不同剂量去甲氧柔红霉素为基础的联合诱导方案治疗年轻初发急性髓细胞白血病的临床疗效观察
发布时间：2018-09-14 13:47
【摘要】：目的：探讨不同剂量去甲氧柔红霉素为基础的联合诱导方案治疗年轻初发急性髓细胞白血病的临床疗效和长期预后。 方法：收集2009年1月至2014年7月期间我院收治的采用IA方案诱导化疗的年轻(55岁)初发AML的临床资料,筛选出病例资料完整的病例149例,对患者身高体重、确诊时血象、外周血异常细胞数、免疫分型、染色体等资料进行回顾性分析研究,并用NCCN诊疗指南进行预后分组,根据使用去甲氧柔红霉素(IDA)剂量,将患者分成高标准剂量IA组(10-12mg/m2/d)、低标准剂量IA组(8-9mg/m2/d)和低剂量IA组(8mg/m2/d),比较初次诱导完全缓解率、总完全缓解率等疗效指标,比较化疗期间血液学及非血液学不良事件,并对2年的OS、EFS、RFS等长期预后指标进行评估。 结果： 共纳入149例年轻(55岁)初发AML患者,高标准剂量IA组34例,低标准剂量IA组53例,低剂量IA组62例。低标准剂量IA组的一疗程CR率(75.5%)、一疗程有效率(94.3%)、总CR率(81.1%),均显著高于低剂量IA组(P0.05)；高标准剂量IA组的一疗程CR率(79.4%)、一疗程有效率(97.1%)、总CR率(85.3%),也均显著高于低剂量IA组(P0.05)。亚组分析中显示,标准剂量IA的优势主要体现在细胞遗传学中危及NPM1基因突变阴性、FLT3-ITD基因突变阴性的患者中。多因素分析后也证实了标准剂量IA的确在诱导缓解疗效上优于低剂量IA：低标准剂量IA相比于低剂量IA,总完全缓解的比值比是2.597(95%CI1.010-6.678；p=0.048),高标准剂量IA相比于低剂量IA,总完全缓解的比值比是4.721(95%CI1.495-14.906；p=0.008)。不良反应方面,除化疗期间白细胞最低值存在显著差异外,其余均无明显差异,两组早期死亡病例数也相当。生存预后方面,低标准剂量IA组在OS上显著优于低剂量IA(p=0.030),而且高标准剂量IA组与低剂量IA组相比,OS也有改善的趋势,但未达到统计学差异(p=0.054)；而低标准剂量IA组与高标准剂量IA组在OS上无明显统计学差异(p=0.888)。其余EFS及RFS等预后指标上,三组间无统计学差异。结论： 对于年轻(55岁)初发急性髓细胞白血病患者,标准剂量去甲氧柔红霉素方案化疗可以显著提高患者诱导缓解率。年轻AML患者可很好的耐受标准剂量IDA,不同剂量去甲氧柔红霉素方案在不良反应方面相似。高剂量IDA在一定程度上能改善年轻(55岁)AML患者OS,但对EFS、RFS影响不显著。
[Abstract]:Objective: to investigate the clinical efficacy and long term prognosis of different doses of normodaunorubicin in the treatment of young primary acute myeloid leukemia. Methods: from January 2009 to July 2014, we collected the clinical data of the young (55 years old) patients who were treated with IA regimen induced chemotherapy, and screened out 149 cases with complete data. The height and weight of the patients and the blood picture of the patients at the time of diagnosis were obtained. The number of abnormal cells in peripheral blood, immunophenotype, chromosome and other data were analyzed retrospectively. According to the dose of normodaunorubicin (IDA), the prognostic group was divided into two groups according to the NCCN guidelines. The patients were divided into high standard dose IA group (10-12mg/m2/d), low standard dose IA group (8-9mg/m2/d) and low dose IA group (8mg/m2/d). The first induced complete remission rate and total complete remission rate were compared, and hematological and non-hematological adverse events during chemotherapy were compared. Long-term prognostic indexes such as 2 years OS,EFS,RFS were evaluated. Results: a total of 149 young (55 years old) patients with primary AML were included, including 34 cases in high standard dose IA group, 53 cases in low standard dose IA group and 62 cases in low dose IA group. The CR rate of one course of treatment (75.5%), the effective rate of one course (94.3%) and the total CR rate (81.1%) of the low standard dose IA group were significantly higher than those of the low dose IA group (P0.05), the CR rate of one course of treatment in the high standard dose IA group (79.4%), the effective rate of one course (97.1%) and the total CR rate (85.3%) were significantly higher than those of the low dose IA group (P0.05). Subgroup analysis showed that the advantage of standard dose IA was mainly in patients with NPM1 gene mutation negative and FLT3-ITD mutation negative in cytogenetics. After multivariate analysis, it was also confirmed that the ratio of total complete remission of standard dose IA to low dose IA: low standard dose IA was 2.597 (95 CI 1.010-6.678), which was better than that of low dose IA: low standard dose IA (95 CI 1.010-6.678). The ratio of total complete remission of high standard dose IA to that of low dose IA, was 4.721 (95 CI 1.495-14.906 p0.008). There was no significant difference in adverse reactions except the lowest value of leukocyte during chemotherapy, and the number of early death cases in the two groups was the same. In terms of survival and prognosis, low standard dose IA group was significantly superior to low dose IA group in OS (p0. 030), and high standard dose IA group had a tendency to improve compared with low dose IA group, but there was no statistical difference (p0. 054). There was no significant difference in OS between low standard dose IA group and high standard dose IA group (p0. 888). There was no statistical difference between the three groups in other prognostic indexes such as EFS and RFS. Conclusion: the standard dose of normodaunorubicin regimen can significantly improve the induced remission rate of young (55 years old) patients with primary acute myeloid leukemia. Young AML patients can well tolerate standard doses of IDA, with different doses of normodaunorubicin in similar adverse reactions. High dose IDA could improve OS, in young (55 years) patients with AML to some extent, but had no significant effect on EFS,RFS.
【学位授予单位】：浙江大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R733.71
本文编号：2242882
[Abstract]:Objective: to investigate the clinical efficacy and long term prognosis of different doses of normodaunorubicin in the treatment of young primary acute myeloid leukemia. Methods: from January 2009 to July 2014, we collected the clinical data of the young (55 years old) patients who were treated with IA regimen induced chemotherapy, and screened out 149 cases with complete data. The height and weight of the patients and the blood picture of the patients at the time of diagnosis were obtained. The number of abnormal cells in peripheral blood, immunophenotype, chromosome and other data were analyzed retrospectively. According to the dose of normodaunorubicin (IDA), the prognostic group was divided into two groups according to the NCCN guidelines. The patients were divided into high standard dose IA group (10-12mg/m2/d), low standard dose IA group (8-9mg/m2/d) and low dose IA group (8mg/m2/d). The first induced complete remission rate and total complete remission rate were compared, and hematological and non-hematological adverse events during chemotherapy were compared. Long-term prognostic indexes such as 2 years OS,EFS,RFS were evaluated. Results: a total of 149 young (55 years old) patients with primary AML were included, including 34 cases in high standard dose IA group, 53 cases in low standard dose IA group and 62 cases in low dose IA group. The CR rate of one course of treatment (75.5%), the effective rate of one course (94.3%) and the total CR rate (81.1%) of the low standard dose IA group were significantly higher than those of the low dose IA group (P0.05), the CR rate of one course of treatment in the high standard dose IA group (79.4%), the effective rate of one course (97.1%) and the total CR rate (85.3%) were significantly higher than those of the low dose IA group (P0.05). Subgroup analysis showed that the advantage of standard dose IA was mainly in patients with NPM1 gene mutation negative and FLT3-ITD mutation negative in cytogenetics. After multivariate analysis, it was also confirmed that the ratio of total complete remission of standard dose IA to low dose IA: low standard dose IA was 2.597 (95 CI 1.010-6.678), which was better than that of low dose IA: low standard dose IA (95 CI 1.010-6.678). The ratio of total complete remission of high standard dose IA to that of low dose IA, was 4.721 (95 CI 1.495-14.906 p0.008). There was no significant difference in adverse reactions except the lowest value of leukocyte during chemotherapy, and the number of early death cases in the two groups was the same. In terms of survival and prognosis, low standard dose IA group was significantly superior to low dose IA group in OS (p0. 030), and high standard dose IA group had a tendency to improve compared with low dose IA group, but there was no statistical difference (p0. 054). There was no significant difference in OS between low standard dose IA group and high standard dose IA group (p0. 888). There was no statistical difference between the three groups in other prognostic indexes such as EFS and RFS. Conclusion: the standard dose of normodaunorubicin regimen can significantly improve the induced remission rate of young (55 years old) patients with primary acute myeloid leukemia. Young AML patients can well tolerate standard doses of IDA, with different doses of normodaunorubicin in similar adverse reactions. High dose IDA could improve OS, in young (55 years) patients with AML to some extent, but had no significant effect on EFS,RFS.
【学位授予单位】：浙江大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R733.71
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