Real-world outcomes with palbociclib, ribociclib, and abemaciclib plus endocrine therapy in HR+/HER2- advanced breast cancer: A multicenter retrospective study.
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Duchnowska Renata, Soter Katarzyna, Pogoda Katarzyna, Smok-Kalwat Jolanta, Grela-Wojewoda Aleksandra, Winsko-Szczęsnowicz Karolina, Kowalewska-Felczak Agnieszka, Szwiec Marek, Danielewicz Iwona, Streb Joanna, Lewandowski Tomasz, Szymanowski Bartosz, Kiszka Joanna, Radecka Barbara, Kalinka Ewa, Sobocki Bartosz K, Litwiniuk Maria, Łacko Aleksandra, Bałata Anna, Żubrowska Justyna, Ziobro Marek, Czartoryska-Arłukowicz Bogumiła, Ramlau Rodryg, Myśliwiec Paulina, Lipiec Paulina, Jurczyk Michał, Kade Grzegorz, Łobaza Magdalena, Hudała-Klecha Joanna, Szymanik-Resko Magdalena, Kustra Ewa, Koriat-Błońska Anna, Tomasik Bartłomiej, Bieńkowski Michał, Jassem Jacek
Аннотация
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.