阿贝西利全程管理临床实践  

Clinical practice of whole process administration of abemaciclib

作　　者：邵彬[1] 李俏 沈松杰[3] 郝晓鹏 程琳[5] 郭宝良[6] 葛洁 冀学宁[8] 吕铮[9] 马杰[10] 马力[11] 齐立强 石晶[13] 史业辉 尹胜杰[15] 王芳[16] 徐玲[17] 杨飏 杨华[19] 张夕凉 张聚良 周金妹 贺飞 SHAO Bin;LI Qiao;SHEN Songjie;HAO Xiaopeng;CHENG Lin;GUO Baoliang;GE Jie;JI Xuening;LYU Zheng;MA Jie;MA Li;QI Liqiang;SHI Jing;SHI Yehui;YIN Shengjie;WANG Fang;XU Ling;YANG Yang;YANG Hua;ZHANG Xiliang;ZHANG Juliang;ZHOU Jinmei;HE Fei(Department of Breast Oncology,Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education),Peking University Cancer Hospital&Institute,Beijing 100142,China;Department of Medical Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Department of Breast Surgery,Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of General Surgery,the First Medical Center of Chinese PLA General Hospital,Beijing 100853,China;Department of Breast Center,Peking University People’s Hospital,Beijing 100044,China;Department of Breast Surgery,the Second Affiliated Hospital of Harbin Medical University,Harbin 150001,Heilongjiang,China;the First Department of Breast Cancer,Tianjin Medical University Cancer Institute and Hospital,National Clinical Research Center for Cancer,Tianjin Clinical Research Center for Cancer,Key Laboratory of Breast Cancer Prevention and Therapy,Ministry of Education,Tianjin Key Laboratory of Cancer Prevention and Therapy,Tianjin 300060,China;Department of Oncology,Affiliated Zhongshan Hospital of Dalian University,Dalian 116001,Liaoning,China;Department of Oncology,the First Hospital of Jilin University,Changchun 130021,Jilin,China;Breast Disease Prevention and Control Center,Tangshan People’s Hospital,Tangshan 063001,Hebei,China;Department of Breast Center,the Fourth Hospital of Hebei Medical University,Shijiazhuang 050011,Hebei,China;Department of Breast Surgery,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Department of Me

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所乳腺肿瘤内科,恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [2]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院肿瘤内科,北京100021 [3]中国医学科学院北京协和医院乳腺外科,北京100730 [4]中国人民解放军总医院第一医学中心普通外科医学部,北京100853 [5]北京大学人民医院乳腺中心,北京100044 [6]哈尔滨医科大学附属第二医院乳腺外科,哈尔滨150001 [7]天津医科大学肿瘤医院乳腺肿瘤一科,国家恶性肿瘤临床医学研究中心,天津市恶性肿瘤临床医学研究中心,乳腺癌防治教育部重点实验室,天津市肿瘤防治重点实验室,天津300060 [8]大连大学附属中山医院肿瘤科,辽宁大连116001 [9]吉林大学第一医院肿瘤科,长春130021 [10]唐山市人民医院乳腺疾病防治中心,河北唐山063001 [11]河北医科大学第四医院乳腺中心,石家庄050011 [12]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院乳腺外科,北京100021 [13]中国医科大学附属第一医院肿瘤内科,沈阳110001 [14]天津医科大学肿瘤医院乳腺内科,国家恶性肿瘤临床医学研究中心,天津市恶性肿瘤临床医学研究中心,乳腺癌防治教育部重点实验室,天津市肿瘤防治重点实验室,天津300060 [15]赤峰市医院肿瘤内科,内蒙古赤峰024000 [16]郑州大学第一附属医院乳腺外科,郑州450052 [17]北京大学第一医院乳腺疾病中心,北京100034 [18]北京大学肿瘤医院乳腺癌预防治疗中心,北京100142 [19]河北大学附属医院肿瘤内科,河北省肿瘤放化疗机制与规程研究重点实验室,河北保定071000 [20]解放军总医院第六医学中心普通外科,北京100048 [21]空军军医大学第一附属医院甲乳血管外科,西安710032 [22]解放军总医院第五医学中心肿瘤学部,北京100071

出　　处：《癌症进展》2023年第2期184-190,201,共8页Oncology Progress

摘　　要：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.

关 键 词：乳腺癌 细胞周期蛋白依赖性激酶4/6 阿贝西利 全程管理 临床实践 

分 类 号：R737.9[医药卫生—肿瘤]