Lee Philip, Kistler Kristin D, Douyon Luc, Volodarsky Raisa, Young Alex, Karve Sudeep, Challagulla Swetha
Pharmacyclics LLC, an AbbVie Company, South San Francisco, CA, USA.
Xcenda, Carrollton, TX, USA.
Drugs Real World Outcomes. 2023 Mar;10(1):11-22. doi: 10.1007/s40801-022-00332-4. Epub 2022 Dec 19.
Ibrutinib, an oral Bruton's tyrosine kinase inhibitor, has demonstrated efficacy as a first-line treatment for chronic lymphocytic leukemia in multiple, phase III, randomized clinical trials. This systematic literature review assessed the clinical effectiveness of ibrutinib in the first-line treatment of chronic lymphocytic leukemia in real-world clinical settings.
MEDLINE, EMBASE, and relevant conference websites were searched for articles published in the USA from 1 January, 2014 to 30 June, 2020. Overall survival, progression-free survival, overall response rate, and time to next treatment were summarized.
This analysis included a total of 12 publications representing data from 112 to 2033 patients from community and academic centers, and the multicenter informCLL registry. Patients were predominantly male (60-99%) with a median age range from 62 to 77 years, and included those with high-risk genomic features (del[17p]: 21-33%; del[11q]: 33%; and unmutated immunoglobulin heavy chain variable gene: 59%). Real-world effectiveness with ibrutinib complemented the efficacy demonstrated in randomized clinical trials. Across various studies, the 12-month overall survival rates ranged from 95% to 96%; 18-month overall survival rates were similarly high (91%). Twelve-month progression-free survival rates ranged from 89% to 93%, and the overall response rate ranged from 71% to 90% across four studies. In the studies that reported time to next treatment, 91% and 87% of patients treated with first-line ibrutinib did not initiate new treatment at 12 months and 24 months, respectively.
This systematic literature review confirms the benefit of ibrutinib as a first-line treatment in patients with chronic lymphocytic leukemia in real-world clinical settings and is consistent with results from randomized clinical trials, including in patients with high-risk genomic features.
伊布替尼是一种口服布鲁顿酪氨酸激酶抑制剂，在多项III期随机临床试验中已证明其作为慢性淋巴细胞白血病一线治疗药物的有效性。本系统文献综述评估了伊布替尼在真实临床环境中一线治疗慢性淋巴细胞白血病的临床疗效。
检索MEDLINE、EMBASE及相关会议网站，查找2014年1月1日至2020年6月30日在美国发表的文章。总结总生存期、无进展生存期、总缓解率及下次治疗时间。
该分析共纳入12篇出版物，数据来自社区和学术中心的112至2033例患者以及多中心informCLL注册研究。患者以男性为主（60 - 99%），中位年龄在62至77岁之间，包括具有高危基因组特征的患者（17p缺失：21 - 33%；11q缺失：33%；免疫球蛋白重链可变基因未突变：59%）。伊布替尼在真实世界中的有效性补充了随机临床试验中所证明的疗效。在各项研究中，12个月总生存率在95%至96%之间；18个月总生存率同样较高（91%）。12个月无进展生存率在89%至93%之间，四项研究的总缓解率在71%至90%之间。在报告下次治疗时间的研究中，接受一线伊布替尼治疗的患者分别有91%和87%在12个月和24个月时未开始新的治疗。
本系统文献综述证实了伊布替尼作为慢性淋巴细胞白血病患者一线治疗药物在真实临床环境中的益处，且与随机临床试验结果一致，包括对具有高危基因组特征的患者。
