RESONATE：伊布替尼治疗伴del17p的rrCLL患者：Ⅱ期开放性多中心研究

2017-10-17 梅斯医学梅斯医学

研究背景与目的•编码肿瘤抑制蛋白p53的TP53基因，位于17号染色体的短臂上(17p)•伴del17p的CLL患者化疗及化学免疫治疗预后差，缓解率低且生存期短•伊布替尼是首个每日一次口服的BTK抑制剂，在既往研究中已证实可延长CLL患者的生存期并提高缓解率•RESONATE-17研究旨在评估伊布替尼治疗伴del17p的rrCLL/SLL患者的疗效与安全性研究方法与入组人群•国际多中心开放性单臂

研究背景与目的

•编码肿瘤抑制蛋白p53的TP53基因，位于17号染色体的短臂上(17p)

•伴del17p的CLL患者化疗及化学免疫治疗预后差，缓解率低且生存期短

•伊布替尼是首个每日一次口服的BTK抑制剂，在既往研究中已证实可延长CLL患者的生存期并提高缓解率

•RESONATE-17研究旨在评估伊布替尼治疗伴del17p的rrCLL/SLL患者的疗效与安全性

研究方法与入组人群

•国际多中心开放性单臂Ⅱ期研究，在美国、加拿大、欧洲、澳大利亚和新西兰40个中心开展

•主要终点：根据2008IWCLL标准评估所有接受治疗患者的总缓解率

•预设探索性分析：PFS，OS，持续的血液学改善及免疫学改善

研究结果——ORR

•初步分析中位随访11.5个月及延长分析中位随访27.6个月时，研究者评估的患者总缓解率均为83%

•中位缓解持续时间未达到，预计12个月时持续缓解率为88%，24个月时持续缓解率为70%

•在所有亚组中，总缓解率结果均相似

研究结果——PFS及OS

•延长分析中伊布替尼治疗的中位PFS及OS均未达到

•24个月估计的PFS率为63%，OS率为75%

研究结果——血液学免疫学

•79%(72/91)基线血细胞减少的患者发生持续的血液学改善，包括88%(23/26)基线中性粒细胞计数≤1.5X10-9/L的患者、59%(37/63)基线血红蛋白浓度≤110g/L的患者、76%(44/58)基线血小板计数≤100X10-9/L的患者

•自基线至6个月或24个月，未观察到IgA、IgG、IgM临床相关的改变

研究结果——安全性

•治疗中断的常见原因为疾病进展(24%)及不良反应、无法耐受的毒性、或死亡(17%)

•9%的患者发生大出血，3-4级大出血为8% •30%的患者发生≥3级感染，包括13%的患者发生肺炎

•延长分析中，38例患者死亡，其中18例是因为不良反应

研究意义

•RESONATE-17是目前为止最大型的专门针对del17p rrCLL/SLL患者的前瞻性多中心研究，也是唯一一项报告了del17p患者中位随访时间超过2年结果的伊布替尼研究

•伊布替尼治疗del17p rrCLL/SLL患者缓解率高且风险获益好，为其在最难治人群中的应用提供了更多证据

•目前伊布替尼已被FDA批准用于del17p CLL患者，并被推荐为del17p CLL的一线标准治疗

•这些数据标志着靶向治疗正在改变del17p CLL等高危患者的治疗现状

如需了解更多淋巴瘤的前沿信息请扫描二维码访问“淋巴瘤亿刻”网站。

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2017-11-16 liye789132251

#Nat#

55 0
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2018-09-08 仁医06

#del17p#

64 0
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2018-05-12 luoxiaog

#多中心#

45 0
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2018-05-31 redcrab

#多中心研究#

0 0
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2017-10-19 hongbochen

#伊布替尼#

55 0
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2017-10-19 hongbochen

#ESO#

70 0
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2017-10-18 1e145228m78(暂无匿称)

学习了谢谢作者分享!

88 0
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2017-10-17 131****1460

学习了受益匪浅

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