期刊
BRITISH JOURNAL OF HAEMATOLOGY
卷 194, 期 1, 页码 69-77出版社
WILEY
DOI: 10.1111/bjh.17475
关键词
chronic lymphocytic leukaemia; B-cell receptor inhibitor; idelalisib; PI3K; retrospective
类别
资金
- Gilead Sciences Ltd.
- Oxford Biomedical Research Centre
The study examined the efficacy and safety of IDL-R treatment in 110 CLL patients and found clear efficacy in routine practice without identifying new safety signals. Careful management of known toxicities is crucial during treatment.
Idelalisib (IDL) is an oral first-in-class phosphatidylinositol 3-kinase delta (PI3K delta) inhibitor approved for chronic lymphocytic leukaemia (CLL) alongside rituximab (R) since 2014. However, little data exist on routine practice. The RETRO-idel was a protocol-led, retrospective study of 110 patients [n = 27 front-line (1L)] who received IDL-R. The primary end-point was clinical overall response rate (ORR). The median (range) follow-up of the whole cohort was 30 center dot 2 (0 center dot 1-51 center dot 9) months. The median (range) age was 72 (48-89) years. Tumour protein p53-disruption was common [100% 1L, 32 center dot 5% relapsed/refractory (R/R)]. The best ORR (intention-to-treat) was 88 center dot 2% (1L 96 center dot 3%, R/R 85 center dot 5%). Overall, the median event-free survival (mEFS) was 20 center dot 3 months and time-to-next treatment was 29 center dot 2 months. The mEFS for 1L patients was 18 center dot 7 months and R/R patients was 21 center dot 7 months. The 3-year overall survival was 56 center dot 1% (95% confidence interval 45 center dot 7-65 center dot 3). IDL was discontinued in 87 center dot 3% (n = 96). More patients discontinued due to adverse events in the front-line setting (1L 63 center dot 0% vs. R/R 44 center dot 6%) and due to progressive disease in R/R patients (20 center dot 5% vs. 3 center dot 7% in 1L). Lower respiratory tract infection/pneumonia were reported in 34 center dot 5% (Grade >= 3, 19 center dot 1%), diarrhoea in 30 center dot 9% (Grade >= 3, 6 center dot 4%), and colitis in 9 center dot 1% (Grade >= 3, 5 center dot 5%). Overall, these data describe clear efficacy for IDL-R in routine practice. No new safety signals were identified, although careful management of known toxicities is required.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据