ORIGINAL RESEARCH article

Front. Oncol.

Sec. Breast Cancer

Volume 15 - 2025 | doi: 10.3389/fonc.2025.1512496

A Real-world study of palbociclib plus endocrine therapy with or without a short course chemotherapy in the first-line treatment of HR-positive HER2-negative metastatic breast cancer

Provisionally accepted
Xiangjun  LiXiangjun LiYuhua  SongYuhua SongMeng  LvMeng LvYongmei  WangYongmei WangXueqiang  GaoXueqiang GaoTianyi  MaTianyi MaTeng  MaTeng MaLiu  ChanggenLiu ChanggenXInyi  SunXInyi SunHaibo  WangHaibo Wang*Yan  MaoYan Mao*
  • The Affiliated Hospital of Qingdao University, Qingdao, China

The final, formatted version of the article will be published soon.

Background: To investigate the efficacy of palbociclib plus endocrine therapy (ET) as the initial treatment compared with post-chemotherapy maintenance therapy in the first-line treatment of hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer (MBC).Methods: A total of 110 patients with HR-positive HER2-negative MBC were enrolled in this study between 2018 and 2023. Progression-free-survivals (PFS) and Overall Survival (OS) of palbociclib plus ET as the initial treatment (group A, n:78) or as post-chemotherapy maintenance therapy (group B, n:32) were calculated. We used the multivariable Cox model to investigate the relationship between each factor and prognosis and performed subgroup analysis.The median duration of follow-up across the cohort was 45.3 months (95% CI, 42.7 to 50.9 months) in all patients. Statistical analysis revealed no significant difference in PFS between the two groups (p=0.21). 50% was the objective response rate (ORR) for both groups. The disease control rate (DCR) for group A was 95.1% (95%CI 0.88 to 0.98), and for group B, it was 100% (95% CI 0.89 to 1.00). Multivariate Cox regression analysis indicated that the initial administration of palbociclib plus ET was significantly correlated with improved OS (Hazard Ratio [HR] = 0.36, 95% CI, 1.20 to 11.14, p < 0.05). Conclusion: This real-world study revealed that the commencement of therapy with palbociclib in synergy with ET was preferable to effective chemotherapy followed by palbociclib plus ET.

Keywords: metastatic breast cancer, Palbociclib, endocrine treatment, Cyclin-dependent kinases 4/6 inhibitor, chemotherapy

Received: 16 Oct 2024; Accepted: 20 Jun 2025.

Copyright: © 2025 Li, Song, Lv, Wang, Gao, Ma, Ma, Changgen, Sun, Wang and Mao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Haibo Wang, The Affiliated Hospital of Qingdao University, Qingdao, China
Yan Mao, The Affiliated Hospital of Qingdao University, Qingdao, China

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