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美国综合医疗保健系统中初治慢性髓性白血病患者使用酪氨酸激酶抑制剂的真实世界治疗模式。

Real world treatment patterns in chronic myeloid leukemia patients newly initiated on tyrosine kinase inhibitors in an U.S. integrated healthcare system.

作者信息

Rashid Nazia, Koh Han A, Lin Kathy J, Stwalley Brian, Felber Eugene

机构信息

1 Kaiser Permanente, Southern California Region, Drug Information Services, Downey, CA, USA.

2 Southern California Permanente Medical Group, Kaiser Permanente Southern California, Bellflower, CA, USA.

出版信息

J Oncol Pharm Pract. 2018 Jun;24(4):253-263. doi: 10.1177/1078155217697484. Epub 2017 Mar 10.

Abstract

Purpose To evaluate treatment patterns in patients diagnosed with incident chronic myelogenous leukemia (CML) newly initiating therapy with imatinib, dasatinib, or nilotinib. Patients were followed to determine switching and discontinuation rates. Factors associated with switching or discontinuation from index TKI therapy, reasons for discontinuation based on electronic chart notes, and frequency of laboratory monitoring were assessed during the follow-up period. Methods A retrospective cohort study was conducted in chronic myelogenous leukemia patients aged ≥ 18 years who were identified from the Kaiser Permanente Southern California (KPSC) Cancer Registry database during the study time period of 1 January 2007 to 12 December 2013. The index date was defined as the date of the first TKI prescription (imatinib, dasatinib, or nilotinib) identified during the study time period with no prior history of TKI use within 12 months. Patients had to have continuous membership with drug benefit eligibility and no prior history of stem cell transplant (SCT) or other cancers during the 12 months prior to the index date. Baseline characteristics were identified during 12 months prior to the index date and outcomes were identified during the follow-up period after the index date. All patients were followed from index TKI therapy until end of study time period (12 December 2014), death, stem cell transplant, or disenrollment from the health plan unless one of the following occurred first: a patient switched their index therapy, or a patient discontinued their index therapy. Forward stepwise selection multivariable logistic regression models were used to evaluate factors associated with patients who continued therapy compared to those who switched or discontinued therapy with the index TKI. Chart notes were reviewed 30 days prior and 30 days post index TKI discontinuation to evaluate reasons for discontinuation. Molecular and cytogenetic testing frequency was also assessed during the follow-up period among the different patient groups. Results Two hundred sixteen patients were identified with incident chronic myelogenous leukemia and use of TKI therapy: 189 (87.5%) received imatinib, 19 (8.8%) received dasatinib, and 8 (3.7%) received nilotinib. The mean age on index date was 53 years and 63% were male; 103 patients (48%) continued on their index therapy, while 62 patients (28%) switched, and 51 patients (24%) discontinued.

摘要

目的 评估初诊为慢性髓性白血病(CML)且新开始使用伊马替尼、达沙替尼或尼洛替尼治疗的患者的治疗模式。对患者进行随访以确定换药和停药率。在随访期间,评估与从初始酪氨酸激酶抑制剂(TKI)治疗换药或停药相关的因素、基于电子病历记录的停药原因以及实验室监测频率。方法 对2007年1月1日至2013年12月期间从南加州凯撒医疗集团(KPSC)癌症登记数据库中识别出的年龄≥18岁的慢性髓性白血病患者进行了一项回顾性队列研究。索引日期定义为在研究期间首次开具TKI处方(伊马替尼、达沙替尼或尼洛替尼)的日期,且在12个月内无TKI使用史。患者在索引日期前12个月必须持续享有药物福利资格,且无干细胞移植(SCT)或其他癌症病史。在索引日期前12个月确定基线特征,在索引日期后的随访期间确定结局。所有患者从初始TKI治疗开始随访至研究结束(2014年12月)、死亡、干细胞移植或退出健康计划,除非先出现以下情况之一:患者更换初始治疗方案,或患者停止初始治疗。采用向前逐步选择多变量逻辑回归模型评估与继续治疗的患者相比,更换或停止初始TKI治疗的患者相关的因素。在索引TKI停药前30天和停药后30天审查病历记录,以评估停药原因。在随访期间还评估了不同患者组的分子和细胞遗传学检测频率。结果 共识别出患有初诊慢性髓性白血病并使用TKI治疗的216例患者:189例(87.5%)接受伊马替尼治疗,19例(8.8%)接受达沙替尼治疗,8例(3.7%)接受尼洛替尼治疗。索引日期时的平均年龄为53岁,63%为男性;103例患者(48%)继续接受初始治疗,62例患者(28%)换药,51例患者(24%)停药。

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