Nekoohesh Ladan, Ghahremani Mohammad H, Rostami Shahrbano, Nikbakht Mohsen, Nekoohesh Leila, Naemi Roozbeh, Mohammadi Saeed, Ghadyani Nejad Laya, Mousavi Seyed Asadollah, Vaezi Mohammad, Alimoghaddam Kamran, Chahardouli Bahram
Department of Molecular Medicine, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.
Hematology-Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Int J Hematol Oncol Stem Cell Res. 2020 Jan 1;14(1):11-18.
The present study investigated the patients with Chronic Myeloid Leukemia in chronic phase (CP-CML) who had been on the first- line Imatinib Mesylate (IM) therapy for a period of 84 months. : This retrospective study was conducted in 295 newly-diagnosed CP-CML patients(age >18 years) who were admitted to the Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran during 1 January, 2009 to 30 December, 2016. Response to treatment was evaluated by molecular response assessment. Rates of IM dose adjustment, switching to another drug therapy, progression to Accelerate Phase (AP) and Blastic Crisis (BC) and long-term outcomes included Overall Survival (OS) and Progression Free Survival (PFS) were assesed. Patients' average age was 41.7 years, and 52.9% were male. 44.4% of patients at the month 18 achieved Major Molecular Response (MMR). Progression to AP/BC occurred in 26 patients during 84 months, and the estimated rate of OS and PFS were 71.83 and 74.48, respectively. Among the patients who did not achieve MMR at month 18 , 61 patients were treated with IM ( 400 mg /day), and then after month 18, 24(39.3%) of whom achieved MMR. Dose adjustments occurred in 60 patients (20.33%). IM dose increase was observed in 53 patients who did not achive optimal response to imatinib or loss of optimal response. IM dose decrease was observed in 7 patients. 25 (8.47%) patients were switched to a different Tyrosine Kinase Inhibitor (TKI). Most of TKI changes(n=21) happened in patients who did not achieve optimal response to IM and TKI changes owing to adverse events of IM were observed in 4 patients.. Among the patients undergoing change in treatment, 24(43.75%) patients achieved MMR. Our data showed the high effectiveness of the change in the treatment of IM-resistant condition. Moreover, our finding suggests that imatinib be effective in Iranian patients after a long period of time compared to the referenced studies.
本研究调查了处于慢性期的慢性髓性白血病(CP-CML)患者,这些患者接受一线甲磺酸伊马替尼(IM)治疗长达84个月。这项回顾性研究纳入了295例新诊断的CP-CML患者(年龄>18岁),他们于2009年1月1日至2016年12月31日期间入住德黑兰沙里亚蒂医院血液学、肿瘤学和干细胞移植研究中心。通过分子反应评估来评价治疗反应。评估了IM剂量调整率、换用其他药物治疗率、进展为加速期(AP)和急变期(BC)的发生率以及包括总生存期(OS)和无进展生存期(PFS)在内的长期结局。患者的平均年龄为41.7岁,男性占52.9%。44.4%的患者在第18个月时达到主要分子反应(MMR)。在84个月期间,26例患者进展为AP/BC,估计OS率和PFS率分别为71.83和74.48。在第18个月未达到MMR的患者中,61例患者接受IM(400mg/天)治疗,18个月后,其中24例(39.3%)达到MMR。60例患者(20.33%)进行了剂量调整。在未对伊马替尼取得最佳反应或失去最佳反应的53例患者中观察到IM剂量增加。7例患者观察到IM剂量减少。25例(8.47%)患者换用了不同的酪氨酸激酶抑制剂(TKI)。大多数TKI更换(n=21)发生在对IM未取得最佳反应的患者中,4例患者因IM的不良事件而更换TKI。在接受治疗改变的患者中,24例(43.75%)患者达到MMR。我们的数据显示了改变治疗对伊马替尼耐药情况的高效性。此外,我们的研究结果表明,与参考研究相比,伊马替尼在伊朗患者中经过长时间治疗后是有效的。