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首页> 美国卫生研究院文献>Neuro-Oncology >AT-47PHASE I TRIAL OF INTRATHECAL TRASTUZUMAB IN HER2 POSITIVE LEPTOMENINGEAL METASTASES
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AT-47PHASE I TRIAL OF INTRATHECAL TRASTUZUMAB IN HER2 POSITIVE LEPTOMENINGEAL METASTASES

机译：鞘内注射曲妥珠单抗在HER2阳性淋巴结转移中的AT-47阶段I试验

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INTRODUCTION: Trastuzimab is a humanized monoclonal antibody against Her2 whose limitation is central nervous system penetration that often leads to brain and leptomeningeal metastases (LM) in the setting to controlled systemic HER2 positive breast cancer. We performed a phase I clinical trial of intrathecal (IT) trastuzumab in patients with HER2 positive breast cancer and LM. METHODS: IRB consented patients were treated at defined dose levels; protocol was modified to accelerate dose escalation and increase IT dosage. Dose levels of IT treatment 10 mg, 20 mg, 40 mg, 60 mg and 80 mg were examined. Treatment was given twice a week x4 weeks, then once a week x4 weeks then every other week until progressive disease. MRI was done at 4 week intervals x2 then every 8 weeks. CSF was assessed every other week x2 then every 4 weeks. RESULTS: 13 women with HER2 positive breast cancer, 1 man with a glioblastoma, and one woman with anaplastic ependymoma were enrolled with a median age of 55 (42-67) and median KPS of 80 (60-90). Three patients were treated at the 10mg dose level, three at 20mg, one at 40mg, one at 60mg and 7 at 80mg. At the 80 mg dose level a patient was added as one patient was removed before complete evaluation and another patient had a grade 4 DLT of arachnoiditis. One patient had the Ommaya reservoir removed for infection unrelated to treatment. Data on CSF levels shows therapeutic levels in the patients treated with 10 mg, 20 mg and 40 mg; data analysis on CSF at 60 and 80 mg is pending. CONCLUSION: IT Trastuzumab is well tolerated up to 80 mg IT. Complete CSF PK data will be presented. A phase II study is underway at the 80 mg dose.
机译：简介：曲妥珠单抗是针对Her2的人源化单克隆抗体，其局限性是中枢神经系统的渗透，在控制性系统性HER2阳性乳腺癌的背景下，该渗透常导致脑部和软脑膜转移瘤（LM）。我们对HER2阳性乳腺癌和LM患者进行鞘内（IT）曲妥珠单抗的I期临床试验。方法：IRB同意的患者以确定的剂量水平治疗；修改协议以加速剂量升级并增加IT剂量。检查IT治疗的剂量水平10 mg，20 mg，40 mg，60 mg和80 mg。每周两次x4周给予治疗，然后每周一次x4周给予治疗，然后每隔一周进行一次，直到疾病进展。 MRI每隔4周x2进行一次，然后每8周进行一次。每隔2周x2评估一次CSF，然后每4周评估一次。结果：招募了13例HER2阳性乳腺癌女性，1例胶质母细胞瘤男性和1例间变性性室管膜瘤女性，年龄中位数为55岁（42-67岁），KPS中位数为80岁（60-90岁）。三名患者以10mg的剂量治疗，三名20mg，一名40mg，一名60mg和七名80mg。在80 mg剂量水平下，增加了一名患者，其中一名患者在完全评估之前被移除，另一名患者患有蛛网膜炎的4级DLT。一名患者因与治疗无关的感染而移除了Ommaya水库。脑脊液水平的数据显示了接受10 mg，20 mg和40 mg治疗的患者的治疗水平； 60和80 mg CSF的数据分析尚在进行中。结论：IT曲妥珠单抗最高耐受80 mg。将显示完整的CSF PK数据。 II期研究正在以80毫克的剂量进行。

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