Henk Henry J, Woloj Mabel, Shapiro Mark, Whiteley Jennifer
Optum, Eden Prairie, Minnesota.
Pfizer Inc, New York, New York.
Clin Ther. 2015 Jan 1;37(1):124-33. doi: 10.1016/j.clinthera.2014.10.019. Epub 2014 Nov 22.
The treatment of chronic myeloid leukemia (CML) has improved considerably since the introduction of the tyrosine kinase inhibitor (TKI) imatinib in 2001 and the approval of second-generation TKIs (dasatinib and nilotinib) beginning in 2006.The objective of this study was to explore treatment patterns of TKI therapy (adherence, duration, and switching) among patients with CML in the United States, following the availability of second-generation TKIs.
This study used US health plan claims data from January 1, 2007, through December 31, 2011. Patients were required to be aged ≥18 years, have a prescription fill for a TKI, and a diagnosis of CML. Duration of TKI use was determined based on a gap in TKI coverage of ≥180 consecutive days after TKI initiation or switch to another TKI within the 180-day window. To account for censoring due to disenrollment from the health plan or end of the study period, median treatment duration was projected by using the Kaplan-Meier estimator.
We identified 695 patients who started TKI treatment and had a CML diagnosis during the study time frame. The mean age of patients was 55 years, and 58% of patients were male. The most common first-line TKI was imatinib (82%), with dasatinib and nilotinib use equally distributed (9%). Among the 148 (21.3%) patients who initiated a second-line TKI, the majority had switched from imatinib to dasatinib or nilotinib (86%). The median duration of first-line TKI use was 39.8 months and second-line TKI use was 22.4 months. Median duration of treatment for first-line (P = 0.4342) and second-line (P = 0.1792) treatment did not differ significantly according to TKI. Mean adherence (ie, proportion of days covered) during the first line of therapy was 0.90.
For the US patients studied, we found that imatinib was used more frequently than other TKIs in the first-line setting, but there was an increased use of second-generation TKIs in the first-line setting over time (9% in 2008 vs 43% in 2011 were nilotinib or dasatinib users). Only about one fifth of patients switched to a second-line TKI during the period of data collection.
自2001年酪氨酸激酶抑制剂（TKI）伊马替尼问世以及2006年第二代TKI（达沙替尼和尼洛替尼）获批以来，慢性髓性白血病（CML）的治疗有了显著改善。本研究的目的是探讨在美国第二代TKI上市后，CML患者中TKI治疗的模式（依从性、持续时间和换药情况）。
本研究使用了2007年1月1日至2011年12月31日美国健康计划的理赔数据。患者需年满18岁，有TKI的处方配药记录，且诊断为CML。TKI使用持续时间根据TKI起始或在180天内换用另一种TKI后连续180天以上的TKI覆盖中断情况来确定。为了考虑因退出健康计划或研究期结束导致的删失情况，使用Kaplan-Meier估计器预测中位治疗持续时间。
我们确定了695例在研究时间段内开始TKI治疗并诊断为CML的患者。患者的平均年龄为55岁，58%为男性。最常用的一线TKI是伊马替尼（82%），达沙替尼和尼洛替尼的使用分布均匀（9%）。在148例（21.3%）开始二线TKI治疗的患者中，大多数已从伊马替尼换用达沙替尼或尼洛替尼（86%）。一线TKI使用的中位持续时间为39.8个月，二线TKI使用的中位持续时间为22.4个月。根据TKI不同，一线（P = 0.4342）和二线（P = 0.1792）治疗的中位持续时间无显著差异。一线治疗期间的平均依从性（即覆盖天数的比例）为0.90。
对于本研究中的美国患者，我们发现一线治疗中伊马替尼的使用频率高于其他TKI，但随着时间推移，一线治疗中第二代TKI的使用有所增加（2008年为9%，2011年为43%的患者使用尼洛替尼或达沙替尼）。在数据收集期间只有约五分之一的患者换用二线TKI。
