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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

1
Medical Oncology and Translational Medical Oncology Units, Department of Experimental and Clinical Medicine, Magna Graecia University, AOU Materdomini Catanzaro, Campus Salvatore Venuta, 88100 Catanzaro, Italy
2
Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, 10060 Candiolo, Italy
3
Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, 90133 Palermo, Italy
4
Department of Oncology, Azienda Sanitaria Universitaria Friuli Centrale, 33100 Udine, Italy
5
Department of Oncology, Radiation Therapy Unit, Careggi University Hospital, 50134 Florence, Italy
6
Medical Oncology 2, Istituto Oncologico Veneto IRCCS, 35128 Padova, Italy
7
Department of Oncology, University of Florence, 50134 Florence, Italy
8
Medical Oncology Unit, La Maddalena Hospital, 90146 Palermo, Italy
9
Oncologia Medica USL Umbria 1, Gubbio, 06024 Perugia, Italy
10
UOC Oncologia Ospedale Civile Livorno USL Toscana Nord Ovest Livorno, 57124 Livorno, Italy
11
Villa Sofia-Cervello Hospital, 90146 Palermo, Italy
12
Sandro Pitigliani’ Medical Oncology Department, Istituto Toscano Tumori, 59100 Prato, Italy
13
Novartis Farma S.p.A., 21042 Origgio, Italy
*
Author to whom correspondence should be addressed.
Current affiliation: Daiichi Sankyo, 00142 Rome, Italy.
Curr. Oncol. 2022, 29(9), 6635-6641; https://doi.org/10.3390/curroncol29090521
Received: 7 July 2022 / Revised: 24 August 2022 / Accepted: 31 August 2022 / Published: 17 September 2022
(This article belongs to the Collection New Insights into Breast Cancer Diagnosis and Treatment)
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. View Full-Text
Keywords: advanced breast cancer; MAP; MONALEESA-7; premenopausal; ribociclib; young breast cancer advanced breast cancer; MAP; MONALEESA-7; premenopausal; ribociclib; young breast cancer
MDPI and ACS Style

Staropoli, N.; Geuna, E.; Rinaldi, G.; Bisagni, G.; Scotti, V.; Faggioni, G.; Vannini, L.; Arcara, C.; Moretti, G.; Gunnellini, M.; Coltelli, L.; Verderame, F.; Livi, L.; Sanna, G.; Grasso, D.; Abbinante, G.; Ragni, F. 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. Curr. Oncol. 2022, 29, 6635-6641. https://doi.org/10.3390/curroncol29090521

AMA Style

Staropoli N, Geuna E, Rinaldi G, Bisagni G, Scotti V, Faggioni G, Vannini L, Arcara C, Moretti G, Gunnellini M, Coltelli L, Verderame F, Livi L, Sanna G, Grasso D, Abbinante G, Ragni F. 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. 2022; 29(9):6635-6641. https://doi.org/10.3390/curroncol29090521

Chicago/Turabian Style

Staropoli, Nicoletta, 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, and Francesca Ragni. 2022. "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 29, no. 9: 6635-6641. https://doi.org/10.3390/curroncol29090521

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