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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 103-114 |
| Number of pages | 12 |
| Journal | Breast Cancer Research and Treatment |
| Volume | 177 |
| Issue number | 1 |
| DOIs | |
| State | Published - Aug 30 2019 |
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Keywords
- Breast cancer
- Estrogen receptor
- HER2
- Progesterone receptor
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
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. / Lambertini, Matteo; Campbell, Christine; Gelber, Richard D.; Viale, Giuseppe; McCullough, Ann; Hilbers, Florentine; Korde, Larissa A.; Werner, Olena; Chumsri, Saranya; Jackisch, Christian; Wolff, Antonio C; Vaz-Luis, Ines; Ferreira, Arlindo R.; Prat, Aleix; Moreno-Aspitia, Alvaro; Piccart, Martine; Loi, Sherene; de Azambuja, Evandro.
In: Breast Cancer Research and Treatment, Vol. 177, No. 1, 30.08.2019, p. 103-114.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Dissecting the effect of hormone receptor status in patients with HER2-positive early breast cancer
T2 - exploratory analysis from the ALTTO (BIG 2-06) randomized clinical trial
AU - Lambertini, Matteo
AU - Campbell, Christine
AU - Gelber, Richard D.
AU - Viale, Giuseppe
AU - McCullough, Ann
AU - Hilbers, Florentine
AU - Korde, Larissa A.
AU - Werner, Olena
AU - Chumsri, Saranya
AU - Jackisch, Christian
AU - Wolff, Antonio C
AU - Vaz-Luis, Ines
AU - Ferreira, Arlindo R.
AU - Prat, Aleix
AU - Moreno-Aspitia, Alvaro
AU - Piccart, Martine
AU - Loi, Sherene
AU - de Azambuja, Evandro
PY - 2019/8/30
Y1 - 2019/8/30
N2 - 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.
AB - 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.
KW - Breast cancer
KW - Estrogen receptor
KW - HER2
KW - Progesterone receptor
UR - http://www.scopus.com/inward/record.url?scp=85069158221&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85069158221&partnerID=8YFLogxK
U2 - 10.1007/s10549-019-05284-y
DO - 10.1007/s10549-019-05284-y
M3 - Article
C2 - 31134488
AN - SCOPUS:85069158221
VL - 177
SP - 103
EP - 114
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
SN - 0167-6806
IS - 1
ER -