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)]

• Autores: de, Azambuja, E, Piccart-Gebhart, M, Fielding, S, Townend, J, Hillman, DW, Colleoni, M, Roylance, R, Kelly, CM, Lombard, J, El-Abed, S, Choudhury, A, Korde, L, Vicente, M, Chumsri, S, Rodeheffer, R, Ellard, SL, Wolff, AC, Holtschmidt, J, Lang, I, Untch, M, Boyle, F, Xu, B, Werutsky, G, Tujakowski, J, Huang, C-S, Baruch, NB, Bliss, J, Ferro, A, Gralow, J, Kim, S-B, Kroep, JR, Krop, I, Kuemmel, S, McConnell, R, Moscetti, L, Knop, AS, van, Duijnhoven, F, Gomez, H, Cameron, D, Di, Cosimo, S, Gelber, RD, Moreno-Aspitia, A
• Formato: artículo
• Fecha de Publicación: 2024
• Institución: Instituto Nacional de Enfermedades Neoplásicas
• Repositorio: INEN-Institucional
• Lenguaje: inglés
• OAI Identifier: oai:repositorio.inen.sld.pe:20.500.14703/380
• Enlace del recurso: https://hdl.handle.net/20.500.14703/380
• Nivel de acceso: acceso abierto
• Materia: adjuvant chemotherapy; early breast cancer; HER2-positive; lapatinib; trastuzumab; https://purl.org/pe-repo/ocde/ford#3.02.21

Background: 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. Patients and methods: 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. Results: 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. Conclusions: 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.