伊布替尼单药治疗初治及rrCLL患者：5年随访结果

2017-10-17 梅斯医学梅斯医学

研究背景与目的•伊布替尼是首个每日一次口服BTK抑制剂，已被FDA批准用于CLL/SLL患者一线及复发治疗，且可无化疗单药使用•1b/2期研究及延长研究PCYC-1102/03的早期结果已证实伊布替尼单药治疗初治及rrCLL/SLL的有效性及耐受性•本文旨在评估伊布替尼单药治疗初治及rrCLL/SLL的5年长期随访结果研究方法与入组人群CLL/SLL患者口服伊布替尼，每日一次(420或840mg/

研究背景与目的

•伊布替尼是首个每日一次口服BTK抑制剂，已被FDA批准用于CLL/SLL患者一线及复发治疗，且可无化疗单药使用

•1b/2期研究及延长研究PCYC-1102/03的早期结果已证实伊布替尼单药治疗初治及rrCLL/SLL的有效性及耐受性

•本文旨在评估伊布替尼单药治疗初治及rrCLL/SLL的5年长期随访结果

研究方法与入组人群

CLL/SLL患者

口服伊布替尼，每日一次(420或840mg/d)

•初治患者中位年龄为71岁，del17p患者占6%；复发/难治患者中位年龄为64岁， del17p患者占34%

•复发/难治患者中位既往治疗次数为4次(1-12)

研究结果——起效时间及缓解率

•最早缓解的中位时间为1.9m，出现最佳缓解的中位时间为7.4m，出现完全缓解的中位时间为21.2m

•随访5年时，rrCLL/SLL患者的ORR高达89%，del17p患者的ORR为79%

研究结果——生存获益

研究结果——高危人群

研究结果——更早使用

研究结果——安全性

研究结论与意义

•目前为止伊布替尼最长期的研究结果

•5年随访伊布替尼治疗初治及rrCLL/SLL患者持续缓解，rr患者中位PFS 52个月，5年OS 57%；完全缓解率(CR)增加

•患者更早使用伊布替尼，生存获益更多

•伊布替尼治疗患者耐受性好，多数≥3级不良反应随时间减少；良好的安全性允许患者延长剂量，65%初治患者及30%rr患者随访5年时仍继续治疗

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2018-05-07 维他命

#随访结果#

60 0
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2018-09-13 12498717m75(暂无昵称)

#单药治疗#

77 0
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2017-12-15 tm10051981

#5年随访#

68 0
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2017-10-19 hongbochen

#伊布替尼#

64 0

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