Clinical breast cancer · 2026
CDK4/6i in the Underrepresented Histological Subtypes of HR±/HER2- Metastatic Breast Cancer: A Real-World Cohort Study of Effectiveness and Safety.
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von Arx Claudia, Calabrese Alessandra, Piezzo Michela, Di Lauro Vincenzo, Martinelli Claudia, Calderaio Claudia, Tafuro Margherita, Verrazzo Annarita, Di Monda Raffaella, Magri Enrico, Garigliota Maria Luisa D'aulisio, Di Filippo Anna Maria, Buonaiuto Roberto, Buono Giuseppe, Caputo Roberta, Cianniello Daniela, Cerillo Ivana, Cocco Stefania, Di Rienzo Rossana, Nuzzo Francesco, Pacilio Carmen, Pagliuca Martina, Parola Sara, Pensabene Matilde, Poggio Francesca, De Angelis Carmine, Del Mastro Lucia, De Laurentiis Michelino
Аннотация
BACKGROUND: Metastatic (m) HR-positive/HER2-negative special-type breast cancer (STBC) exhibits distinct biological behaviors compared with no special-type BC (NSTBC), yet their management is largely extrapolated from trials dominated by NSTBC. To improve understanding of real-world (rw) clinical outcomes, this study evaluated the effectiveness of CDK4/6 inhibitors (i) specifically in patients with mSTBC, providing clinical relevant insights into their therapeutic impact.
PATIENTS AND METHODS: This retrospective cohort study included patients with mSTBC treated with first- or second-line CDK4/6i plus endocrine therapy (ET). Real-world progression-free survival (rwPFS) and overall survival (rwOS) were estimated using the Kaplan-Meier method, and differences between subgroups were evaluated using log-rank tests.
RESULTS: From April 2016 to December 2024, 181 patients received CDK4/6i-based therapy. Median rwPFS was 18.2 months (95% CI, 16-22.1) and median rwOS was 58.1 months (95% CI, 49.4-77.4). A statistically significant difference in rwOS was observed between patients treated with aromatase inhibitors + CDK4/6i versus fulvestrant + CDK4/6i (77.4 vs. 42.4 months; unadjusted HR = 2.2; P = .002). No other subgroup analyses demonstrated statistically significant differences. Common adverse events included neutropenia, anemia, and diarrhea; 32% of patients required dose reductions, which did not adversely affect survival outcomes. Following CDK4/6i progression, overall rwPFS2 was 29.7 months (95% CI, 25.9-32.2). Chemotherapy was the most frequently used post-CDK4/6i treatment, while ET combined with an mTOR-inhibitor provided the longest rwPFS2.
CONCLUSION: CDK4/6i represent a safe and effective therapeutic option for mSTBC. Nevertheless, dedicated studies and tailored treatment strategies are warranted to optimize post-CDK4/6i treatment in these subgroups.
PATIENTS AND METHODS: This retrospective cohort study included patients with mSTBC treated with first- or second-line CDK4/6i plus endocrine therapy (ET). Real-world progression-free survival (rwPFS) and overall survival (rwOS) were estimated using the Kaplan-Meier method, and differences between subgroups were evaluated using log-rank tests.
RESULTS: From April 2016 to December 2024, 181 patients received CDK4/6i-based therapy. Median rwPFS was 18.2 months (95% CI, 16-22.1) and median rwOS was 58.1 months (95% CI, 49.4-77.4). A statistically significant difference in rwOS was observed between patients treated with aromatase inhibitors + CDK4/6i versus fulvestrant + CDK4/6i (77.4 vs. 42.4 months; unadjusted HR = 2.2; P = .002). No other subgroup analyses demonstrated statistically significant differences. Common adverse events included neutropenia, anemia, and diarrhea; 32% of patients required dose reductions, which did not adversely affect survival outcomes. Following CDK4/6i progression, overall rwPFS2 was 29.7 months (95% CI, 25.9-32.2). Chemotherapy was the most frequently used post-CDK4/6i treatment, while ET combined with an mTOR-inhibitor provided the longest rwPFS2.
CONCLUSION: CDK4/6i represent a safe and effective therapeutic option for mSTBC. Nevertheless, dedicated studies and tailored treatment strategies are warranted to optimize post-CDK4/6i treatment in these subgroups.