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EUR J Cancer：一项比较SB3（曲妥珠单抗生物类似物）和曲妥珠单抗的III期临床研究

2018-02-26 MedSci MedSci原创

曲妥珠单抗SB3生物类似物
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在早期或局部晚期人表皮生长因子受体2阳性乳腺癌患者的治疗中，研究人员对比了SB3（曲妥珠单抗生物类似物）和曲妥珠单抗的在最终安全性，免疫原性和生存结果等方面的差异。

在早期或局部晚期人表皮生长因子受体2阳性乳腺癌患者的治疗中，研究人员对比了SB3（曲妥珠单抗生物类似物）和曲妥珠单抗的在最终安全性，免疫原性和生存结果等方面的差异。

患者被随机平均分配为两组，分别接受SB3或曲妥珠单抗治疗 8个周期，同时进行化疗（4个周期的多西他赛，然后4个周期的5-氟尿嘧啶/ epirubicin /环磷酰胺）。在随机分配的875例患者中，764例（SB3，n = 380；曲妥珠单抗，n = 384）完成了研究。中位随访时间分别为437天（SB3组）和438天（曲妥珠单抗组）。在整个研究期间，各组间治疗出现不良事件的发生率相当（SB3，97.5%；曲妥珠单抗，96.1%）。在研究结束时，两个治疗组的抗药物抗体总发生率较低。12个月时的无事件存活率（EFS）率为93.7%（SB3）和93.4%（曲妥珠单抗）。风险比（SB3 / 曲妥珠单抗）为0.94（95%的置信区间为0.59-1.51）。 

原始出处：

Pivot, X., et al. "A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results." European Journal of Cancer 2018 93: 19-27. doi.org/10.1016/j.ejca.

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    2018-03-18 linlin2320

    #曲妥珠#

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    2018-04-06 tastas

    #III期临床研究#

    0

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    2019-01-26 juliusluan78

    #III#

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    2018-10-22 huiwelcome

    #II期临床研究#

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    2018-04-09 villahu

    #曲妥珠单抗生物类似物#

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    2018-09-12 医生2402

    #I期临床#

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    2018-02-28 guihongzh

    #II期临床#

    0

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    2018-02-28 智智灵药

    #III期#

    0

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