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Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D)

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  • Alvaro Moreno-Aspitia
  • Eileen M Holmes
  • Christian Jackisch
  • Evandro de Azambuja
  • Frances Boyle
  • David W Hillman
  • Larissa Korde
  • Debora Fumagalli
  • Miguel A Izquierdo
  • Ann E McCullough
  • Antonio C Wolff
  • Kathleen I Pritchard
  • Michael Untch
  • Sébastien Guillaume
  • Michael S Ewer
  • Zhimin Shao
  • Sung Hoon Sim
  • Zeba Aziz
  • Georgia Demetriou
  • Ajay O Mehta
  • Michael Andersson
  • Masakazu Toi
  • Istvan Lang
  • Binghe Xu
  • Ian E Smith
  • Carlos H Barrios
  • Jose Baselga
  • Richard D Gelber
  • Martine Piccart-Gebhart
  • ALTTO Steering Committee and Investigators
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AIM: To present the pre-specified analyses of >5-years follow-up of the Phase III ALTTO trial.

PATIENTS AND METHODS: 8381 patients with stage I-III HER2 positive breast cancer randomised to chemotherapy plus 1-year of trastuzumab (T), oral lapatinib (L; no longer evaluated), trastuzumab followed by lapatinib (T→L), and lapatinib + trastuzumab (L+T). The primary endpoint was disease-free survival (DFS). A secondary analysis examined DFS treatment effects by hormone receptor status, nodal status and chemotherapy timing; time to recurrence; overall survival (OS) and safety (overall and cardiac).

RESULTS: At a median follow-up of 6.9 years, 705 DFS events for L+T versus T were observed. Hazard Ratio (HR) for DFS was 0.86 (95% CI, 0.74-1.00) for L+T versus T and 0.93 (95% CI, 0.81-1.08) for T→L versus T. The 6-year DFS were 85%, 84%, and 82% for L+T, T→L, and T, respectively. HR for OS was 0.86 (95% CI, 0.70-1.06) for L+T versus T and 0.88 (95% CI, 0.71-1.08) for T→L versus T. The 6-year OS were 93%, 92%, and 91% for L+T, T→L, and T, respectively. Subset analyses showed a numerically better HR for DFS in favour of L+T versus T for the hormone-receptor-negative [HR 0.80 (95% CI, 0.64-1.00; 6-yr DFS% = 84% versus 80%)] and the sequential chemotherapy [HR 0.83 (95% CI, 0.69-1.00; 6-yr DFS% = 83% versus79%)] subgroups.

CONCLUSION: T+L did not significantly improve DFS and OS over T alone, both with chemotherapy, and, therefore, cannot be recommended for adjuvant treatment of early-stage HER2-positive breast cancer.

TRIAL REGISTRATION: clinicaltrials.gov Identifier NCT00490139.

Original languageEnglish
JournalEuropean journal of cancer (Oxford, England : 1990)
Volume148
Pages (from-to)287-296
ISSN0959-8049
DOIs
Publication statusPublished - May 2021

Bibliographical note

Copyright © 2021 Elsevier Ltd. All rights reserved.

    Research areas

  • Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Breast Neoplasms/drug therapy, Chemotherapy, Adjuvant/mortality, Female, Follow-Up Studies, Humans, Middle Aged, Neoadjuvant Therapy/mortality, Prognosis, Prospective Studies, Survival Rate, Young Adult

ID: 68603878