阿贝西利全程管理临床实践

Clinical practice of whole process administration of abemaciclib

细胞周期蛋白依赖性激酶(CDK)4/6抑制剂的研发开启了激素受体(HR)阳性(+)、人表皮生长因子受体2(HER2)阴性(-)乳腺癌患者内分泌治疗的新格局。目前国家药品监督管理局已经批准阿贝西利用于HR+HER2-局部晚期或转移性乳腺癌、早期高危乳腺癌辅助治疗的适应证,而且是首个纳入国家医保目录的CDK4/6抑制剂,随着阿贝西利在国内患者使用比例的急速升高,为推动临床实践中阿贝西利的全程管理,本文系统性介绍该药的药理学特征、临床循证证据和临床应用,尤其是不良反应的发生机制及管理措施。阿贝西利的治疗不良反应包括腹泻、血液学毒性、静脉血栓栓塞、肝损伤、间质性肺疾病和血清肌酐升高等,本文对上述阿贝西利所致不良反应的临床表现、分级标准、发生特点、患者教育、阿贝西利剂量调整进行了详细描述,加深临床肿瘤医师对阿贝西利疗效和不良事件的管理,推进临床决策的精准性,提高患者“净”获益,达到延长患者生存时间和提高生活质量的目的。

The advent of cyclin dependent kinase(CDK)4/6 inhibitor has opened a new pattern of management of patients with hormone receptor positive(HR+),human epidermal growth factor receptor 2 negative(HER2-)breast cancer patients.At present,National Medical Products Administration has approved the indications of abemaciclib in HR+HER2-locally advanced or metastatic breast cancer and high-risk early breast cancer,and it is the first CDK4/6 inhibitor covered by the national medical insurance.With the rapid increased proportion of domestic patients for abemaciclib,in order to promote the whole process management of abemaciclib in clinical practice,the pharmacology properties,clinical evidence and clinical application,especially the mechanism and management of adverse events was introduced in this paper.The adverse events of abemaciclib include diarrhea,hematology toxicity,venous thromboembolism,liver injury,interstitial lung disease and increased serum creatinine.The clinical manifestation,grading criteria,onset characteristics,patient education and dose adjustment of abemaciclib were described in this paper with the intention to improve the management of clinical oncologist for efficacy and adverse events of abemaciclib,promote the accuracy of clinical decision-making and improve the"net"benefit of patients on prolonging the survival time of patients and improving the quality of life.