Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1080, USA.
Curr Med Res Opin. 2012 Nov;28(11):1831-9. doi: 10.1185/03007995.2012.741577. Epub 2012 Nov 5.
Monitoring treatment response is an integral part of chronic myeloid leukemia (CML) treatment. The guidelines recommend regular monitoring using standard methods (e.g., real-time quantitative polymerase chain reaction based on the international scale for molecular response) and treatment adjustment when failure is detected among patients treated with imatinib. The objective of this study was to assess the real-world monitoring and therapy adjustment in this patient population in the US.
Twenty-nine physicians from community practices across the US participated in an online chart review. Adult patients with chronic phase CML who initiated imatinib as first-line therapy during 2006-2010 were selected. Information was collected up to 36 months after imatinib initiation, including response monitoring, response status, and therapy adjustment upon treatment failure.
The study included 297 eligible patients. By 18 months, 47% of patients had received cytogenetic response assessment continuously as recommended by the guidelines. The corresponding proportion was 39% for continuous molecular response assessment. Among patients who experienced treatment failure by 18 months, only 14%-38% of patients switched to a second-generation tyrosine kinase inhibitor as recommended by the National Comprehensive Cancer Network and the European Leukemia Net guidelines.
Major limitations included limited generalizability and the inability to accurately assess molecular response due to the variations in testing methods during the study period.
Based on the guidelines, the rates of treatment monitoring and switching upon failure were low, demonstrating the need for improvement in CML care in community settings in the US.
监测治疗反应是慢性髓性白血病（CML）治疗的一个组成部分。指南建议使用标准方法（例如，基于国际分子反应标准的实时定量聚合酶链反应）进行定期监测，并在接受伊马替尼治疗的患者出现失败时调整治疗。本研究的目的是评估美国这一患者群体的实际监测和治疗调整情况。
美国各地社区实践的 29 名医生参与了在线图表审查。选择了 2006-2010 年期间作为一线治疗开始使用伊马替尼的慢性期 CML 成年患者。在伊马替尼起始后长达 36 个月收集信息，包括反应监测、反应状态以及治疗失败后的治疗调整。
该研究纳入了 297 名符合条件的患者。在 18 个月时，47%的患者按照指南的建议连续接受细胞遗传学反应评估。连续分子反应评估的相应比例为 39%。在 18 个月时发生治疗失败的患者中，仅有 14%-38%的患者按照国家综合癌症网络和欧洲白血病网络指南的建议改用第二代酪氨酸激酶抑制剂。
主要局限性包括推广性有限，以及由于研究期间检测方法的变化而无法准确评估分子反应。
根据指南，治疗监测和失败后换药的比率较低，表明美国社区环境中 CML 治疗需要改进。
