Phase I and II clinical trials of trastuzumab
Phase I and II clinical trials of trastuzumab
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DOI：
10.1023/a:1011167909059
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发表时间：
2001-01-01
影响因子：
50.5
通讯作者：
Baselga, J
中科院分区：
文献类型：
--
作者：
Baselga, J
这份报告总结了曲妥珠单抗(Herceptin)在HER2阳性转移性乳腺癌患者的I期和II期临床试验计划的基础上的疗效，这些研究到目前为止已经完成，并整合在导致曲妥珠单抗获准在美国临床使用的提交文件中。进行了三个小规模的I期临床试验，主要是为了确定静脉注射曲妥珠单抗(10-500 mg)的安全性和药代动力学。作为单剂或每周剂量。紧随其后的是固定剂量曲妥珠单抗的两个II期临床试验，分别为46例和39例患者，分别作为单一药物或与顺铂联合使用，总有效率分别为11.6%和24.3%。在一项关键的II期临床试验中，曲妥珠单抗在体重调整的基础上作为单一药物应用于222名HER2阳性转移性乳腺癌患者，这些患者在之前的一到两个化疗方案后复发。当研究人员对可评估的患者进行评估时，总体应答率为21%，当由独立的反应评估委员会根据治疗意向进行分析时，总应答率为15%。对曲妥珠单抗的药代动力学进行了评价，并对结果进行了总结。
This report summarizes the efficacy of trastuzumab (Herceptin) based on its completed clinical trial program in patients with HER2-positive metastatic breast cancer for phase I and II studies which have been completed to date and were integral in the submission that led to approval of trastuzumab for clinical use in the USA. There were three small-scale, phase I clinical trials conducted, which were primarily designed to determine the safety and pharmacokinetics of trastuzumab (10-500 mg) administered i.v. as single or weekly doses. This was followed by two phase II clinical trials of fixed-dose trastuzumab either as a single-agent or in combination with cisplatin in 46 and 39 patients, which produced overall response rates of 11.6% and 24.3%, respectively. In a pivotal phase II clinical trial, trastuzumab was administered on a bodyweight-adjusted basis as a single agent to 222 patients with HER2-positive metastatic breast cancer who had relapsed after one or two prior chemotherapy regimens. The overall response rate was 21% when assessed in evaluable patients by the investigators and 15% when analyzed on an intent-to-treat basis by an independent Response Evaluation Committee. The pharmacokinetics of trastuzumab were evaluated in these studies and the results are summarized.