Real-World, National Study of Palbociclib in HR+/HER2− Metastatic Breast Cancer: A 2.5-Year Follow-Up PALBO01/2021
<b>Background:</b> Palbociclib, when combined with endocrine therapy, represents a valuable treatment option for patients diagnosed with hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer (BC) or metastatic breast cancer (MBC)....
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2025-05-01
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| author | Cristina Marinela Oprean Larisa Maria Badau Ramona Petrita Mircea Dragos Median Alis Dema |
| author_facet | Cristina Marinela Oprean Larisa Maria Badau Ramona Petrita Mircea Dragos Median Alis Dema |
| author_sort | Cristina Marinela Oprean |
| collection | DOAJ |
| description | <b>Background:</b> Palbociclib, when combined with endocrine therapy, represents a valuable treatment option for patients diagnosed with hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer (BC) or metastatic breast cancer (MBC). Approved in Europe following phase II/III trials, it became the first CDK4/6 inhibitor used alongside hormone therapy. Available real-world data demonstrate the strong performance of Palbociclib in unselected, heavily pretreated patient groups. Our retrospective, observational, multicenter study, conducted in six Romanian institutions during a follow-up period of 2.5 years, aimed to assess Palbociclib’s safety and effectiveness in clinical practice. <b>Objectives:</b> The primary endpoints included response rate such as overall response rate (ORR), duration of response (DOR), disease control rate (DCR) and best clinical response (BCR), progression free survival (PFS) and overall survival (OS). The secondary objectives focused on treatment duration with aromatase inhibitors (AI) or fulvestrant and subsequent therapies after disease progression. Grade 3/4 adverse events were individually recorded. Exploratory analysis evaluated the potential predictive biomarkers such as Ki67, lower levels of HER2 expression (HER2-low), and histological or luminal subtype. <b>Methods:</b> Approximately 650 patients were planned for inclusion. PFS and OS were analyzed via the Kaplan–Meier method, with median times, 1- and 2-year estimates, and 95% confidence intervals reported. <b>Conclusions:</b> This study supports the integration of clinical trial evidence into real-world settings, enhancing patient selection and treatment personalization. |
| format | Article |
| id | doaj-art-0f37d6f058a247fc8ba64e5c2138bfa8 |
| institution | Kabale University |
| issn | 2075-4418 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj-art-0f37d6f058a247fc8ba64e5c2138bfa82025-08-20T03:52:56ZengMDPI AGDiagnostics2075-44182025-05-01159117310.3390/diagnostics15091173Real-World, National Study of Palbociclib in HR+/HER2− Metastatic Breast Cancer: A 2.5-Year Follow-Up PALBO01/2021Cristina Marinela Oprean0Larisa Maria Badau1Ramona Petrita2Mircea Dragos Median3Alis Dema4ANAPATMOL Research Center, ‘Victor Babes’ University of Medicine and Pharmacy of Timisoara, 300041 Timisoara, RomaniaDepartment of Oncology, ONCOHELP Hospital Timisoara, 300239 Timisoara, RomaniaBiometrics Unit MDX Research SRL Vasile Voichita 1-3 SAD2, Building C, 300633 Timisoara, RomaniaGynecologic Oncology Department, Filantropia Clinical Hospital Bucharest, 011171 Bucharest, RomaniaANAPATMOL Research Center, ‘Victor Babes’ University of Medicine and Pharmacy of Timisoara, 300041 Timisoara, Romania<b>Background:</b> Palbociclib, when combined with endocrine therapy, represents a valuable treatment option for patients diagnosed with hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer (BC) or metastatic breast cancer (MBC). Approved in Europe following phase II/III trials, it became the first CDK4/6 inhibitor used alongside hormone therapy. Available real-world data demonstrate the strong performance of Palbociclib in unselected, heavily pretreated patient groups. Our retrospective, observational, multicenter study, conducted in six Romanian institutions during a follow-up period of 2.5 years, aimed to assess Palbociclib’s safety and effectiveness in clinical practice. <b>Objectives:</b> The primary endpoints included response rate such as overall response rate (ORR), duration of response (DOR), disease control rate (DCR) and best clinical response (BCR), progression free survival (PFS) and overall survival (OS). The secondary objectives focused on treatment duration with aromatase inhibitors (AI) or fulvestrant and subsequent therapies after disease progression. Grade 3/4 adverse events were individually recorded. Exploratory analysis evaluated the potential predictive biomarkers such as Ki67, lower levels of HER2 expression (HER2-low), and histological or luminal subtype. <b>Methods:</b> Approximately 650 patients were planned for inclusion. PFS and OS were analyzed via the Kaplan–Meier method, with median times, 1- and 2-year estimates, and 95% confidence intervals reported. <b>Conclusions:</b> This study supports the integration of clinical trial evidence into real-world settings, enhancing patient selection and treatment personalization.https://www.mdpi.com/2075-4418/15/9/1173breast cancercyclin-dependent kinase 4/6 inhibitorpalbociclibreal-worldHer2 lowKi67 |
| spellingShingle | Cristina Marinela Oprean Larisa Maria Badau Ramona Petrita Mircea Dragos Median Alis Dema Real-World, National Study of Palbociclib in HR+/HER2− Metastatic Breast Cancer: A 2.5-Year Follow-Up PALBO01/2021 Diagnostics breast cancer cyclin-dependent kinase 4/6 inhibitor palbociclib real-world Her2 low Ki67 |
| title | Real-World, National Study of Palbociclib in HR+/HER2− Metastatic Breast Cancer: A 2.5-Year Follow-Up PALBO01/2021 |
| title_full | Real-World, National Study of Palbociclib in HR+/HER2− Metastatic Breast Cancer: A 2.5-Year Follow-Up PALBO01/2021 |
| title_fullStr | Real-World, National Study of Palbociclib in HR+/HER2− Metastatic Breast Cancer: A 2.5-Year Follow-Up PALBO01/2021 |
| title_full_unstemmed | Real-World, National Study of Palbociclib in HR+/HER2− Metastatic Breast Cancer: A 2.5-Year Follow-Up PALBO01/2021 |
| title_short | Real-World, National Study of Palbociclib in HR+/HER2− Metastatic Breast Cancer: A 2.5-Year Follow-Up PALBO01/2021 |
| title_sort | real world national study of palbociclib in hr her2 metastatic breast cancer a 2 5 year follow up palbo01 2021 |
| topic | breast cancer cyclin-dependent kinase 4/6 inhibitor palbociclib real-world Her2 low Ki67 |
| url | https://www.mdpi.com/2075-4418/15/9/1173 |
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