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...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-12-01
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| Series: | Breast |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0960977622001795 |
| _version_ | 1811195602338316288 |
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| author | Federica Miglietta Michela Cinquini Maria Vittoria Dieci Laura Cortesi Carmen Criscitiello Filippo Montemurro Lucia Del Mastro Alberto Zambelli Laura Biganzoli Alessia Levaggi Chiara Delle Piane Caterina Marchiò Massimo Calabrese Lucio Fortunato Pierfrancesco Franco Bruno Meduri Veronica Andrea Fittipaldo Stefania Gori |
| author_facet | Federica Miglietta Michela Cinquini Maria Vittoria Dieci Laura Cortesi Carmen Criscitiello Filippo Montemurro Lucia Del Mastro Alberto Zambelli Laura Biganzoli Alessia Levaggi Chiara Delle Piane Caterina Marchiò Massimo Calabrese Lucio Fortunato Pierfrancesco Franco Bruno Meduri Veronica Andrea Fittipaldo Stefania Gori |
| author_sort | Federica Miglietta |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-12T00:45:54Z |
| format | Article |
| id | doaj.art-3ea861a9be254e08959bcd109a71e6ee |
| institution | Directory Open Access Journal |
| issn | 1532-3080 |
| language | English |
| last_indexed | 2024-04-12T00:45:54Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Breast |
| spelling | doaj.art-3ea861a9be254e08959bcd109a71e6ee2022-12-22T03:54:52ZengElsevierBreast1532-30802022-12-0166293304PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical OncologyFederica Miglietta0Michela Cinquini1Maria Vittoria Dieci2Laura Cortesi3Carmen Criscitiello4Filippo Montemurro5Lucia Del Mastro6Alberto Zambelli7Laura Biganzoli8Alessia Levaggi9Chiara Delle Piane10Caterina Marchiò11Massimo Calabrese12Lucio Fortunato13Pierfrancesco Franco14Bruno Meduri15Veronica Andrea Fittipaldo16Stefania Gori17Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Division of Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy; Corresponding author. Division of Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy.Istituto di Ricerche Farmacologiche Mario Negri IRCCS., Laboratory of Methodology of Sistematic Reviews and Guidelines production; Department of Oncology, Milano, ItalyDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Division of Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, ItalyDepartment of Oncology and Hematology Azienda Ospedaliero-Universitaria di Modena, ItalyEuropean Institute of Oncology IRCCS, Milan, Italy; University of Milan, Milan, ItalyMultidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, ItalyClinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Internal Medicine and Medical Specialities, School of Medicine, University of Genova, Genova, ItalyDepartment of Biomedical Sciences, Humanitas University, Milan, Italy; IRCCS Humanitas Research Hospital, Milan, ItalyMedical Oncology Division, Hospital of Prato, Prato, ItalyDepartment of Oncology, Sant'Andrea Hospital, La Spezia, ItalyClinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genova, ItalyCandiolo Cancer Institute FPO-IRCCS, Candiolo, Italy; Department of Medical Sciences, University of Turin, Turin, ItalySenologia Diagnostica, IRCCS-Ospedale Policlinico San Martino - Genova, ItalyCentro di Senologia - Azienda Ospedaliera San Giovanni-Addolorata, Roma, ItalyDepartment of Translational Medicine (DIMET), University of Eastern Piedmont, Novara, ItalyRadioterapia - Azienda ospedaliera-Universitaria di Modena, Modena, ItalyIstituto di Ricerche Farmacologiche Mario Negri IRCCS., Laboratory of Methodology of Sistematic Reviews and Guidelines production; Department of Oncology, Milano, ItalyMedical Oncology Unit, Sacro Cuore - Don Calabria Hospital, Cancer Care Center, Negrar, ItalyBackground: 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.http://www.sciencedirect.com/science/article/pii/S0960977622001795BRCA germline mutationsBreast cancerHER2-negativePARP-InhibitorsGRADE methodology |
| spellingShingle | Federica Miglietta Michela Cinquini Maria Vittoria Dieci Laura Cortesi Carmen Criscitiello Filippo Montemurro Lucia Del Mastro Alberto Zambelli Laura Biganzoli Alessia Levaggi Chiara Delle Piane Caterina Marchiò Massimo Calabrese Lucio Fortunato Pierfrancesco Franco Bruno Meduri Veronica Andrea Fittipaldo Stefania Gori PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical Oncology Breast BRCA germline mutations Breast cancer HER2-negative PARP-Inhibitors GRADE methodology |
| 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 | BRCA germline mutations Breast cancer HER2-negative PARP-Inhibitors GRADE methodology |
| url | http://www.sciencedirect.com/science/article/pii/S0960977622001795 |
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