Lancet Oncol:Denosumab对早期乳腺癌患者骨转移的影响

2019-12-03 MedSci MedSci原创

研究认为,RANKL抑制剂Denosumab并未改善高危早期乳腺癌患者的疾病相关预后

近日研究人员考察了Denosumab联合标准辅助化疗对乳腺癌无骨转移生存率的影响。

D-CARE研究为国际、双盲、随机、安慰剂对照的III期研究,组织学证实为II或III期乳腺癌的女性(年龄为≥18岁)参与研究,在辅助化疗基础上,随机每3-4周接受Denosumab(120mg)或安慰剂,持续约6个月,然后每12周一次,共持续5年。研究的主要终点是无骨转移生存。

4509名妇女被随机分配接受denosumab(n=2256)或安慰剂(n=2253)。5年随访结束后,两组无骨转移生存率无显著性差异(危险比为0.97)。最常见的3或4级治疗引起的不良事件是嗜中性白血球减少症(340例[15%]vs 328例[15%])、发热性中性粒细胞减少(112例[5%]vs 142例[6%])和白细胞减少(62例[3%]vs 61例[3%])。denosumab 治疗组的2241例患者中,有122例(5%)发生颌骨坏死,而安慰剂治疗组的2218例患者中,4例(<1%)发生了颌骨坏死,denosumab 治疗组152例(7%)发生了急性低钙血症,安慰剂治疗组82例(4%)出现了急性低钙血症。安慰剂组因急性髓系白血病和意识下降而发生2例治疗相关死亡。

研究认为,RANKL抑制剂Denosumab并未改善高危早期乳腺癌患者的疾病相关预后。

原始出处:


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    2020-07-09 minlingfeng
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    2020-03-17 howi
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    2019-12-09 snf701207
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    2019-12-03 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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