Saleh Mansoor N, Haislip Sally, Sharpe Joyce, Hess Tamara, Gilmore James, Jackson James, Sail Kavita R, Ericson Solveig G, Chen Lei
Georgia Cancer Specialists , Atlanta, GA , USA.
Curr Med Res Opin. 2014 Apr;30(4):529-36. doi: 10.1185/03007995.2013.858621. Epub 2013 Nov 21.
Real-world treatment and monitoring patterns have not been well documented among imatinib-treated chronic phase chronic myeloid leukemia (CP-CML) patients. Thus, we evaluated these patterns and responses to imatinib in CP-CML patients.
This retrospective study, based on the Georgia Cancer Specialists' electronic medical record (EMR) system, identified CP-CML patients initiating treatment with imatinib from 01/01/2002 to 11/01/2011 who were subsequently followed for ≥6 months.
A total of 177 patients met the study criteria. Imatinib dose modification occurred in 59 patients (33%). Rates of treatment interruption, discontinuation, and switching to another therapy were 16%, 24%, and 23%, respectively. Of 27 patients discontinuing imatinib for lack of efficacy, 9 (33%) had initial dose escalation; 26 patients (96%) eventually switched to a second-generation tyrosine kinase inhibitor. By 3 months, 168 patients remained on imatinib, of whom 96 (57%) had undergone cytogenetic and/or molecular testing. The frequency of response monitoring fluctuated over time, with rates as high as 28% for cytogenetic and 69% for molecular testing. Cumulative response rates steadily increased; 18 month rates were 47% for complete cytogenetic response and 26% for major or complete molecular response. There were no cases of progression and/or death among 38 patients who were regularly monitored for molecular response within the first 12 months of imatinib. Ten of 98 patients (10%) not regularly monitored had progressed or died.
Almost one-third of patients initiating imatinib for CP-CML required dose modification, treatment interruption, or discontinuation. Opportunities for improved monitoring in this setting were identified. Limitations include those inherent to retrospective analyses based on EMR and the uncertain extrapolability of the results.
伊马替尼治疗的慢性期慢性髓性白血病（CP-CML）患者的真实世界治疗和监测模式尚未得到充分记录。因此，我们评估了CP-CML患者的这些模式以及对伊马替尼的反应。
这项回顾性研究基于佐治亚癌症专家的电子病历（EMR）系统，确定了2002年1月1日至2011年11月1日开始使用伊马替尼治疗且随后随访≥6个月的CP-CML患者。
共有177名患者符合研究标准。59名患者（33%）发生了伊马替尼剂量调整。治疗中断、停药和换用另一种治疗的发生率分别为16%、24%和23%。在27名因疗效不佳而停用伊马替尼的患者中，9名（33%）最初进行了剂量增加；26名患者（96%）最终换用了第二代酪氨酸激酶抑制剂。到3个月时，168名患者仍在使用伊马替尼，其中96名（57%）进行了细胞遗传学和/或分子检测。反应监测的频率随时间波动，细胞遗传学检测率高达28%，分子检测率高达69%。累积反应率稳步上升；18个月时完全细胞遗传学反应率为47%，主要或完全分子反应率为26%。在伊马替尼治疗的前12个月内定期监测分子反应的38名患者中，没有进展和/或死亡病例。98名未定期监测的患者中有10名（10%）出现了进展或死亡。
几乎三分之一开始使用伊马替尼治疗CP-CML的患者需要进行剂量调整、治疗中断或停药。确定了在这种情况下改善监测的机会。局限性包括基于EMR的回顾性分析固有的局限性以及结果的不确定外推性。
