In The Lancet today, Luca Gianni and colleagues1 present data from one of the largest randomised neoadjuvant trials of trastuzumab. The NOAH (NeOAdjuvant Herceptin) study is a phase 3 trial of a non-cross-resistant neoadjuvant chemotherapy regimen with trastuzumab versus chemotherapy alone in women with a locally advanced or inflammatory breast cancer that was positive for human epidermal growth factor receptor 2 (HER2, also known as ERBB2). 235 women were randomly assigned to doxorubicin, paclitaxel, cyclophosphamide, methotrexate, and fluorouracil with or without 1 year of trastuzumab (delivered with chemotherapy and as monotherapy after surgery). The primary endpoint, event-free survival, was significantly improved by the addition of trastuzumab (hazard ratio 0.59, 95% Cl 0.38-0.90; p=0.013), as was the secondary endpoint of pathological complete response.
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机译：在今天的《柳叶刀》杂志上，Luca Gianni及其同事1提供了曲妥珠单抗最大的随机新辅助试验之一的数据。 NOAH（NeOAdjuvant Herceptin）研究是一项非交叉耐药性新辅助化疗方案与曲妥珠单抗相比单独化疗的三阶段试验，该方案对人类表皮生长因子受体2（HER2，也称为ERBB2）。 235名妇女被随机分为阿霉素，紫杉醇，环磷酰胺，甲氨蝶呤和氟尿嘧啶，伴或不伴曲妥珠单抗治疗1年（分娩时进行化学疗法和作为单一疗法）。主要终点，无事件生存，通过添加曲妥珠单抗（危险比0.59，95％Cl 0.38-0.90; p = 0.013）而得到显着改善，病理完全缓解的次要终点也是如此。
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