对Altto试验的最终分析：辅助曲妥珠单抗在HER2阳性早期乳腺癌患者中序列或与Lapatinib结合使用[BIG 2-06/NCCTG N063D（Alliance）]
Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Alliance)]
影响因子:8.30000
分区:医学1区 Top / 肿瘤学2区
发表日期:2024 Nov
作者:
E de Azambuja, M Piccart-Gebhart, S Fielding, J Townend, D W Hillman, M Colleoni, R Roylance, C M Kelly, J Lombard, S El-Abed, A Choudhury, L Korde, M Vicente, S Chumsri, R Rodeheffer, S L Ellard, A C Wolff, J Holtschmidt, I Lang, M Untch, F Boyle, B Xu, G Werutsky, J Tujakowski, C-S Huang, N B Baruch, J Bliss, A Ferro, J Gralow, S-B Kim, J R Kroep, I Krop, S Kuemmel, R McConnell, L Moscetti, A S Knop, F van Duijnhoven, H Gomez, D Cameron, S Di Cosimo, R D Gelber, A Moreno-Aspitia
摘要
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阳性乳腺癌患者的结局。在这里，我们介绍了对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，与Lapatinib合并或顺序与Lapatinib合并。 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).两组之间的基线特征很好地平衡。在9。8年的中位随访中，将拉帕替尼添加到曲妥珠单抗和化疗并不能显着改善DFS或OS。 10年的DFS为77％，L+ T为79％，T→L为79％，10年OS分别为87％，89％和89％。在三个治疗组中，任何心脏事件的发生率都很低，并且在更长的随访中，与单独的曲妥珠单抗相比，用Lapatinib+ trastuzumab双重抗HER2阻断治疗的患者在DFS中没有明显改善。组合组的10年生存率与探索双重抗HER2治疗的其他研究一致。
Abstract
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.