Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial
Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial
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DOI：
10.1016/s1470-2045(11)70033-x
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发表时间：
2011-03-01
期刊：
影响因子：
51.1
通讯作者：
Bell, Richard
中科院分区：
文献类型：
--
作者：
Gianni, Luca;Dafni, Urania;Bell, Richard
辅助曲妥珠单抗的背景治疗1年可改善人类表皮生长因子受体2（HER2）阳性早期乳腺癌患者的无疾病生存率和总体存活率。我们旨在评估参加Herceptin辅助（HERA）试验的患者4年的中位随访4年后的中位随访后，我们旨在评估无病生存期和整体生存期。方法HERA试验是一项国际，多中心，随机，开放标签，第3阶段的试验试验将曲妥珠单抗治疗1年和2年与标准新辅助，辅助化疗后的观察结果进行了比较，或者在HER2阳性早期乳腺癌患者中进行了比较。主要终点是无病生存。经过1年的中位随访中的首次临时分析，以比较曲妥珠单抗1年的治疗与观察结果，观察组中无事件的患者被允许跨越以接受曲妥珠单抗。我们报告了1年曲妥珠单抗和观察组的试验结果，中位随访48.4个月（IQR 42.0-56.5），并评估广泛的交叉对曲妥珠单抗的影响。我们的分析是通过意向性治疗的。 HERA试验已在欧洲临床试验数据库中注册，编号2005-002385-11。发现HERA试验人群由1698例随机分配给观察组的患者，1703患者和1年的曲妥珠单抗组。与观察组相比，无疾病生存的意向性治疗分析对1年曲妥珠单抗组的患者有很大的好处（4年无病生存率为78.6％）（4年无病生存率72.2％；危险比[HR] 0.76;
Background Treatment with adjuvant trastuzumab for 1 year improves disease-free survival and overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess disease-free survival and overall survival after a median follow-up of 4 years for patients enrolled on the Herceptin Adjuvant (HERA) trial.Methods The HERA trial is an international, multicentre, randomised, open-label, phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after standard neoadjuvant, adjuvant chemotherapy, or both in patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. After a positive first interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation, event-free patients in the observation group were allowed to cross over to receive trastuzumab. We report trial outcomes for the 1-year trastuzumab and observation groups at a median follow-up of 48.4 months (IQR 42.0-56.5) and assess the effect of the extensive crossover to trastuzumab. Our analysis was by intention-to-treat. The HERA trial is registered with the European Clinical Trials Database, number 2005-002385-11.Findings The HERA trial population comprised 1698 patients randomly assigned to the observation group and 1703 to the 1-year trastuzumab group. Intention-to-treat analysis of disease-free survival showed a significant benefit in favour of patients in the 1-year trastuzumab group (4-year disease-free survival 78.6%) compared with the observation group (4-year disease-free survival 72.2%; hazard ratio [HR] 0.76; 95% CI 0.66-0.87; p