrophil count decreased (46.5%), upper respiratory tract infection (38.4%), rash (36.0%), white blood cell count decreased (33.7%), and platelet count decreased (32.6%); most were grade 1/2 events. Most common (≥10%) grade ≥3 AEs were neutrophil count decreased (18.6%) and pneumonia (12.8%). Rates of infection, neutropenia, and bleeding were highest in the first 6 months of therapy and decreased thereafter. No cases of atrial fibrillation/flutter, grade ≥3 cardiac AEs, second primary malignancies, or tumor lysis syndrome were reported. After extended follow-up, zanubrutinib demonstrated durable responses and a favorable safety profile in R/R MCL. The trial is registered at ClinicalTrials.gov as NCT03206970.
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