Real-World Outcomes of First-Line Palbociclib Plus Endocrine Therapy for HR+/HER2- Metastatic Breast Cancer in Japan: A Single-Center Retrospective Study.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
3 patients achieved disease control.
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Importantly, elderly patients tolerated treatment well, and selected PS 2-3 patients also derived clinical benefit. These findings indicate that neither age nor PS alone should preclude the use of palbociclib in carefully monitored real-world patients.
[BACKGROUND] Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have transformed the management of hormone receptor-positive/HER2-negative (HR+/HER2-) advanced breast cancer, yet evidence for elderly or
APA
Yanagihara K, Yoshida M, et al. (2025). Real-World Outcomes of First-Line Palbociclib Plus Endocrine Therapy for HR+/HER2- Metastatic Breast Cancer in Japan: A Single-Center Retrospective Study.. Oncology research, 34(1), 11. https://doi.org/10.32604/or.2025.073891
MLA
Yanagihara K, et al.. "Real-World Outcomes of First-Line Palbociclib Plus Endocrine Therapy for HR+/HER2- Metastatic Breast Cancer in Japan: A Single-Center Retrospective Study.." Oncology research, vol. 34, no. 1, 2025, pp. 11.
PMID
41502524
Abstract
[BACKGROUND] Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have transformed the management of hormone receptor-positive/HER2-negative (HR+/HER2-) advanced breast cancer, yet evidence for elderly or poor-performance patients remains limited. This study examined real-world outcomes of palbociclib plus endocrine therapy in Asian patients, with additional subgroup analyses by age and performance status.
[METHODS] We retrospectively analyzed 46 consecutive Asian patients with recurrent or HR+/HER2- breast cancer treated with first-line palbociclib plus ET between April 2021 and March 2025. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall response rate (ORR), disease control rate (DCR), and safety. Subgroup analyses were performed by age (<70 vs. ≥70 years) and performance status (PS; 0-1 vs. 2-3).
[RESULTS] The median PFS was 26.6 months (range, 1.4-69.5). Stratified by age, median PFS was 26.9 months in patients <70 years and 26.2 months in those ≥70 years ( = 0.760). By PS, PFS was 26.9 months for PS 0-1 and 17.8 months for PS 2-3 ( = 0.099). ORR was 60.9% and DCR 93.5%; notably, all PS 2-3 patients achieved disease control. Hematologic toxicities were common, with neutropenia (80.4%) and leukopenia (86.7%) predominating, but grade ≥ 3 anemia was rare (2.2%). Elderly patients experienced anemia more frequently, while overall toxicity remained manageable. Dose reductions occurred in 47.8% without loss of efficacy.
[CONCLUSIONS] In routine Japanese practice, palbociclib plus ET provided prolonged PFS and high disease control consistent with pivotal trials and international real-world evidence. Importantly, elderly patients tolerated treatment well, and selected PS 2-3 patients also derived clinical benefit. These findings indicate that neither age nor PS alone should preclude the use of palbociclib in carefully monitored real-world patients.
[METHODS] We retrospectively analyzed 46 consecutive Asian patients with recurrent or HR+/HER2- breast cancer treated with first-line palbociclib plus ET between April 2021 and March 2025. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall response rate (ORR), disease control rate (DCR), and safety. Subgroup analyses were performed by age (<70 vs. ≥70 years) and performance status (PS; 0-1 vs. 2-3).
[RESULTS] The median PFS was 26.6 months (range, 1.4-69.5). Stratified by age, median PFS was 26.9 months in patients <70 years and 26.2 months in those ≥70 years ( = 0.760). By PS, PFS was 26.9 months for PS 0-1 and 17.8 months for PS 2-3 ( = 0.099). ORR was 60.9% and DCR 93.5%; notably, all PS 2-3 patients achieved disease control. Hematologic toxicities were common, with neutropenia (80.4%) and leukopenia (86.7%) predominating, but grade ≥ 3 anemia was rare (2.2%). Elderly patients experienced anemia more frequently, while overall toxicity remained manageable. Dose reductions occurred in 47.8% without loss of efficacy.
[CONCLUSIONS] In routine Japanese practice, palbociclib plus ET provided prolonged PFS and high disease control consistent with pivotal trials and international real-world evidence. Importantly, elderly patients tolerated treatment well, and selected PS 2-3 patients also derived clinical benefit. These findings indicate that neither age nor PS alone should preclude the use of palbociclib in carefully monitored real-world patients.
MeSH Terms
Humans; Female; Breast Neoplasms; Retrospective Studies; Pyridines; Aged; Middle Aged; Piperazines; Antineoplastic Combined Chemotherapy Protocols; Erb-b2 Receptor Tyrosine Kinases; Receptors, Estrogen; Adult; Receptors, Progesterone; Aged, 80 and over; Japan; Progression-Free Survival; Treatment Outcome