Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Clin Lymphoma Myeloma Leuk. 2019 Apr;19(4):206-212. doi: 10.1016/j.clml.2019.01.006. Epub 2019 Jan 19.
The hypothesis of an effect by thiazolidinedione on leukemia cells was proposed 2 decades ago, but there is little clinical evidence regarding its efficacy. We evaluated the safety and efficacy of adding pioglitazone to standard induction chemotherapy in patients with acute myeloid leukemia (AML).
In this randomized clinical trial, newly diagnosed AML patients were randomized to 1 of 2 groups. Patients in both groups received cytarabine (100 mg/m per day for 7 days) and daunorubicin (60 mg/m per day for 3 days). Patients in the pioglitazone group additionally received oral pioglitazone (45 mg per day). The 2 groups were compared according to remission rate, laboratory findings, and adverse events during treatment.
Forty patients were evaluated, 20 patients in each group. The complete remission rate was 20% more in the pioglitazone group compared to the control group (P = .202). Complications due to pioglitazone discontinuation were observed in 2 cases. The mean serum alanine aminotransferase in the fourth treatment week was significantly more in pioglitazone group compared to the control group (65.5 vs. 33.6 mg/dL, P = .039). The mean serum creatinine in all treatment phases was significantly higher in the pioglitazone group compared to the control group (P < .05). There were no significant differences between the 2 groups regarding other laboratory findings (P > .05).
Adding pioglitazone to cytarabine and daunorubicin increased the remission rate in AML patients compared to control subjects. Although this difference in remission rate between the 2 groups was not statistically significant, it could be important in the clinical setting. Pioglitazone may provide benefits as an adjuvant therapy for AML patients without causing serious adverse events.
20 年前就提出了噻唑烷二酮对白血病细胞有作用的假说，但关于其疗效的临床证据很少。我们评估了在急性髓系白血病（AML）患者中添加吡格列酮到标准诱导化疗中的安全性和疗效。
在这项随机临床试验中，新诊断的 AML 患者被随机分为两组。两组患者均接受阿糖胞苷（每天 100 mg/m ，连用 7 天）和柔红霉素（每天 60 mg/m ，连用 3 天）。吡格列酮组患者另外接受口服吡格列酮（每天 45 mg）。根据缓解率、实验室检查结果和治疗期间的不良事件比较两组。
共评估了 40 例患者，每组 20 例。吡格列酮组的完全缓解率比对照组高 20%（P=.202）。由于停用吡格列酮，有 2 例出现并发症。第 4 治疗周的血清丙氨酸氨基转移酶均值在吡格列酮组明显高于对照组（65.5 比 33.6 mg/dL，P=.039）。所有治疗阶段的血清肌酐均值在吡格列酮组明显高于对照组（P ＜.05）。两组间其他实验室检查结果无显著差异（P ＞.05）。
与对照组相比，阿糖胞苷和柔红霉素中添加吡格列酮可增加 AML 患者的缓解率。尽管两组间的缓解率差异无统计学意义，但在临床环境中可能有重要意义。吡格列酮作为 AML 患者的辅助治疗可能带来益处，而不会引起严重的不良事件。
