Malhotra Hemant, Sharma Pratibha, Bhargava Shipra, Rathore Om Singh, Malhotra Bharti, Kumar Madhu
Division of Medical Oncology, Department of Medicine, SMS Medical College , Jaipur , India.
Leuk Lymphoma. 2014 Nov;55(11):2614-9. doi: 10.3109/10428194.2014.885515. Epub 2014 Mar 7.
The present study looked at the correlation between mean trough Imatinib plasma levels and molecular response in 131 CML patients on imatinib. Patients receiving Glivec versus generic Imatinib were also compared. A ROC curve was constructed to estimate a threshold level that correlates with a favourable response. Patients were grouped into Responders (bcr/abl ration by RQ-PCR less than 1) and Non Responders (ration ≥ 1). The mean trough imatinib plasma level in the responders was significantly higher than in the non responders (p = 0.001). The area under ROC curve was 0.733, with best sensitivity (51.85%) and specificity (89.42%) at a plasma threshold of 0.988 g/ml [1.675 M]. Levels in the patients on Glivec versus generic drug (p > 0.05) were comparable. Trough Imatinib plasma levels may be a marker for suboptimal response and may identify patients in whom increase of drug dose or change in therapy may be indicated.
本研究观察了131例接受伊马替尼治疗的慢性粒细胞白血病（CML）患者的伊马替尼血浆平均谷浓度与分子反应之间的相关性。同时还比较了接受格列卫与普通伊马替尼治疗的患者。构建了一条ROC曲线，以估计与良好反应相关的阈值水平。患者被分为反应者（通过实时定量聚合酶链反应（RQ-PCR）检测的bcr/abl比值小于1）和无反应者（比值≥1）。反应者的伊马替尼血浆平均谷浓度显著高于无反应者（p = 0.001）。ROC曲线下面积为0.733，血浆阈值为0.988 μg/ml [1.675 μM]时，敏感性最佳（51.85%），特异性最佳（89.42%）。接受格列卫与普通药物治疗的患者的血药浓度相当（p > 0.05）。伊马替尼血浆谷浓度可能是反应欠佳的一个标志物，可用于识别可能需要增加药物剂量或改变治疗方案的患者。
