不同劑量去甲氧柔紅霉素為基礎(chǔ)的聯(lián)合誘導方案治療年輕初發(fā)急性髓細胞白血病的臨床療效觀察
發(fā)布時間：2018-09-14 13:47
【摘要】：目的：探討不同劑量去甲氧柔紅霉素為基礎(chǔ)的聯(lián)合誘導方案治療年輕初發(fā)急性髓細胞白血病的臨床療效和長期預后。 方法：收集2009年1月至2014年7月期間我院收治的采用IA方案誘導化療的年輕(55歲)初發(fā)AML的臨床資料,篩選出病例資料完整的病例149例,對患者身高體重、確診時血象、外周血異常細胞數(shù)、免疫分型、染色體等資料進行回顧性分析研究,并用NCCN診療指南進行預后分組,根據(jù)使用去甲氧柔紅霉素(IDA)劑量,將患者分成高標準劑量IA組(10-12mg/m2/d)、低標準劑量IA組(8-9mg/m2/d)和低劑量IA組(8mg/m2/d),比較初次誘導完全緩解率、總完全緩解率等療效指標,比較化療期間血液學及非血液學不良事件,并對2年的OS、EFS、RFS等長期預后指標進行評估。 結(jié)果： 共納入149例年輕(55歲)初發(fā)AML患者,高標準劑量IA組34例,低標準劑量IA組53例,低劑量IA組62例。低標準劑量IA組的一療程CR率(75.5%)、一療程有效率(94.3%)、總CR率(81.1%),均顯著高于低劑量IA組(P0.05)；高標準劑量IA組的一療程CR率(79.4%)、一療程有效率(97.1%)、總CR率(85.3%),也均顯著高于低劑量IA組(P0.05)。亞組分析中顯示,標準劑量IA的優(yōu)勢主要體現(xiàn)在細胞遺傳學中危及NPM1基因突變陰性、FLT3-ITD基因突變陰性的患者中。多因素分析后也證實了標準劑量IA的確在誘導緩解療效上優(yōu)于低劑量IA：低標準劑量IA相比于低劑量IA,總完全緩解的比值比是2.597(95%CI1.010-6.678；p=0.048),高標準劑量IA相比于低劑量IA,總完全緩解的比值比是4.721(95%CI1.495-14.906；p=0.008)。不良反應(yīng)方面,除化療期間白細胞最低值存在顯著差異外,其余均無明顯差異,兩組早期死亡病例數(shù)也相當。生存預后方面,低標準劑量IA組在OS上顯著優(yōu)于低劑量IA(p=0.030),而且高標準劑量IA組與低劑量IA組相比,OS也有改善的趨勢,但未達到統(tǒng)計學差異(p=0.054)；而低標準劑量IA組與高標準劑量IA組在OS上無明顯統(tǒng)計學差異(p=0.888)。其余EFS及RFS等預后指標上,三組間無統(tǒng)計學差異。結(jié)論： 對于年輕(55歲)初發(fā)急性髓細胞白血病患者,標準劑量去甲氧柔紅霉素方案化療可以顯著提高患者誘導緩解率。年輕AML患者可很好的耐受標準劑量IDA,不同劑量去甲氧柔紅霉素方案在不良反應(yīng)方面相似。高劑量IDA在一定程度上能改善年輕(55歲)AML患者OS,但對EFS、RFS影響不顯著。
[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.
【學位授予單位】：浙江大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R733.71
本文編號：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.
【學位授予單位】：浙江大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R733.71
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