奥加伊妥珠单抗治疗急性淋巴细胞白血病临床应用指导原则(2023年版)  

Guideline principles for clinical application of inotuzumab ozogamicin in treatment of acute lymphoblastic leukemia(2023 version)

作　　者：中国临床肿瘤学会(CSCO)白血病专家委员会 马军[2] Lymphoma Expert Committee of Chinese Society of Clinical Oncology(CSCO);Ma Jun(不详;Harbin Institute of Hematology and Oncology,Harbin 150010,China)

机构地区：[1]不详 [2]哈尔滨血液病肿瘤研究所,哈尔滨150010

出　　处：《白血病．淋巴瘤》2023年第8期449-456,共8页Journal of Leukemia & Lymphoma

摘　　要：奥加伊妥珠单抗是一种靶向CD22的抗体-药物偶联物(ADC),因其在复发难治急性淋巴细胞白血病(ALL)临床试验中显示出的卓越疗效,于2017年8月被美国食品药品管理局(FDA)批准用于复发或难治前体B细胞ALL的治疗。2021年12月奥加伊妥珠单抗在我国获批上市,为我国复发难治ALL患者提供了新的治疗手段。然而由于奥加伊妥珠单抗在我国上市时间较短,临床医生用药经验较少,临床规范应用和患者管理的相关共识缺乏。为进一步规范奥加伊妥珠单抗在ALL治疗中的临床应用,专家组成员参考国内外相关研究进展,并结合国内外权威指南和循证医学证据,制定了本临床应用指导原则,以供临床参考。Inotuzumab ozogamicin,an antibody-drug conjugate(ADC)targeting CD22,was approved by the U.S.Food and Drug Administration(FDA)for the treatment of relapsed/refractory precursor B-cell acute lymphoblastic leukemia(ALL)in August 2017 due to its excellent efficacy shown in clinical trials of relapsed/refractory ALL.Inotuzumab ozogamicin was approved for marketing in December 2021 in China,providing a new treatment option for Chinese patients with relapsed/refractory ALL.However,because inotuzumab ozogamicin has been on the market for a short time in China,clinicians have less experience in using the drug,and there is a lack of consensus on its standardized clinical application and management of patients.Therefore,in order to further standardize the clinical application of inotuzumab ozogamicin in the treatment of ALL,members of the expert group formulated the clinical application guidelines for clinical reference by referring to the relevant research progress,authoritative guidelines and evidence-based medical evidence nationwide and abroad.

关 键 词：前体细胞淋巴母细胞白血病淋巴瘤 免疫轭合物 奥加伊妥珠单抗 唾液酸结合Ig样凝集素2 

分 类 号：R733.71[医药卫生—肿瘤]