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Prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) studies
BACKGROUND: Prior exposure to adjuvant endocrine therapy (ET) and timing to recurrence are crucial factors for first-line treatment choices in patients with hormone receptor-positive/HER2-negative (HR+/HER2−) breast cancer (BC) and in clinical trial eligibility, classifying metastatic HR+/HER2− BC a...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10225659/ https://www.ncbi.nlm.nih.gov/pubmed/37256095 http://dx.doi.org/10.1016/j.eclinm.2023.101931 |
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author | Lambertini, Matteo Blondeaux, Eva Bisagni, Giancarlo Mura, Silvia De Placido, Sabino De Laurentiis, Michelino Fabi, Alessandra Rimanti, Anita Michelotti, Andrea Mansutti, Mauro Russo, Antonio Montemurro, Filippo Frassoldati, Antonio Durando, Antonio Gori, Stefania Turletti, Anna Tamberi, Stefano Urracci, Ylenia Fregatti, Piero Razeti, Maria Grazia Caputo, Roberta De Angelis, Carmine Sanna, Valeria Gasparini, Elisa Agostinetto, Elisa de Azambuja, Evandro Poggio, Francesca Boni, Luca Del Mastro, Lucia |
author_facet | Lambertini, Matteo Blondeaux, Eva Bisagni, Giancarlo Mura, Silvia De Placido, Sabino De Laurentiis, Michelino Fabi, Alessandra Rimanti, Anita Michelotti, Andrea Mansutti, Mauro Russo, Antonio Montemurro, Filippo Frassoldati, Antonio Durando, Antonio Gori, Stefania Turletti, Anna Tamberi, Stefano Urracci, Ylenia Fregatti, Piero Razeti, Maria Grazia Caputo, Roberta De Angelis, Carmine Sanna, Valeria Gasparini, Elisa Agostinetto, Elisa de Azambuja, Evandro Poggio, Francesca Boni, Luca Del Mastro, Lucia |
author_sort | Lambertini, Matteo |
collection | PubMed |
description | BACKGROUND: Prior exposure to adjuvant endocrine therapy (ET) and timing to recurrence are crucial factors for first-line treatment choices in patients with hormone receptor-positive/HER2-negative (HR+/HER2−) breast cancer (BC) and in clinical trial eligibility, classifying metastatic HR+/HER2− BC as endocrine sensitive (ES) or primary (1ER)/secondary (2ER) resistant. However, this classification is largely based on expert opinion and no proper evidence exists to date to support its possible prognostic and clinical impact. METHODS: This analysis included individual patient-level data from 4 adjuvant phase III randomized trials by the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) study groups. The impact of endocrine resistance/sensitivity classification on overall survival (mOS, defined as time between date of distant relapse and death) was assessed in both univariate and multivariate Cox proportional hazards models. FINDINGS: Between November 1992 and July 2012, 9058 patients were randomized in 4 trials, of whom 6612 had HR+/HER2− BC. Median follow-up was 9.1 years (interquartile range [IQR] 5.6–15.0). In the whole cohort, disease-free survival and OS were 90.4% and 96.6% at 5 years, and 79.1% and 89.4% at 10 years, respectively. The estimated hazard of recurrence raised constantly during the first 15 years from diagnosis, being more pronounced during the first 2 years and less pronounced after year 7. Among the 493 patients with a distant relapse as first disease-free survival event and available date on ET completion, 72 (14.6%), 207 (42.0%) and 214 (43.4%) were classified as having 1ER, 2ER and ES, respectively. Median follow-up from diagnosis of a distant relapse was 3.8 years (IQR 1.6–7.5). Patients with 1ER were significantly more likely to be younger, to have N2/N3 nodal status, grade 3 tumours and to develop visceral metastases. Site of first distant relapse was significantly different between the 3 groups (p = 0.005). In patients with 1ER, 2ER and ES breast cancer, median mOS was 27.2, 38.4 and 43.2 months, respectively (p = 0.03). As compared to patients with ES disease, a higher risk of death was observed in those with 1 ER (adjusted Hazard Ratio [aHR] 1.54; 95% CI 1.03–2.30) and 2ER (aHR 1.17; 95% CI 0.87–1.56) (p = 0.11). INTERPRETATION: This large analysis with long-term follow-up provides evidence on the prognostic and clinical impact of the currently adopted endocrine resistance/sensitivity classification in patients with HR+/HER2− advanced BC. This classification may be considered a valid tool to guide clinical decision-making and to design future ET trials in the metastatic setting. FUNDING: 10.13039/501100005010AIRC. |
format | Online Article Text |
id | pubmed-10225659 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-102256592023-05-30 Prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) studies Lambertini, Matteo Blondeaux, Eva Bisagni, Giancarlo Mura, Silvia De Placido, Sabino De Laurentiis, Michelino Fabi, Alessandra Rimanti, Anita Michelotti, Andrea Mansutti, Mauro Russo, Antonio Montemurro, Filippo Frassoldati, Antonio Durando, Antonio Gori, Stefania Turletti, Anna Tamberi, Stefano Urracci, Ylenia Fregatti, Piero Razeti, Maria Grazia Caputo, Roberta De Angelis, Carmine Sanna, Valeria Gasparini, Elisa Agostinetto, Elisa de Azambuja, Evandro Poggio, Francesca Boni, Luca Del Mastro, Lucia eClinicalMedicine Articles BACKGROUND: Prior exposure to adjuvant endocrine therapy (ET) and timing to recurrence are crucial factors for first-line treatment choices in patients with hormone receptor-positive/HER2-negative (HR+/HER2−) breast cancer (BC) and in clinical trial eligibility, classifying metastatic HR+/HER2− BC as endocrine sensitive (ES) or primary (1ER)/secondary (2ER) resistant. However, this classification is largely based on expert opinion and no proper evidence exists to date to support its possible prognostic and clinical impact. METHODS: This analysis included individual patient-level data from 4 adjuvant phase III randomized trials by the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) study groups. The impact of endocrine resistance/sensitivity classification on overall survival (mOS, defined as time between date of distant relapse and death) was assessed in both univariate and multivariate Cox proportional hazards models. FINDINGS: Between November 1992 and July 2012, 9058 patients were randomized in 4 trials, of whom 6612 had HR+/HER2− BC. Median follow-up was 9.1 years (interquartile range [IQR] 5.6–15.0). In the whole cohort, disease-free survival and OS were 90.4% and 96.6% at 5 years, and 79.1% and 89.4% at 10 years, respectively. The estimated hazard of recurrence raised constantly during the first 15 years from diagnosis, being more pronounced during the first 2 years and less pronounced after year 7. Among the 493 patients with a distant relapse as first disease-free survival event and available date on ET completion, 72 (14.6%), 207 (42.0%) and 214 (43.4%) were classified as having 1ER, 2ER and ES, respectively. Median follow-up from diagnosis of a distant relapse was 3.8 years (IQR 1.6–7.5). Patients with 1ER were significantly more likely to be younger, to have N2/N3 nodal status, grade 3 tumours and to develop visceral metastases. Site of first distant relapse was significantly different between the 3 groups (p = 0.005). In patients with 1ER, 2ER and ES breast cancer, median mOS was 27.2, 38.4 and 43.2 months, respectively (p = 0.03). As compared to patients with ES disease, a higher risk of death was observed in those with 1 ER (adjusted Hazard Ratio [aHR] 1.54; 95% CI 1.03–2.30) and 2ER (aHR 1.17; 95% CI 0.87–1.56) (p = 0.11). INTERPRETATION: This large analysis with long-term follow-up provides evidence on the prognostic and clinical impact of the currently adopted endocrine resistance/sensitivity classification in patients with HR+/HER2− advanced BC. This classification may be considered a valid tool to guide clinical decision-making and to design future ET trials in the metastatic setting. FUNDING: 10.13039/501100005010AIRC. Elsevier 2023-05-12 /pmc/articles/PMC10225659/ /pubmed/37256095 http://dx.doi.org/10.1016/j.eclinm.2023.101931 Text en © 2023 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Articles Lambertini, Matteo Blondeaux, Eva Bisagni, Giancarlo Mura, Silvia De Placido, Sabino De Laurentiis, Michelino Fabi, Alessandra Rimanti, Anita Michelotti, Andrea Mansutti, Mauro Russo, Antonio Montemurro, Filippo Frassoldati, Antonio Durando, Antonio Gori, Stefania Turletti, Anna Tamberi, Stefano Urracci, Ylenia Fregatti, Piero Razeti, Maria Grazia Caputo, Roberta De Angelis, Carmine Sanna, Valeria Gasparini, Elisa Agostinetto, Elisa de Azambuja, Evandro Poggio, Francesca Boni, Luca Del Mastro, Lucia Prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) studies |
title | Prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) studies |
title_full | Prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) studies |
title_fullStr | Prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) studies |
title_full_unstemmed | Prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) studies |
title_short | Prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) studies |
title_sort | prognostic and clinical impact of the endocrine resistance/sensitivity classification according to international consensus guidelines for advanced breast cancer: an individual patient-level analysis from the mammella intergruppo (mig) and gruppo italiano mammella (gim) studies |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10225659/ https://www.ncbi.nlm.nih.gov/pubmed/37256095 http://dx.doi.org/10.1016/j.eclinm.2023.101931 |
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