{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T08:06:57Z","timestamp":1777363617005,"version":"3.51.4"},"reference-count":24,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2025,5,5]],"date-time":"2025-05-05T00:00:00Z","timestamp":1746403200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Pfizer Romania","award":["4794\/06 October 2021"],"award-info":[{"award-number":["4794\/06 October 2021"]}]},{"name":"the \u201cVictor Babes\u201d University of Medicine and Pharmacy Timisoara, Romania","award":["4794\/06 October 2021"],"award-info":[{"award-number":["4794\/06 October 2021"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background: 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\u2019s safety and effectiveness in clinical practice. Objectives: 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. Methods: Approximately 650 patients were planned for inclusion. PFS and OS were analyzed via the Kaplan\u2013Meier method, with median times, 1- and 2-year estimates, and 95% confidence intervals reported. Conclusions: This study supports the integration of clinical trial evidence into real-world settings, enhancing patient selection and treatment personalization.<\/jats:p>","DOI":"10.3390\/diagnostics15091173","type":"journal-article","created":{"date-parts":[[2025,5,5]],"date-time":"2025-05-05T21:42:09Z","timestamp":1746481329000},"page":"1173","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Real-World, National Study of Palbociclib in HR+\/HER2\u2212 Metastatic Breast Cancer: A 2.5-Year Follow-Up PALBO01\/2021"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5000-5422","authenticated-orcid":false,"given":"Cristina Marinela","family":"Oprean","sequence":"first","affiliation":[{"name":"ANAPATMOL Research Center, \u2018Victor Babes\u2019 University of Medicine and Pharmacy of Timisoara, 300041 Timisoara, Romania"},{"name":"Department of Oncology, ONCOHELP Hospital Timisoara, 300239 Timisoara, Romania"},{"name":"Department of Oncology, ONCOMED Outpatient Unit Timisoara, 300239 Timisoara, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Larisa Maria","family":"Badau","sequence":"additional","affiliation":[{"name":"Department of Oncology, ONCOHELP Hospital Timisoara, 300239 Timisoara, Romania"},{"name":"Hygiene Discipline, \u201cVictor Babes\u201d University of Medicine and Pharmacy, 300041 Timisoara, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8626-1222","authenticated-orcid":false,"given":"Ramona","family":"Petrita","sequence":"additional","affiliation":[{"name":"Biometrics Unit MDX Research SRL Vasile Voichita 1-3 SAD2, Building C, 300633 Timisoara, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5842-1850","authenticated-orcid":false,"given":"Mircea Dragos","family":"Median","sequence":"additional","affiliation":[{"name":"Gynecologic Oncology Department, Filantropia Clinical Hospital Bucharest, 011171 Bucharest, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alis","family":"Dema","sequence":"additional","affiliation":[{"name":"ANAPATMOL Research Center, \u2018Victor Babes\u2019 University of Medicine and Pharmacy of Timisoara, 300041 Timisoara, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,5,5]]},"reference":[{"key":"ref_1","unstructured":"(2025, April 12). Metastatic Breast Cancer|Cancer Support Community. Available online: https:\/\/www.cancersupportcommunity.org\/metastatic-breast-cancer."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1016\/j.breast.2018.03.002","article-title":"Global analysis of advanced\/metastatic breast cancer: Decade report (2005\u20132015)","volume":"39","author":"Cardoso","year":"2018","journal-title":"Breast"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"S91","DOI":"10.4103\/0019-5545.196977","article-title":"Clinical Practice Guidelines for Management of Sexual Dysfunction","volume":"59","author":"Avasthi","year":"2017","journal-title":"Indian J. Psychiatry"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Oprean, C.M., Negru, S.M., Popovici, D.I., Saftescu, S., Han, R.A., Dragomir, G.M., Hoinoiu, T., and Dema, A. (2020). Postmenopausal Breast Cancer in Women, Clinical and Epidemiological Factors Related to the Molecular Subtype: A Retrospective Cohort Study in a Single Institution for 13 Years. Follow-Up Data. Int. J. Env. Res. Public Health, 17.","DOI":"10.3390\/ijerph17238722"},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Tapia, M., Hernando, C., Mart\u00ednez, M.T., Burgu\u00e9s, O., Tebar-S\u00e1nchez, C., Lameirinhas, A., \u00c1greda-Roca, A., Torres-Ruiz, S., Garrido-Cano, I., and Lluch, A. (2023). Clinical Impact of New Treatment Strategies for HER2-Positive Metastatic Breast Cancer Patients with Resistance to Classical Anti-HER Therapies. Cancers, 15.","DOI":"10.3390\/cancers15184522"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"541","DOI":"10.1038\/nrclinonc.2015.99","article-title":"Challenges in the management of advanced, ER-positive, HER2-negative breast cancer","volume":"12","author":"Hart","year":"2015","journal-title":"Nat. Rev. Clin. Oncol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1016\/S1470-2045(14)71159-3","article-title":"The cyclin-dependent kinase 4\/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1\/TRIO-18): A randomised phase 2 study","volume":"16","author":"Finn","year":"2015","journal-title":"Lancet Oncol."},{"key":"ref_8","unstructured":"(2025, March 04). Palbociclib and Letrozole in Advanced Breast Cancer\u2014PubMed, Available online: https:\/\/pubmed.ncbi.nlm.nih.gov\/27959613\/."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"3638","DOI":"10.1200\/JCO.2017.75.6155","article-title":"MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer","volume":"35","author":"Goetz","year":"2017","journal-title":"J. Clin. Oncol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1186\/s13058-016-0721-5","article-title":"Efficacy and safety of palbociclib in combination with letrozole as first-line treatment of ER-positive, HER2-negative, advanced breast cancer: Expanded analyses of subgroups from the randomized pivotal trial PALOMA-1\/TRIO-18","volume":"18","author":"Finn","year":"2016","journal-title":"Breast Cancer Res. BCR"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1926","DOI":"10.1056\/NEJMoa1810527","article-title":"Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer","volume":"379","author":"Turner","year":"2018","journal-title":"N. Engl. J. Med."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"JGO1800239","DOI":"10.1200\/JGO.18.00239","article-title":"Real-World Treatment Patterns and Clinical Outcomes in Patients Receiving Palbociclib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer in Argentina: The IRIS Study","volume":"5","author":"Waller","year":"2019","journal-title":"J. Glob. Oncol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"852","DOI":"10.1038\/s41416-023-02352-5","article-title":"A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance\u00ae Patient Program","volume":"129","author":"Palmieri","year":"2023","journal-title":"Br. J. Cancer"},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Yang, J., Zhao, B., Ling, X., Li, D., Zhao, J., Lv, Y., Wang, G., Liu, X., Li, N., and Yang, J. (2023). Palbociclib plus endocrine therapy in hormone receptor-positive and HER2 negative metastatic breast cancer: A multicenter real-world study in the northwest of China. BMC Cancer, 23.","DOI":"10.1186\/s12885-023-10568-0"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"286","DOI":"10.1016\/j.breast.2020.11.005","article-title":"Palbociclib combined with endocrine therapy in heavily pretreated HR+\/HER2- advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP)","volume":"54","author":"Manso","year":"2020","journal-title":"Breast"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"302","DOI":"10.1002\/cpt.2454","article-title":"Real-World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men","volume":"111","author":"Kraus","year":"2022","journal-title":"Clin. Pharmacol. Ther."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1159\/000350774","article-title":"A Brief Overview of the WHO Classification of Breast Tumors, 4th Edition, Focusing on Issues and Updates from the 3rd Edition","volume":"8","author":"Sinn","year":"2013","journal-title":"Breast Care"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1159\/000475698","article-title":"St. Gallen\/Vienna 2017: A Brief Summary of the Consensus Discussion about Escalation and De-Escalation of Primary Breast Cancer Treatment","volume":"12","author":"Gnant","year":"2017","journal-title":"Breast Care"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1111\/his.14091","article-title":"The 2019 World Health Organization classification of tumours of the breast","volume":"77","author":"Tan","year":"2020","journal-title":"Histopathology"},{"key":"ref_20","unstructured":"(2025, March 04). IBRANCE\u00ae (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+\/HER2- Metastatic Breast Cancer|Pfizer. Available online: https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/ibrance_palbociclib_receives_approval_in_european_union_for_the_treatment_of_women_with_hr_her2_metastatic_breast_cancer."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"719","DOI":"10.1007\/s10549-018-05125-4","article-title":"Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive\/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up","volume":"174","author":"Rugo","year":"2019","journal-title":"Breast Cancer Res. Treat."},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Rath, S., Elamarthi, P., Parab, P., Gulia, S., Nandhana, R., Mokal, S., Kembhavi, Y., Perumal, P., Bajpai, J., and Ghosh, J. (2021). Efficacy and safety of palbociclib and ribociclib in patients with estrogen and\/or progesterone receptor positive, HER2 receptor negative metastatic breast cancer in routine clinical practice. PLoS ONE, 16.","DOI":"10.1371\/journal.pone.0253722"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"707","DOI":"10.21037\/atm-21-1340","article-title":"Ki67 and progesterone receptor status predicts sensitivity to palbociclib: A real-world study","volume":"9","author":"Shao","year":"2021","journal-title":"Ann. Transl. Med."},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Palleschi, M., Maltoni, R., Ravaioli, S., Vagheggini, A., Mannozzi, F., Fanini, F., Pirini, F., Tumedei, M.M., Barzotti, E., and Cecconetto, L. (2020). Ki67 and PR in Patients Treated with CDK4\/6 Inhibitors: A Real-World Experience. Diagnostics, 10.","DOI":"10.3390\/diagnostics10080573"}],"container-title":["Diagnostics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4418\/15\/9\/1173\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T17:27:13Z","timestamp":1760030833000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4418\/15\/9\/1173"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,5]]},"references-count":24,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,5]]}},"alternative-id":["diagnostics15091173"],"URL":"https:\/\/doi.org\/10.3390\/diagnostics15091173","relation":{},"ISSN":["2075-4418"],"issn-type":[{"value":"2075-4418","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,5]]}}}