伊马替尼治疗慢性粒细胞白血病慢性期患者换药时机的临床研究

doi:10.3969/j.issn.1007-9572.2017.00.223

摘要/Abstract

摘要： 目的　观察伊马替尼治疗慢性粒细胞白血病慢性期（CML-CP）患者3个月时断裂点簇集区/艾贝尔逊白血病病毒（BCR/ABL）IS及BCR/ABL拷贝数下降率的变化，进行早期预后评估，探寻最佳换药时机。方法　选取2013年9月—2015年12月连云港市第一人民医院收治的初诊CML-CP患者35例，予第一代酪氨酸激酶抑制剂（TKI）伊马替尼400 mg/d治疗，观察治疗3个月时BCR/ABLIS及BCR/ABL拷贝数下降率对治疗12个月时分子学反应的影响。结果　治疗3个月时BCR/ABLIS≤10%的患者29例，随访至治疗12个月时10例达到完全分子学反应（CMR），14例达到主要分子学反应（MMR），余5例未达到分子学缓解；BCR/ABLIS>10%的患者6例，仅1例达到MMR，余5例未达到分子学缓解。治疗3个月时BCR/ABLIS≤10%者较BCR/ABLIS>10%者治疗12个月时分子学反应程度更高（u=-2.456，P=0.014）。治疗3个月时BCR/ABL拷贝数下降率≥90%的患者19例，随访至治疗12个月时均取得分子学缓解，其中10例达到CMR，9例达到MMR；BCR/ABL拷贝数下降率<90%的患者16例，5例达到MMR，余11例未获得分子学缓解。治疗3个月时BCR/ABL拷贝数下降率≥90%者较下降率<90%者治疗12个月时分子学反应程度更高（u=-2.803，P=0.005）。治疗3个月时BCR/ABLIS≤10%、BCR/ABL拷贝数下降率≥90%的患者19例，治疗12个月时10例达到CMR，9例达到MMR，均取得分子学缓解；BCR/ABLIS≤10%、BCR/ABL拷贝数下降率<90%的患者10例，治疗12个月时5例取得MMR、5例未获得分子学缓解；BCR/ABLIS>10%、BCR/ABL拷贝数下降率<90%的患者6例，治疗12个月时均未获得MMR；无患者同时符合BCR/ABLIS>10%及BCR/ABL拷贝数下降率≥90%。治疗3个月时不同BCR/ABLIS及BCR/ABL拷贝数下降率患者治疗12个月时分子学反应比较，差异有统计学意义（u=12.977，P=0.002）。结论　治疗3个月时BCR/ABLIS、BCR/ABL拷贝数下降率对治疗12个月时分子学反应均有预测作用，联合观察两项指标可能更有意义。对于BCR/ABLIS≤10%但BCR/ABL拷贝数下降率<90%的患者，在条件允许下可考虑换药；对于BCR/ABLIS>10%及BCR/ABL拷贝数下降率<90%的患者，早期更换第二代TKI可能会取得更好的分子学反应。

关键词: 白血病, 粒-单核细胞, 慢性；伊马替尼；酪氨酸激酶抑制剂

Abstract: Objective　To dynamically investigate the changes of the breakpoint cluster region-Abelson leukemia virusinternational scale（BCR/ABL）IS values and the reduction in BCR/ABL copy numbers in patients with chronic myelogenous leukemia-chronic phase（CML-CP） at 3 months following imatinib treatment，and given early prognostic evaluation，to explore the optimal timing for changing medications.Methods　A total of 35 first-visit CML-CP patients admitted to the First People's Hospital of Lianyungang from September 2013 to December 2015 were enrolled and given treatment with the first generation tyrosine kinase inhibitor（TKI），imatinib，at a daily dose of 400 mg.The effects of BCR/ABLIS values and BCR/ABL copy number reductions at 3 months after treatment on the molecular responses at 12 months after treatment were evaluated.Results　There were 29 patients with ≤10% BCR/ABLIS at 3 months after imatinib treatment，and there were 10 cases with complete molecular response（CMR） and 14 cases with major molecular response（MMR） at 12 months after treatment，with only five cases failing in molecular remission.Of the six cases with >10% BCR/ABLIS at 3 months after imatinib treatment，only one case achieved MMR and five cases failed in molecular remission at 12 months after treatment.The degree of molecular response at 12 months after imatinib treatment was higher in patients with ≤10% BCR/ABLIS at 3 months after treatment than in those with >10% BCR/ABLIS（u=-2.456，P=0.014）．There were 19 patients with ≥ 90% reductions in BCR/ABL copy numbers at 3 months after imatinib treatment，and all achieved molecular remission at 12 months after treatment，including 10 cases with CMR and nine cases with MMR.Among the 16 cases with < 90% reductions in BCR/ABL copy numbers at 3 months after treatment，five cases achieved MMR and the other 11 cases failed in molecular remission at 12 months after treatment.The degree of molecular response at 12 months after imatinib treatment was greater in patients with ≥ 90% reductions in BCR/ABL copy numbers at 3 months after treatment than in those with < 90% reductions（u=-2.803，P=0.005）．There were 19 patients with ≤10% BCR/ABLIS and ≥ 90% reductions in BCR/ABL copy numbers at 3 months after imatinib treatment，and 10 cases achieved CMR and nine cases achieved MMR.Among the 10 patients with ≤10% BCR/ABLIS and < 90% reductions in BCR/ABL copy numbers at 3 months after imatinib treatment，there were five cases with MMR and five cases with failure in molecular remission at 12 months after treatment，and of the six cases with >10% BCR/ABLIS and < 90% reductions in BCR/ABL copy numbers at 3 months after imatinib treatment，none achieved MMR at 12 months after treatment.In addition，none had >10% BCR/ABLIS and ≥ 90% reductions in BCR/ABL copy numbers at 3 months after imatinib treatment.There was a significant difference in the molecular response among the patients with various BCR/ABLIS values and diverse reductions in BCR/ABL copy numbers at 3 months after imatinib treatment（u=12.977，P=0.002）．Conclusion　Either the BCR/ABLIS value or the reduction of BCR/ABL copy numbers at 3 months after imatinib treatment can be used to predict the molecular response at 12 months after treatment，and the combination of these two indicators seems to be of greater significance.If possible，changing medications can be considered in CML-CP patients with ≤10% BCR/ABLIS and < 90% reductions in BCR/ABL copy numbers，and an early change of the second-generation TKIs may achieve better molecular responses in patients with >10% BCR/ABLIS and < 90% reductions in BCR/ABL copy numbers.

Key words: Leukemia, myelomonocytic, chronic；Imatinib；Tyrosine kinase inhibitor

蔡志梅,陈泽,王莹,等. 伊马替尼治疗慢性粒细胞白血病慢性期患者换药时机的临床研究[J]. 中国全科医学, 2018, 21(23): 2814-2817. DOI: 10.3969/j.issn.1007-9572.2017.00.223.
CAI Zhi-mei,CHEN Ze,WANG Ying, et al. Clinical Study on the Timing for Changing Medications in the Treatment of Chronic Myelogenous Leukemia-chronic Phase with Imatinib　[J]. Chinese General Practice, 2018, 21(23): 2814-2817. DOI: 10.3969/j.issn.1007-9572.2017.00.223.

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伊马替尼治疗慢性粒细胞白血病慢性期患者换药时机的临床研究

Clinical Study on the Timing for Changing Medications in the Treatment of Chronic Myelogenous Leukemia-chronic Phase with Imatinib

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