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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...

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Autores principales: 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
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
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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.
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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
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