HER2阳性乳腺癌性脑膜炎患者鞘内注射曲妥珠单抗的可行性研究

2018-04-29 MedSci MedSci原创

软脑膜癌病(MC)通常与HER2阳性乳腺癌(HER2-BC)相关,预后较差且没有标准化治疗方法。临床医生进行了一项患有MC的HER2-BC患者进行鞘内(IT)注射曲妥珠单抗的I期剂量递增研究以确定最大耐受剂量(MTD),基于曲妥珠单抗脑脊液浓度的接近到常规治疗性血浆浓度(30mg / L)和/或剂量限制性毒性(DLT)。该研究计划每周一次给予曲妥珠单抗(30mg,60mg,100mg或150mg剂

软脑膜癌病(MC)通常与HER2阳性乳腺癌HER2-BC)相关,预后较差且没有标准化治疗方法。临床医生进行了一项患有MCHER2-BC患者进行鞘内(IT)注射曲妥珠单抗的I期剂量递增研究以确定最大耐受剂量(MTD),基于曲妥珠单抗脑脊液浓度的接近到常规治疗性血浆浓度(30mg / L)和/或剂量限制性毒性(DLT)。该研究计划每周一次给予曲妥珠单抗(30mg60mg100mg150mg剂量水平)。16名患有MCHER2阳性乳腺癌患者接受IT曲妥珠单抗治疗。

研究人员没有观察到IT曲妥珠单抗的DLT11名患者没有归因于IT曲妥珠单抗的毒性。对于60mg或更高剂量水平,归因于IT曲妥珠单抗的轻微毒性包括头痛(2名患者),恶心(2名患者),呕吐(1名患者),颈部疼痛(1名患者)和周围神经病变(1名患者)。三名患者达到临床反应,七名患者疾病稳定,四名患者患有进行性疾病。

综上所述,患有MCHER2阳性乳腺癌患者的MTD和推荐的IT曲妥珠单抗剂量为150 mgHER2-BCMC中使用该剂量方案的II期试验正在进行中。

原始出处:

Claire Bonneau et al., Phase I feasibility study for intrathecal administration of trastuzumab in patients with HER2 positive breast carcinomatous meningitis. ejcancer. 2018 95: 75–84. doi.org/10.1016/j.ejca.

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