Department of Medical, Surgery and Health Sciences, University of Trieste, Piazza Ospitale 1, 34129 Trieste, Italy.
Department of Biology and Biochemistry, University of Bath, Bath BA2 7AY, UK.
Cells. 2019 Apr 6;8(4):321. doi: 10.3390/cells8040321.
Breast Cancer (BC) is the second most common type of cancer worldwide and displays the highest cancer-related mortality among women worldwide. Targeted therapies have revolutionized the way BC has been treated in recent decades, improving the life expectancies of millions of women. Among the different molecular pathways that have been of interest for the development of targeted therapies are the Cyclin-Dependent Kinases (CDK). CDK inhibitors are a class of molecules that already exist in nature and those belonging to the Cyclin dependent kinase inhibitors family INK4 that specifically inhibit CDK4/6 proteins. CDK4/6 inhibitors specifically block the transition from the G1 to the S phase of the cell cycle by dephosphorylation of the retinoblastoma tumor suppressor protein. In the past four years, the CDK4/6 inhibitors, palbociclib, ribociclib, and abemaciclib, received their first FDA approval for the treatment of Hormone Receptor (HR)-positive and Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer after showing significant improvements in progression-free survival in the PALOMA-1, MONALEESA-2 and the MONARCH-2 randomized clinical trials, respectively. After the encouraging results from these clinical trials, CDK4/6 inhibitors have also been investigated in other BC subtypes. In HER2-positive BC, a combination of CDK4/6 inhibitors with HER2-targeted therapies showed promise in preclinical studies and their clinical evaluation is ongoing. Moreover, in triple-negative BC, the efficacy of CDK4/6 inhibitors has been investigated in combination with other targeted therapies or immunotherapies. This review summarizes the molecular background and clinical efficacy of CDK4/6 inhibitors as single agents or in combination with other targeted therapies for the treatment of BC. Future directions for ongoing clinical trials and predictive biomarkers will be further debated.
乳腺癌(BC)是全球第二常见的癌症类型,也是全球女性癌症相关死亡率最高的癌症。靶向治疗在最近几十年彻底改变了 BC 的治疗方式,提高了数百万女性的预期寿命。在已经引起人们关注以开发靶向治疗的不同分子途径中,有细胞周期蛋白依赖性激酶(CDK)。CDK 抑制剂是一类已经存在于自然界中的分子,属于细胞周期蛋白依赖性激酶抑制剂家族 INK4 的那些抑制剂专门抑制 CDK4/6 蛋白。CDK4/6 抑制剂通过使视网膜母细胞瘤肿瘤抑制蛋白去磷酸化,特异性地阻止细胞周期从 G1 期到 S 期的过渡。在过去的四年中,CDK4/6 抑制剂 palbociclib、ribociclib 和 abemaciclib 分别在 PALOMA-1、MONALEESA-2 和 MONARCH-2 随机临床试验中显示出无进展生存期的显著改善后,获得了美国食品和药物管理局(FDA)对激素受体(HR)阳性和人表皮生长因子受体 2(HER2)阴性乳腺癌的首次批准。在这些临床试验取得令人鼓舞的结果后,CDK4/6 抑制剂也在其他 BC 亚型中进行了研究。在 HER2 阳性 BC 中,CDK4/6 抑制剂与 HER2 靶向治疗联合在临床前研究中显示出前景,其临床评估正在进行中。此外,在三阴性 BC 中,CDK4/6 抑制剂与其他靶向治疗或免疫疗法联合的疗效已在临床试验中进行了研究。这篇综述总结了 CDK4/6 抑制剂作为单一药物或与其他靶向治疗联合治疗 BC 的分子背景和临床疗效。将进一步讨论正在进行的临床试验和预测生物标志物的未来方向。
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