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[CDK4/6抑制剂在激素受体阳性、人表皮生长因子受体2阴性晚期乳腺癌患者中临床应用的共识推荐]

[Consensus recommendations for the clinical application of CDK4/6 inhibitors in patients with hormone receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer].

出版信息

Zhonghua Zhong Liu Za Zhi. 2021 Apr 23;43(4):405-413. doi: 10.3760/cma.j.cn112152-20210113-00045.

Abstract

The introduction of cyclin-dependent kinase (CDK) 4/6 inhibitors has revolutionized the clinical management paradigm of hormone receptor (HR) positive/human epidermal growth factor receptor (HER) 2 negative breast cancer. As of today, CDK 4/6 inhibitors including Palbociclib, Ribociclib, and Abemaciclib have been widely approved by regulatory agencies. Randomized clinical trials demonstrated that CDK 4/6 inhibitors in combination with an aromatase inhibitor (AI) or fulvestrant in the first-, second- or later-line setting for HR positive/HER2 negative locally advanced or metastatic breast cancer led to substantial reduction in the risk of disease progression or death. Adverse effects of treatment were manageable and as or better than expected in terms of patient satisfaction. Considering CDK4/6 inhibitors in combination with endocrine therapy being a novel approach in China clinical practice, the panel developed the consensus comprehensively describing the pharmacology properties, monitoring strategy during treatment and adverse events management, to facilitate greater understanding in Chinese oncologists of a whole new therapeutic class of drug, promote accuracy of clinical decision and help reach the ultimate goal of improving survival and quality of life of the target patient population.

摘要

细胞周期蛋白依赖性激酶(CDK)4/6抑制剂的引入彻底改变了激素受体(HR)阳性/人表皮生长因子受体(HER)2阴性乳腺癌的临床管理模式。截至目前,包括帕博西尼、瑞博西尼和阿贝西利在内的CDK 4/6抑制剂已获得监管机构的广泛批准。随机临床试验表明,在HR阳性/HER2阴性局部晚期或转移性乳腺癌的一线、二线或后续治疗中,CDK 4/6抑制剂联合芳香化酶抑制剂(AI)或氟维司群可显著降低疾病进展或死亡风险。治疗的不良反应可控,在患者满意度方面与预期相当或更好。鉴于CDK4/6抑制剂联合内分泌治疗在中国临床实践中是一种新方法,该专家组制定了共识,全面描述其药理学特性、治疗期间的监测策略及不良事件管理,以促进中国肿瘤学家更好地了解这一全新治疗类别的药物,提高临床决策的准确性,并帮助实现改善目标患者群体生存和生活质量的最终目标。

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