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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| Format: | Article |
| Language: | English |
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MDPI AG
2022-09-01
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| Series: | Current Oncology |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1718-7729/29/9/521 |
| _version_ | 1797489587234275328 |
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| author | Nicoletta Staropoli Elena Geuna Gaetana Rinaldi Giancarlo Bisagni Vieri Scotti Giovanni Faggioni Laura Vannini Carlo Arcara Gabriella Moretti Marco Gunnellini Luigi Coltelli Francesco Verderame Lorenzo Livi Giuseppina Sanna Donatella Grasso Giulia Abbinante Francesca Ragni |
| author_facet | Nicoletta Staropoli Elena Geuna Gaetana Rinaldi Giancarlo Bisagni Vieri Scotti Giovanni Faggioni Laura Vannini Carlo Arcara Gabriella Moretti Marco Gunnellini Luigi Coltelli Francesco Verderame Lorenzo Livi Giuseppina Sanna Donatella Grasso Giulia Abbinante Francesca Ragni |
| author_sort | Nicoletta Staropoli |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-10T00:18:45Z |
| format | Article |
| id | doaj.art-3f3f4fb521364b87877acb92d608198e |
| institution | Directory Open Access Journal |
| issn | 1198-0052 1718-7729 |
| language | English |
| last_indexed | 2024-03-10T00:18:45Z |
| publishDate | 2022-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj.art-3f3f4fb521364b87877acb92d608198e2023-11-23T15:46:14ZengMDPI AGCurrent Oncology1198-00521718-77292022-09-012996635664110.3390/curroncol29090521Real-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 ProgramNicoletta Staropoli0Elena Geuna1Gaetana Rinaldi2Giancarlo Bisagni3Vieri Scotti4Giovanni Faggioni5Laura Vannini6Carlo Arcara7Gabriella Moretti8Marco Gunnellini9Luigi Coltelli10Francesco Verderame11Lorenzo Livi12Giuseppina Sanna13Donatella Grasso14Giulia Abbinante15Francesca Ragni16Medical Oncology and Translational Medical Oncology Units, Department of Experimental and Clinical Medicine, Magna Graecia University, AOU Materdomini Catanzaro, Campus Salvatore Venuta, 88100 Catanzaro, ItalyMultidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, 10060 Candiolo, ItalyDepartment of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, 90133 Palermo, ItalyMedical Oncology Unit, Azienda USL-IRCCS di Reggio Emilia, 42123 Reggio Emilia, ItalyDepartment of Oncology, Radiation Therapy Unit, Careggi University Hospital, 50134 Florence, ItalyMedical Oncology 2, Istituto Oncologico Veneto IRCCS, 35128 Padova, ItalyDepartment of Oncology, University of Florence, 50134 Florence, ItalyMedical Oncology Unit, La Maddalena Hospital, 90146 Palermo, ItalyMedical Oncology Unit, Azienda USL-IRCCS di Reggio Emilia, 42123 Reggio Emilia, ItalyOncologia Medica USL Umbria 1, Gubbio, 06024 Perugia, ItalyUOC Oncologia Ospedale Civile Livorno USL Toscana Nord Ovest Livorno, 57124 Livorno, ItalyVilla Sofia-Cervello Hospital, 90146 Palermo, ItalyDepartment of Oncology, Radiation Therapy Unit, Careggi University Hospital, 50134 Florence, ItalySandro Pitigliani’ Medical Oncology Department, Istituto Toscano Tumori, 59100 Prato, ItalyNovartis Farma S.p.A., 21042 Origgio, ItalyNovartis Farma S.p.A., 21042 Origgio, ItalyNovartis Farma S.p.A., 21042 Origgio, ItalyRibociclib 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.https://www.mdpi.com/1718-7729/29/9/521advanced breast cancerMAPMONALEESA-7premenopausalribociclibyoung breast cancer |
| spellingShingle | Nicoletta Staropoli Elena Geuna Gaetana Rinaldi Giancarlo Bisagni Vieri Scotti Giovanni Faggioni Laura Vannini Carlo Arcara Gabriella Moretti Marco Gunnellini Luigi Coltelli Francesco Verderame Lorenzo Livi Giuseppina Sanna Donatella Grasso Giulia Abbinante Francesca Ragni 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 Current Oncology advanced breast cancer MAP MONALEESA-7 premenopausal ribociclib young breast cancer |
| 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 | advanced breast cancer MAP MONALEESA-7 premenopausal ribociclib young breast cancer |
| url | https://www.mdpi.com/1718-7729/29/9/521 |
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