Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer

作者：Gϋnter von Minckwitz, Marion Jennifer Procter, Evandro de Azambuja, Dimitrios Zardavas, Mark C. Benyunes, Giuseppe Viale, Thomas Suter, Amal Arahmani, Nathalie Rouchet, Emma Clark, Adam Knott, István Láng, Christelle Lévy, Denise Aysel Yardley, José Bines, Richard D. Gelber, Martine J Piccart, José Baselga · 发表于：New England Journal of Medicine · 年份：2017 · DOI：10.1056/nejmoa1703643 · 被引用次数：1425 · 研究领域：HER2/EGFR in Cancer Research、Breast Cancer Treatment Studies、Breast Lesions and Carcinomas

BACKGROUND: Pertuzumab increases the rate of pathological complete response in the preoperative context and increases overall survival among patients with metastatic disease when it is added to trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. In this trial, we investigated whether pertuzumab, when added to adjuvant trastuzumab and chemotherapy, improves outcomes among patients with HER2-positive early breast cancer. METHODS: We randomly assigned patients with node-positive or high-risk node-negative HER2-positive, operable breast cancer to receive either pertuzumab or placebo added to standard adjuvant chemotherapy plus 1 year of treatment with trastuzumab. We assumed a 3-year invasive-disease-free survival rate of 91.8% with pertuzumab and 89.2% with placebo. RESULTS: In the trial population, 63% of the patients who were randomly assigned to receive pertuzumab (2400 patients) or placebo (2405 patients) had node-positive disease and 36% had hormone-receptor-negative disease. Disease recurrence occurred in 171 patients (7.1%) in the pertuzumab group and 210 patients (8.7%) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.66 to 1.00; P=0.045). The estimates of the 3-year rates of invasive-disease-free survival were 94.1% in the pertuzumab group and 93.2% in the placebo group. In the cohort of patients with node-positive disease, the 3-year rate of invasive-disease-free survival was...