Cargando…
Real-World Clinical Outcomes of Ribociclib in Combination with a Non-Steroidal Aromatase Inhibitor and a Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal HR+/HER2− Advanced Breast Cancer Patients: An Italian Managed Access Program
Ribociclib plus an aromatase inhibitor and ovarian function suppression is the preferred first-line option for pre-/perimenopausal women with hormone receptor-positive/human epidermal growth factor receptor-2-negative advanced or metastatic breast cancer. We opened an italian managed access program...
Autores principales: | , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9498176/ https://www.ncbi.nlm.nih.gov/pubmed/36135090 http://dx.doi.org/10.3390/curroncol29090521 |
_version_ | 1784794692317085696 |
---|---|
author | Staropoli, Nicoletta Geuna, Elena Rinaldi, Gaetana Bisagni, Giancarlo Scotti, Vieri Faggioni, Giovanni Vannini, Laura Arcara, Carlo Moretti, Gabriella Gunnellini, Marco Coltelli, Luigi Verderame, Francesco Livi, Lorenzo Sanna, Giuseppina Grasso, Donatella Abbinante, Giulia Ragni, Francesca |
author_facet | Staropoli, Nicoletta Geuna, Elena Rinaldi, Gaetana Bisagni, Giancarlo Scotti, Vieri Faggioni, Giovanni Vannini, Laura Arcara, Carlo Moretti, Gabriella Gunnellini, Marco Coltelli, Luigi Verderame, Francesco Livi, Lorenzo Sanna, Giuseppina Grasso, Donatella Abbinante, Giulia Ragni, Francesca |
author_sort | Staropoli, Nicoletta |
collection | PubMed |
description | Ribociclib plus an aromatase inhibitor and ovarian function suppression is the preferred first-line option for pre-/perimenopausal women with hormone receptor-positive/human epidermal growth factor receptor-2-negative advanced or metastatic breast cancer. We opened an italian managed access program (MAP) that permitted access to ribociclib to selected patients and allowed to collect informative results on the clinical impact of the therapy. The MAP (April 2018–May 2020) included 64 premenopausal patients, with characteristics similar to those of the MONALEESA-7 trial. Of 57 patients with a known response, 48 (84.2%) achieved a clinical benefit (i.e., complete response, N = 7 (12.3%); partial response, N = 17 (29.8%); stable disease, N = 24 (42.1%)), while 9 (15.8%) experienced tumor progression. Some patients (N = 15–23.4%) needed ribociclib dose reduction because of adverse events. Thereafter, the treatment was well tolerated, and no new safety signals emerged. Our study is the first reported Italian real-world evidence of ribociclib effectiveness in premenopausal HR+/HER2− advanced breast cancer patients. Response and clinical benefit rates were particularly encouraging compared with those of the ribociclib group of MONALEESA-7. Our work confirms that ribociclib in combination with endocrine therapy is highly effective in the treatment of premenopausal HR+/HER2− advanced breast cancer patients with an expected safety profile. |
format | Online Article Text |
id | pubmed-9498176 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-94981762022-09-23 Real-World Clinical Outcomes of Ribociclib in Combination with a Non-Steroidal Aromatase Inhibitor and a Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal HR+/HER2− Advanced Breast Cancer Patients: An Italian Managed Access Program Staropoli, Nicoletta Geuna, Elena Rinaldi, Gaetana Bisagni, Giancarlo Scotti, Vieri Faggioni, Giovanni Vannini, Laura Arcara, Carlo Moretti, Gabriella Gunnellini, Marco Coltelli, Luigi Verderame, Francesco Livi, Lorenzo Sanna, Giuseppina Grasso, Donatella Abbinante, Giulia Ragni, Francesca Curr Oncol Article Ribociclib plus an aromatase inhibitor and ovarian function suppression is the preferred first-line option for pre-/perimenopausal women with hormone receptor-positive/human epidermal growth factor receptor-2-negative advanced or metastatic breast cancer. We opened an italian managed access program (MAP) that permitted access to ribociclib to selected patients and allowed to collect informative results on the clinical impact of the therapy. The MAP (April 2018–May 2020) included 64 premenopausal patients, with characteristics similar to those of the MONALEESA-7 trial. Of 57 patients with a known response, 48 (84.2%) achieved a clinical benefit (i.e., complete response, N = 7 (12.3%); partial response, N = 17 (29.8%); stable disease, N = 24 (42.1%)), while 9 (15.8%) experienced tumor progression. Some patients (N = 15–23.4%) needed ribociclib dose reduction because of adverse events. Thereafter, the treatment was well tolerated, and no new safety signals emerged. Our study is the first reported Italian real-world evidence of ribociclib effectiveness in premenopausal HR+/HER2− advanced breast cancer patients. Response and clinical benefit rates were particularly encouraging compared with those of the ribociclib group of MONALEESA-7. Our work confirms that ribociclib in combination with endocrine therapy is highly effective in the treatment of premenopausal HR+/HER2− advanced breast cancer patients with an expected safety profile. MDPI 2022-09-17 /pmc/articles/PMC9498176/ /pubmed/36135090 http://dx.doi.org/10.3390/curroncol29090521 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Staropoli, Nicoletta Geuna, Elena Rinaldi, Gaetana Bisagni, Giancarlo Scotti, Vieri Faggioni, Giovanni Vannini, Laura Arcara, Carlo Moretti, Gabriella Gunnellini, Marco Coltelli, Luigi Verderame, Francesco Livi, Lorenzo Sanna, Giuseppina Grasso, Donatella Abbinante, Giulia Ragni, Francesca Real-World Clinical Outcomes of Ribociclib in Combination with a Non-Steroidal Aromatase Inhibitor and a Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal HR+/HER2− Advanced Breast Cancer Patients: An Italian Managed Access Program |
title | Real-World Clinical Outcomes of Ribociclib in Combination with a Non-Steroidal Aromatase Inhibitor and a Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal HR+/HER2− Advanced Breast Cancer Patients: An Italian Managed Access Program |
title_full | Real-World Clinical Outcomes of Ribociclib in Combination with a Non-Steroidal Aromatase Inhibitor and a Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal HR+/HER2− Advanced Breast Cancer Patients: An Italian Managed Access Program |
title_fullStr | Real-World Clinical Outcomes of Ribociclib in Combination with a Non-Steroidal Aromatase Inhibitor and a Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal HR+/HER2− Advanced Breast Cancer Patients: An Italian Managed Access Program |
title_full_unstemmed | Real-World Clinical Outcomes of Ribociclib in Combination with a Non-Steroidal Aromatase Inhibitor and a Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal HR+/HER2− Advanced Breast Cancer Patients: An Italian Managed Access Program |
title_short | Real-World Clinical Outcomes of Ribociclib in Combination with a Non-Steroidal Aromatase Inhibitor and a Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal HR+/HER2− Advanced Breast Cancer Patients: An Italian Managed Access Program |
title_sort | real-world clinical outcomes of ribociclib in combination with a non-steroidal aromatase inhibitor and a luteinizing hormone-releasing hormone agonist in premenopausal hr+/her2− advanced breast cancer patients: an italian managed access program |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9498176/ https://www.ncbi.nlm.nih.gov/pubmed/36135090 http://dx.doi.org/10.3390/curroncol29090521 |
work_keys_str_mv | AT staropolinicoletta realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT geunaelena realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT rinaldigaetana realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT bisagnigiancarlo realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT scottivieri realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT faggionigiovanni realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT vanninilaura realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT arcaracarlo realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT morettigabriella realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT gunnellinimarco realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT coltelliluigi realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT verderamefrancesco realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT livilorenzo realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT sannagiuseppina realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT grassodonatella realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT abbinantegiulia realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram AT ragnifrancesca realworldclinicaloutcomesofribociclibincombinationwithanonsteroidalaromataseinhibitorandaluteinizinghormonereleasinghormoneagonistinpremenopausalhrher2advancedbreastcancerpatientsanitalianmanagedaccessprogram |