2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial
2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial
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DOI：
10.1016/s0140-6736(07)60028-2
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发表时间：
2007-01-06
期刊：
影响因子：
168.9
通讯作者：
Piccart-Gebhart, Martine
中科院分区：
文献类型：
--
作者：
Smith, Ian;Procter, Marion;Piccart-Gebhart, Martine
曲妥珠单抗是一种抗HER 2的人源化单克隆抗体，已被证明可改善HER 2阳性早期乳腺癌女性化疗后的无病生存期。我们调查了药物的总生存率的影响后，中位随访2年的赫赛汀佐剂（HERA）study.Methods HERA是一个国际多中心的随机试验，比较1或2年的曲妥珠单抗治疗与观察单独后，标准的新辅助或辅助化疗的妇女与HER 2阳性淋巴结阳性或高危淋巴结阴性乳腺癌。5102名妇女参加了试验;我们分析了1703名随机接受曲妥珠单抗治疗1年的妇女和1698名对照组妇女的数据，中位随访时间为23.5个月（范围0-48个月）。试验的主要终点是无病生存期。在这里，我们评估总生存期，这是一个次要终点。在意向治疗基础上进行分析。该试验在欧洲临床试验数据库中注册，编号2005-002385- 11。结果：97例（5.7%）随机分配至单独观察组的患者和58例（3.4%）随机分配至1年曲妥珠单抗治疗组的患者失访。172名女性过早停用曲妥珠单抗。曲妥珠单抗组报告了59例死亡，对照组报告了90例死亡。与单独观察相比，曲妥珠单抗组死亡风险的未校正风险比（HR）为0. 66（95% CI 0. 47 - 0. 91; p= 0. 0115）。曲妥珠单抗组报告了218例无病生存事件，而对照组为321例。与单独观察相比，曲妥珠单抗组事件风险的未校正HR为0.64（0.54-0.76; p
Background Trastuzumab-a humanised monoclonal antibody against HER2-has been shown to improve disease-free survival after chemotherapy in women with HER2-positive early breast cancer. We investigated the drug's effect on overall survival after a median follow-up of 2 years in the Herceptin Adjuvant (HERA) study.Methods HERA is an international multicentre randomised trial that compared 1 or 2 years of trastuzumab treatment with observation alone after standard neoadjuvant or adjuvant chemotherapy in women with HER2-positive node positive or high-risk node negative breast cancer. 5102 women participated in the trial; we analysed data from 1703 women who had been randomised for treatment with trastuzumab for 1 year and 1698 women from the control group, with median follow-up of 23.5 months (range 0-48 months). The primary endpoint of the trial was disease-free survival. Here, we assess overall survival, a secondary endpoint. Analyses were done on an intent-to-treat basis. This trial is registered with the European Clinical Trials Database, number 2005-002385-11.Findings 97 (5.7%) patients randomised to observation alone and 58 (3.4%) patients randomised to 1 year of treatment with trastuzumab were lost to follow-up. 172 women stopped trastuzumab prematurely. 59 deaths were reported for trastuzumab and 90 in the control group. The unadjusted hazard ratio (HR) for the risk of death with trastuzumab compared with observation alone was 0.66 (95% CI 0.47-0.91; p=0.0115). 218 disease-free survival events were reported with trastuzumab compared with 321 in the control group. The unadjusted HR for the risk of an event with trastuzumab compared with observation alone was 0.64 (0.54-0.76; p