达尔西利在HR+/HER2−乳腺癌治疗中的研究进展
Research Progress of Dalpiciclib in the Treatment of HR+/HER2− Breast Cancer
DOI: 10.12677/acm.2025.15102976, PDF,   
作者: 陈德成, 韦新鼎, 奉少春, 李鑫鑫：右江民族医学院研究生学院，广西 百色；蒙以良*：宾阳县人民医院，广西 南宁
关键词: 乳腺癌；HR+/HER2−；CDK4/6抑制剂；达尔西利；疗效差异；Breast Cancer； HR+/HER2−； CDK4/6 Inhibitor； Dalpiciclib； Therapeutic Difference
摘要: 本文阐述了乳腺癌的全球与中国流行病学特征，并深入探讨CDK4/6抑制剂达尔西利的作用机制、临床应用及循证证据。重点剖析其在HR+/HER2−乳腺癌中的联合策略疗效、人群差异、长期获益与成本效益，同时展望新适应症拓展、创新研究方向及国际合作趋势，以期为临床实践与科研布局提供参考。
Abstract: This article describes the global and Chinese epidemiological characteristics of breast cancer, and deeply discusses the mechanism of action, clinical application and evidence-based evidence of CDK4/6 inhibitor Dalpiciclib. Focus on analyzing the efficacy, population differences, long-term benefits and cost-effectiveness of its joint strategy in HR+/HER2− breast cancer, and look forward to the expansion of new indications, innovative research directions and international cooperation trends, with a view to providing reference for clinical practice and scientific research layout.
文章引用：陈德成, 韦新鼎, 奉少春, 李鑫鑫, 蒙以良. 达尔西利在HR+/HER2−乳腺癌治疗中的研究进展[J]. 临床医学进展, 2025, 15(10): 2012-2017. https://doi.org/10.12677/acm.2025.15102976

参考文献

[1] Siegel, R.L., Miller, K.D. and Jemal, A. (2020) Cancer Statistics, 2020. CA: A Cancer Journal for Clinicians, 70, 7-30. [Google Scholar] [CrossRef] [PubMed]
[2] Tao, F., Xu, M., Zou, Q., Tang, L., Feng, J. and Li, Z. (2023) Prevalence and Severity of Anxiety and Depression in Chinese Patients with Breast Cancer: A Systematic Review and Meta-Analysis. Frontiers in Psychiatry, 14, Article ID: 1080413. [Google Scholar] [CrossRef] [PubMed]
[3] Walker, A.J., Wedam, S., Amiri-Kordestani, L., Bloomquist, E., Tang, S., Sridhara, R., et al. (2016) FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer. Clinical Cancer Research, 22, 4968-4972. [Google Scholar] [CrossRef] [PubMed]
[4] Jeong, E., Wang, C., Wilson, L. and Zhong, L. (2021) Cost-Effectiveness of Adding Ribociclib to Endocrine Therapy for Patients with HR-Positive, HER2-Negative Advanced Breast Cancer among Premenopausal or Perimenopausal Women. Frontiers in Oncology, 11, Article ID: 658054. [Google Scholar] [CrossRef] [PubMed]
[5] Goetz, M.P., André, V. and Johnston, S.R.D. (2024) Response to Letters to the Editor on ‘Abemaciclib Plus a Nonsteroidal Aromatase Inhibitor as Initial Therapy for HR+, HER2− Advanced Breast Cancer: Final Overall Survival Results of MONARCH 3’. Annals of Oncology, 35, 1202-1204. [Google Scholar] [CrossRef] [PubMed]
[6] Chia, S., Gandhi, S., Joy, A.A., Edwards, S., Gorr, M., Hopkins, S., et al. (2015) Novel Agents and Associated Toxicities of Inhibitors of the PI3K/Akt/mTOR Pathway for the Treatment of Breast Cancer. Current Oncology, 22, 33-48. [Google Scholar] [CrossRef] [PubMed]
[7] O’Shaughnessy, J., Thaddeus Beck, J. and Royce, M. (2018) Everolimus-Based Combination Therapies for HR+, HER2− Metastatic Breast Cancer. Cancer Treatment Reviews, 69, 204-214. [Google Scholar] [CrossRef] [PubMed]
[8] Ettl, J. and Harbeck, N. (2017) The Safety and Efficacy of Palbociclib in the Treatment of Metastatic Breast Cancer. Expert Review of Anticancer Therapy, 17, 661-668. [Google Scholar] [CrossRef] [PubMed]
[9] Tomiguchi, M., Yamamoto, Y., Yamamoto‐Ibusuki, M., Goto-Yamaguchi, L., Fujiki, Y., Fujiwara, S., et al. (2016) Fibroblast Growth Factor Receptor-1 Protein Expression Is Associated with Prognosis in Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor-2-Negative Primary Breast Cancer. Cancer Science, 107, 491-498. [Google Scholar] [CrossRef] [PubMed]
[10] Petrossian, K., Kanaya, N., Lo, C., Hsu, P., Nguyen, D., Yang, L., et al. (2018) Erα-Mediated Cell Cycle Progression Is an Important Requisite for CDK4/6 Inhibitor Response in HR+ Breast Cancer. Oncotarget, 9, 27736-27751. [Google Scholar] [CrossRef] [PubMed]
[11] Long, F., He, Y., Fu, H., Li, Y., Bao, X., Wang, Q., et al. (2019) Preclinical Characterization of SHR6390, a Novel CDK 4/6 Inhibitor, in Vitro and in Human Tumor Xenograft Models. Cancer Science, 110, 1420-1430. [Google Scholar] [CrossRef] [PubMed]
[12] Zhang, P., Xu, B., Gui, L., Wang, W., Xiu, M., Zhang, X., et al. (2021) A Phase 1 Study of Dalpiciclib, a Cyclin-Dependent Kinase 4/6 Inhibitor in Chinese Patients with Advanced Breast Cancer. Biomarker Research, 9, Article No. 24. [Google Scholar] [CrossRef] [PubMed]
[13] Cheng, J., Feng, J., Hu, X., et al. (2021) Dalpiciclib or Placebo Plus Fulvestrant in Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer: A Randomized, Phase 3 Trial. Nature Medicine, 27, 1904-1909.
[14] Zhang, Q., Zhang, P., Yan, M., Yan, X., Wang, X., Gu, Y., et al. (2024) Dalpiciclib in Combination with Letrozole/Anastrozole or Fulvestrant in HR-Positive and HER2-Negative Advanced Breast Cancer: Results from a Phase IB Study. Therapeutic Advances in Medical Oncology, 16, 1-12. [Google Scholar] [CrossRef] [PubMed]
[15] Wang, Y., Yuan, X., Li, J., Liu, Z., Li, X., Wang, Z., et al. (2022) The Synergistic Effects of SHR6390 Combined with Pyrotinib on HER2+/HR+ Breast Cancer. Frontiers in Cell and Developmental Biology, 9, Article ID: 785796. [Google Scholar] [CrossRef] [PubMed]
[16] Bu, J., Zhang, Y., Niu, N., et al. (2023) Dalpiciclib Partially Abrogates ER Signaling Activation Induced by Pyrotinib in HER2+ HR+ Breast Cancer. Elife, 12, e85246.
[17] Wang, H., Zhang, G., Gao, W., Li, S., Yang, S., Zhang, X., et al. (2025) Dalpiciclib Plus Aromatase Inhibitor versus Neoadjuvant Chemotherapy for ER-Positive, HER2-Negative Breast Cancer. Frontiers in Oncology, 15, Article ID: 1566146. [Google Scholar] [CrossRef] [PubMed]
[18] Yu, W.L. and Hua, Z.C. (2022) Efficacy and Prognosis of Adalimumab for Crohns Disease at Different Disease Locations: A Systematic Review and Meta-Analysis. European Review for Medical and Pharmacological Sciences, 26, 2036-2048.
[19] Finn, R.S., Rugo, H.S., Gelmon, K.A., Cristofanilli, M., Colleoni, M., Loi, S., et al. (2021) Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. The Oncologist, 26, e749-e755. [Google Scholar] [CrossRef] [PubMed]
[20] Hong, J., Chen, T., Ouyang, L., et al. (2024) Cost-Effectiveness Comparison of Dalpiciclib and Abemaciclib Combined with an Aromatase Inhibitor as First-Line Treatment for HR+/HER2− Advanced Breast Cancer. Expert Review of Phar-Macoeconomics & Outcomes Research, 24, 559-566.
[21] Ma, J., Li, X., Zhang, Q., Li, N., Sun, S., Zhao, S., et al. (2022) A Novel Treatment Strategy of HER2-Targeted Therapy in Combination with Everolimus for HR+/HER2− Advanced Breast Cancer Patients with HER2 Mutations. Translational Oncology, 21, Article 101444. [Google Scholar] [CrossRef] [PubMed]
[22] Zhang, J., Meng, Y., Wang, B., Wang, L., Cao, J., Tao, Z., et al. (2022) Dalpiciclib Combined with Pyrotinib and Letrozole in Women with HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer (LORDSHIPS): A Phase IB Study. Frontiers in Oncology, 12, Article ID: 775081. [Google Scholar] [CrossRef] [PubMed]
[23] Scirocchi, F., Scagnoli, S., Botticelli, A., Di Filippo, A., Napoletano, C., Zizzari, I.G., et al. (2022) Immune Effects of CDK4/6 Inhibitors in Patients with HR+/HER2− Metastatic Breast Cancer: Relief from Immunosuppression Is Associated with Clinical Response. eBioMedicine, 79, Article 104010. [Google Scholar] [CrossRef] [PubMed]

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