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Breast Cancer Research and Treatment
Published in: Breast Cancer Research and Treatment 1/2019

01-08-2019 | Breast Cancer | Clinical trial

Dissecting the effect of hormone receptor status in patients with HER2-positive early breast cancer: exploratory analysis from the ALTTO (BIG 2-06) randomized clinical trial

Authors: Matteo Lambertini, Christine Campbell, Richard D. Gelber, Giuseppe Viale, Ann McCullough, Florentine Hilbers, Larissa A. Korde, Olena Werner, Saranya Chumsri, Christian Jackisch, Antonio C. Wolff, Ines Vaz-Luis, Arlindo R. Ferreira, Aleix Prat, Alvaro Moreno-Aspitia, Martine Piccart, Sherene Loi, Evandro de Azambuja

Published in: Breast Cancer Research and Treatment | Issue 1/2019

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Abstract

Purpose

Limited evidence exists on the impact of hormone receptor (HR) status to counsel HER2-positive early breast cancer patients receiving adjuvant anti-HER2 therapy.

Methods

ALTTO (BIG 2-06) was an international, intergroup, open-label, randomized phase III trial in HER2-positive early breast cancer patients randomized to receive 1 year of trastuzumab and/or lapatinib. HER2, estrogen and progesterone receptors were centrally tested for all patients. We investigated the impact of HR status on prognosis, risk of disease-free survival (DFS) events over time, patterns of first DFS events, and factors associated with risk of DFS events overall, in years 0–5 and 6–8.

Results

Out of 6273 patients included in this analysis, 3603 (57.4%) had HR-positive tumors. Median follow-up was 6.93 years. Five-year and 8-year DFS were 86% and 80% in patients with HR-positive disease, and 83% and 79% in those with HR-negative tumors, respectively. Mean annual hazards of recurrence in years 0–5 were 3% in patients with HR-positive disease and 4% in those with HR-negative tumors, while in years 6–8 they were 3% and 2%, respectively. Distribution of first DFS event in years 6–8 (P = 0.005) and type of first distant recurrence (P < 0.001) were significantly different between the two groups. Risk factors for DFS events overall, in years 0–5, and 6–8 were different in patients with HR-positive and HR-negative tumors.

Conclusions

HER2-positive early breast cancer is characterized by the presence of two diseases with distinct natural history based on HR status requiring the development of different follow-up strategies and future de-escalation and escalation clinical trials.
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Metadata
Title
Dissecting the effect of hormone receptor status in patients with HER2-positive early breast cancer: exploratory analysis from the ALTTO (BIG 2-06) randomized clinical trial
Authors
Matteo Lambertini
Christine Campbell
Richard D. Gelber
Giuseppe Viale
Ann McCullough
Florentine Hilbers
Larissa A. Korde
Olena Werner
Saranya Chumsri
Christian Jackisch
Antonio C. Wolff
Ines Vaz-Luis
Arlindo R. Ferreira
Aleix Prat
Alvaro Moreno-Aspitia
Martine Piccart
Sherene Loi
Evandro de Azambuja
Publication date
01-08-2019
Publisher
Springer US
Published in
Breast Cancer Research and Treatment / Issue 1/2019
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI
https://doi.org/10.1007/s10549-019-05284-y

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