CDK4/6抑制剂治疗激素受体阳性人表皮生长因子受体2阴性乳腺癌临床应用专家共识(2023版)

Consensus on the clinical use of CDK4/6 inhibitors for the treatment of hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer(2023 edition)

细胞周期蛋白依赖性激酶4/6(CDK4/6)抑制剂为激素受体(HR)阳性、人表皮生长因子受体2(HER-2)阴性乳腺癌患者的临床治疗模式带来变革性的突破。中国已上市的CDK4/6抑制剂包括瑞波西利、哌柏西利、阿贝西利和达尔西利。对于HR阳性HER-2阴性局部晚期和转移性乳腺癌,CDK4/6抑制剂联合内分泌治疗已经成为标准方案,能够延长患者的生存。在早期乳腺癌辅助治疗阶段,也已有CDK4/6抑制剂取得阳性结果并获批适应证。目前,CDK4/6抑制剂广泛进入中国临床实践,为进一步提高CDK4/6抑制剂在中国的规范化应用,国家肿瘤质控中心乳腺癌专家委员会和中国抗癌协会肿瘤药物临床研究专业委员会在2021版《CDK4/6抑制剂治疗激素受体阳性人表皮生长因子受体2阴性晚期乳腺癌的临床应用共识》基础上,组织相关领域专家,对该共识进行更新,系统性介绍CDK4/6抑制剂的药理学特征、在晚期及早期乳腺癌中的适应证、患者用药监测以及不良事件管理等,以期推进临床决策的精准性,达到延长患者生存时间和提高生活质量的最终目标。

Cyclin-dependent kinase 4/6(CDK4/6)inhibitors have led transformative breakthrough of clinical therapy for hormone receptor(HR)-positive,human epidermal growth factor receptor 2(HER-2)-negative breast cancer patients.CDK4/6 inhibitors that have been marketed in China include Ribociclib,Palbociclib,Abemaciclib and Dalpiciclib.For HR-positive HER-2-negative locally advanced and metastatic breast cancer,CDK4/6 inhibitors combined with endocrine therapy have become standard regimen,which can prolong the survival of patients.In the adjuvant treatment stage of early breast cancer,CDK4/6 inhibitors have also achieved positive results and been approved for indications.At present,CDK4/6 inhibitors have been widely used in clinical practice in China.In order to further improve the standardized application of CDK4/6 inhibitors in China,the Breast Cancer Expert Committee of the National Center for Cancer Quality Control and the Professional Committee of Clinical Research of Cancer Drugs of the Chinese Anti-Cancer Association organized the related expert to update the consensus based on the"CDK4/6 inhibitor consensus on clinical application of in the treatment of hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer(2021 edition)".The updated consensus systematically introduces the pharmacological characteristics,drug monitoring and adverse event management,etc.,of CDK4/6 inhibitors to promote the accuracy of clinical decision-making with the ultimate goal to prolong the overall survival of patients and improve the quality of life.