Real-world outcomes with palbociclib, ribociclib, and abemaciclib plus endocrine therapy in HR+/HER2− advanced breast cancer: A multicenter retrospective study
Year: 2025
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) are the standard first- and second-line treatments for hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). Real-world data (RWD) may inform the optimal use of these agents in routine practice. PATIENTS AND METHODS: The multicenter, population-based POLiCDK study compared progression-free survival (PFS), second PFS, and overall survival (OS) in ABC patients with HR+/HER2- ABC treated with palbociclib (PAL), ribociclib (RIB), or abemaciclib (ABE) in first- or second-line ET settings at 16 Polish centers between September 2017 and January 2025. Analyses were stratified by endocrine sensitivity/resistance, and stabilized inverse probability of treatment weighting was used to balance baseline characteristics. RESULTS: Among 2063 patients (701 PAL, 968 RIB, 394 ABE), 1583 (76.7 %) received CDK4/6i in the first-line and 480 (23.3 %) in the second-line setting. Overall, 927 (44.9 %) had de novo ABC; 819 (39.7 %) were endocrine-naïve, 158 (8.9 %) primary resistant, and 808 (39.2 %) secondary resistant. Median follow-up was 35.9, 24.1, and 21.4 months for PAL, RIB, and ABE, respectively. In endocrine-naïve patients, PFS did not differ significantly between CDK4/6i combined with aromatase inhibitors (AIs). In secondary endocrine-resistant disease, RIB and ABE outperformed PAL with AI combinations, whereas outcomes with fulvestrant were similar. In second-line therapy, all three CDK4/6i showed comparable results. Adjusted hazard ratios confirmed these trends without consistent superiority of any single agent. CONCLUSIONS: Endocrine sensitivity/resistance and ET partner were major determinants of outcome with CDK4/6i plus ET in HR+/HER2- ABC, informing individualized treatment selection and sequencing.
Source: The Breast
Authors: Renata Duchnowska, Katarzyna Soter, Katarzyna Pogoda, Jolanta Smok-Kalwat, Aleksandra Grela-Wojewoda, Karolina Winsko-Szczęsnowicz, Agnieszka Kowalewska-Felczak, Marek Szwiec, Iwona Danielewicz, Joanna Streb, Tomasz Lewandowski, Bartosz Szymanowski, Joanna Kiszka, Barbara Radecka, Ewa Kalinka, Bartosz K. Sobocki, Maria Litwiniuk, Aleksandra Łacko, Anna Bałata, Justyna Żubrowska, Marek Ziobro, Bogumiła Czartoryska-Arłukowicz, Rodryg Ramlau, Paulina Myśliwiec, Paulina Lipiec, Michał Jurczyk, Grzegorz Kade, Magdalena Łobaza, Joanna Hudała-Klecha, Magdalena Szymanik-Resko, Ewa Kustra, Anna Koriat-Błońska, Bartłomiej Tomasik, Michał Bieńkowski, Jacek Jassem
Institutions: Wroclaw Medical University, The Maria Sklodowska-Curie National Research Institute of Oncology, Poznan University of Medical Sciences, University of Zielona Góra, Szpital Morski im. PCK, Jagiellonian University, University of Opole, Polish Mother’s Memorial Hospital Research Institute, Gdańsk Medical University, Greater Poland Cancer Center, Wojskowy Instytut Medycyny Lotniczej
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,200
OpenAlex ID: W4416772922