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)]

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 CS, Baruch NB, Bliss J, Ferro A, Gralow J, Kim SB, 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 (2024)

Publication Type: Journal article

Publication year: 2024

Journal

Book Volume: 9

Article Number: 103938

Journal Issue: 11

DOI: 10.1016/j.esmoop.2024.103938

Abstract

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.

Involved external institutions

Institut Jules Bordet Belgium (BE) Frontier Science (Scotland) Ltd United Kingdom (GB) Mayo Clinic United States (USA) (US) European Institute of Oncology / Istituto Europeo di Oncologia (IEO) Italy (IT) University College London Hospitals (UCLH) United Kingdom (GB) Breast Cancer Trials Australia (AU) Breast International Group Belgium (BE) Novartis India India (IN) National Cancer Institute (NCI) United States (USA) (US) Mayo Clinic College of Medicine and Science (MCCMS) United States (USA) (US) British Columbia Cancer Agency Canada (CA) Sidney Kimmel Comprehensive Cancer Center (SKCCC) United States (USA) (US) GBG Forschungs GmbH (German Breast Group) Germany (DE) HELIOS Kliniken Germany (DE) Peking Union Medical College / 北京协和医学院 China (CN) LACOG - Latin American Cooperative Oncology Group Brazil (BR) Oncology Centre Poland (PL) National Taiwan University (NTU) Taiwan (TW) The Institute of Cancer Research (ICR) United Kingdom (GB) Centro di Protonterapia Italy (IT) American Society of Clinical Oncology (ASCO) United States (USA) (US) Asan Medical Center / 서울아산병원 Korea, Republic of (KR) Leiden University Medical Center Netherlands (NL) Yale School of Medicine United States (USA) (US) Kliniken Essen-Mitte Germany (DE) University-Hospital Polyclinic of Modena / Azienda Ospedaliero-Universitaria di Modena Italy (IT) Copenhagen University Hospital Denmark (DK) Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI / NKI-AVL) Netherlands (NL) Instituto Nacional de Enfermedades Neoplásicas (INEN) Peru (PE) Fondazione IRCCS: Istituto Nazionale dei Tumori Italy (IT) Harvard University United States (USA) (US) University of Edinburgh United Kingdom (GB)

How to cite

APA:

de Azambuja, E., Piccart-Gebhart, M., Fielding, S., Townend, J., Hillman, D.W., Colleoni, M.,... Moreno-Aspitia, A. (2024). 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)]. ESMO Open, 9(11). https://doi.org/10.1016/j.esmoop.2024.103938

MLA:

de Azambuja, E., et al. "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)]." ESMO Open 9.11 (2024).

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