双重抗人表皮生长因子受体 2 (HER2) 阻断改善了早期和转移性 HER2 阳性乳腺癌患者的预后。在此，我们介绍 ALTTO 试验的最终 10 年分析。 ALTTO 试验 (NCT00490139) 是一项前瞻性随机、III 期、开放标签、多中心研究，研究了辅助化疗和曲妥珠单抗单独、联合或序贯的作用。拉帕替尼。主要终点是无病生存期 (DFS)，次要终点包括总生存期 (OS)、远处复发时间和安全性。 总体而言，三个治疗组的 6281 名 HER2 阳性早期乳腺癌患者被纳入最终疗效分析：曲妥珠单抗 (T)、拉帕替尼曲妥珠单抗 (L T) 和曲妥珠单抗随后拉帕替尼 (T→L)。各组之间的基线特征非常平衡。中位随访时间为 9.8 年，在曲妥珠单抗和化疗中添加拉帕替尼并没有显着改善 DFS 或 OS。 T 组的 10 年 DFS 为 77%，L T 组为 79%，T→L 组为 79%，10 年 OS 分别为 87%、89% 和 89%。三个治疗组中任何心脏事件的发生率均较低且相似。经过较长时间的随访，与单独使用曲妥珠单抗相比，接受拉帕替尼曲妥珠单抗双重抗 HER2 阻断治疗的患者的 DFS 并未观察到显着改善。联合治疗组的 10 年生存率与探索双重抗 HER2 疗法的其他研究一致。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

Dual anti-human epidermal growth factor receptor 2 (HER2) blockade has improved the outcomes of patients with early and metastatic HER2-positive breast cancer. Here we present the final 10-year analysis of the ALTTO trial.The ALTTO trial (NCT00490139) is a prospective randomized, phase III, open-label, multicenter study that investigated the role of adjuvant chemotherapy and trastuzumab alone, in combination or sequentially with lapatinib. The primary endpoint was disease-free survival (DFS) and secondary endpoints included overall survival (OS), time to distant recurrence and safety.Overall, 6281 patients with HER2-positive early breast cancer were included in the final efficacy analysis in three treatment groups: trastuzumab (T), lapatinib + trastuzumab (L + T) and trastuzumab followed by lapatinib (T→L). Baseline characteristics were well balanced between groups. At a median follow-up of 9.8 years, the addition of lapatinib to trastuzumab and chemotherapy did not significantly improve DFS nor OS. The 10-year DFS was 77% in T, 79% in L + T and 79% in T→L, and the 10-year OS was 87%, 89% and 89%, respectively. The incidence of any cardiac event was low and similar in the three treatment groups.With a longer follow-up, no significant improvement was observed in DFS in patients treated with dual anti-HER2 blockade with lapatinib + trastuzumab compared to trastuzumab alone. The 10-year survival rates for the combination group are consistent with other studies that have explored dual anti-HER2 therapy.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.