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PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology
BACKGROUND: Approximately 5–10% of unselected breast cancer (BC) patients retain a hereditary predisposition related to a germline mutation in BRCA1/2 genes. The poly-ADP ribose polymerase (PARP)-inhibitors olaparib and talazoparib have been granted marketing authorization by both FDA and EMA for ad...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9663524/ https://www.ncbi.nlm.nih.gov/pubmed/36379199 http://dx.doi.org/10.1016/j.breast.2022.10.014 |
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author | Miglietta, Federica Cinquini, Michela Dieci, Maria Vittoria Cortesi, Laura Criscitiello, Carmen Montemurro, Filippo Del Mastro, Lucia Zambelli, Alberto Biganzoli, Laura Levaggi, Alessia Delle Piane, Chiara Marchiò, Caterina Calabrese, Massimo Fortunato, Lucio Franco, Pierfrancesco Meduri, Bruno Fittipaldo, Veronica Andrea Gori, Stefania |
author_facet | Miglietta, Federica Cinquini, Michela Dieci, Maria Vittoria Cortesi, Laura Criscitiello, Carmen Montemurro, Filippo Del Mastro, Lucia Zambelli, Alberto Biganzoli, Laura Levaggi, Alessia Delle Piane, Chiara Marchiò, Caterina Calabrese, Massimo Fortunato, Lucio Franco, Pierfrancesco Meduri, Bruno Fittipaldo, Veronica Andrea Gori, Stefania |
author_sort | Miglietta, Federica |
collection | PubMed |
description | BACKGROUND: Approximately 5–10% of unselected breast cancer (BC) patients retain a hereditary predisposition related to a germline mutation in BRCA1/2 genes. The poly-ADP ribose polymerase (PARP)-inhibitors olaparib and talazoparib have been granted marketing authorization by both FDA and EMA for adults with BRCA1/2 germline mutations and HER2-negative (HER2-) advanced BC based on the results from the phase III OlympiAd and EMBRACA trials. METHODS: The panel of the Italian Association of Medical Oncology (AIOM) Clinical Practice Guidelines on Breast Cancer addressed two critical clinical questions, adopting the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach and the Evidence to Decision framework (EtD), to develop recommendations on the use of PARP-inhibitors, with respect to single-agent chemotherapy, in patients with BRCA-related triple-negative (clinical question 1) and hormone receptor-positive (HR+)/HER2- (clinical question 2) advanced BC. RESULTS: Two studies were eligible (OlympiAd and EMBRACA). For both clinical questions, the Panel judged the benefit/harm balance probably in favor of the intervention, given the favorable impact in terms of PFS, ORR, and QoL at an acceptable cost in terms of toxicity; the overall certainty of the evidence was low. The panel's final recommendations were conditional in favor of PARP-inhibitors over single-agent chemotherapy in both HR+/HER2-and triple-negative BC. Finally, the Panel identified and discussed areas of uncertainty calling for further exploration. CONCLUSIONS: The Panel of AIOM BC Clinical Practice Guideline provided clinical recommendations on the use of PARP-inhibitors, with respect to single-agent chemotherapy, in patients with BRCA-related HER2-advanced BC by adopting the GRADE methodology. |
format | Online Article Text |
id | pubmed-9663524 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-96635242022-11-15 PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology Miglietta, Federica Cinquini, Michela Dieci, Maria Vittoria Cortesi, Laura Criscitiello, Carmen Montemurro, Filippo Del Mastro, Lucia Zambelli, Alberto Biganzoli, Laura Levaggi, Alessia Delle Piane, Chiara Marchiò, Caterina Calabrese, Massimo Fortunato, Lucio Franco, Pierfrancesco Meduri, Bruno Fittipaldo, Veronica Andrea Gori, Stefania Breast Review BACKGROUND: Approximately 5–10% of unselected breast cancer (BC) patients retain a hereditary predisposition related to a germline mutation in BRCA1/2 genes. The poly-ADP ribose polymerase (PARP)-inhibitors olaparib and talazoparib have been granted marketing authorization by both FDA and EMA for adults with BRCA1/2 germline mutations and HER2-negative (HER2-) advanced BC based on the results from the phase III OlympiAd and EMBRACA trials. METHODS: The panel of the Italian Association of Medical Oncology (AIOM) Clinical Practice Guidelines on Breast Cancer addressed two critical clinical questions, adopting the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach and the Evidence to Decision framework (EtD), to develop recommendations on the use of PARP-inhibitors, with respect to single-agent chemotherapy, in patients with BRCA-related triple-negative (clinical question 1) and hormone receptor-positive (HR+)/HER2- (clinical question 2) advanced BC. RESULTS: Two studies were eligible (OlympiAd and EMBRACA). For both clinical questions, the Panel judged the benefit/harm balance probably in favor of the intervention, given the favorable impact in terms of PFS, ORR, and QoL at an acceptable cost in terms of toxicity; the overall certainty of the evidence was low. The panel's final recommendations were conditional in favor of PARP-inhibitors over single-agent chemotherapy in both HR+/HER2-and triple-negative BC. Finally, the Panel identified and discussed areas of uncertainty calling for further exploration. CONCLUSIONS: The Panel of AIOM BC Clinical Practice Guideline provided clinical recommendations on the use of PARP-inhibitors, with respect to single-agent chemotherapy, in patients with BRCA-related HER2-advanced BC by adopting the GRADE methodology. Elsevier 2022-10-29 /pmc/articles/PMC9663524/ /pubmed/36379199 http://dx.doi.org/10.1016/j.breast.2022.10.014 Text en © 2022 The Authors 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 | Review Miglietta, Federica Cinquini, Michela Dieci, Maria Vittoria Cortesi, Laura Criscitiello, Carmen Montemurro, Filippo Del Mastro, Lucia Zambelli, Alberto Biganzoli, Laura Levaggi, Alessia Delle Piane, Chiara Marchiò, Caterina Calabrese, Massimo Fortunato, Lucio Franco, Pierfrancesco Meduri, Bruno Fittipaldo, Veronica Andrea Gori, Stefania PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology |
title | PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology |
title_full | PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology |
title_fullStr | PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology |
title_full_unstemmed | PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology |
title_short | PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology |
title_sort | parp-inhibitors for brca1/2-related advanced her2-negative breast cancer: a meta-analysis and grade recommendations by the italian association of medical oncology |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9663524/ https://www.ncbi.nlm.nih.gov/pubmed/36379199 http://dx.doi.org/10.1016/j.breast.2022.10.014 |
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