Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 103-114 |
| Number of pages | 12 |
| Journal | Breast Cancer Res. Treat. |
| Volume | 177 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2019 |
Keywords
- Breast cancer
- Estrogen receptor
- HER2
- Progesterone receptor
- anthracycline
- carboplatin
- docetaxel
- estrogen receptor
- lapatinib
- progesterone receptor
- taxane derivative
- trastuzumab
- antineoplastic agent
- epidermal growth factor receptor 2
- adjuvant chemotherapy
- adjuvant therapy
- adult
- aged
- Article
- bone metastasis
- brain metastasis
- cancer chemotherapy
- cancer combination chemotherapy
- cancer grading
- cancer incidence
- cancer patient
- cancer prognosis
- cancer recurrence
- cancer risk
- cancer survival
- controlled study
- disease association
- disease free survival
- distant disease free survival
- drug efficacy
- early cancer
- ethnicity
- exploratory factor analysis
- false negative result
- false positive result
- follow up
- human
- human epidermal growth factor receptor 2 positive breast cancer
- human tissue
- liver metastasis
- major clinical study
- monotherapy
- multicenter study (topic)
- multiple cycle treatment
- overall survival
- phase 3 clinical trial (topic)
- predictive value
- priority journal
- randomized controlled trial (topic)
- survival rate
- survival time
- symptom
- treatment duration
- tumor volume
- visceral metastasis
- breast tumor
- clinical trial
- female
- metabolism
- molecularly targeted therapy
- mortality
- phase 3 clinical trial
- proportional hazards model
- randomized controlled trial
- treatment outcome
- Antineoplastic Combined Chemotherapy Protocols
- Breast Neoplasms
- Chemotherapy, Adjuvant
- Disease-Free Survival
- Female
- Humans
- Molecular Targeted Therapy
- Proportional Hazards Models
- Receptor, ErbB-2
- Receptors, Progesterone
- Treatment Outcome
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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 : Breast Cancer Research and Treatment. / Lambertini, M.; Campbell, C.; Gelber, R.D.; Viale, G.; McCullough, A.; Hilbers, F.; Korde, L.A.; Werner, O.; Chumsri, S.; Jackisch, C.; Wolff, A.C.; Vaz-Luis, I.; Ferreira, A.R.; Prat, A.; Moreno-Aspitia, A.; Piccart, M.; Loi, S.; de Azambuja, E.
In: Breast Cancer Res. Treat., Vol. 177, No. 1, 2019, p. 103-114.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - 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
T2 - Breast Cancer Research and Treatment
AU - Lambertini, M.
AU - Campbell, C.
AU - Gelber, R.D.
AU - Viale, G.
AU - McCullough, A.
AU - Hilbers, F.
AU - Korde, L.A.
AU - Werner, O.
AU - Chumsri, S.
AU - Jackisch, C.
AU - Wolff, A.C.
AU - Vaz-Luis, I.
AU - Ferreira, A.R.
AU - Prat, A.
AU - Moreno-Aspitia, A.
AU - Piccart, M.
AU - Loi, S.
AU - de Azambuja, E.
N1 - Cited By :1 Export Date: 27 February 2020 CODEN: BCTRD Correspondence Address: Lambertini, M.; Department of Medical Oncology, U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, Italy; email: matteo.lambertini@unige.it Chemicals/CAS: carboplatin, 41575-94-4; docetaxel, 114977-28-5; lapatinib, 231277-92-2, 388082-78-8, 437755-78-7; trastuzumab, 180288-69-1, 1446410-98-5; epidermal growth factor receptor 2, 137632-09-8; Receptor, ErbB-2; Receptors, Progesterone Funding details: Foundation for the National Institutes of Health, FNIH Funding details: GlaxoSmithKline, GSK Funding details: U10CA180882, U10CA180821 Funding details: European Musculoskeletal Oncology Society, EMSOS Funding details: European Society for Medical Oncology, ESMO Funding text 1: The ALTTO trial received financial support from GlaxoSmithKline (until January 2015), Novartis Pharma AG (as of January 2015), and the National Cancer Institute of the National Institutes of Health (NCI-NIH; Grant No. U10CA180821 and U10CA180882 to the Alliance for Clinical Trials in Oncology and Grant No. CA025224 to the legacy North Central Cancer Treatment Group). The present analysis did not receive additional funding. The funders and sponsors had no role in the design or conduct of the study, in the collection, analysis, or interpretation of the data, neither in the preparation, review, or approval of the manuscript. Funding text 2: Matteo Lambertini acknowledges the support from the European Society for Medical Oncology (ESMO) for a Translational Research Fellowship at the Institut Jules Bordet in Brussels (Belgium) during the conduction of this analysis. We also acknowledge the ALTTO staff of the BrEAST Data Centre at Institut Jules Bordet in Brussels (Belgium), for clinical record online management, and Sebastien Guillaume of BrEAST Data Centre at Institut Jules Bordet in Brussels (Belgium) for administrative support. None of the individuals named in the acknowledgment received any compensation for their contributions. 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PY - 2019
Y1 - 2019
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. © 2019, Springer Science+Business Media, LLC, part of Springer Nature.
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. © 2019, Springer Science+Business Media, LLC, part of Springer Nature.
KW - Breast cancer
KW - Estrogen receptor
KW - HER2
KW - Progesterone receptor
KW - anthracycline
KW - carboplatin
KW - docetaxel
KW - estrogen receptor
KW - lapatinib
KW - progesterone receptor
KW - taxane derivative
KW - trastuzumab
KW - antineoplastic agent
KW - epidermal growth factor receptor 2
KW - adjuvant chemotherapy
KW - adjuvant therapy
KW - adult
KW - aged
KW - Article
KW - bone metastasis
KW - brain metastasis
KW - cancer chemotherapy
KW - cancer combination chemotherapy
KW - cancer grading
KW - cancer incidence
KW - cancer patient
KW - cancer prognosis
KW - cancer recurrence
KW - cancer risk
KW - cancer survival
KW - controlled study
KW - disease association
KW - disease free survival
KW - distant disease free survival
KW - drug efficacy
KW - early cancer
KW - ethnicity
KW - exploratory factor analysis
KW - false negative result
KW - false positive result
KW - follow up
KW - human
KW - human epidermal growth factor receptor 2 positive breast cancer
KW - human tissue
KW - liver metastasis
KW - major clinical study
KW - monotherapy
KW - multicenter study (topic)
KW - multiple cycle treatment
KW - overall survival
KW - phase 3 clinical trial (topic)
KW - predictive value
KW - priority journal
KW - randomized controlled trial (topic)
KW - survival rate
KW - survival time
KW - symptom
KW - treatment duration
KW - tumor volume
KW - visceral metastasis
KW - breast tumor
KW - clinical trial
KW - female
KW - metabolism
KW - molecularly targeted therapy
KW - mortality
KW - phase 3 clinical trial
KW - proportional hazards model
KW - randomized controlled trial
KW - treatment outcome
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Breast Neoplasms
KW - Chemotherapy, Adjuvant
KW - Disease-Free Survival
KW - Female
KW - Humans
KW - Molecular Targeted Therapy
KW - Proportional Hazards Models
KW - Receptor, ErbB-2
KW - Receptors, Progesterone
KW - Treatment Outcome
U2 - 10.1007/s10549-019-05284-y
DO - 10.1007/s10549-019-05284-y
M3 - Article
VL - 177
SP - 103
EP - 114
JO - Breast Cancer Res. Treat.
JF - Breast Cancer Res. Treat.
SN - 0167-6806
IS - 1
ER -