First-line Herceptin® monotherapy in metastatic breast cancer
First-line Herceptin® monotherapy in metastatic breast cancer
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DOI：
10.1159/000055400
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发表时间：
2001-01-01
期刊：
影响因子：
3.5
通讯作者：
Stewart, SJ
中科院分区：
文献类型：
--
作者：
Vogel, CL;Cobleigh, MA;Stewart, SJ
赫赛汀（R）的关键II期和III期试验分别证明了二线或三线单药赫赛汀和一线赫赛汀联合化疗的疗效和安全性。在本试验中，114例患者被随机分配至一线赫赛汀单药治疗的两个剂量组之一：标准剂量4 mg/kg初始剂量，随后2 mg/kg静脉（i. v.）每周一次;或高剂量8 mg/kg初始剂量，随后4 mg/kg im。周刊该方案通常耐受良好。两个剂量组中不良事件的发生率相似，但急性输注相关事件（如发热和寒战以及皮疹和呼吸困难）可能除外，这些事件在较高剂量组中似乎更常见。总体缓解率为26%，两个剂量组的缓解率相似（标准赫赛汀剂量组为24%，高赫赛汀剂量组为28%）。亚组分析确定IHC 3+患者（35%）和FISH阳性患者（41%）的应答率较高。当病情稳定大于或等于6个月的女性被纳入应答者中时，IHC 3+患者的临床获益率为47%。中位生存期为24.4个月，与关键III期联合试验中观察到的生存率（25个月）相当。因此，赫赛汀单药是HER 2阳性转移性乳腺癌患者一线治疗的重要新选择。版权所有（C）2001 S. Karger AG，巴塞尔。
The pivotal phase II and III Herceptin (R) trials proved the efficacy and safety of second- or third-line single-agent Herceptin and first-line Herceptin in combination with chemotherapy, respectively. In the current trial, 114 patients were randomized to one of two dose groups of first-line Herceptin monotherapy: standard dose of 4 mg/kg initial dose followed by 2 mg/kg intravenous (i.v.) weekly; or high dose of 8 mg/kg initial dose followed by 4 mg/kg im. weekly. The regimen was generally well tolerated. A similar incidence of adverse events was demonstrated in the two dose groups with the possible exception of acute infusion-related events such as fever and chills as well as rash and dyspnea, which appear to be more prevalent in the higher dose group. The overall response rate was 26% and response rates were similar between the two dose groups (24% for the standard Herceptin dose group and 28% for the high Herceptin dose group). Subgroup analysis determined a higher response rate in IHC 3+ patients (35%) and FISH-positive patients (41%). When women with stable disease for greater than or equal to6 months were included with responders, the clinical benefit rate in IHC 3+ patients was 47%. Median survival was 24.4 months, which is comparable with the survival rate seen in the pivotal phase Ill combination trial (25 months). Therefore, single-agent Herceptin is an important new option for the first-line treatment of HER2-positive metastatic breast cancer patients. Copyright (C) 2001 S. Karger AG, Basel.